Lone Patient Outcome Prompts FDA Hold on ALPHA2 CAR-T Trial

By Mara Shapiro, Staff Writer

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According to a recent press release, the FDA has put the alloCAR T clinical trials on hold pending investigation after one patient presented with a chromosomal abnormality in ALLO-501A CAR T cells after being treated in the ALPHA2 trial.

The ALPHA2 trial is investigating the ALLO-501A allogeneic CAR-T cell therapy for patients with large B cell lymphoma.

Though the patient was enrolled in the ALPHA2 trial, this hold affects all trials in the alloCAR T portfolio, including a BCMA-targeting therapy for multiple myeloma, a CD70-targeting therapy for renal cell carcinoma, and a DLL3-targeting therapy for small cell lung cancer. 

This patient case under review is a patient with stage IV transformed follicular lymphoma and c-MYC rearrangement whose cancer was refractory to two lines of immune-chemotherapy and radiation therapy. Following infusion of ALLO-501A the patient experienced Grade 1 cytokine release syndrome and Grade 2 immune effector cell-associated neurotoxicity syndrome which required high dose steroid treatment. Thereafter, the patient developed progressive pancytopenia and the bone marrow biopsy performed showed aplastic anemia and presence of ALLO-501A CAR T cells with a chromosomal abnormality. The patient is said to have had a partial response to ALLO-501A and has gone on to receive an allogeneic stem cell transplant. 

The clinical significance of this detected chromosomal abnormality is still unclear. The FDA has placed a hold on the trials until the abnormality and its clinical relevance is understood. In addition, evidence of clonal expansion or a potential relationship to gene editing is being investigated. 

Despite this setback, early results from this trial have shown a favorable clinical profile for ALLO-501A in patients with large B cell lymphoma.


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