CD16a modulators(Low affinity immunoglobulin gamma Fc region receptor III-A modulators), CD30 modulators(Tumor necrosis factor receptor superfamily member 8 modulators)

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases+ [1]

Active Indication

B-cell lymphoma recurrentB-cell lymphoma refractoryCD30 positive Non-Hodgkin Lymphoma+ [6]

Inactive Indication

CD-30 positive LymphomaCD-30 positive Peripheral T-Cell LymphomaCD30-Positive recurrent or refractory Cutaneous T-Cell Lymphoma+ [5]

Originator Organization

The University of Texas MD Anderson Cancer Center

Active Organization

The University of Texas MD Anderson Cancer Center

Inactive Organization

Affimed GmbH

Columbia University

License Organization

Artiva Biotherapeutics, Inc.

Affimed NV

Washington University School of Medicine

+ [1]

Drug Highest PhasePhase 1/2

First Approval Date-

RegulationRegenerative Medicine Advanced Therapy (United States)

Structure/Sequence

Sequence Code 1191632852

Source: *****

Clinical Trials associated with Acimtamig

NCT05883449

/ TerminatedPhase 2

A Phase 2, Open-Label, Multi-Center Study of Innate Cell Engager AFM13 in Combination With Allogeneic Natural Killer Cells (AB-101) in Subjects With Recurrent or Refractory Hodgkin Lymphoma and CD-30 Positive Peripheral T-Cell Lymphoma

AFM13-203 is a phase 2, open-label, multi-center, multi-cohort study with a safety run-in followed by expansion cohorts. The study is evaluating the safety and efficacy of AFM13 in combination with AB-101 in subjects with R/R classical HL and CD30-positive PTCL.

Start Date10 Oct 2023

Sponsor / Collaborator

Affimed GmbH

[+1]

NCT04074746

/ CompletedPhase 1/2IIT

Bispecific NK Engager AFM13 Combined With NK Cells for Patients With Recurrent of Refractory CD30 Positive Hodgkin or Non-Hodgkin Lymphomas

This phase I/II trial studies the side effects and best dose of modified umbilical cord blood immune cells (natural killer [NK] cells) combined with the antibody AFM13 (AFM13-NK) and AFM13 alone in treating patients with CD30 positive Hodgkin lymphoma or non-Hodgkin lymphoma that has come back (recurrent) or does not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as AFM13, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Giving AFM13 loaded with NK cells followed by AFM13 alone may kill more cancer cells and decrease cancer growth in patients with CD30 positive AFM13-NK Hodgkin and Non-Hodgkin lymphomas.

Start Date18 Jul 2020

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

NCT04101331

/ CompletedPhase 2

A Phase II Open-label Multicenter Study to Assess the Efficacy and Safety of AFM13 in Patients With Relapsed or Refractory CD30-positive Peripheral T-cell Lymphoma or Transformed Mycosis Fungoides (REDIRECT)

This is a phase II study to evaluate the antitumor activity and safety of AFM13 given as monotherapy in patients with CD30-positive T-cell lymphoma. The investigational medicinal product AFM13 is a tetravalent bispecific chimeric (anti-human CD30 x anti-human CD16A) recombinant antibody construct which is being developed to treat CD30-positive malignancies.
Patients who suffer from peripheral T-cell lymphoma or transformed mycosis fungoides, whose tumor expresses the surface marker CD30, and who have relapsed after an earlier treatment or have refractory disease will be enrolled into this study if all of the study entry criteria are fulfilled. Dependent on their disease type and the magnitude of CD30 expression, study participants will be assigned to one of 3 study cohorts, each cohort receiving the same treatment of weekly AFM13 infusions (a 200mg dose per infusion).
The main goal of the study is to assess the efficacy of AFM13 treatment as judged by the rate of overall responses. Further goals are to assess the safety of AFM13 treatment, the immunogenicity of AFM13 (as measured by the potential formation of anti-AFM13 antibodies) and the concentration of AFM13 in the blood.
Approx. 1 month after the last dose of AFM13 there will be a final study visit to assess the patients' health status after therapy, followed by quarterly phone contacts to check on their overall health status and long-term survival.

Start Date13 Nov 2019

Sponsor / Collaborator

Affimed GmbH

100 Clinical Results associated with Acimtamig

100 Translational Medicine associated with Acimtamig

100 Patents (Medical) associated with Acimtamig

Literatures (Medical) associated with Acimtamig

01 Jan 2026·ONCOLOGY RESEARCH

Put the CAR-T before the HRS: Advances in Anti-CD30 Immunotherapy Targeting Hodgkin/Reed-Sternberg Cells in Classical Hodgkin Lymphoma

Review

Author: Dmitrienko, Victoria ; Kharisova, Chulpan ; Mayasin, Yuriy ; Osinnikova, Maria ; Gorodilova, Anna ; Rizvanov, Albert ; Osadchaya, Daria ; Kitaeva, Kristina ; Solovyeva, Valeria

Classical Hodgkin lymphoma (cHL) is characterized by rare Hodgkin/Reed-Sternberg (HRS) tumor cells that uniformly express cluster of differentiation (CD)30 molecules and orchestrate an immunosuppressive tumor microenvironment, making CD30 an attractive and selective therapeutic target. We summarize the biological rationale for CD30 as a therapeutic target and the preclinical and clinical evidence across major platforms: antibody-drug conjugates (brentuximab vedotin), monoclonal antibodies (including acimtamig and its combinations with Natural Killer cells), second- and third-generation chimeric antigen receptor (CAR)-T cells, and alternative modalities. Particular attention is given to standardized response assessment (IWG, Lugano, RECIL criteria), which enables appropriate cross-trial comparisons. Taken together, the data indicate that beyond the established role of brentuximab vedotin, CD30-directed CAR-T cells and bispecific antibodies demonstrate high activity in refractory cHL, especially when used with fludarabine-containing lymphodepletion, combined with programmed cell death 1 (PD-1) receptor blockade as a strategy to eradicate minimal residual disease. Key challenges include durable effector-cell persistence and optimization of sequencing and combinations; notably, loss of CD30 as an escape mechanism appears uncommon. Integrating mechanistic insights into HRS biology with clinical trial data highlights strategies to enhance the efficacy, safety, and accessibility of CD30-directed immunotherapy. This review aims to provide a concise overview of CD30-targeted approaches in cHL, emphasizing therapeutic outcomes and the evolution of CAR-T technologies.

01 Oct 2025·EUROPEAN JOURNAL OF IMMUNOLOGY

CD16A Shedding Regulates Innate Cell Engager‐Induced Serial Killing by Natural Killer Cells

Article

Author: Sandström, Niklas ; Knoch, Julia ; Wagner, Arnika K. ; Fontana, Jacopo ; Breunig, Christian ; Pahl, Jens ; Hussain, Alamdar ; Ross, Patrick ; Kuhnigk, Kyra ; Alici, Evren ; Zambarda, Chiara ; Carannante, Valentina ; Sandoz, Patrick A. ; Koch, Joachim ; Toullec, Damien ; Xu, Shanshan ; Guldevall, Karolin ; Wingert, Susanne ; Pinto, Sheena ; Önfelt, Björn

ABSTRACT:

Natural killer (NK) cells can protect from tumor‐transformed cells using a fine‐tuned machinery of activating and inhibiting receptors. An important activating receptor is Fc gamma receptor IIIa (FcγRIIIA or CD16A), which can trigger antibody‐dependent cellular cytotoxicity (ADCC) when recognizing antibody‐opsonized target cells. One strategy to boost ADCC responses may be achieved by inhibiting activation‐induced shedding of CD16A from the NK cell surface. However, previous preclinical studies have shown contrasting results regarding the effectiveness and limitations of this approach. Here, microchip‐based live cell‐imaging was used to assess the consequences of CD16A shedding inhibition on the dynamics of NK cell cytotoxicity. The bispecific innate cell engager acimtamig (AFM13) was superior to IgG1 monoclonal antibodies in ADCC and in increasing the fraction of cytotoxic NK cells and serial killers. Under conditions where CD16A shedding was inhibited, acimtamig still triggered ADCC; however, the ability to promote serial killing was reduced and associated with impaired NK cell detachment from target cells. These results demonstrate that CD16A shedding represents an intrinsic feature of NK cell biology that is critical to sustain the antitumoral cytotoxicity of NK cells. This has implications for CD16A engineering of NK cell products and their combination with CD16A‐directed NK cell engagers.

01 Jun 2025·NATURE MEDICINE

Allogeneic NK cells with a bispecific innate cell engager in refractory relapsed lymphoma: a phase 1 trial

Article

Author: Ramirez, Alejandro ; Hosing, Chitra ; Shrestha, Rejeena ; Vega, Francisco ; Ahmed, Sairah ; Kaur, Indreshpal ; Banerjee, Pinaki ; Popat, Uday ; Rafei, Hind ; Griffin, Lori ; Iyer, Swaminathan ; Ganesh, Christina ; Kaplan, Mecit ; Li, Ye ; Shpall, Elizabeth J ; Marin, David ; Nieto, Yago ; Alousi, Amin ; Daher, May ; Islam, Sanjida ; Uprety, Nadima ; Silva, Francia Reyes ; Borneo, Zephanie ; Sainz, Tania P ; Bassett, Roland ; Fowlkes, Natalie W ; Ramdial, Jeremy ; Alexis, Karenza ; Emig, Michael ; Harstrick, Andreas ; Rezvani, Katayoun ; Kerbauy, Lucila N ; Basar, Rafet ; Barnett, Melissa ; Qazilbash, Muzaffar ; Overesch, Andre

Outcomes of patients with CD30-positive (CD30⁺) lymphomas have improved with the advent of brentuximab vedotin (BV) and, in Hodgkin lymphoma, anti-PD1 checkpoint inhibitors (CPI). However, there is a need for new therapies for patients with tumors refractory to both BV and CPI, who face dismal outcomes. AFM13-a CD30/CD16A bispecific antibody-activates natural killer (NK) cells to kill CD30⁺ cells. Here we studied cord-blood-derived cytokine-preactivated and expanded NK cells precomplexed with AFM13 (AFM13-NK) in patients with CD30⁺ lymphoma refractory to BV and CPI. The primary endpoint of this phase 1 trial was to establish the safety and recommended phase 2 dose of AFM13-NK followed by intravenous AFM13 infusions. Secondary endpoints included the overall response rate and complete response (CR) rate, event-free survival and overall survival, and persistence of infused AFM13-NK cells. This is the final analysis of this trial; 42 heavily pretreated patients received 2 to 4 cycles of lymphodepletion followed by AFM13-NK cell infusion at 3 dose levels (10⁶, 10⁷ and 10⁸ kg^-1) and 3 weekly AFM13 infusions. No cytokine release syndrome, neurotoxicity or graft-versus-host disease was observed. The highest NK dose was established as the recommended phase 2 dose. Donor NK cells peaked in blood 1 day postinfusion, persisted up to 3 weeks and trafficked to tumor sites. The overall response and CR rates were 92.9% and 66.7%, respectively. At a median follow-up of 20 months, the 2-year event-free and overall survival rates were 26.2% and 76.2%, respectively. Eleven patients (6 with and 5 without consolidation) remained in CR at 14-40 months. This therapy showed encouraging preliminary safety and efficacy. ClinicalTrials.gov Identifier: NCT04074746 .

News (Medical) associated with Acimtamig

29 May 2025

·www.prnewswire.com

John Theurer Cancer Center Presents Innovative Cancer Research at Major Annual Cancer Meeting, Offering New Hope for Patients

Presentations and publications address novel therapeutics, molecular biology studies, and global trends for blood cancers and solid tumors HACKENSACK, N.J., May 29, 2025 /PRNewswire/ -- Investigators from Hackensack Meridian John Theurer Cancer Center (JTCC)—part of the National Cancer Institute-designated Lombardi Comprehensive Cancer Center at Georgetown University—and Hackensack University Medical Center are reporting research findings from 32 studies at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The meeting is the premier event for cancer professionals and takes place in Chicago from May 30 to June 3. "The future of cancer treatment begins with the pioneering exploration being carried out today," notes Andre Goy, MD, chair, vice president, physician-in-chief of oncology, at Hackensack Meridian John Theurer Cancer Center. "We are fortunate to be in a time where many cancers will respond to standard treatments. But for those cancers that don't, it's critical that patients have access to a world-class research program that will yield innovative therapies. At John Theurer Cancer Center, our globally recognized investigators continue to drive the latest oncology advances in cellular therapy, immunotherapy and other areas, enabling improved outcomes for patients across the Hackensack Meridian Health network and beyond." Several studies address novel drug combinations for multiple myeloma, as well as racial disparities in treatment outcomes and the expression of key biomarkers. Investigators are also presenting data on emerging immunotherapies for leukemia and lymphoma, molecular markers predicting disease relapse, and innovative treatment regimens such as all-oral therapies for acute myeloid leukemia. Solid tumor studies focus on disparities in gastric cancer, machine learning applications for breast cancer metastasis, and promising antibody-drug conjugates for lung cancer. Investigations related to melanoma and skin cancer examine circulating tumor DNA as a marker for disease progression, comparative survival analyses based on biomarkers, and the identification of targetable mutations across different skin cancer types. These findings underscore the breadth of ongoing efforts at John Theurer Cancer Center—New Jersey's largest cancer center—to refine therapeutic strategies, enhance precision oncology, and improve patient outcomes. Multiple Myeloma Research Carfilzomib, iberdomide, and dexamethasone in patients with transplant-eligible newly diagnosed multiple myeloma: Updated results from phase 1/2 study Updated results from phase 2b study of selinexor in combination with carfilzomib, daratumumab, or pomalidomide in patients with multiple myeloma relapsing on current therapy Real-world outcomes of patients with multiple myeloma treated with T-cell engagers compared to those treated on clinical trials Impact of racial disparities on efficacy and safety outcomes for patients with relapsing/refractory multiple myeloma receiving T-cell engagers Heterogeneity in the expression of GPRC5D between patients with multiple myeloma Evaluation of immune checkpoint inhibitors and concurrent radiation therapy for the treatment of extramedullary multiple myeloma Global burden of multiple myeloma: Analysis from 1980 to 2021 Efficacy and safety of less frequent dosing with elranatamab in patients with relapsed or refractory multiple myeloma: A US subgroup analysis from MagnetisMM-3 Leukemia and Lymphoma Peripheral blood cell-free DNA testing as a predictor for relapse post-allogeneic stem cell transplant for acute myeloid leukemia An all-oral regimen of decitabine-cedazuridine plus venetoclax in patients with newly diagnosed acute myeloid leukemia ineligible for intensive induction chemotherapy: Results from a phase 2 cohort of 101 pts Employing novel pan-cancer targets for immunotherapy in leukemias and solid tumors MRD negativity after end of induction in the phase 3 PhALLCON trial: A post hoc analysis Results from the completed dose-finding part of phase 2 study of the innate cell engager acimtamig (AFM13) in combination with AlloNK (AB-101) in relapsed or refractory classical Hodgkin lymphoma (LuminICE-203) Novel analysis of 3-y results from the pivotal EPCORE NHL-1 study: Outcomes in patients with relapsed/refractory large B-cell lymphoma and complete response at 2 years with epcoritamab monotherapy TITANium: An open-label, global multicenter phase 1/2 study of AZD5492, a first-in-class subcutaneous CD8-guided tri-specific T-cell engager, in patients with relapsed or refractory B-cell malignancies Solid Tumor Research Limited changes in the central nervous system immune microenvironment in patients with breast cancer metastasis and capturing these changes using machine learning Relationship between FOLR1 expression and pan-cancer subgroup of tumors with specific transcriptomic profile Disparities and trends in gastric cancer: Incidence, mortality, and stage-specific trends Prevalence of the HPV, EBV, and TTV viral RNA in the plasma of patients with solid and hematologic neoplasms and the detection of a specific immune signature Global trends in soft tissue and extraosseous sarcomas (1980–2021): Regional and economic disparities ZL-1310, a DLL3 antibody-drug conjugate, in patients with extensive stage small cell lung cancer: Phase 1 trial update Ongoing phase 1/2 trial of the hematopoietic progenitor kinase 1 (HPK1) inhibitor NDI-101150 as monotherapy or in combination with pembrolizumab: Clinical safety and efficacy update in clear cell renal cell carcinoma Ipilimumab and nivolumab in patients with metastatic clear cell renal cell carcinoma treated on the phase 3 PDIGREE (Alliance A031704) trial: Results from Step 1 analysis Initial safety and efficacy results from a first-in-human, phase 1/2 study of SAR445877, an anti-PD-1/IL-15 fusion protein, for patients with advanced solid tumors An open-label, phase I trial of the SIRPα monoclonal antibody, BI 770371, alone and in combination with the PD-1 inhibitor ezabenlimab in patients with advanced solid tumors A phase 1 dose escalation and dose expansion study for LNCB74, a B7-H4 targeted antibody drug conjugate, as monotherapy in participants with advanced solid tumors A phase 1, open-label, multi-center study of the safety, tolerability, and efficacy of IPH4502 as a single agent in advanced solid tumors A phase 2 safety and efficacy study of PRT3789 in combination with pembrolizumab in patients with advanced or metastatic solid tumors and a SMARCA4 mutation Phase 3, randomized, placebo-controlled clinical trial of CAN-2409+prodrug in combination with standard of care external beam radiation (EBRT) for newly diagnosed localized prostate cancer Melanoma and Other Skin Cancers Comparison of ctDNA and hematologic ratios as markers of disease progression in early versus late-stage melanoma: A single-center retrospective study Survival analysis based on markers of progression in melanoma: A single-center comparison of survival in patients with high vs low biomarkers Targetable mutations in cutaneous skin cancers: A comparative study across melanoma, squamous cell carcinoma, basal cell carcinoma, and Merkel cell carcinoma SOURCE Hackensack Meridian John Theurer Cancer Center WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 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ASCOClinical ResultImmunotherapyPhase 1Phase 2

23 Apr 2025

·www.globenewswire.com

Affimed Announces Acceptance of Three Abstracts for Presentation at the American Society for Clinical Oncology Annual Meeting

MANNHEIM, Germany, April 23, 2025 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed”, or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced an abstract on the phase 2 LuminICE-203 study of its innate cell engager (ICE®) acimtamig in combination with AlloNK® (AB-101) has been accepted for an oral presentation at the Annual Meeting of the American Society for Clinical Oncology (ASCO) taking place May 30 – June 3, 2025 in Chicago, Illinois. In addition, two abstracts on AFM24 in combination with atezolizumab in non-small cell lung cancer (NSCLC) have been accepted as poster presentations. Details of the acimtamig oral presentation and AFM24 poster presentations are as follows: Abstract Title & NumberDate & Time Session Type & TitleResults from the completed dose-finding part of a phase 2 study of the innate cell engager acimtamig (AFM13) in combination with AlloNK (AB-101) in relapsed or refractory classical Hodgkin lymphoma (LuminICE-203)Abstract Number for Publication: 7008May 30, 20252:45 PM-5:45 PM CDTOral Abstract Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic LeukemiaBispecific innate cell engager (ICE) AFM24 in combination with atezolizumab in patients with advanced/metastatic EGFR-expressing non-small cell lung cancer (NSCLC) without driver mutations: Initial results from a phase 2a studyAbstract Number for Publication: 2609June 2, 20251:30 PM-4:30 PM CDTPoster Session – Developmental Therapeutics—ImmunotherapyPoster Board: 256Combination of bispecific innate cell engager (ICE) AFM24 with atezolizumab in patients with advanced/metastatic non-small cell lung cancer (NSCLC) with EGFR kinase domain mutations (EGFRmut): Initial results from a phase 2a studyAbstract Number for Publication: 2610 June 2, 20251:30 PM-4:30 PM CDTPoster Session – Developmental Therapeutics—ImmunotherapyPoster Board: 257 The full abstracts will be published online on May 22, 2025. More details about the programs for the 2025 ASCO Annual Meeting are available online at Attend | ASCO Annual Meeting. About Affimed N.V. Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer by actualizing the untapped potential of the innate immune system. The Company’s innate cell engagers (ICE®) enable a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors. ICE® are generated on the Company’s proprietary ROCK® platform which predictably generates customized molecules that leverage the power of innate immune cells to destroy tumor cells. A number of ICE® molecules are in clinical development, being studied as mono- or combination therapy. Headquartered in Mannheim, Germany, Affimed is led by an experienced team of biotechnology and pharmaceutical leaders united by the bold vision to stop cancer from ever derailing patients’ lives. For more about the Company’s people, pipeline and partners, please visit: www.affimed.com. Investor Relations Contact Alexander FudukidisDirector, Investor RelationsE-Mail: a.fudukidis@affimed.comTel.: +1 (917) 436-8102 Media Contact Mary Beth Sandin Vice President, Marketing and CommunicationsE-Mail: m.sandin@affimed.com

Phase 2ImmunotherapyASCOClinical Result

09 Dec 2024

·www.globenewswire.com

Affimed Announces Acimtamig and AlloNK® Combination Granted Regenerative Medicine Advanced Therapy (RMAT) Designation by the U.S. Food and Drug Administration (FDA)

Designation was based on early efficacy data demonstrating an 83.3% (10/12) overall response rate and a 50% (6/12) complete response rate, with a well-managed safety profile in Relapsed/Refractory Hodgkin Lymphoma patients Dec. 05, 2024 -- Affimed N.V. (Nasdaq: AFMD) (“Affimed”, or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced that the U.S. FDA has granted RMAT designation to the combination therapy of Affimed’s innate cell engager (ICE®) acimtamig and Artiva Biotherapeutic’s AlloNK® (AB101) for the treatment of relapsed or refractory Hodgkin Lymphoma (R/R HL). The combination is being evaluated in the on-going LuminICE-203 multicenter, multi-cohort phase 2 trial. RMAT designation is intended to expedite the development and review of regenerative medicine therapies, including cell therapies, that aim to address serious or life-threatening conditions. RMAT designation provides the same expedited review benefits as a Breakthrough Therapy Designation, but is exclusively focused on regenerative medicine products. This designation provides Affimed enhanced access to FDA resources including the potential for accelerated approval and priority review. These benefits could significantly reduce the time required to deliver the acimtamig and AlloNK® combination to R/R HL patients in need. “This is an important regulatory milestone demonstrating that the FDA acknowledges the critical need for new therapies in R/R HL, in particular for double refractory HL patients where there are no approved therapies,” said Dr. Shawn M. Leland, PharmD, RPh, Chief Executive Officer of Affimed. “In addition, the RMAT designation validates the strength of our growing clinical data and the promise of our innovative treatment to bring hope to patients battling this rare and difficult-to-treat cancer.” Earlier this year, Affimed reported promising early efficacy data from cohorts 1 and 2 (12 patients) of the LuminICE-203 trial. The data showed an overall response rate (ORR) of 83.3% (10/12) and a complete response rate (CRR) of 50% (6/12), with a well-managed safety profile. Data from all four cohorts of the run-in phase of the LuminICE-203 trial will be featured in a poster session at the 66th ASH Annual Meeting and Exposition on December 8, 2024. This promising combination has applicability not only in HL, but also in other CD30 positive lymphomas such as peripheral T-cell lymphoma (PTCL), which can also be resistant to conventional therapies, has a high risk of relapse, and where few products are approved. Generating clinical proof-of-concept in PTCL would also highlight a potential path to increasing the commercial potential of the combination by two to three-fold in comparison to the number of patients with double-refractory HL. Acimtamig (AFM13) is a first-in-class ICE® that uniquely activates the innate immune system to destroy CD30-positive hematologic tumors. Acimtamig induces specific and selective killing of CD30-positive tumor cells, leveraging the power of the innate immune system by engaging and activating natural killer (NK) cells and macrophages. Acimtamig is a tetravalent bispecific innate cell engager designed to act as a bridge between the innate immune cells and the tumor, creating the necessary proximity for the innate immune cells to destroy the tumor cells. LuminICE-203 (AFM13-203) is a Phase 2 open-label, multicenter, multi-cohort study. The trial is evaluating the safety and efficacy of the combination of acimtamig (AFM13) with Artiva Biotherapeutics’ allogeneic NK cell AlloNK® (AB-101) in patients with relapsed/refractory classical Hodgkin lymphoma and CD30-positive peripheral T cell lymphoma (NCT05883449). The study builds on the unprecedented efficacy results from an investigator sponsored study, AFM13-104, which investigated acimtamig in combination with cord blood-derived NK cells in patients with refractory/recurrent CD30-positive Hodgkin or non-Hodgkin lymphoma (NCT04074746). Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer by actualizing the untapped potential of the innate immune system. The Company’s innate cell engagers (ICE®) enable a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors. ICE® are generated on the Company’s proprietary ROCK® platform which predictably generates customized molecules that leverage the power of innate immune cells to destroy tumor cells. A number of ICE® molecules are in clinical development, being studied as mono- or combination therapy. Headquartered in Mannheim, Germany, Affimed is led by an experienced team of biotechnology and pharmaceutical leaders united by the bold vision to stop cancer from ever derailing patients’ lives. For more about the Company’s people, pipeline and partners, please visit: www.affimed.com. The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultImmunotherapyCell Therapy

100 Deals associated with Acimtamig

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
CD-30 positive Peripheral T-Cell Lymphoma	Phase 2	United States	Affimed GmbH	10 Oct 2023
Recurrent Hodgkin Lymphoma	Phase 2	United States	Affimed GmbH	10 Oct 2023
B-cell lymphoma recurrent	Phase 2	United States	The University of Texas MD Anderson Cancer Center	18 Jul 2020
B-cell lymphoma refractory	Phase 2	United States	The University of Texas MD Anderson Cancer Center	18 Jul 2020
CD30 positive Non-Hodgkin Lymphoma	Phase 2	United States	The University of Texas MD Anderson Cancer Center	18 Jul 2020
Peripheral T-cell lymphoma unspecified refractory	Phase 2	United States	The University of Texas MD Anderson Cancer Center	18 Jul 2020
Recurrent Anaplastic Large Cell Lymphoma	Phase 2	United States	The University of Texas MD Anderson Cancer Center	18 Jul 2020
Refractory Classic Hodgkin Lymphoma	Phase 2	United States	The University of Texas MD Anderson Cancer Center	18 Jul 2020
Refractory Systemic Anaplastic Large Cell Lymphoma	Phase 2	United States	The University of Texas MD Anderson Cancer Center	18 Jul 2020
Relapsing classical Hodgkin lymphoma	Phase 2	United States	The University of Texas MD Anderson Cancer Center	18 Jul 2020

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05883449 (LuminICE-203, CTgov)	Phase 2	Refractory Hodgkin Lymphoma \| CD-30 positive Peripheral T-Cell Lymphoma \| Recurrent Hodgkin Lymphoma	25	anti-human CD16A recombinant antibody+AB-101+Fludarabine+Cyclophosphamide+Interleukin-2 (Safety run-in Cohort 1)	dekaauedcy = aljqvnmyhv fkbdycgipr (sdjymtygxa, eeculavldg - irrvfjcozy) View more	-	20 Aug 2025
NCT05883449 (LuminICE-203, CTgov)	Phase 2		25	anti-human CD16A recombinant antibody+AB-101+Fludarabine+Cyclophosphamide+Interleukin-2 (Safety run-in Cohort 2)	dekaauedcy = qrzmddcurb fkbdycgipr (sdjymtygxa, gqwfwwkeua - tixljqbczc) View more	-	20 Aug 2025
NCT05883449 (LuminICE-203, ASCO2025)	Phase 2	Refractory Classic Hodgkin Lymphoma CD30+ \| CD16A	24	Acimtamig 200 mg	gcyvwqyrmg(rsaigftxmj) = sgjudjkjwj dyzofrjyqe (lylqnosnmc ) View more	Positive	30 May 2025
NCT04074746 (Pubmed) Manual	Phase 1	Lymphoma TNFRSF8 Positive	42	AFM13	dzhwnktyjz(qpbylmwzqj) = wvjqwsgmqd ueucfiuctg (ktbgqwwcov ) View more	Positive	04 Apr 2025
NCT05883449 (LuminICE-203, NEWS) Manual	Not Applicable	Refractory Hodgkin Lymphoma	7	acimtamig+AlloNK	wpnydzdqfe(rqbcswqvtz) = nnzwywmtpy vajssumtmo (dwflbnnblr ) View more	Positive	13 Jun 2024
NCT04074746 (ASH2023) Manual	Phase 1/2	CD-30 positive Lymphoma TNFRSF8 Positive	42	Anti-CD30/anti-CD16A antibody (Affimed)+NK	dxzsefrclu(ayyghiiham) = syakvkxlip pvavhwwmhb (ipsytfsszc ) View more	Positive	11 Dec 2023
NCT03192202 (not available, CTgov)	Phase 1/2	CD-30 positive Lymphoma \| Lymphomatoid Papulosis \| Cutaneous lymphoma ... View more	18	AFM13 (Cohort 1)	oubvljcgua = cgwrphjxfw clcmpcoihv (stoxgfnewo, mdjandqafv - wkwfpbjxdf) View more	-	20 Jul 2023
NCT03192202 (not available, CTgov)	Phase 1/2		18	AFM13 (Cohort 2)	oubvljcgua = olzdqqvims clcmpcoihv (stoxgfnewo, vpebqmuuqx - giuksagpfx) View more	-	20 Jul 2023
NCT04101331 (REDIRECT, ICML2023)	Phase 2	Peripheral T-Cell Lymphoma \| Mycosis Fungoides \| CD30-Positive recurrent or refractory Cutaneous T-Cell Lymphoma ... CD30 positive View more	108	AFM13 200 mg	uyincrkdps(uaoawnnyqj) = okjzfgffes slcauxmxmo (skctldhbve ) View more	Positive	09 Jun 2023
NCT04101331 (REDIRECT, EHA2023)	Phase 2	Peripheral T-Cell Lymphoma	108	AFM13	tmelkuwear(vzjgircjft) = dzpezmxmkc hfxcmutucr (ndhuqkeuso ) View more	-	08 Jun 2023
NCT04101331 (REDIRECT, CTgov)	Phase 2	Peripheral T-Cell Lymphoma \| Mycosis Fungoides \| CD30-Positive recurrent or refractory Cutaneous T-Cell Lymphoma ... View more	108	AFM13	wnazihvfwn = vktiktgmcu magajjwtkj (nsxsjisofa, cxvmnfqiyu - eysijnbqfp) View more	-	05 Jun 2023
NCT04101331 (REDIRECT, AACR2023) Manual	Phase 2	CD-30 positive Peripheral T-Cell Lymphoma CD30 Positive	108	AFM13 200 mg	zgoygbilge(rfpesaiaca) = jwkkukhejh knyqukzotf (hdeowmsjkn ) View more	Positive	14 Apr 2023
NCT04101331 (REDIRECT, AACR2023) Manual	Phase 2	CD-30 positive Peripheral T-Cell Lymphoma CD30 Positive	108	AFM13 200 mg (PTCL not-otherwise-specified (PTCL-NOS))	zgoygbilge(rfpesaiaca) = dmepdvvzkz knyqukzotf (hdeowmsjkn )	Positive	14 Apr 2023

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Identify the latest clinical trials across global registries.

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Approval

Accelerate your research with the latest regulatory approval information.

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Regulation

Understand key drug designations in just a few clicks with Synapse.

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Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis