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TScan Advances Allogeneic Cell Therapy Pipeline With FDA IND Clearances and Trial Enrollment Milestones

GlobeNewswire Inc.GlobeNewswire Inc.
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Key Takeaway

TScan completes Phase 1 trial enrollment and receives FDA clearance for two allogeneic cell therapy candidates, advancing its pipeline toward pivotal studies in 2026.

TScan Advances Allogeneic Cell Therapy Pipeline With FDA IND Clearances and Trial Enrollment Milestones
$TCRXpositive

TScan Therapeutics announced the completion of enrollment in Cohort C of its Phase 1 ALLOHA™ trial, utilizing a manufacturing process designed for commercial-scale production. Simultaneously, the company received FDA clearance for investigational new drug applications targeting two heme-derived candidates, TSC-102-A01 and TSC-102-A03, which are engineered to address CD45 expression in patients with HLA types A01:01 and A03:01 respectively.

The advancement represents a significant milestone in TScan's allogeneic cell therapy development strategy. The completion of Cohort C enrollment demonstrates progress in establishing the safety and efficacy profile of the ALLOHA™ platform using manufacturing processes that align with potential commercial requirements. The dual IND clearances expand the company's pipeline by enabling early-stage clinical evaluation of the TSC-102 candidates.

Looking ahead, TScan intends to present safety and chimerism data from the ALLOHA™ trial in the second quarter of 2026. The company also plans to initiate a pivotal trial for TSC-101 and launch Phase 1 studies for both TSC-102 candidates during the second half of 2026. These upcoming milestones will be critical in evaluating the therapeutic potential of TScan's engineered cell therapy approach across multiple candidate programs.

Topics

clinical trialTCR-T therapyhematologic malignanciesallogeneic hematopoietic cell transplantationFDA clearanceCD45 targetingcommercial manufacturingrelapse prevention

Source: GlobeNewswire Inc.

Back to newsPublished Feb 26

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