Tempest Therapeutics Plans First Clinical Trial for In Vivo CAR-T Candidate TPST-4003 in Q4 2026 — Tempest Therapeutics, Inc.

Event summary

Tempest Therapeutics plans to initiate a first investigator-initiated clinical trial for TPST-4003 in Q4 2026, focusing on nervous system autoimmune diseases like MG and MS.
TPST-4003 combines CD7-targeted mRNA/LNP delivery with a dual-targeting CD19/BCMA CAR construct, leveraging the clinically validated architecture from TPST-2003.
The trial is expected to enroll approximately 10 patients, with initial clinical data anticipated in H1 2027 and an interim update in H2 2027.

The big picture

Tempest Therapeutics is advancing its next-generation in vivo CAR-T pipeline with a focus on autoimmune diseases, leveraging its proprietary CD7-targeted mRNA/LNP delivery platform. This strategic shift aims to differentiate Tempest in the competitive CAR-T therapy landscape by enabling broader T-cell coverage and potentially improving efficacy and durability compared to single-target approaches.

What we're watching

Clinical Efficacy: How the dual-targeting CD19/BCMA CAR construct will perform in autoimmune diseases compared to its validated use in oncology.
Execution Risk: The pace at which Tempest can advance TPST-4003 through clinical trials and secure regulatory approvals.
Market Differentiation: Whether Tempest's in vivo CAR-T platform can achieve broader T-cell coverage and support scalable repeat dosing, enhancing commercial attractiveness.