Caribou Biosciences presented data from its CaMMouflage Phase 1 trial of the allogeneic anti‑BCMA CAR‑T therapy CB‑011 in patients with relapsed or refractory multiple myeloma. The study enrolled 48 patients, 35 of whom received the selected lymphodepletion regimen of 500 mg/m² cyclophosphamide and 30 mg/m² fludarabine. Twelve BCMA‑naïve patients were treated with the recommended dose of 450 × 10⁶ CAR‑T cells, with a median follow‑up of 8.3 months. The longest responding patient achieved a stringent complete response 15 months after infusion.
Safety data were manageable across all dose levels. No graft‑versus‑host disease or immune‑effector cell‑associated neurotoxicity was observed. Treatment‑emergent adverse events occurring in ≥25 % of patients included neutropenia (80 %), anemia (60 %), thrombocytopenia (49 %), infections (49 %), and cytokine release syndrome (31 %). The trial recorded one grade 5 immune‑effector cell‑associated hematotoxicity, one grade 5 pneumonia unrelated to CB‑011, and one grade 4 Guillain‑Barré syndrome that is resolving.
The results demonstrate deep, durable responses in heavily pre‑treated patients and support an outpatient administration model. Caribou plans to initiate dose expansion by the end of 2025, with expanded data expected in 2026. The company also reported positive data from its ANTLER Phase 1 trial of vispacabtagene regedleucel (vispa‑cel) for non‑Hodgkin lymphoma on the same day.
CB‑011 is engineered using Caribou’s proprietary CRISPR‑Cas12a chRDNA platform, which incorporates B2M knockout and B2M‑HLA‑E insertion to reduce immune rejection and a TRAC knockout to prevent graft‑versus‑host disease. The therapy has received Fast Track and Orphan Drug designations from the FDA, positioning it as a potential best‑in‑class allogeneic CAR‑T product.
Caribou’s financial results for the quarter ended September 30 2025 showed a net loss of $45 million, driven by increased clinical development expenses and research and development costs. Revenue for the quarter was $12 million, primarily from licensing and milestone payments. The company remains focused on advancing its allogeneic CAR‑T pipeline and expanding manufacturing capacity to meet anticipated demand.
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