Tempest partners Senlang to advance TPST-4003 in China trial
Tempest Therapeutics has partnered with Hebei Senlang Biotechnology to advance TPST-4003, an in vivo CAR-T candidate, into a clinical trial in China for myasthenia gravis and multiple sclerosis. The trial, targeting approximately 10 patients, is set to begin dosing in Q4 2026, with initial data expected in H1 2027.

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Tempest Therapeutics, Inc. (NASDAQ: TPST) has entered a strategic partnership with Hebei Senlang Biotechnology Co., Ltd. to develop its proprietary TPST-4003 product candidate. The collaboration begins with an investigator-initiated trial (IIT) in China, evaluating TPST-4003 in approximately 10 patients with neurological autoimmune diseases, specifically myasthenia gravis (MG) and multiple sclerosis (MS). First patient enrollment and dosing are anticipated in the fourth quarter of 2026, with initial data readouts expected in the first half of 2027.
TPST-4003 is a next-generation in vivo CAR-T candidate that combines Tempest's proprietary CD7-targeted mRNA/LNP delivery approach with a dual-targeting CD19/BCMA CAR construct. This design aims to enable broad B-cell lineage depletion and immune reset for autoimmune and oncology indications. The platform differentiates itself through its mRNA/LNP delivery method, which targets CD7, a key marker in T-cell development, potentially reducing the complexity and cost associated with ex vivo cell manipulation.
Under the agreement, Senlang, a clinical-stage cell therapy company with extensive expertise in CD7-targeted CAR-T development, will coordinate and support trial execution in China. The study is designed to generate clinical evidence of safety, pharmacodynamic (PD) activity, and therapeutic potential, building on promising preclinical and clinical research findings. Additionally, the agreement grants Senlang an exclusive option to negotiate and enter into a definitive license agreement for TPST-4003 in China.
| Key Details | Information |
|---|---|
| Lead Candidate | TPST-4003 |
| Partner | Hebei Senlang Biotechnology Co., Ltd. |
| Target Indications | Myasthenia Gravis (MG), Multiple Sclerosis (MS) |
| Trial Location | China |
| Trial Start Date | Q4 2026 |
| Initial Data Readout | H1 2027 |
| Patient Enrollment | Approximately 10 patients |
| Delivery Mechanism | CD7-targeted mRNA/LNP |
| CAR Construct | Dual-targeting CD19/BCMA |
Tempest Therapeutics is a clinical-stage biotechnology company focused on developing a pipeline of advanced CAR-T product candidates. The advancement of TPST-4003 into clinical testing through this partnership marks a key milestone in the company's strategy to expand the application of CAR-T technology beyond oncology into immunology.
What are the potential regulatory hurdles for introducing an mRNA/LNP delivery CAR-T platform in China compared to traditional ex vivo therapies?
How will the cost structure of TPST-4003 compare to existing autologous CAR-T treatments if the in vivo delivery method successfully eliminates ex vivo manufacturing?
What specific criteria will determine if Senlang exercises its exclusive option to license TPST-4003 following the initial data readout?

























