Tempest and Senlang Join Forces to Advance TPST-4003, a CD7-Targeted Next-Generation In Vivo CAR-T

Tempest Therapeutics (Nasdaq: TPST) announced today that it has entered a strategic partnership with Hebei Senlang Biotechnology Co., Ltd. to develop TPST-4003, its lead in vivo CAR-T candidate. Under the agreement, the two companies will collaborate first on an investigator-initiated trial (IIT) in China, enrolling roughly 10 patients with myasthenia gravis (MG) or multiple sclerosis (MS). Notably, Tempest expects to enroll and dose its first patient in the fourth quarter of 2026.

Why the Collaboration Matters

Tempest, a Brisbane, California-based clinical-stage biotechnology company, is building a pipeline of advanced CAR-T product candidates. Senlang, meanwhile, brings deep, clinically validated expertise in CD7-targeted CAR-T development and clinical translation. By combining these strengths, the partners aim to move quickly into first-in-human testing.

Beyond executing the trial, Senlang will coordinate and support operations on the ground in China. Furthermore, the agreement grants Senlang an exclusive option to negotiate a definitive license for TPST-4003 in China, signaling a longer-term commercial relationship rather than a one-off study.

What the First Trial Will Measure

The initial study is designed to generate early clinical evidence of safety, pharmacodynamic (PD) activity, and therapeutic potential. Specifically, investigators will track treatment-emergent adverse events, the generation and expansion of peripheral blood CD4+ and CD8+ CAR-T cells and CD56+ CAR-NK cells, CAR transgene copy number, and the depth and timing of CD19+ B-cell depletion alongside B-cell subset recovery.

Where clinically appropriate, the team may also look deeper. For example, exploratory assessments could detect CAR-positive immune cells in cerebrospinal fluid and evaluate B-cell depletion in lymphoid tissue. In addition, the trial will gauge disease-specific clinical activity using established measures.

Leadership Perspectives

Matt Angel, Ph.D., President and CEO of Tempest, framed the deal as a pivotal move for the program. He said the collaboration marks “an important step in developing TPST-4003” and added that the company expects to begin dosing patients later this year, with initial safety and PD data from the first patients potentially arriving as early as the first half of 2027.

Shengmin Guo, Founder and CEO of Senlang, echoed that optimism. Drawing on his company’s clinical experience, he called CD7 “a highly attractive target” and pointed to the strategic fit: Senlang’s CD7 know-how paired with Tempest’s CD7-targeted mRNA/LNP delivery platform and clinically validated CD19/BCMA CAR architecture.

Inside TPST-4003

TPST-4003 is an in vivo, dual-targeting CD19/BCMA CAR-T candidate. Essentially, it merges Tempest’s proprietary CD7-targeted mRNA/LNP delivery with the dual-target CAR architecture already used in the company’s TPST-2003 program. As a result, the candidate is designed to drive broad B-cell lineage depletion and immune reset across a range of autoimmune and oncology indications, starting with MG and MS.

Crucially, its delivery strategy sets it apart from other in vivo approaches. Rather than relying on ex vivo manufacturing, the CD7-targeted mRNA/LNP platform is built to engage endogenous CD4+ and CD8+ T-cell populations directly, generating CAR cells inside the body.

About the Partners

Tempest Therapeutics is pioneering next-generation in vivo CAR-T cell therapies for autoimmune and oncology indications. The company’s immune reset technology anchors TPST-4003, while additional preclinical programs leverage advanced payloads to build out a modular in vivo CAR-T portfolio. More information is available at the company’s website.

Hebei Senlang Biotechnology, for its part, focuses on next-generation CAR-T technologies with specialized CD7-targeted expertise. The company has established end-to-end capabilities spanning CAR design, vector and plasmid development, GMP manufacturing, and clinical trial execution. Currently, it is advancing multiple CD7 CAR-T programs, including a pivotal trial for relapsed or refractory T-cell lymphoblastic lymphoma/leukemia (T-LBL/ALL).