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# Poseida Orphan Status for CAR-T Cell Therapy
- URL: https://www.fdaweb.com/poseida-orphan-status-for-car-t-cell-therapy/
- Published: 2024-03-14T12:00:00.000Z
- Updated: 2026-09-14T14:25:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156556

FDA has granted Poseida Therapeutics an orphan drug designation for its P-BCMA-ALLO1, a BCMA-targeted allogeneic, T stem cell chimeric antigen receptor (CAR)-T therapy candidate for treating multiple myeloma.

Poseida is currently evaluating P-BCMA-ALLO1 in a Phase 1 clinical trial and recently shared early safety and preliminary efficacy data, which the company says showed that it was a well-tolerated off-the-shelf therapy with a favorable emerging safety profile. Preliminary data also showed that the CAR-T cells persisted at least six weeks after treatment, “which support the hypothesis of cell persistence at tumor-relevant sites,” it adds.