Caribou Biosciences Outlines Plans for Vispa-cel Phase 3 Trial in LBCL

Company also provides updates on CB-011 program and financing strategy at Leerink Conference

Mar. 14, 2026 at 8:27pm

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Executives from Caribou Biosciences outlined upcoming clinical, regulatory, and financing milestones for its allogeneic cell therapy pipeline during a discussion at the Leerink Global Healthcare Conference in Miami. Management focused on plans to advance its lead program, vispa-cel, into a pivotal Phase 3 study in second-line large B-cell lymphoma (LBCL) and provided updates on CB-011 in multiple myeloma, along with broader partnering and commercialization considerations.

Why it matters

Caribou's vispa-cel represents a potential 'off-the-shelf' allogeneic CAR T-cell therapy that could address access challenges associated with autologous CAR T treatments, which require a multi-week manufacturing process. The company's plans for a pivotal trial in second-line LBCL, a patient population with limited options, could pave the way for vispa-cel to become an important new treatment option.

The details

Caribou said it is in discussions with the FDA to finalize the design of a Phase 3 randomized controlled trial evaluating vispa-cel versus a control arm in second-line LBCL patients who are not eligible for transplant and/or autologous CAR T therapy. The potential trial could enroll around 250 patients, with progression-free survival (PFS) as the primary endpoint. The company aims to initiate the pivotal trial later this year, contingent on concluding FDA discussions. On the control arm, immunochemotherapy is expected to be the general category, with Pola-BR among the options. Caribou also outlined plans to enroll patients at academic centers and 'sophisticated' community centers, and discussed manufacturing and global commercialization strategies for vispa-cel.

  • Caribou expects to provide additional follow-up data on vispa-cel and CB-011 in 2026.
  • The company aims to conclude discussions with the FDA on the Phase 3 vispa-cel trial design in the first half of 2026.
  • Caribou plans to initiate the pivotal vispa-cel trial later in 2026, contingent on finalizing the study design with the FDA.

The players

Caribou Biosciences

A clinical-stage biopharmaceutical company that leverages its proprietary CRISPR-Cas gene-editing platform to develop transformative cell therapies and in vivo treatments for a range of cancers and genetic diseases.

Jennifer Doudna

A Nobel laureate and one of the pioneers of CRISPR gene-editing technology, who co-founded Caribou Biosciences in 2011.

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