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FDA Grants RMAT and Fast Track Designations to Caribou's Allogeneic CAR-T Therapy CB-010 for B-Cell Lymphoma

CAR-T
  • The FDA granted CB-010, an allogeneic anti-CD19 CAR-T cell therapy, both RMAT and fast track designations for treating relapsed or refractory B-cell non-Hodgkin lymphoma based on promising early clinical data.
  • All six patients in the phase 1 ANTLER trial achieved complete responses at the first dose level, with three maintaining durable responses at six months.
  • CB-010 represents the first allogeneic anti-CD19 CAR-T therapy in clinical trials to include a PD-1 knockout, designed to improve persistence and prevent premature T-cell exhaustion.
  • The therapy demonstrated encouraging safety data with no graft-versus-host disease reported and manageable treatment-related adverse events primarily involving blood count decreases.

CLBR001 and SWI019 in Patients With Relapsed / Refractory B-cell Malignancies

NCT04450069CompletedPhase 1
Calibr, a division of Scripps Research
Posted 8/14/2020

Study to Assess Safety, Tolerability and Efficacy of MB-106 in Patients With Relapsed or Refractory B-Cell NHL or CLL

NCT05360238TerminatedPhase 1
Mustang Bio
Posted 5/24/2022

CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy for Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER)

NCT04637763RecruitingPhase 1
Caribou Biosciences, Inc.
Posted 5/26/2021

A Phase I/II Study to Evaluate the Safety of Cellular Immunotherapy Using Autologous T Cells Engineered to Express a CD20-Specific Chimeric Antigen Receptor for Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphomas

NCT03277729Active, Not RecruitingPhase 1
Fred Hutchinson Cancer Center
Posted 12/5/2017

Modified Immune Cells (CD19/CD20 CAR-T Cells) in Treating Patients With Recurrent or Refractory B-Cell Lymphoma or Chronic Lymphocytic Leukemia

NCT04007029Active, Not RecruitingPhase 1
Jonsson Comprehensive Cancer Center
Posted 10/4/2019

Real-World Study Shows Axicabtagene Ciloleucel Outperforms Tisagenlecleucel in Relapsed/Refractory DLBCL

CAR-TReal World Evidence
  • A large French real-world study of 809 patients with relapsed/refractory DLBCL found axicabtagene ciloleucel (axi-cel) demonstrated superior efficacy compared to tisagenlecleucel (tisa-cel) with significantly higher response rates and improved survival outcomes.
  • After propensity score matching of 418 patients, axi-cel achieved 80.4% overall response rate and 60.3% complete response rate versus 66.0% and 42.1% respectively for tisa-cel, with one-year progression-free survival of 46.6% versus 33.2%.
  • The superior efficacy of axi-cel came with increased toxicity, including significantly higher rates of severe immune cell-associated neurotoxicity syndrome (13.9% vs 2.9%) and prolonged hematological toxicity.
  • This comprehensive analysis from the DESCAR-T registry provides the first real-world evidence of overall survival advantage for axi-cel over tisa-cel in third-line or later treatment of DLBCL.

French Register Of Patients With Hemopathy Eligible For CAR-T Cell Treatment (DESCAR-T)

NCT04328298Recruiting
The Lymphoma Academic Research Organisation
Posted 12/19/2019

CAR T-Cell Therapy Advances: From Manufacturing Innovations to Solid Tumor Breakthroughs

CAR-T
  • CAR T-cell therapy has achieved remarkable 12-year remission rates in blood cancer patients, with researchers asserting it can cure certain leukemia cases, though manufacturing complexity and solid tumor limitations remain significant challenges.
  • New manufacturing approaches including off-the-shelf allogeneic therapies, 24-hour production methods, and in vivo CAR T-cell generation platforms are being developed to reduce costs and improve accessibility.
  • Novel combination strategies with mRNA vaccines, oncolytic viruses, and "armored" CAR designs are showing promise in overcoming solid tumor microenvironment barriers that have limited therapy effectiveness.

Dual-Targeting CAR-T Therapies Show Promise in Overcoming B-Cell Cancer Treatment Resistance

CAR-T
  • Researchers at University Hospitals Seidman Cancer Center developed a novel BAFF CAR-T therapy that targets three receptors (BAFF-R, BCMA, TACI) instead of one, potentially reducing antigen escape seen in CD19-only therapies.
  • A separate bispecific CAR-T therapy (LV20.19) targeting both CD20 and CD19 achieved a 90% overall response rate in a phase 1/2 trial for relapsed/refractory B-cell non-Hodgkin lymphoma.
  • The BAFF CAR-T approach may cause less severe B-cell aplasia compared to CD19 therapies since BAFF receptors are not expressed by early-stage B-cells.
  • Both therapies represent significant advances in addressing treatment resistance and improving outcomes for patients with B-cell malignancies.

Anti-CD19 White Blood Cells for Children and Young Adults With B Cell Leukemia or Lymphoma

NCT01593696CompletedPhase 1
National Cancer Institute (NCI)
Posted 6/29/2012

Retrospective Study of Immunotherapy Related Toxicities and Factors Impacting Outcomes in Children and Adults With Cancer

NCT03827343Active, Not Recruiting
National Cancer Institute (NCI)
Posted 1/23/2019

Anti-CD22 Chimeric Receptor T Cells in Pediatric and Young Adults With Recurrent or Refractory CD22-expressing B Cell Malignancies

NCT02315612CompletedPhase 1
National Cancer Institute (NCI)
Posted 12/12/2014

FDA Grants Orphan Drug Designation to CT120 Dual-Targeted CAR-T Therapy for Acute Lymphoblastic Leukemia

CAR-T
  • The FDA has granted orphan drug designation to CT120, a fully human CD19/CD22 dual-targeted CAR-T cell therapy developed by IASO Biotherapeutics for treating acute lymphoblastic leukemia.
  • In an investigator-initiated clinical study, all 4 subjects with B-cell ALL achieved complete response after CT120 treatment, with a 100% complete remission rate and no Grade 3 or higher cytokine release syndrome or neurotoxicity observed.
  • The orphan drug designation provides CT120 with several advantages including FDA support for clinical research, fee waivers, and seven years of marketing exclusivity upon approval.
  • CT120 is described as the first dual-targeted CAR-T cell therapy and has already obtained two IND approvals for B-NHL and B-ALL in China, with clinical trials for B-NHL treatment progressing well.

Bispecific CAR-T Therapy Targeting CD19/CD20 Shows Promise in Relapsed B-Cell Lymphoma

CAR-T
  • A novel bispecific CAR-T cell therapy targeting both CD19 and CD20 antigens demonstrated complete remission in four out of five patients with relapsed or refractory B-cell lymphoma.
  • The therapy uses naïve memory T cells and showed minimal toxicity with only grade 1 cytokine release syndrome observed across all patients.
  • After a median follow-up of 13 months, all responding patients maintained CAR-T cell persistence and ongoing complete remission without reaching median progression-free survival endpoints.

CD19/CD20 Dual-CAR-T in B-cell Leukemia Patients

NCT04260945CompletedPhase 1
Hebei Yanda Ludaopei Hospital
Posted 3/10/2020

Study of Efficacy and Safety of CTL019 in Pediatric ALL Patients

NCT02435849CompletedPhase 2
Novartis Pharmaceuticals
Posted 4/8/2015

A Study Evaluating the Safety and Efficacy of Brexucabtagene Autoleucel (KTE-X19) in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ZUMA-3)

NCT02614066CompletedPhase 1
Kite, A Gilead Company
Posted 3/7/2016

Novartis's Kymriah: Breakthrough CAR-T Therapy Priced at $475,000 Sparks Value Debate

CAR-TDrug ApprovalOncology
  • Novartis's Kymriah, the first FDA-approved CAR-T cell therapy for pediatric acute lymphoblastic leukemia, demonstrates an impressive 83% remission rate in patients who failed traditional treatments.
  • The therapy's $475,000 price tag has ignited debate among healthcare experts, with some defending it as comparable to bone marrow transplants while others argue it's excessive despite its breakthrough status.
  • Novartis has implemented innovative value-based pricing models, including outcome-based contracts where payment is contingent upon patient response and indication-specific pricing for future approvals.

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