Caribou Biosciences Reports Long-Term Vispa-cel Data in Second-line Large B Cell Lymphoma at EHA 2026
Rhea-AI Summary
Caribou Biosciences (Nasdaq: CRBU) reported long-term ANTLER phase 1 data for vispa-cel, an allogeneic CD19 CAR-T, in second-line large B cell lymphoma (2L LBCL). In 27 optimized-dose patients, a single 80-million-cell infusion achieved 82% ORR, 67% CR, and 17.1-month median PFS.
The safety profile showed no graft-versus-host disease, no ≥grade 3 ICANS, one (4%) ≥grade 3 CRS, and serious infections and cytopenias in some patients. Caribou outlined the ANTLER-3 pivotal phase 3 trial, enrolling ~250 CD19-naïve 2L LBCL patients versus standard regimens, with PFS as the primary endpoint.
AI-generated analysis. Not financial advice.
Positive
- Single 80M-cell vispa-cel dose achieved 82% overall response rate in 2L LBCL
- Complete response rate reached 67% in the pivotal optimized vispa-cel subgroup (N=27)
- Median progression-free survival reported at 17.1 months in optimized-dose patients
- No graft-versus-host disease or ≥grade 3 ICANS observed in the 27-patient subgroup
- Only one (4%) ≥grade 3 cytokine release syndrome case reported in the pivotal subgroup
- ANTLER-3 phase 3 trial planned to enroll ~250 2L LBCL patients with PFS primary endpoint
Negative
- Six patients (22%) experienced ≥grade 3 infections in the optimized vispa-cel subgroup
- Five of 24 patients (21%) had ≥grade 3 prolonged cytopenias after vispa-cel
- One (4%) ≥grade 3 IEC-HS event and vispa-cel–related death reported
- One possibly vispa-cel–related death due to progressive multifocal leukoencephalopathy
News Market Reaction – CRBU
On the day this news was published, CRBU declined 7.26%, reflecting a notable negative market reaction. Argus tracked a trough of -13.6% from its starting point during tracking. Our momentum scanner triggered 23 alerts that day, indicating elevated trading interest and price volatility. This price movement removed approximately $14M from the company's valuation, bringing the market cap to $177.53M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
CRBU was down 2.72% pre-news while peers were mixed: CCCC up 7.42%, TRDA down 5.84%, KYTX and IPHA also negative, and VTYX slightly positive. Momentum scanner only flagged NTHI (+7.03%), suggesting moves were stock-specific rather than a coordinated sector rotation.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| May 27 | Conference participation | Neutral | +0.0% | Jefferies Global Healthcare Conference fireside chat announcement with webcast access. |
| May 13 | Conference participation | Neutral | +0.9% | H.C. Wainwright BioConnect fireside chat and webcast availability disclosure. |
| May 12 | Clinical meeting update | Positive | +0.0% | Planned EHA oral presentations for vispa-cel and CB-011 phase 1 data. |
| May 7 | Earnings and pipeline | Positive | +3.2% | Q1 2026 results with FDA alignment on ANTLER-3 and RMAT for CB-011. |
| May 5 | Conference participation | Neutral | +1.0% | BofA Health Care Conference fireside chat with webcast details. |
Recent CRBU news has generally led to flat or modestly positive moves, with the largest reaction a +3.19% gain on the Q1 2026 business update tied to vispa-cel and CB-011 progress.
In the last few months, CRBU’s news flow centered on investor conferences, financial updates, and progress of its allogeneic CAR-T pipeline. On May 7, 2026, Q1 results highlighted $118.6M in cash and FDA alignment on the pivotal ANTLER-3 vispa-cel trial, prompting a +3.19% move. Multiple conference appearances in May, plus prior EHA presentation announcements on vispa-cel and CB-011, saw flat to small positive reactions, underscoring steady but measured market responses to non-pivotal updates.
Market Pulse Summary
The stock moved -7.3% in the session following this news. A negative reaction despite encouraging vispa-cel data, with an 82% ORR and 67% CR rate, would fit a cautious pattern where markets discount early-stage results and focus on risks like serious adverse events and pivotal trial execution. Prior news, including FDA alignment on ANTLER-3 and cash of $118.6M, produced only modest gains, suggesting sentiment has remained measured and susceptible to concerns about timelines and capital needs.
Key Terms
car-t cell therapy medical
graft-versus-host disease medical
immune effector cell-associated neurotoxicity syndrome medical
cytokine release syndrome medical
progression-free survival medical
allogeneic medical
lymphodepletion medical
phase 3 medical
AI-generated analysis. Not financial advice.
-- Single dose of vispa-cel produced durable responses in 2L LBCL patients:
-- Generally well-tolerated safety profile continues to support outpatient administration and further expansion to community centers --
-- ANTLER-3 pivotal phase 3 trial designed to address the unmet need in 2L LBCL patients at academic and community centers who lack treatment options with curative intent --
-- EHA oral presentation scheduled for Friday, June 12, 2026, at 5:15pm CEST --
BERKELEY, Calif., June 11, 2026 (GLOBE NEWSWIRE) -- Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, today announced 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) Annual Meeting on June 12, 2026, at 5:15pm CEST, in Stockholm, Sweden.
“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 with at least two matched human leukocyte antigen (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 (
“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.
About Caribou Biosciences, Inc.
Caribou is a clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. Caribou’s chRDNA genome-editing technology enables superior precision to develop cell therapies that are armored to potentially improve activity against diseases. Caribou is focused on vispacabtagene regedleucel (vispa-cel) and CB-011 as off-the-shelf CAR-T cell therapies that have the potential to provide broad access and rapid treatment for patients with hematologic malignancies. Follow the company @CaribouBio and visit www.cariboubio.com.
Forward-looking statements and important information
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential,” or “continue,” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. These forward-looking statements include, but are not limited to, any statements regarding the initiation, timing, progress, strategy, plans, objectives, expectations (including as to the results) with respect to the Company’s CAR-T cell therapy product candidate clinical trials, including the expected design, protocol, and timing of initiation of the pivotal phase 3 clinical trial for vispa-cel in 2L LBCL CD19-naïve patients; its ability to successfully develop its CAR-T cell therapy product candidates and to obtain and maintain regulatory approval for these product candidates; the likelihood of its clinical trials demonstrating safety and efficacy of its CAR-T cell therapy product candidates; the beneficial characteristics, safety, efficacy, therapeutic effects, and potential advantages of its CAR-T cell therapy product candidates; and the expected timing or likelihood of regulatory filings and approval for its CAR-T cell therapy product candidates. Management believes that these forward-looking statements are reasonable as and when made. However, such forward-looking statements are subject to risks and uncertainties, and actual results may differ materially from any future results expressed or implied by the forward-looking statements. Risks and uncertainties include, without limitation, risks inherent in the development of allogeneic CAR-T cell therapy products; uncertainties related to the initiation, cost, timing, progress, and results of its current and future clinical trials; the risk that initial, preliminary, or interim clinical trial data will not ultimately be predictive of the safety and efficacy of its CAR-T cell therapy product candidates or that clinical outcomes may differ as patient enrollment continues and as more patient data becomes available; the risk that different conclusions or considerations are reached once additional data have been received and fully evaluated; the ability to obtain key regulatory input and approvals; and risks related to its limited operating history, history of net operating losses, financial position, and its ability to raise additional capital as needed to fund its operations and CAR-T cell therapy product candidate development, including the ability to fully fund its pivotal phase 3 clinical trial for vispa-cel; as well as other risk factors described from time to time in the Company’s filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2025, and subsequent SEC filings. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason.
Caution should be exercised when interpreting results from separate trials involving commercially approved autologous CAR-T cell therapies. The results of autologous CAR-T cell therapies referenced in this press release have been derived from publicly available reports of clinical trials not conducted by the Company, and the Company has not performed any head-to-head trials comparing any of these autologous CAR-T cell therapies with vispa-cel. As such, the results of these autologous CAR-T cell therapy clinical trials may not be comparable to clinical results for vispa-cel. The autologous CAR-T cell therapy clinical trials vary in material ways from the ANTLER clinical trial for vispa-cel including with respect to trial design and duration, patient population, patient characteristics, clinical trial phase, treatment protocols, investigators, and other important factors. As a result, cross-trial comparisons may have no interpretive value on the Company’s existing or future clinical results. For further information and to understand these material differences, you should read the reports for the autologous CAR-T cell therapy clinical trials and the sources included in the Company’s corporate presentations on its website.
Note: Dr. Schuster receives compensation as a member of the Company’s scientific advisory board.
Caribou Biosciences, Inc. contact:
Peggy Vorwald, PhD
investor.relations@cariboubio.com
media@cariboubio.com
