- Tempest Therapeutics reached a manufacturing milestone for its TPST-2003 CAR-T therapy with delivery of a lentiviral vector, supporting plans for a registrational study.
- Clinical data showed a 100% overall response rate among evaluable patients across trials in relapsed/refractory multiple myeloma.
Tempest Therapeutics, Inc. announced a development milestone for its TPST-2003 dual-targeting CD19/BCMA CAR-T therapy, following the delivery of a lentiviral vector to its manufacturing partner, Cincinnati Children’s Applied Gene and Cell Therapy Center (AGCTC). The milestone supports manufacturing activities required for a planned registrational study in patients with relapsed or refractory multiple myeloma (rrMM), expected to begin later in 2026.
The lentiviral vector is a key component used in the contract manufacturing of autologous CAR-T therapies. AGCTC, which provides CDMO services in cell and gene therapy, will support production of TPST-2003 as the program advances toward late-stage clinical development. The therapy is being evaluated in patients with rrMM, including those with extramedullary disease.
Tempest reported that 36 patients had received TPST-2003 across clinical studies as of January 31, 2026. This includes 24 patients in a Phase 1/2 investigator-initiated trial and 12 patients in the ongoing REDEEM-1 trial. Among six efficacy-evaluable patients in REDEEM-1, all achieved a complete response. Across both studies, the overall response rate was reported as 100% among 25 evaluable patients with measurable disease.
“The delivery of lentiviral vector, which is a critical component in the manufacturing of autologous CAR-T products, has enabled us to proceed with the manufacturing activities required for the pivotal development of TPST-2003.”
Dr. Matt Angel, President and CEO of Tempest Therapeutics
AGCTC will continue to support manufacturing and development activities as Tempest prepares for further clinical evaluation. The company also plans to present updated clinical data from its trials at a scientific meeting later this year.
