A Phase I Study of B-Cell Maturation Antigen (BCMA)-Specific Chimeric Antigen Receptor T Cells in Combination With JSMD194, a Small Molecule Inhibitor of Gamma Secretase, in Patients With Relapsed or Persistent Multiple Myeloma

This phase I trial determines the side effects and best dose of B-cell maturation antigen (BCMA)-chimeric antigen receptor (CAR) T-cells when combined with gamma-secretase inhibitor LY3039478 (JSMD194), cyclophosphamide, and fludarabine in treating participants with multiple myeloma that that has come back or remains despite treatment. Placing genes added in the laboratory into immune T-cells may make the T-cells recognize BCMA, a protein on the surface of cancer cells. JSMD194 may enhance the killing of cancer cells by increasing the BCMA expression on multiple myeloma cells, making the targeted BCMA CAR-T treatment more effective. JSMD194 also decreases the amount of BCMA found in the circulation (called soluble BCMA) that is not bound to the myeloma cells. JSMD194 can therefore reduce the potential for soluble BCMA to act as a decoy. Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving BCMA CAR T therapy with JSMD194, cyclophosphamide, and fludarabine may work better in treating participants with relapsed or persistent multiple myeloma.

Start Date23 May 2018

Sponsor / Collaborator

Fred Hutchinson Cancer Research Center

[+2]

NCT03436771 / TerminatedNot Applicable

Long-Term Follow-up Protocol for Subjects Treated With a CAR T-Cell Product on a Juno-Sponsored Clinical Trial

This study will provide long-term follow-up for patients who have received treatment with a Juno CAR T-cell product in a Juno-sponsored clinical trial. In this study, patients will be followed for up to 15 years after their last dose of Juno CAR T cells for evaluation of delayed adverse events, presence of persisting CAR T-cell vector sequences, presence of replication-competent retrovirus (RCR) or lentivirus (RCL), and survival.

Start Date19 Feb 2018

Sponsor / Collaborator

Juno Therapeutics, Inc.

NCT03430011 / CompletedPhase 1/2

Protocol H125001: An Open-Label Phase 1/2 Study of JCARH125, BCMA-targeted Chimeric Antigen Receptor (CAR) T Cells, in Subjects With Relapsed or Refractory Multiple Myeloma

This is an open-label, multicenter, Phase 1/2 study to determine the safety and efficacy of JCARH125, a CAR T-cell product that targets B-cell maturation antigen (BCMA), in adult subjects with relapsed and/or refractory multiple myeloma. The study will include a Phase 1 part to determine the recommended dose of JCARH125 in subjects with relapsed and/or refractory multiple myeloma, followed by a Phase 2 part to further evaluate the safety and efficacy of JCARH125 at the recommended dose. The safety and tolerability of JCARH125 in subjects who receive prophylactic treatment with anakinra will be evaluated in a separate Phase 1 cohort. The antitumor activity of JCARH125 in subjects who have been previously treated with BCMA-directed therapy will be evaluated in separate Phase 2a cohorts.

Start Date01 Feb 2018

Sponsor / Collaborator

Juno Therapeutics, Inc.

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12 Sep 2023

·www.biospace.com

CARGO Therapeutics Announces Appointment of Michael Ports, PhD, as Chief Scientific Officer

– Scientific leader with multi-company cell therapy drug development experience spanning early discovery initiatives through late-stage development – SAN MATEO, Calif., Sept. 12, 2023 (GLOBE NEWSWIRE) -- CARGO Therapeutics, Inc. (CARGO), a clinical-stage biotechnology company uniquely positioned to advance next generation, potentially curative cell therapies for cancer patients, today announced the appointment of Michael Ports, PhD, as Chief Scientific Officer. Dr. Ports will be responsible for advancing CARGO's proprietary platform technologies and discovery-stage programs. “I am delighted to welcome Michael, an experienced leader in cell therapy, to CARGO as our Chief Scientific Officer. Michael brings strong scientific leadership and a deep understanding of cell therapy to this role and will be an inspiring thought partner to our research and development teams,” said Gina Chapman, CARGO's President and Chief Executive Officer. “We look forward to partnering with Michael to further progress our platform technologies and pipeline programs to the clinic as we strive to deliver more cures to patients.” “I am pleased to join the exceptional team at CARGO and am inspired by their dedication, scientific excellence and vision. Throughout my career, I have sought opportunities to develop differentiated therapeutics and treatment strategies to significantly improve outcomes for patients,” said Michael Ports, Chief Scientific Officer, CARGO Therapeutics. “I have a passion for bringing new cell therapy options to the clinic, and I am eager to contribute to CARGO’s important work to bring new CAR T-cell therapies to patients.” Prior to joining CARGO, Dr. Ports was the Vice President and Head of Cell Therapy Discovery at Janssen Pharmaceuticals, overseeing the strategy and management of teams to advance both autologous and allogeneic cell therapy development candidates. Before joining Janssen, Dr. Ports held roles of increasing responsibility at Juno Therapeutics (acquired by Celgene Corporation) and Celgene (acquired by Bristol-Myers Squibb) where he served as head of late-stage research. In this role, he led preclinical efforts that enabled two investigational new drug (IND) applications in multiple myeloma for the anti-BCMA CAR T, JCARH125, and five IND/IND amendments and documentation for a BLA filing in support of the anti-CD19 CAR T, Breyanzi®. Breyanzi® is a CAR T-cell therapy approved in the United States and the European Union to treat certain types of lymphoma including large B cell lymphoma (LBCL). Dr. Ports began his industry career at Gilead Sciences where he explored the use of Zydelig® and other small molecules as immuno-oncology agents for use in solid tumors. Dr. Ports was a Postdoctoral Fellow at the Netherlands Cancer Institute and Fred Hutchinson Cancer Research Center. He received his PhD in Cancer Biology from the University of Arizona and his BS in Molecular, Cellular and Developmental Biology from University of California, Santa Barbara. About CARGO Therapeutics CARGO Therapeutics is a clinical-stage biotechnology company uniquely positioned to advance next generation, potentially curative cell therapies for cancer patients. CARGO’s programs, platform technologies, and manufacturing strategy are designed to directly address the limitations of approved cell therapies, including limited durability of effect, safety concerns and unreliable supply. CARGO is currently evaluating its lead program, CRG-022, an autologous CD22 chimeric antigen receptor (CAR) T-cell therapy candidate, in a potentially pivotal Phase 2 clinical trial in patients with large B-cell lymphoma (LBCL) whose disease relapsed or was refractory (R/R) to CD19 CAR T-cell therapy. CARGO also plans to evaluate CRG-022 in patients at earlier stages of disease, including LBCL and other hematologic malignancies. Beyond its lead program, CARGO is leveraging its proprietary cell engineering platform technologies to develop a pipeline of programs that incorporate multiple transgene therapeutic “cargo” designed to enhance CAR T-cell persistence and trafficking to tumor lesions, as well as to help safeguard against tumor resistance and T-cell exhaustion. CARGO’s founders are pioneers and world-class experts in CAR T-cell therapy, and its team has significant experience and success developing, manufacturing, launching and commercializing oncology and cell therapy products. For more information, please visit the CARGO Therapeutics website at . Find more information at cargo-tx.com Follow us on LinkedIn: CARGO Therapeutics Follow us on Twitter: @CARGOTx Media Contact: Maura Gavaghan maura@redhousecomms.com Investor Contact: Laurence Watts laurence@gilmartinir.com

Cell TherapyExecutive ChangePhase 2Immunotherapy

19 May 2021

·www.globenewswire.com

Multiple Myeloma Pipeline Analysis Demonstrates Stunning Growth With A Gamut of Pharma Companies Involved Worldwide

Los Angeles, USA, May 18, 2021 (GLOBE NEWSWIRE) -- Multiple Myeloma Pipeline Analysis Demonstrates Stunning Growth with a Gamut of Pharma Companies Involved Worldwide The Multiple Myeloma pipeline is majorly thriving owing to the several different companies developing novel and sophisticated blockbuster drugs, increasing R&D, increasing global prevalence, better awareness and appropriate diagnosis in patients. DelveInsight’s ‘Multiple Myeloma Pipeline Insights’ report provides a holistic view of the pipeline therapies that are under development in preclinical as well as clinical stages of development, and growth prospects across the Multiple Myeloma domain. Some of the key takeaways from the Multiple Myeloma Pipeline report: Got queries? Want to know more? Request for Sample @ Multiple Myeloma Pipeline Insights Multiple Myeloma is a malignant disorder characterized by uncontrolled proliferation of clonal plasma cells causing a wide variety of complications leading to organ dysfunction and eventually death. It is the second most prevalent hematological malignancy worldwide, with a median onset of 60 years. This incurable malignancy develops from an accumulation of terminally differentiated monoclonal plasma cells (PC) in the bone marrow. Reach out @ Multiple Myeloma Pipeline: Novel therapies and emerging technologies The Multiple Myeloma pipeline report proffers a holistic view of the business opportunities, threats, prospective collaborations and agreements, strong competitors, growth strategies, failed as well as discontinued drugs. Multiple Myeloma Pipeline: Drug Portfolio The report lays down a complete coverage of the therapeutics by development stage, product type, route of administration, molecule type, and MOA type for Multiple Myeloma across the complete product development cycle, including all clinical and non-clinical stages. Multiple Myeloma Therapeutic Assessment By Product Type By Stage By Molecule Type By Route of Administration By Mechanism of Action By Targets By Stage and Route of AdministrationBy Stage and Product Type Scope of the Report Coverage: GlobalKey Players: Kiadis Pharma, CASI Pharmaceuticals, NOXXON Pharma, MorphoSys), Sana Biotechnology, Ayala Pharmaceuticals, Cellectar Biosciences, Bristol-Myers Squibb, Poseida Therapeutics, AbbVie/Genentech, Janssen Research and Development, Nanjing Legend Biotech, Genenta Science, Biotest AG, Teneobio, iCell Gene Therapeutics, Juno Therapeutics, Arch Oncology, Regeneron Pharmaceuticals, Incyte Corporation, NexImmune Inc., Chongqing Precision Biotech, Novartis, CASI Pharmaceuticals, Ionis Pharmaceuticals, AgenTus Therapeutics, Biohaven Pharmaceuticals, CRISPR Therapeutics, Pfizer, GlaxoSmithKline, Seagen Inc., Heidelberg Pharma, Bluebird Bio, C4 Therapeutics, Inc., Hoffmann-La Roche, Phosplatin Therapeutics, Arcellx, Inc., HitGen Inc., Boehringer Ingelheim, I-Mab Biopharma, Celyad Oncology, Amgen and othersKey Multiple Myeloma Pipeline Therapies: TNB-383B, ONC201, AO-176, JCARH125, REGN5458, INCB001158, TAK-573, NEXI-002 T Cells, PHE885, CID-103, ION251, EMB-06, agenT-797, CTX120, PF-06863135, SEA-BCMA, AEVI-007, HDP-101, bb21217, CFT7455, RO7425781, PT-112, HG146, CYAD-211, AMG 701, Nivolumab, ventoclax, RAPA-201 autologous T cells, K NK004, CID 103, NOX-A12, TJ202, APG-2575, AL 102, CLR 131 and others. Reach out @ Multiple Myeloma Pipeline: Novel therapies and emerging technologies Table of Contents Visit to know more of what’s covered @ Multiple Myeloma Emerging Therapies Related Reports Multiple Myeloma MarketDelveInsight’s ‘Multiple Myeloma (MM)-Market Insights, Epidemiology and Market Forecast—2030’ report. Multiple Myeloma Epidemiology ForecastDelveInsight’s ‘Multiple Myeloma (MM)- Epidemiology Forecast to 2030’ report. Car T Cell Therapy For Multiple Myeloma MarketDelveInsight’s ‘CAR T-Cell Therapy for Multiple Myeloma-Market Insights and Market Forecast-2030’ report. Refractory Multiple Myeloma MarketDelveInsight's "Refractory Multiple Myeloma - Market Insights, Epidemiology, and Market Forecast-2030" report. Relapsed Refractory Multiple Myeloma MarketDelveInsight's "Relapsed/Refractory Multiple Myeloma (RRMM) - Market Insights, Epidemiology, and Market Forecast-2030" report. Triple Refractory Multiple Myeloma MarketDelveInsight's "Triple-refractory Multiple Myeloma - Market Insights, Epidemiology, and Market Forecast-2030" report. Higher Risk Chronic Myelomonocytic Leukemia MarketDelveInsight's "Higher-Risk Chronic Myelomonocytic Leukemia Market Insights, Epidemiology, and Market Forecast-2030" report. Related Posts Multiple Myeloma Market Insights Multiple Myeloma Therapies MarketRare Cancer Market Outlook About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing end-to-end comprehensive solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. For more insights, visit Pharma, Healthcare, and Biotech News

Small molecular drugCell TherapyCollaborate

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Multiple Myeloma	Phase 2	US	Juno Therapeutics, Inc.	01 Feb 2018
Plasma cell myeloma refractory	Phase 2	US	Juno Therapeutics, Inc.	01 Feb 2018
Relapse multiple myeloma	Phase 2	US	Juno Therapeutics, Inc.	01 Feb 2018
Acute Lymphoblastic Leukemia	Phase 2	-	Juno Therapeutics, Inc.	-
Non-Hodgkin Lymphoma	Phase 2	-	Juno Therapeutics, Inc.	-

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03430011 (H125001, CTgov)	Phase 1/2	Relapse multiple myeloma \| Plasma cell myeloma refractory	165	CD3+CAR+T cells+JCARH125 (Phase 1 50 x 10^6 Cells)	vxwvoumrek(jkpkjgkqrw) = zsmqchqqys xqzvfkjgtd (xuhzrfimvc, nytuyjakyc - gytmxiydxm) View more	-	24 May 2024
				CD3+CAR+T cells+JCARH125 (Phase 1 150 x 10^6 Cells)	vxwvoumrek(jkpkjgkqrw) = ofpgxpqqtd xqzvfkjgtd (xuhzrfimvc, dhqkpaywji - mewtwlxgoa) View more
NCT03338972 (CTgov)	Phase 1	Recurrent Multiple Myeloma \| BCMA Positive Multiple Myeloma \| Plasma cell myeloma refractory	28	Leukapheresis+Fludarabine+cyclophosphamide+Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143 (Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 1)	xameemyngm(mdngwuzlzp) = ifqdcnqlqo hlboqjvzay (lpqhinmylc, jftzwolfve - nqkktfpkbf) View more	-	05 Aug 2022
				Leukapheresis+Fludarabine+cyclophosphamide+Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143 (Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 2)	xameemyngm(mdngwuzlzp) = roxnqyjhec hlboqjvzay (lpqhinmylc, qwsrddgujd - ikmqvrjcxf) View more
EVOLVE (EHA2020)	Phase 1/2	Relapse multiple myeloma	51	Orva-cel 300 × 10^6 CAR+ T cells	elotipzjcd(wksyjlthrs) = nshvyzmfej rcdzoreehi (ypxydohkis ) View more	Positive	14 May 2020
				Orva-cel 450 × 10^6 CAR+ T cells	cxrylgauyv(fzxzubrjmx) = ercivvgkmv fcvmwxkdga (crbvbydweb )
NCT03430011 (H125001, ASH2018) Manual	Phase 1/2	Relapse multiple myeloma	19	JCARH125	uuwajjbkcx(mxggkzcwip) = 75% (Cytokine release syndrome) jducwvqpqx (haoerbswkr ) View more	Positive	29 Nov 2018

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