On June 11, 2026 Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, reported longer follow up data for the ongoing CaMMouflage phase 1 trial of CB-011, the Company’s off-the-shelf CAR-T cell therapy being evaluated for relapsed or refractory multiple myeloma (r/r MM). A single dose of CB-011 produced early, deep, and durable responses in a high-risk, heavily pretreated BCMA-naïve patient population. The Company also reported a case study of a patient previously treated with an approved autologous CAR-T cell therapy who achieved an early complete response after treatment with CB-011. These data are being presented during an oral presentation at the 2026 European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting, taking place June 14, 2026, at 11:00am CEST, in Stockholm, Sweden.

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"Despite recent advances, only about 10% of multiple myeloma patients receive autologous CAR-T cell therapy, highlighting the urgent need for more accessible treatment options," said Binod Dhakal, MD, professor of medicine, Medical College of Wisconsin and investigator on the CaMMouflage trial. "The encouraging CB-011 clinical data demonstrate the potential of a single-dose, off-the-shelf CAR-T cell approach to deliver deep and durable responses, including MRD negativity, for heavily pretreated patients who often have limited treatment options."

CaMMouflage BCMA-naïve dose escalation data
As of the May 26, 2026, efficacy data cutoff date, 48 patients had been treated with CB-011 in the dose escalation portion of the CaMMouflage phase 1 trial. The recommended dose for expansion (RDE) is 450 million CB-011 CAR-T cells after lymphodepletion (LD) with 500 mg/m2 cyclophosphamide and 30 mg/m2 fludarabine daily for three days (selected LD regimen).

Twelve BCMA-naïve patients were treated with the RDE. Median follow up for this cohort is 17.7 months. Data continue to demonstrate that CB-011 drives deep, durable responses after a single dose. Details of the efficacy results for this cohort are as follows:
•92% overall response rate (ORR)
•83% complete response or stringent complete response (≥CR) rate
•91% minimal residual disease (MRD) negativity in 10/11 evaluable patients
•50% of patients in ≥CR at 15 months

As of the April 20, 2026, safety data cutoff date, CB-011 continued to show a manageable safety profile with no cases of graft-versus-host disease (GvHD), immune effector cell-associated enterocolitis, parkinsonism, or cranial nerve palsies in any patient treated with CB-011 (N=48). In all patients treated with the selected LD regimen (N=35), there was one CB-011-related death due to immune effector cell-associated hematotoxicity and three unrelated deaths due to pneumonia, respiratory syncytial virus, and respiratory acidosis, respectively. In the 12-patient BCMA-naive RDE cohort, there were no reports of grade 3 or higher (≥Gr 3) immune effector cell-associated neurotoxicity syndrome (ICANS), and one (8%) ≥Gr 3 cytokine release syndrome (CRS). Other adverse events of special interest in the RDE cohort included three (25%) ≥Gr 3 infections, one (8%) ≥Gr 3 immune effector cell-associated HLH-like syndrome, and five (42%; 5/12) ≥Gr 3 prolonged cytopenias.

CaMMouflage patient case study after prior BCMA-targeted therapy
Caribou also reported a patient case study of a 71-year-old male with r/r MM who received eight prior lines of therapy, including ciltacabtagene autoleucel, an approved autologous CAR-T cell therapy. Before entering CaMMouflage, the patient never achieved a complete response following any of his post-front-line therapies. After receiving a single dose of 450 million CB-011 CAR-T cells (the RDE), the patient achieved a CR at day 28 that was maintained at month 3 and remained ongoing as of the May 26, 2026, efficacy data cutoff date.

The safety profile for this patient was manageable, with grade 1 CRS and grade 3/4 aspartate aminotransferase (AST)/alanine aminotransferase (ALT) elevation. The patient had a history of intermittent ALT elevation prior to enrolling in CaMMouflage. Translational data showed robust CB-011 CAR-T cell expansion and a rapid decrease in serum free light chains that correlated with the patient achieving a CR.

"The durability and depth of response we continue to observe with CB-011 reinforce its potential as a single-dose, off-the-shelf approach that could meaningfully expand access to cellular therapies and change the treatment paradigm for patients with relapsed or refractory multiple myeloma," said Rachel Haurwitz, PhD, Caribou’s president and CEO. "Unlike currently available off-the-shelf treatment approaches that require ongoing administration, CB-011 has demonstrated delivery of deep and durable responses following single infusions, providing patients the potential for a treatment-free period. We are encouraged by the emerging translational and clinical data from both BCMA-naïve and BCMA-exposed patients and look forward to reporting initial dose expansion data in the second half of this year."

EHA oral presentation details
Title: CB-011, an allogeneic anti-BCMA CAR-T cell therapy with immune cloaking, for patients with relapsed/refractory multiple myeloma (CaMMouflage phase 1 trial)
Presenter: Binod Dhakal, MD, professor of medicine, Medical College of Wisconsin
Date and time: Sunday, June 14, 2026, at 11:00am – 12:15pm CEST
Session: Immunotherapy in multiple myeloma
Location: Victoria Hall
Abstract number: S201

About CB-011
CB-011 is an allogeneic anti-BCMA CAR-T cell therapy being evaluated in patients with relapsed or refractory multiple myeloma (r/r MM). To Caribou’s knowledge, CB-011 is the first allogeneic CAR-T cell therapy in the clinic that is engineered to enable activity through an immune cloaking strategy with a B2M knockout and insertion of a B2M–HLA-E-peptide fusion protein to blunt immune-mediated rejection. The FDA granted CB-011 RMAT, Fast Track, and Orphan Drug designations for r/r MM.

About the CaMMouflage phase 1 clinical trial
The CaMMouflage clinical trial is a multicenter, open-label phase 1 trial evaluating CB-011 in adults with r/r MM who have been treated with three or more prior lines of therapy. Using a 3+3 dose escalation design, safety and efficacy of CB-011 were evaluated in 48 patients at multiple dose levels and two different lymphodepletion (LD) regimens. Thirty-five patients were treated with a single dose of CB-011 (150 million [N=6], 300 million [N=13], 450 million [N=13], and 800 million [N=3] CAR-T cells) with an LD regimen of 500 mg/m2 cyclophosphamide and 30 mg/m2 fludarabine daily for three days. The dose expansion portion of the trial is evaluating safety and efficacy of 450 million CB-011 CAR-T cells with the selected LD of 500 mg/m2 cyclophosphamide and 30 mg/m2 fludarabine daily for three days. Additional information on the CaMMouflage trial (NCT05722418) can be found at www.clinicaltrials.gov.

(Press release, Caribou Biosciences, JUN 11, 2026, View Source [SID1234666563])