A Pilot Study of Immunotherapy Including Haploidentical NK Cell Infusion Following CD133+ Positively-Selected Autologous Hematopoietic Stem Cells in Children With High Risk Solid Tumors or Lymphomas

This is a pilot clinical trial investigating the addition of haploidentical natural killer cell infusion to autologous stem cell transplantation. This intervention will be evaluated in children with high-risk solid tumors for whom autologous transplantation is indicated. Natural killer cells from a haploidentical family member will be given after high dose chemotherapy and positively selected autologous stem cells. In patients with neuroblastoma, the anti-GD2 antibody hu14.18K322A will also be given. The effect on normal hematopoietic cell recovery will be evaluated and survival of children treated with this approach will be determined.
The investigators expect to enroll 36 participants. Haploidentical family members (donors) will also be recruited to provide natural killer cells.

Start Date10 Oct 2014

Sponsor / Collaborator

St. Jude Children's Research Hospital, Inc.

NCT01857934

/ Active, not recruitingPhase 2IIT

Neuroblastoma Protocol 2012: Therapy for Children With Advanced Stage High-Risk Neuroblastoma

Neuroblastoma is the most common extracranial solid tumor in childhood, with nearly 50% of patients presenting with widespread metastatic disease. The current treatment for this group of high-risk patients includes intensive multi-agent chemotherapy (induction) followed by myeloablative therapy with stem-cell rescue (consolidation) and then treatment of minimal residual disease (MRD) with isotretinoin. Recently a new standard of care was established by enhancing the treatment of MRD with the addition of a monoclonal antibody (ch14.18) which targets a tumor-associated antigen, the disialoganglioside GD2, which is uniformly expressed by neuroblasts. Despite improvement in 2-year event-free survival (EFS) of 20%, more than one-third of children with high-risk neuroblastoma (HR defined in) still cannot be cured by this approach. Therefore, novel therapeutic approaches are needed for this subset of patients. This study will be a pilot Phase II study of a unique anti-disialoganglioside (anti-GD2) monoclonal antibody (mAb) called hu14.18K322A, given with induction chemotherapy.
PRIMARY OBJECTIVE:
* To study the efficacy [response: complete remission + partial remission (CR+PR)] to two initial courses of cyclophosphamide and topotecan combined with hu14.18K322A (4 doses/course followed by GM-CSF) in previously untreated children with high-risk neuroblastoma.
* To estimate the event-free survival of patients with newly diagnosed high-risk neuroblastoma treated with the addition of hu14.18K322A to treatment.
SECONDARY OBJECTIVES:
* To study the feasibility of delivering hu14.18K322A to 6 cycles induction chemotherapy and describe the antitumor activity (CR+PR) of this 6 course induction therapy.
* To estimate local control and pattern of failure associated with focal intensity modulated or proton beam radiation therapy dose delivery in high-risk abdominal neuroblastoma.
* To describe the tolerability of four doses of hu14.18K322A with allogeneic natural killer (NK) cells from an acceptable parent, in the immediate post-transplant period [day +2 - +5 after peripheral blood stem cell (PBSC) infusion] in consenting participants.
* To describe the tolerability of hu14.18K322A with interleukin-2 and GM-CSF as treatment for minimal residual disease (MRD).

Start Date05 Jul 2013

Sponsor / Collaborator

St. Jude Children's Research Hospital, Inc.

[+2]

NCT01576692

/ CompletedPhase 1IIT

A Safety/Feasibility Trial of the Addition of the Humanized Anti-GD2 Antibody (hu14.18K322A) With and Without Natural Killer Cells to Chemotherapy in Children and Adolescents With Recurrent/Refractory Neuroblastoma

This is a safety / feasibility trial evaluating the combination of a humanized anti-GD2 antibody (HU14.18K322A) manufactured at the Children's GMP, LLC at St. Jude with allogeneic natural killer (NK) cells and standard chemotherapy in children with relapsed or refractory neuroblastoma.

Start Date01 Apr 2012

Sponsor / Collaborator

St. Jude Children's Research Hospital, Inc.

[+1]

100 Clinical Results associated with Hu14.18K322A

100 Translational Medicine associated with Hu14.18K322A

100 Patents (Medical) associated with Hu14.18K322A

Literatures (Medical) associated with Hu14.18K322A

01 Sep 2024·Radiotherapy and Oncology

Patterns of recurrence after radiotherapy for high-risk neuroblastoma: Implications for radiation dose and field

Article

Author: Shaaban, Sherif G ; Bagatell, Rochelle ; Liu, Kevin X ; Yock, Torunn I ; Friedmann, Alison M ; Chen, Jie Jane ; Braunstein, Steve E ; Shusterman, Suzanne ; Catalano, Paul J ; Vo, Kieuhoa T ; Ioakeim-Ioannidou, Myrsini ; Diller, Lisa R ; Marcus, Karen J ; Hill-Kayser, Christine E ; Dusenbery, Kathryn E ; Elhalawani, Hesham ; Haas-Kogan, Daphne A ; DuBois, Steven G ; Lerman, Benjamin J ; MacDonald, Shannon M ; Mattei, Peter ; Shamberger, Robert C ; Vu, Lan ; Terezakis, Stephanie A ; Huang, Mary S

BACKGROUNDPrognosis for patients with high-risk neuroblastoma (HR-NBL) is guarded despite aggressive therapy, and few studies have characterized outcomes after radiotherapy in relation to radiation treatment fields.METHODSMulti-institutional retrospective cohort of 293 patients with HR-NBL who received autologous stem cell transplant (ASCT) and EBRT between 1997-2021. LRR was defined as recurrence at the primary site or within one nodal echelon beyond disease present at diagnosis. Follow-up was defined from the end of EBRT. Event-free survival (EFS) and OS were analyzed by Kaplan-Meier method. Cumulative incidence of locoregional progression (CILP) was analyzed using competing risks of distant-only relapse and death with Gray's test.RESULTSMedian follow-up was 7.0 years (range: 0.01-22.4). Five-year CILP, EFS, and OS were 11.9 %, 65.2 %, and 77.5 %, respectively. Of the 31 patients with LRR and imaging review, 15 (48.4 %) had in-field recurrences (>12 Gy), 6 (19.4 %) had marginal failures (≤12 Gy), and 10 (32.3 %) had both in-field and marginal recurrences. No patients receiving total body irradiation (12 Gy) experienced marginal-only failures (p = 0.069). On multivariable analyses, MYCN amplification had higher risk of LRR (HR: 2.42, 95 % CI: 1.06-5.50, p = 0.035) and post-consolidation isotretinoin and anti-GD2 antibody therapy (HR: 0.42, 95 % CI: 0.19-0.94, p = 0.035) had lower risk of LRR.CONCLUSIONSDespite EBRT, LRR remains a contributor to treatment failure in HR-NBL with approximately half of LRRs including a component of marginal failure. Future prospective studies are needed to explore whether radiation fields and doses should be defined based on molecular features such as MYCN amplification, and/or response to chemotherapy.

01 Apr 2024·Journal of American Association for Pediatric Ophthalmology and Strabismus

Bilateral tonic pupils secondary to anti-GD2 antibody therapy for neuroblastoma

Author: Elefant, Daniel ; Gaffar, Majida A ; Edwards, Christopher M ; Isakoff, Michael S

We report the case of a 12-year-old girl with stage 4 neuroblastoma who developed tonic pupils secondary to immunotherapy with dinutuximab, an anti-GD2 antibody, based on the timeline provided by her mother with regard to onset of symptoms. The patient presented with difficulty reading and chronic dilated pupils bilaterally, according to her mother's observations over 6 months prior to presentation. Testing with dilute pilocarpine supported our presumption of tonic pupils.

01 Apr 2024·Pediatric Blood & Cancer

Yoga as a non‐pharmacologic therapy to reduce dinutuximab‐induced pain in patients with neuroblastoma

Article

Author: Bagatell, Rochelle ; Dalton, Kristen ; McGrath, Margaret ; Parisio, Katie N. ; Donnelly, Meghan ; Kulp, Tonia ; Carlowicz, Cecilia ; Li, Yimei ; Heil, Maureen ; Jubelirer, Tracey

AbstractBackgroundAnti‐GD2 antibodies are key components of treatment for high‐risk neuroblastoma; however, they cause neuropathic pain. Yoga therapy may help reduce pain and distress associated with anti‐GD2 therapy.ProcedureChildren 3 years of age or older with neuroblastoma participated in individualized yoga therapy while receiving the anti‐GD2 antibody dinutuximab (DIN). Yoga therapy was deemed feasible if patients participated during 60% or more of DIN admissions. Patients and caregivers assessed pain/distress before and after yoga therapy with a distress thermometer (DT) and Wong‐Baker FACES pain rating scale and completed questionnaires regarding satisfaction with yoga therapy. Therapy was deemed efficacious if there was a ≥1 point pain score change and reduction in distress after yoga.ResultsEighteen patients were enrolled; 52 encounters (admissions for DIN) were evaluable. Ten of 18 were female, three of 18 were Hispanic, and 10/18 were White. Median age at enrollment was 5.5 years (range: 3–11). Yoga therapy was feasible in 39/52 (75%) encounters. Significant reductions in caregiver‐reported pain and distress and reductions in patient‐reported pain and distress after yoga therapy were reported. Twelve of 18 caregivers completed questionnaires: seven agreed/strongly agreed that yoga was valuable, and nine agreed/strongly agreed to continued participation in yoga. Thirty‐four of 36 clinicians reported that they would recommend yoga therapy for other patients receiving DIN.ConclusionsYoga therapy was feasible during DIN therapy and may be effective in reducing DIN‐associated pain and distress. Future studies are needed to evaluate changes in opioid usage with the addition of yoga therapy during anti‐GD2 antibody therapy.

News (Medical) associated with Hu14.18K322A

12 Dec 2024

·www.globenewswire.com

Essential Pharma announces €900 million recapitalisation through a Gyrus Capital Continuation Vehicle led by AlpInvest and new strategic financing from Sixth Street

Essential Pharma announces €900 million recapitalisation through a Gyrus Capital Continuation Vehicle led by AlpInvest and new strategic financing from Sixth Street Provides significant resources to build on diversified portfolio of established and rare disease medicines Egham, UK – 12 December 2024 – Essential Pharma (“Essential” or “the Company”), an international specialty pharma group focused on ensuring that patients have access to low volume, clinically differentiated, niche pharmaceutical products across key therapeutic areas, today announces the completion of a €900 million financing, through a Gyrus Capital single-asset Continuation Vehicle led by AlpInvest, a subsidiary of Carlyle Global Investment Solutions, and a new strategic financing facility with Sixth Street. Essential Pharma was acquired in 2019 by Gyrus Capital, who have supported the transformation of the Company into a global, high-growth specialty pharma group with significant development opportunities. The transaction will enable Essential to deploy additional capital to build on its diversified portfolio and late-stage pipeline across established and rare disease medicines. This will be achieved through its successful acquisition and development strategy under the leadership of CEO, Emma Johnson. This additional capital will support Essential’s mission to ensure access to essential medicines for patients across new and existing markets. Since her appointment in 2023, Emma has driven the Company’s expansion into rare diseases, with the addition of marketed product Colobreathe® and Hu14.18, an immunotherapy in late-stage clinical development for the treatment of high-risk neuroblastoma. Following the transaction, Lee Morley, appointed as Non-Executive Director to the Board in 2023, will assume the role of Chairman of Essential Pharma, succeeding Dr Patrick Vink. Lee has more than 30 years’ experience in the biopharmaceutical industry, with extensive knowledge of commercialisation, pricing, reimbursement and product launch strategy. He was a co-founder and CEO at EUSA Pharma before the company’s €750 million acquisition by Recordati (BIT: REC) in 2022. During his time at EUSA Pharma, he led the company’s transition from specialty pharma to oncology and rare disease, driving sales from €20 million to €150 million. Emma Johnson, CEO of Essential Pharma, commented: “This transaction provides us with substantial additional firepower, strengthening our ability to deliver essential medicines to patients who need them most. By moving into new geographical markets and building on our diversified portfolio and late-stage pipeline across our key therapeutic areas, we can expand our reach to help underserved patient populations across the globe. We are excited to continue our relationship with Gyrus Capital as we execute our strategy to become a leading, global specialty pharma group with a growing rare disease presence, where patient needs are often most acute. As we transition to our new ownership, I’d also like to thank Patrick for his significant contributions as Chairman and welcome Lee as he steps into the role.” Dr Robert Watson, Managing Partner at Gyrus Capital, said: “This is a landmark investment for Essential and for Gyrus Capital. We are delighted to partner with AlpInvest, Stepstone, Sixth Street and other significant private capital institutions, who believe in our shared vision of building an exceptional specialty pharma company, and bringing critical medical products to patients across the globe.” Sixth Street, a leading global investment firm with deep experience supporting biotech companies across all stages of growth, is providing a new strategic financing facility consisting of €300 million in structured equity and growth debt. Jeff Pootoolal, Partner at Sixth Street who will join the board of Essential Pharma, said: “Essential Pharma has assembled a leading team and platform in its pursuit of providing patients around the world with critical medicines. We are excited to support Emma and Essential’s leadership as they continue to execute and expand on their mission.” About Essential Pharma Essential Pharma is an international specialty pharmaceutical group dedicated to maintaining access to clinically differentiated, niche, branded medicines across multiple therapeutic areas. The group has been an important and valued partner to healthcare providers for over 20 years by giving underserved patient populations access to medicines that otherwise might not be available, and addressing clinical unmet needs. Essential Pharma operates globally in more than 70 countries, supplying a portfolio of products with a focus on the central nervous system (CNS), gastroenterology, ophthalmology, and rare disease. The group’s growth strategy is centred on portfolio optimisation and a targeted M&A approach to acquire commercial and late-clinical stage assets in the four therapeutic areas of focus. It is a trusted partner to multiple pharma companies of all sizes, with a proven history of integrating assets and managing complex technology transfers seamlessly while ensuring continuous supply to patients. For more information, please visit essentialpharmagroup.com About Gyrus Capital Gyrus Capital is a European investment firm dedicated to transformational investments in the healthcare and sustainability sectors. Based in Geneva, Switzerland, Gyrus invests in businesses that address the structural needs of society and the environment and are positioned for long-term sustainable growth. The firm focuses on complex transactions, particularly corporate carve-outs in the €50 million to €500 million range. A renowned group of experienced partners and industry experts supports Gyrus’s active investment and value-creation approach, working closely with entrepreneurs and managers. To learn more, please visit www.gyruscapital.com About Sixth Street Sixth Street is a global investment firm with over $80 billion in assets under management and committed capital. Sixth Street uses its long-term flexible capital, data-enabled capabilities, and One Team culture to develop themes and offer solutions to companies across all stages of growth. Sixth Street Healthcare and Life Sciences finances the development and commercialization of innovative therapeutics and invests in healthcare technology companies across all stages of growth. Investments in the sector include Apellis Pharmaceuticals, Arrowhead Pharmaceuticals, Arsenal Biosciences, Biohaven, Blueprint Medicines, Caris Life Sciences, Chroma Medicine, ConcertAI, Datavant, Immunogen, Ironwood, and Mammoth Biosciences, among many others. Founded in 2009, Sixth Street has more than 650 team members including over 250 investment professionals operating around the world. For more information, visit www.sixthstreet.com, or follow Sixth Street on LinkedIn. CONTACTS Essential Pharma Emma Johnson, CEO Tel: +44(0)1784 477 167 Email: info@essentialpharmaceuticals.com ICR Healthcare Tracy Cheung/Sukaina Virji/Isabelle Abdou Tel: +44 (0) 20 3709 5700 Email: Essentialpharma@icrhealthcare.com

Executive ChangeAcquisition

12 Jun 2024

·www.globenewswire.com

Essential Pharma reaches agreement with AGC Biologics for late phase clinical manufacturing of its immunotherapy candidate for the treatment of high-risk neuroblastoma

Essential Pharma reaches agreement with AGC Biologics for late phase clinical manufacturing of its immunotherapy candidate for the treatment of high-risk neuroblastoma 11 June, 2024 – Essential Pharma, an international specialty pharma group focused on ensuring that patients have sustainable access to low volume, clinically differentiated, niche pharmaceutical products across key therapeutic areas, today announced its rare disease business has signed a strategic agreement with AGC Biologics. As a leading global biopharmaceutical contract development and manufacturing organisation (CDMO), AGC Biologics will produce Hu1418K322A (Hu14.18), a humanised monoclonal antibody being developed for Essential Pharma for the treatment of high-risk neuroblastoma (HRNB). Under the agreement, AGC Biologics will support the process development, scale-up and manufacturing as Essential Pharma plans to commence clinical activities and ongoing regulatory agency interactions over the coming months. Simon Ball, Vice President of the rare disease business at Essential Pharma, commented: "This partnership is a tremendous milestone in the development of Hu14.18 and its path to commercialization. The prospect of building an inventory of Hu14.18 is very exciting. Ahead of us is a period of intense regulatory agency interaction, which will take place alongside late-stage clinical development, and we are a step closer to providing this high-potential antibody to a patient group that is desperately in need of more optimal treatments and better outcomes.” "AGC Biologics is a global leader in contract antibody development and manufacturing,” stated Emma Johnson, CEO of Essential Pharma. “This partnership will help us to accelerate the late-stage development of Hu14.18, which shows therapeutic promise for high-risk neuroblastoma patients, the majority of whom are young children. We look forward to working closely with AGC to deliver this potentially transformative therapy in an area of significant unmet need.” Christoph Winterhalter, CBO at AGC Biologics, said: “We are very pleased that Essential Pharma has chosen us to manufacture this innovative therapy. Our Copenhagen site has the expertise and experience in therapeutic antibodies to accelerate the late-stage development and manufacturing of Hu14.18. We look forward to partnering with Essential Pharma and working together to ensure the product meets the high level of quality, yield and all data packages needed to successfully master future clinical trials and regulatory agency submissions to supply patients across the globe with this life-saving product.” Essential Pharma acquired Renaissance Pharma in April 2024 and is now responsible for the development of Hu14.18. A Phase II trial incorporating Hu14.18 into first-line therapy, and additionally within post-consolidation therapy for HRNB patients, demonstrated positive patient outcomes with 3-year event-free survival (EFS) of 73.7% and overall survival (OS) of 86.0%. Data from this study were published in the Journal of Clinical Oncology in December 2021 and are approaching five-year OS readouts.1 Essential Pharma is an international specialty pharmaceutical group dedicated to maintaining access to clinically differentiated, niche medicines in small patient populations. The group has been an important and valued partner to healthcare providers for over 20 years by giving underserved patient populations access to medicines that otherwise might not be available, and addressing clinical unmet needs. Essential Pharma operates globally in more than 70 countries, supplying a portfolio of products with a focus on the central nervous system (CNS), gastroenterology, ophthalmology, and rare disease. The group’s growth strategy is centred on portfolio optimisation and a targeted M&A approach to acquire commercial and late-clinical stage assets in the four therapeutic areas of focus. It is a trusted partner to pharma companies of all sizes, with a proven history of integrating assets and managing complex technology transfers seamlessly while ensuring continuous and sustainable supply to patients. Essential Pharma is backed by Gyrus Capital, an investment firm dedicated to transformational investments in sectors with long-term sustainable growth, including healthcare. AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 Team Members worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is a part of AGC Inc.’s Life Science Company. The Life Science company runs ten different facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit www.agcbio.com. 1 Furman WL, McCarville B, Shulkin BL, Davidoff A, Krasin M, Hsu CW, et al. Improved Outcome in Children With Newly Diagnosed High-Risk Neuroblastoma Treated With Chemoimmunotherapy: Updated Results of a Phase II Study Using hu14.18K322A. Journal of Clinical Oncology [Internet]. 2022 Feb 1;40(4):335–44. Available from: http://dx.doi.org/10.1200/jco.21.01375 The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultImmunotherapy

18 Apr 2024

·www.pharmaceutical-technology.com

Essential Pharma acquires Reminyl from Janssen Pharmaceutica

Reminyl is intended to treat mild to moderately severe dementia of the Alzheimer type. Credit: Hryshchyshen Serhii / Shutterstock.com. Speciality pharmaceutical group Essential Pharma has concluded the acquisition of Reminyl oral capsules from Johnson & Johnson company Janssen Pharmaceutica. The strategic move enhances Essential Pharma’s portfolio of central nervous system (CNS) medicines and expands its global footprint, particularly in Asia-Pacific. A cholinesterase inhibitor, Reminyl is an established CNS drug for mild to moderately severe dementia of the Alzheimer type. Essential Pharma will now hold rights to Reminyl in the European Economic Area, South Korea, Thailand and all other existing markets for this product. The deal excludes the UK and Ireland, Japan and Latin America. See Also: Inaticabtagene autoleucel by Juventas Cell Therapy for Acquired (Autoimmune) Hemolytic Anemia: Likelihood of Approval Ulixacaltamide hydrochloride by Praxis Precision Medicines for Essential Tremor: Likelihood of Approval The acquisition aligns with Essential Pharma’s focus on CNS, gastroenterology, ophthalmology and rare diseases. Essential operates in more than 70 countries and is supported by healthcare investment firm Gyrus Capital. Essential CEO Emma Johnson stated: “Our acquisition of rights to Reminyl in these markets will ensure Alzheimer’s patients and caregivers in those regions have continued access to this vital medicine. “The acquisition represents a significant and synergistic addition to our concentrated portfolio of CNS products, further expanding our global presence and solidifying our position as a leading speciality pharma group.” The latest development comes after Essential Pharma acquired clinical-stage pharmaceutical company Renaissance Pharma for an undisclosed sum in April 2024. Renaissance develops treatments for paediatric rare diseases, with its lead asset, Hu14.18K322A, currently being analysed in a Phase II clinical trial to treat high-risk neuroblastoma.

Phase 2Cell TherapyAcquisitionPhase 1

100 Deals associated with Hu14.18K322A

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
High Risk Neuroblastoma	Phase 2	United States	St. Jude Children's Research Hospital, Inc.	05 Jul 2013
Lymphoma	Discovery	United States	St. Jude Children's Research Hospital, Inc.	10 Oct 2014
Ewing Sarcoma	Discovery	United States	St. Jude Children's Research Hospital, Inc.	08 Oct 2008
Melanoma	Discovery	United States	St. Jude Children's Research Hospital, Inc.	08 Oct 2008
Metastatic osteosarcoma	Discovery	United States	St. Jude Children's Research Hospital, Inc.	08 Oct 2008

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01857934 (CTgov)	Phase 2	Neuroblastoma \| High Risk Neuroblastoma	153	hu14.18K322A (NB2012 Therapy (Including Induction, Consolidation, and MRD) Antibody (hu14.18K322A))	bazdfcuatj(tgeqnfvwaw) = rymzvjxxio wmqtmuqttd (piefdzkmkq, raaajhrkho - esubkhzdiy)	-	24 Feb 2023
NCT01857934 (CTgov)	Phase 2	Neuroblastoma \| High Risk Neuroblastoma	153	NB2012+hu14.18K322A (NB2012 Therapy (Including Induction, Consolidation, and MRD) Plus Antibody (hu14.18K322A))	(didskbvmtt) = kjgwwvpiqy ubjncqtefn (jkajezjocy, ryusddeyrh - xoecqdvzmo) View more	-	24 Feb 2023
NCT01857934 (Pubmed \| J Clin Oncol)	Phase 2	High Risk Neuroblastoma	-	hu14.18K322A	njbztstufe(qheozimcvt) = eatuyiwurb xsoqbubtwf (jpdrvnnnhn, 60.0 - 83.4) View more	Positive	01 Feb 2022
NCT01857934 (Pubmed \| Clin Cancer Res) Manual	Phase 2	Neuroblastoma First line	42	Chemotherapy+hu14.18K322A	(yonoktdhvq) = rrvhcaqore hfxiaqdicy (ircewybmys, 70.9 - 93.3) View more	Positive	01 Nov 2019
SITC2017	Phase 1	anti-therapeutic antibodies	38	hu14.18K322A	bftuuwuzpi(jhploloqhe) = dcbrjcaalh tunupqlgig (lkqafmyecl )	Positive	07 Nov 2017
NCT01576692 (Pubmed \| Clin Cancer Res) Manual	Phase 1	Neuroblastoma recurrent \| Refractory Neuroblastoma	13	Chemotherapy+hu14.18K322A+NK cells	(asexqkmjgw) = One patient developed an unacceptable toxicity (grade 4 thrombocytopenia >35 days). Four patients discontinued treatment for adverse events (hu14.18K322A allergic reaction, viral infection, surgical death, second malignancy). Common toxicities included grade 3/4 myelosuppression (13/13 patients) and grade 1/2 pain (13/13 patients). vbuidmujyk (tuwojgjwgj )	Positive	01 Nov 2017

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