Carisma Therapeutics Inc (Nasdaq: CARM), a US-based clinical stage biopharmaceutical company, announced on Tuesday that it has received approval from the US Food and Drug Administration (FDA) for the Investigational New Drug application (IND) of CT-0525, an ex vivo gene-modified autologous chimeric antigen receptor-monocyte (CAR-Monocyte) cellular therapy for the treatment of solid tumours that overexpress human epidermal growth factor receptor 2 (HER2).
The company has received a Study May Proceed notification from the FDA and is expected to start a phase one study in the coming months and to treat the first patient in the first half of 2024.
The Phase 1 study for CT-0525 is designed to assess the safety, tolerability, and the manufacturing feasibility of CT-0525. This study will enrol participants with locally advanced (unresectable) or metastatic solid tumours overexpressing HER2 whose disease has progressed on standard approved therapies. The study will consist of two cohorts: Cohort 1 will receive IV administration of up to 3 billion CAR-positive cells, while Cohort 2 will receive IV administration of CT-0525 of up to 10 billion CAR-positive cells.
Pierre Fabre Pharmaceuticals reports FDA acceptance and Priority Review of Tabelecleucel BLA
Bavarian Nordic's chikungunya vaccine receives validation from EMA for accelerated review
Atara Biotherapeutics gains FDA Priority Review for tabelecleucel
Hyperfine secures FDA clearance for faster brain imaging software
Silo Pharma agrees Alzheimer's drug licence
Kyverna's KYV-101 granted FDA Regenerative Medicine Advanced Therapy designation
Camurus reports positive Phase 3 ACROINNOVA 2 results
Acurx Pharmaceuticals presents positive Ibezapolstat Phase 2 clinical trial results for CDI