Caribou Biosciences Reports Long-Term Vispa-cel Data in Second-line Large B Cell Lymphoma at EHA 2026

On June 11, 2026 Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, reported that vispa-cel, its off-the-shelf CD19-targeted CAR-T cell therapy, produced durable long-term responses in patients enrolled in the ANTLER phase 1 clinical trial for relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL), with the potential to bring the benefit of cell therapy to patients who lack curative options. The results are being presented during an oral presentation at the 2026 European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting on June 12, 2026, at 5:15pm CEST, in Stockholm, Sweden.

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"Vispa-cel is uniquely positioned as the only single-dose, off-the-shelf therapy to demonstrate deep and durable responses on par with autologous CAR-T cell therapies in second-line LBCL," said Rachel Haurwitz, PhD, Caribou’s president and CEO. "The long-term efficacy and safety outcomes we continue to observe reinforce the potential of vispa-cel, as a readily available CAR-T cell therapy, to overcome many of the logistical and access barriers that prevent the majority of second-line patients from receiving therapies with curative intent."

ANTLER phase 1 efficacy and safety data
As of the March 6, 2026, data cutoff date, 27 second-line (2L) large B cell lymphoma (LBCL) patients had received a single dose of 80 million optimized vispa-cel CAR-T cells, defined as cells from a donor younger than 30 years old and with at least 2 matched HLA alleles between patient and donor. This pivotal optimized vispa-cel subgroup best represents the treatment regimen and patient population for the planned ANTLER-3 phase 3 clinical trial.

Efficacy data from the pivotal optimized vispa-cel subgroup included:
•82% overall response rate (ORR)
•67% complete response (CR) rate
•17.1 months median progression-free survival (PFS)

Vispa-cel continues to demonstrate a generally well-tolerated safety profile. In the pivotal optimized vispa-cel subgroup (N=27), there were no reports of graft-versus-host disease (GvHD) or grade 3 or higher (≥Gr 3) immune effector cell-associated neurotoxicity syndrome (ICANS), and there was one (4%) ≥Gr 3 cytokine release syndrome (CRS). Other adverse events of special interest included six (22%) ≥Gr 3 infections, five (21%; 5/24) ≥Gr 3 prolonged cytopenias, and one (4%) ≥Gr 3 immune effector cell-associated HLH-like syndrome (IEC-HS). In the pivotal optimized vispa-cel subgroup, one vispa-cel-related death occurred due to IEC-HS and one possibly-related death occurred due to progressive multifocal leukoencephalopathy.

"These data demonstrate that vispa-cel’s durable responses may have similar curative potential as we see with approved autologous CAR-T cell therapies. As an allogeneic CAR-T cell therapy, vispa-cel could provide a much-needed treatment option for those patients who cannot receive autologous CAR-T cell therapy as second or later line of therapy," said presenting author, Stephen J. Schuster, MD, Louis-Dreyfus professor of CLL and lymphoma and director of lymphoma program and lymphoma translational research at the Abramson Cancer Center, University of Pennsylvania. "Many patients don’t receive auto CAR-T cell therapy due to rapid disease progression, low blood T cell counts, or lack of access to these specialized therapies. Vispa-cel is well positioned to address these challenges as a readily available, off-the-shelf therapy that can be administered in the community setting."

As previously disclosed, Caribou has reached alignment with the FDA on the design of ANTLER-3, a randomized, controlled pivotal phase 3 clinical trial expected to enroll approximately 250 CD19-naïve 2L LBCL patients who are not eligible for transplant and not candidates or not eligible for autologous CAR-T cell therapy based on access challenges or medical criteria, including the need for urgent therapy. Patients in the investigational arm will receive a single dose of 80 million optimized vispa-cel CAR-T cells following lymphodepletion. Patients in the comparator arm will be treated with an investigator’s choice of standard-of-care regimen: polatuzumab vedotin (Pola), bendamustine (B), and rituximab (R) (Pola-BR); R, gemcitabine, and oxaliplatin (R-GemOx); Pola-R-GemOx (Pola-RGO); or tafasitamab and lenalidomide. Crossover to the vispa-cel arm is permitted after progressive disease. The primary endpoint is progression-free survival (PFS). The study is expected to be conducted at approximately 75 clinical trial sites globally, including academic and sophisticated community centers in the United States.

EHA oral presentation details
Title: Vispa-cel, an allogeneic anti-CD19 CAR-T cell therapy with a PD-1 knockout, in patients with relapsed/refractory B cell non-Hodgkin lymphoma (ANTLER phase 1 clinical trial)
Presenter: Stephen J. Schuster, MD, Robert and Margarita Louis-Dreyfus professor of chronic lymphocytic leukemia and lymphoma; department of medicine, hematology-oncology division; director, lymphoma program and lymphoma translational research; Abramson Cancer Center, University of Pennsylvania
Date and time: Friday, June 12, 2026, at 5:15 – 6:30pm CEST
Session: Prospective lymphoma trials
Location: Nobel Hall
Abstract number: S236

About vispacabtagene regedleucel
Vispacabtagene regedleucel (vispa-cel; formerly known as CB-010) is an allogeneic anti-CD19 CAR-T cell therapy evaluated in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL). To Caribou’s knowledge, vispa-cel is the first allogeneic CAR-T cell therapy in the clinic with a PD-1 knockout, a genome-editing strategy designed to enhance CAR-T cell activity by limiting premature CAR-T cell exhaustion. The FDA granted vispa-cel Regenerative Medicine Advanced Therapy (RMAT), Fast Track, and Orphan Drug designations for B-NHL.

About the ANTLER phase 1 clinical trial
The ANTLER phase 1 clinical trial evaluated vispa-cel in adult patients with r/r B-NHL in a multicenter, open-label trial. As of a March 6, 2026, data cutoff date, 85 patients were treated in the trial. Using a 3+3 enrollment strategy, safety and efficacy were assessed in 16 patients in dose escalation who received a single dose of 40, 80, or 120 million CAR-T cells preceded by a lymphodepletion (LD) regimen of cyclophosphamide at 60 mg/kg/day for 2 days followed by fludarabine at 25 mg/m2/day for 5 days. Eighty million CAR-T cells was selected as the recommended phase 2 dose (RP2D). Sixty-three second-line large B cell lymphoma (2L LBCL) patients received a single dose of vispa-cel during dose expansion. Six patients were enrolled in a cohort of third-line or later LBCL patients with prior exposure to CD19-targeted therapy. Additional information on the ANTLER trial (NCT04637763) can be found at www.clinicaltrials.gov.

(Press release, Caribou Biosciences, JUN 11, 2026, View Source [SID1234666562])