Key Takeaways:

  • Caribou’s off-the-shelf CAR T (vispa-cel) shows strong phase I results for B cell lymphoma.
  • Efficacy matches autologous CAR-T; 82% response, 64% complete response, 51% progression-free at 12 months.
  • Well tolerated, suitable for outpatient use.
  • FDA granted fast-track designations.
  • Phase 3 trial planned; potential best-in-class therapy.

Caribou Biosciences has reported on a new set of data from ANTLER, a phase I clinical trial evaluating their off-the-shelf CAR T therapy for relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL).

The candidate called, vispacabtagene regedleucel, or vispa-cel (formerly CB-010), and targets CD19, a key marker for B cell lymphomas. The allogenic CAR T candidate also includes a PD-1 knockout gene edit which the company says enhances efficacy by limiting premature CAR T cell exhaustion.

“Exciting Advancement for Cellular Immunotherapy”

Medhi Hamadani is an investigator on the ANTLER trial and Professor of Medicine at the Medical College of Wisconsin. He said that the newly released data, “mark an exciting advancement for the field of cellular immunotherapy.”

“This clinical dataset demonstrates vispa-cel’s efficacy and durability are comparable to autologous CAR-T therapies, yet its off-the-shelf availability and favourable tolerability profile make it well suited for outpatient administration at both large academic centres and sophisticated community hospitals.”

ANTLER Trial

The phase I trial has enrolled 84 participants. Patients were given a single dose of vispa-cel and results have shown that efficacy of the candidate matches that of already-approved autologous CAR T cell therapies. Overall response rate was 82%, complete response rate was 64%, and progression-free survival was 51% at 12 months.

In terms of safety, vispa-cel is well tolerated, allowing for administration in an outpatient setting, a key factor in its availability as an ‘off-the-shelf’ therapy.

Caribou’s president and CEO, Rachel Haurwitz, commented: “Caribou has achieved what the field has long sought – strong evidence that an allogeneic CAR-T cell therapy can be on par with the efficacy and durability of autologous treatments and broaden access with a safety profile that allows for outpatient use.”

“This milestone positions vispa-cel as a potentially best-in-class allogeneic CAR-T cell therapy for patients with large B cell lymphoma.”

Caribou says these results are signs of a potential best-in-class therapy. Detailed results from the study were published in a news release on November 3.

Broader Patient Access

“This combination of robust clinical activity and accessibility could significantly broaden patient access to transformative CAR-T cell treatments, particularly for those who cannot wait or are ineligible for transplantation or autologous CAR-T cell therapies,” said Hamadani.

Haurwitz said: “We believe we have a straightforward regulatory path toward full registration by following the FDA’s recommendation for a randomized, controlled phase 3 trial in second-line large B cell lymphoma, and we plan to refine our pivotal trial design in the coming months through continued engagement with the FDA.”

The FDA has granted vispa-cel special designations including Regenerative Medicine Advanced Therapy (RMAT), Orphan Drug, and Fast Track to expedite its approval for B-NHL.