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FDA puts clinical hold on Allogenic CAR T therapy due to safety concerns

08-Oct-2021

Key points from article :

The FDA has sent a clinical hold on all of Allogene’s AlloCAR T clinical trials in response to an abnormality that could cause cancer.

A lymphoma patient suffered a reduction in all blood cell lines after receiving an infusion of anti-CD19 CAR-T candidate ALLO-501A.

Analysis of the biopsy discovered anti-CD19 CAR-T cells with a chromosomal abnormality.

Cells may have acquired the chromosomal change in the gene editing process or as they expanded quickly.

Allogene reported the abnormality to the FDA, prompting to put a clinical hold on all of the biotech’s AlloCAR T clinical trials.

The FDA’s response reflects the potential for chromosomal abnormalities to cause cancer.

The impact could be limited to a delay and the adoption of additional precautions at Allogene.

Allogene’s stock fell more than 30%, tumbling from above $24 to below $17.

A setback to the biotech or the broader off-the-shelf T-cell therapy space.

Chromosome abnormality reported in a clinical trial raises doubts on patient safety

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Clinical-stage biotechnology company pioneering the field of cell therapies