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India's First Indigenous CAR-T Therapy Achieves Two-Year Remission Milestone in Aggressive Blood Cancer

CAR-TOncology
  • Seven patients with relapsed or refractory CD19-positive B-cell Non-Hodgkin Lymphoma treated with India's first indigenous CAR-T therapy have achieved over two years of progression-free survival.
  • Immuneel Therapeutics' Varnimcabtagene autoleucel (IMN-003A) demonstrated an 83% overall response rate at Day 90 and 83% complete response rate in the IMAGINE Phase 2 trial.
  • More than 50 patients across leading Indian hospitals have been treated with consistent outcomes and favorable safety profiles, marking a breakthrough in accessible cancer immunotherapy.
  • The therapy represents a significant advancement in making world-class CAR-T treatments available domestically, supported by government backing through BIRAC grants.

Arcellx Reports Strong CAR-T Clinical Data Despite 72% Revenue Drop in Q2 2025

CAR-TFDA Approval
  • Arcellx's lead CAR-T therapy anito-cel achieved a 97% overall response rate and 93.3% minimal residual disease negativity in 117 multiple myeloma patients from the Phase 2 iMMagine-1 study.
  • The company's Q2 2025 collaboration revenue dropped 72% to $7.6 million, missing analyst expectations by 43.8% due to completion of clinical trial manufacturing activities.
  • Net loss more than doubled to $52.8 million as the company increased commercial readiness spending ahead of a planned 2026 product launch.
  • FDA authorized an investigational new drug application for ACLX-004, expanding Arcellx's pipeline into acute myeloid leukemia treatment.

Expert Highlights Optimal Positioning of Bispecific T-Cell Engagers in Multiple Myeloma Treatment

CAR-TOncology
  • Bispecific T-cell engagers demonstrate variable effectiveness in multiple myeloma depending on treatment setting, with talquetamab showing promise as pre-CAR T therapy to reduce cytokine release syndrome and neurotoxicity.
  • These agents produce deeper and more durable responses compared to standard therapies but carry increased infection risk, particularly with BCMA-targeting bispecifics.
  • Approximately 30% of patients fail to respond to bispecific treatment, potentially due to host immune system factors, patient fitness, and cancer cell soluble BCMA levels.
  • Researchers are exploring fixed-duration treatment strategies followed by observation periods to mitigate prolonged adverse effects associated with infections.

Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma

NCT02252172CompletedPhase 3
Janssen Research & Development, LLC
Posted 2/16/2015

A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma

NCT05552222RecruitingPhase 3
Janssen Research & Development, LLC
Posted 10/25/2022

Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation

NCT05243797RecruitingPhase 3
Stichting European Myeloma Network
Posted 9/8/2022

Galapagos Receives FDA RMAT Designation for CAR-T Therapy GLPG5101 in Relapsed/Refractory Mantle Cell Lymphoma

CAR-T
  • The FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to Galapagos' GLPG5101, a second-generation anti-CD19/4-1BB CAR-T therapy for relapsed/refractory mantle cell lymphoma.
  • Clinical data from the ongoing ATALANTA-1 Phase 1/2 study demonstrated high objective and complete response rates with a manageable safety profile, including low rates of high-grade cytokine release syndrome and neurotoxicity.
  • The RMAT designation provides accelerated development pathways, including increased FDA guidance, eligibility for accelerated approval, and priority review benefits.
  • GLPG5101 utilizes Galapagos' decentralized manufacturing platform designed to deliver fresh CAR-T cells with a median vein-to-vein time of seven days.

A Study Evaluating the Safety and Efficacy of GLPG5101 (19CP02) in Participants With Non-Hodgkin Lymphoma

NCT06561425RecruitingPhase 1
Galapagos NV
Posted 3/9/2022

Long-term Follow-up of Participants Treated with Galapagos Chimeric Antigen Receptor (CAR) T-cell Therapies

NCT06652633RecruitingPhase 3
Galapagos NV
Posted 9/9/2024

Allogene Therapeutics Modifies ALPHA3 Trial Design Following Patient Death, Adopts Standard Lymphodepletion Protocol

CAR-T
  • Allogene Therapeutics has discontinued the FC plus ALLO-647 lymphodepletion arm in its ALPHA3 trial after a patient death from hepatic failure attributed to disseminated adenovirus infection.
  • The company will proceed with standard fludarabine and cyclophosphamide (FC) lymphodepletion for cemacabtagene ansegedleucel (cema-cel) in first-line consolidation for large B-cell lymphoma.
  • This strategic shift eliminates ALLO-647 from all current trials and accelerates focus on the company's next-generation Dagger Platform Technology for future CAR-T development.
  • The modified ALPHA3 trial continues as a two-arm randomized study comparing cema-cel after standard FC to observation, with futility analysis scheduled for first half 2026.

Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL

NCT06500273RecruitingPhase 2
Allogene Therapeutics
Posted 6/18/2024

Everest Medicines Invests $30.9M in I-Mab Following Promising 83% Response Rate for Gastric Cancer Bispecific Antibody

CAR-T
  • Everest Medicines has made a strategic $30.9 million equity investment in I-Mab, bringing its total ownership to 16.1% of the U.S.-based biotech company.
  • I-Mab's lead bispecific antibody givastomig demonstrated an impressive 83% overall response rate in combination with immunotherapy in a Phase 1b trial for first-line gastric cancer.
  • The strategic partnership combines I-Mab's 4-1BB receptor targeting platform with Everest's mRNA cancer vaccines and CAR-T therapies, creating synergistic development opportunities.
  • The collaboration leverages I-Mab's clinical translational capabilities in the U.S. with Everest's strong presence in Asian markets for accelerated global expansion.

UCLA Scientists Achieve First-in-Human Reprogramming of Stem Cells to Generate Renewable Cancer-Fighting T Cells

CAR-T
  • UCLA researchers successfully demonstrated the first-in-human reprogramming of blood-forming stem cells to continuously produce cancer-targeting T cells in a groundbreaking clinical trial.
  • The approach creates an "internal factory" that generates tumor-targeting immune cells over time, potentially offering longer-lasting protection against cancer recurrence.
  • One patient with aggressive sarcoma showed tumor regression and maintained detectable levels of engineered immune cells for months following treatment.
  • The therapy targets NY-ESO-1, a cancer-testis antigen found in approximately 80% of synovial sarcomas but rarely in healthy adult tissues.

Genetically Engineered PBMC and PBSC Expressing NY-ESO-1 TCR After a Myeloablative Conditioning Regimen to Treat Patients With Advanced Cancer

NCT03240861TerminatedPhase 1
Jonsson Comprehensive Cancer Center
Posted 7/26/2017

ZUMA-7 Trial Demonstrates Survival Advantage for Second-Line CAR-T Therapy in Refractory DLBCL

CAR-T
  • The ZUMA-7 trial remains the only randomized CAR-T therapy study to demonstrate an overall survival benefit compared to standard of care in primary refractory diffuse large B-cell lymphoma.
  • Patients who received CAR-T therapy in second-line treatment showed superior outcomes compared to those who delayed treatment until third-line, highlighting the importance of early intervention.
  • CAR-T patients experienced faster recovery and return to baseline quality of life compared to those undergoing high-dose chemotherapy and autologous transplant.
  • Long-term follow-up data from pivotal trials show approximately 35% of patients achieve durable responses, suggesting potential cure in this subset with manageable long-term toxicity profiles.

Study of Effectiveness of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma

NCT03391466CompletedPhase 3
Kite, A Gilead Company
Posted 1/25/2018

ViroCell Biologics Partners with AvenCell Therapeutics to Advance Dual-Targeted Allogeneic CAR-T Therapy

CAR-TOncology
  • ViroCell Biologics has delivered a novel retroviral vector to AvenCell Therapeutics for their investigational CD19/CD20 dual-targeted CAR-T therapy AVC-203, designed for B cell malignancies and autoimmune diseases.
  • AVC-203 is an allogeneic "off-the-shelf" CAR-T cell therapy engineered to mitigate graft-versus-host disease and graft rejection, incorporating AvenCell's RevCAR receptor for additional antigen targeting with in vivo "off/on" capability.
  • The therapy is expected to enter a phase I clinical trial for relapsed/refractory B cell lymphoma in the second half of 2025, with potential advantages of improved efficacy, immediate treatment availability, and reduced cost compared to existing CAR-T therapies.

Leveragen and Propeller Bio Form Strategic Partnership to Advance Next-Generation Antibody Discovery Platform

CAR-T
  • Leveragen, a Boston-based biotech company, has announced a strategic collaboration with newly launched Propeller Bio to advance antibody and protein-based therapeutics development.
  • The partnership provides Propeller Bio access to Leveragen's proprietary Singularity Sapiens Mouse platform, which produces fully human single-domain antibodies with strong developability and diverse epitope coverage.
  • Propeller Bio is led by David Shen, former CEO of Proteologix, which was acquired by Johnson & Johnson for $850 million upfront in 2024.
  • The Singularity Sapiens Mouse platform supports multiple therapeutic formats including bispecifics, antibody-drug conjugates, CAR-T therapies, and mRNA-encoded antibodies.

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