29/07/2026 The US FDA Grants RMAT & Fast Track to Allogene’s Cema‑cel for first‑Line LBCL consolidation The US FDA Grants RMAT & Fast Track to Allogene’s Cema‑cel for first‑Line LBCL consolidation (Ref) RMAT & Fast Track status granted to cemacabtagene ansegedleucel (cema‑cel; CAR T‑cell therapy) for the treatment of adult patients with large B-cell lymphoma (LBCL) who, at the completion of first-line therapy, are in complete or partial response suitable for observation but t

30/09/2025 Umoja Biopharma's UB-VV111 in vivo CAR T cell therapy received the FDA fast track designation for B-Cell Malignancies (Ref) The US FDA granted the fast track designation to Umoja Biopharma's UB-VV111 (off-the-shelf drug product that generates CD19-directed CAR T cells in vivo) for the treatment of relapsed/refractory Large B-cell Lymphoma following two or more lines of prior therapy and relapsed/refractory Chronic Lymphocytic Leukemia following two or more lines of

June 3rd week, 2025 Regulatory Updates 🎯 Senti Biosciences received an ODD from the US FDA for SENTI-202 (off-the-shelf CD33 and/or FLT3 targeting CAR-NK) for R/R AML (Ref 1) 👉 Why it matters: This is the first logic-gated CAR-NK with clinical data, demonstrating encouraging early results (ORR of 71.4% (n=7) with responses sustained beyond 8 months) 🎯 The US FDA granted ODD for CERo Therapeutics, Inc.’ CER-1236 (anti-TIM-4L CER-T), which is being evaluated in Ph1...

June 2nd week, 2025 ⭐ Deals & Collaborations 🤝Neowise Biotechnology granted BeOne Medicines rights to one of its proprietary antigen-specific TCR molecule under a non-exclusive licensing deal for the development of next-generation, iPSC-based off-the-shelf cell therapies for the Tx of Solid Tumors (Ref 1) ❓ What are the advantages of the off-the-shelf cell therapies? ⭐ Regulatory Updates 🎯 Myrio Tx received the US FDA approval for an IND application to initiate Ph1, N

Welcome to the April edition of our CGT Watch newsletter! Autolus’ Aucatzyl’s UK approval; BrainChild Bio’s BCB-276 BTD; Lyell’s LYL314 RMAT designation; TScan’s Ph1 trial update; CERo’s IND approval; CARGO's assets discontinuation; Carisma assessing strategic alternatives; BioNtech co-development option expiration; Caribou Bio restructuring. Stay informed on the latest advancements in the CGT space—subscribe now to receive insightful updates straight to your inbox. Dear R