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IASO Bio Secures FDA Approval for BCMA CAR-T Therapy in Multiple Autoimmune Diseases

CAR-TDrug Approval
  • IASO Bio received FDA IND approval for Equecabtagene Autoleucel (Eque-cel) to treat multiple sclerosis, marking the second autoimmune indication approved in 2024.
  • The fully human anti-BCMA CAR-T therapy has now secured five total IND approvals across China and the US for various autoimmune diseases including lupus and myasthenia gravis.
  • Multiple sclerosis affects approximately 3.07 million patients worldwide with 400,000 in the US, representing a significant unmet medical need in neuroinflammatory diseases.
  • The therapy targets BCMA-expressing B cells and plasma cells to reduce pathogenic autoantibodies and suppress autoimmune inflammation across multiple disease indications.

CAR-E Platform Shows Promise in Preventing CAR-T Cell Therapy Relapse

CAR-T
  • Dana-Farber researchers developed CAR-Enhancer (CAR-E) therapy, combining weakened IL-2 with tumor antigens to extend CAR-T cell persistence and prevent cancer relapse.
  • The platform generates diverse CAR-T cell populations including memory cells and achieved complete tumor clearance in laboratory studies of multiple myeloma.
  • CAR-E therapy could enable treatment with fewer CAR-T cells and allow re-stimulation of cells in relapsed patients, potentially reducing costs and side effects.
  • Clinical trials are planned to begin soon, with initial treatment expected to start one month after CAR-T cell infusion using weekly doses for three to four weeks.

CAR-T Cell Therapy Advances: Overcoming Challenges in Solid Tumors and Enhancing Safety Through Innovative Engineering

CAR-TGene Editing
  • CAR-T cell therapy has achieved remarkable success in hematological malignancies with complete remission rates of 70-90% in B-cell acute lymphoblastic leukemia, but faces significant challenges in solid tumors due to poor infiltration and immunosuppressive microenvironments.
  • Major toxicities including cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) affect nearly 100% of patients in some studies, prompting development of safety mechanisms like suicide genes and reversible inhibition systems.
  • Next-generation CAR-T innovations include multi-targeted designs, armored CAR-T cells with enhanced durability, Boolean logic gates for improved selectivity, and CAR-NK cells that demonstrate superior safety profiles with reduced CRS risk.
  • Novel engineering approaches such as CRISPR/Cas9 gene editing for fifth-generation universal CARs and combination therapies with checkpoint inhibitors show promise for expanding therapeutic applications beyond oncology to autoimmune diseases.

Kite's Yescarta Shows Superior Manufacturing Success and T-Cell Performance in Second-Line Treatment of Large B-Cell Lymphoma

CAR-TReal World Evidence
  • Analysis of 4,175 patients demonstrates that Yescarta achieves significantly higher first-pass manufacturing success rates when used as second-line therapy (95.08%) versus third-line treatment (92.48%) for relapsed/refractory large B-cell lymphoma.
  • Patients receiving second-line treatment showed approximately twice as many naïve-like T-cells during leukapheresis collection compared to third-line patients, potentially supporting improved therapeutic outcomes.
  • Preliminary data from ZUMA-24 and real-world studies suggest outpatient administration of Yescarta and Tecartus is feasible without added toxicity when appropriate monitoring is in place.

IASO Bio's CAR-T Therapy Shows 100% Response Rate in High-Risk Newly Diagnosed Multiple Myeloma Patients

CAR-T
  • IASO Bio presented clinical data showing Equecabtagene Autoleucel achieved 100% overall response rate with 93.8% stringent complete response in high-risk newly diagnosed multiple myeloma patients ineligible for transplant.
  • The FUMANBA-2 study demonstrated all 16 patients achieved minimal residual disease negativity, with 71.4% maintaining this status for over 12 months and a 12-month progression-free survival rate of 84.4%.
  • Safety profile showed 68.8% incidence of grade 1-2 cytokine release syndrome with no grade 3 or higher CRS events and no neurotoxicity, representing the world's first CAR-T therapy used as first-line treatment in this patient population.

Liso-Cel CAR-T Therapy Shows Promising Results Across Multiple Lymphoma Subtypes

CAR-TOncology
  • Lisocabtagene maraleucel (liso-cel) demonstrates clinically meaningful activity across various lymphoma subgroups, including mantle cell lymphoma, diffuse large B-cell lymphoma, and follicular lymphoma.
  • In relapsed/refractory mantle cell lymphoma patients, liso-cel achieved a median overall survival of 13.5 months and progression-free survival of 7.4 months despite heavy pretreatment.
  • Follicular lymphoma patients show particularly stellar response rates with durable complete remissions lasting nearly 3 years of follow-up.
  • Experts advocate for exploring liso-cel use in earlier treatment lines, particularly for high-risk patient subgroups who may benefit from better-preserved T-cell health.

Study Evaluating the Safety and Pharmacokinetics of JCAR017 in B-cell Non-Hodgkin Lymphoma (TRANSCEND-NHL-001)

NCT02631044CompletedPhase 1
Juno Therapeutics, a Subsidiary of Celgene
Posted 1/6/2016

A Study to Compare the Efficacy and Safety of JCAR017 to Standard of Care in Adult Subjects With High-risk, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas

NCT03575351CompletedPhase 3
Celgene
Posted 10/23/2018

CARsgen's Satri-cel Shows Promise in Phase 1 Trial for Gastrointestinal Cancers

CAR-TOncology
  • Final results from the Phase 1 trial of satricabtagene autoleucel (satri-cel) demonstrate promising efficacy and manageable safety in patients with Claudin18.2-positive advanced gastrointestinal cancers, particularly gastric and gastroesophageal junction cancers.
  • The groundbreaking CAR T-cell therapy targeting Claudin18.2 represents a significant advancement in solid tumor treatment, with results simultaneously published in Nature Medicine and presented at the 2024 ASCO Annual Meeting.
  • Satri-cel has received multiple regulatory designations including RMAT designation from the FDA and PRIME eligibility from the EMA, positioning it as a potential first-in-class therapy globally for Claudin18.2-positive solid tumors.

Chimeric Antigen Receptor T Cells Targeting claudin18.2 in Solid Tumors.

NCT03874897CompletedPhase 1
Peking University
Posted 3/26/2019

A Study to Evaluate the Efficacy and Safety of CT041 After Adjuvant Chemotherapy for Pancreatic Cancer

NCT05911217RecruitingPhase 1
CARsgen Therapeutics Co., Ltd.
Posted 7/11/2023

Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CT041 Autologous CAR T-cell Injection

NCT04581473Active, Not RecruitingPhase 1
CARsgen Therapeutics Co., Ltd.
Posted 10/23/2020

Claudin18.2 CAR-T (CT041) in Patients with Gastric, Pancreatic Cancer, or Other Specified Digestive Cancers

NCT04404595Active, Not RecruitingPhase 1
CARsgen Therapeutics Co., Ltd.
Posted 10/23/2020

Bispecific Antibodies Show Promise in Multiple Myeloma Treatment Across Different Patient Populations

OncologyCAR-TMonoclonal Antibody
  • Talquetamab demonstrated a 71.4% objective response rate and 28.6% complete response rate in heavily pretreated relapsed/refractory multiple myeloma patients, including those with poor functional status and prior CAR-T therapy.
  • The teclistamab combination with daratumumab and lenalidomide achieved a 92.3% overall response rate and 80.8% complete response rate in newly diagnosed multiple myeloma patients ineligible for transplant.
  • Both bispecific antibody treatments showed manageable safety profiles with cytokine release syndrome as the primary toxicity, though infection risk requires careful monitoring and prophylaxis.
  • These findings expand treatment options for multiple myeloma patients across the disease spectrum, from newly diagnosed to heavily pretreated cases.

Dose Escalation Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma

NCT03399799Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 12/16/2017

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

Fate Therapeutics Treats First Lupus Patient with Off-the-Shelf CAR-T Cell Therapy FT819

CAR-T
  • Fate Therapeutics has treated the first patient with systemic lupus erythematosus using FT819, an off-the-shelf CD19-targeted CAR-T cell therapy derived from induced pluripotent stem cells.
  • The 27-year-old patient with refractory SLE received 360 million FT819 cells after conditioning chemotherapy and was discharged after three days without notable adverse events.
  • Phase 1 data from B-cell malignancy studies demonstrated that FT819 achieves rapid and sustained CD19+ B cell depletion, tissue infiltration, and immune reconstitution mechanisms crucial for autoimmune disease treatment.
  • The iPSC-derived platform offers advantages over traditional CAR-T therapies by eliminating the need for patient apheresis and providing off-the-shelf availability for broader patient access.

A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease

NCT06308978RecruitingPhase 1
Fate Therapeutics
Posted 3/28/2024

India Launches World's Most Affordable CAR-T Cell Therapy at One-Tenth International Cost

CAR-T
  • President Droupadi Murmu launched India's first indigenously-developed CAR-T cell therapy, NexCAR19, marking a major breakthrough in the country's battle against cancer.
  • The therapy, developed through collaboration between IIT Bombay and Tata Memorial Centre with industry partner ImmunoACT, costs approximately one-tenth the price of international alternatives.
  • NexCAR19 represents the world's most affordable CAR-T cell therapy, making this advanced cancer treatment accessible to patients who previously couldn't afford the ₹4 crore international cost.
  • The launch positions India among the few countries capable of producing indigenous cellular therapy and demonstrates successful academia-industry partnership in biotechnology innovation.

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