Fate Therapeutics Inc. has obtained IND clearance from the FDA for FT-839, the company’s next-generation, off-the-shelf CAR T-cell product candidate targeting CD19 and CD38 for autoimmune diseases.
China’s National Medical Products Administration approved Carsgen Therapeutics Holdings Ltd.’s NDA for satricabtagene autoleucel (satri-cel, CT-041), marking the first global approval of a CAR T therapy for solid tumors. The autologous Claudin18.2-targeted CAR T was approved for patients with Claudin18.2-positive, HER2-negative advanced gastric/gastroesophageal junction adenocarcinoma who have failed at least two prior lines of therapy.
Oricell Therapeutics Holdings Ltd.’s glypican-3 (GPC3)-targeted autologous CAR T therapy, Ori-C101, is heading into a confirmatory registration phase II trial in patients with GPC3-positive advanced hepatocellular carcinoma, positioning it as the first GPC3-directed immune cell therapy – and the first CAR T therapy for liver cancer – to reach that stage of development.
Oricell Therapeutics Holdings Ltd.’s glypican-3 (GPC3)-targeted autologous CAR T therapy, Ori-C101, is heading into a confirmatory registration phase II trial in patients with GPC3-positive advanced hepatocellular carcinoma, positioning it as the first GPC3-directed immune cell therapy – and the first CAR T therapy for liver cancer – to reach that stage of development.
T-Curx GmbH has obtained clinical trial approval from the Swiss agency Swissmedic for the company’s nonviral lead CAR T program, TCX-001. The first-in-human phase I study will open in Switzerland, and a submission to the EMA will seek to expand the trial to sites in Germany. The study will enroll adults with relapsed or refractory acute myeloid leukemia (AML) and chronic lymphocytic leukemia (CLL), including patients not eligible for stem cell transplantation.
Although CD19-directed CAR T cells can initially induce remission in 70-90% of patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL), post-CAR relapses are frequent. These relapses are driven by insufficient persistence of CAR T cells, allowing for antigen-positive B-ALL re-emergence and loss of the targeted epitope either in isolation or as part of lineage-switching.
Poseida Therapeutics Inc. is being bought out for $1.5 billion by partner Roche Holdings Inc. to develop allogeneic CAR T therapies to treat hematologic malignancies. The two companies began their collaboration in August 2022, a deal that brought Poseida $110 million up front and another $110 million in near-term milestone payments. With the acquisition, Roche plans to develop CAR T programs for solid tumors and autoimmune diseases with Poseida's genetic engineering platform and preclinical programs.
Hemogenyx Pharmaceuticals plc has obtained approval by the institutional review board (IRB) of the company’s first clinical site to initiate a phase I trial of the company’s lead asset, HEMO-CAR-T, for the treatment of relapsed or refractory acute myeloid leukemia (AML) in adults.
The FDA has lifted a clinical hold on Carsgen Therapeutics Holdings Ltd.’s. CAR T products after issuing the company a warning letter following a December 2023 FDA inspection that found the company violated good manufacturing practices at its Research Triangle Park facility in Durham, N.C.
The FDA has lifted a clinical hold on Carsgen Therapeutics Holdings Ltd.’s. CAR T products after issuing the company a warning letter following a December 2023 FDA inspection that found the company violated good manufacturing practices at its Research Triangle Park facility in Durham, N.C.
