FDA places clinical hold on Allogene’s allogeneic CAR-T trials
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The FDA placed a clinical hold on a series of clinical trials that use Allogene Therapeutics’ AlloCAR T chimeric antigen receptor T-cell therapies, according to a press release from the manufacturer.
The agency placed the hold on the trials after the manufacturer reported one patient with pretreated stage IV follicular lymphoma who received its ALLO-501A CAR T cells in the ALPHA2 study showed evidence of a chromosomal abnormality.
The abnormality was detected in a bone marrow biopsy taken after the patient developed progressive pancytopenia. The biopsy “showed aplastic anemia and the presence of ALLO-501A CAR T cells with the chromosomal abnormality,” the release stated.
AlloCAR T are allogeneic CAR T cells derived from induced pluripotent stem cells from healthy donors that are genetically modified using transcription activator-like effector nucleases (TALEN) gene-editing technology.
“Patient safety is our highest priority, and we are committed to working closely with the FDA to evaluate any potential clinical implications of this finding and determine next steps for advancing ALLO-501A and our clinical programs,” Rafael Amado, MD, executive vice president of research and development and chief medical officer for Allogene, said in the release.
“As a leading developer of allogeneic cell therapies, we recognize our added responsibility to fully assess all aspects of our therapies to advance the field,” he added. “We are grateful for the partnership with the patient community, clinical investigators, our scientific advisory board and the FDA as we work diligently toward understanding the clinical significance of this finding and to support the development of allogeneic CAR-T therapy for cancer.”
The clinical hold affects five trials in the AlloCAR T portfolio for relapsed or refractory cancers, including therapies designed to treat non-Hodgkin lymphoma, multiple myeloma and renal cell carcinoma.
Allogene is investigating the findings to determine any evidence of clonal expansion and whether the situation was related to gene editing used to develop the therapy. Updates will be provided in the coming weeks in consultation with the FDA, and the regulator will continue to review materials for its planned phase 2 study of ALLO-501A, the press release stated.
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