CRISPR Therapeutics disclosed that its investigational allogeneic CAR‑T therapy, zugocaptagene geleucel (zugo‑cel), achieved an overall response rate of 90% and a complete response rate of 70% in a Phase 1/2 study of 10 relapsed or refractory large B‑cell lymphoma (LBCL) patients treated at the recommended Phase 2 dose of 600 million cells.
Safety data from the same cohort show that 17% of patients experienced Grade 3 cytokine release syndrome and 17% experienced Grade 3 immune‑cell‑associated neurotoxicity (ICANS). No Grade 4 or 5 events were reported, and serious infections occurred in 8% of patients. These findings indicate that while high‑grade toxicity was absent, the therapy still carries a manageable risk profile that will be closely monitored in larger studies.
Durability data are encouraging: 67% of the patients who achieved a complete response remain in remission at 12 months, and two of the three patients who were still in CR at 12 months remain in CR at the latest follow‑up. This suggests that the early responses may translate into sustained disease control, a critical factor for regulatory and payer discussions.
The results reinforce the potential of allogeneic CAR‑T therapies to offer a scalable, off‑the‑shelf alternative to autologous products. Zugocaptagene geleucel has already received Regenerative Medicine Advanced Therapy (RMAT) designation for certain CD19‑positive B‑cell malignancies, which could accelerate its regulatory pathway. In addition, CRISPR has announced a collaboration with Lilly to evaluate the drug in combination with pirtobrutinib, expanding its therapeutic reach and strengthening its pipeline.
Financially, CRISPR reported a Q3 2025 net loss of $106.4 million on revenue of $0.889 million, with cash and cash equivalents totaling $286.5 million. The company’s strong liquidity position supports continued investment in clinical development, including the upcoming larger LBCL trials and autoimmune indications.
Investor sentiment has been positive following the announcement, reflecting confidence in the drug’s efficacy profile and the broader pipeline strategy. The data are expected to influence future guidance and may shape the company’s commercial planning for the next phase of development.
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