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CB-011 elicited responses in patients with relapsed/refractory multiple myeloma.
Treatment with the allogeneic, off-the-shelf, BCMA-targeted CAR T-cell therapy CB-011 led to responses in patients with relapsed/refractory multiple myeloma who received at least 3 prior lines of therapy, according to data from the phase 1 CaMMouflage trial (NCT05722418).1
Findings announced by Caribou Biosciences showed that evaluable patients who were naive to BCMA-directed therapy and treated with the recommended dose for expansion (RDE) of CB-011 at 450 x 106 CAR T cells (n = 12) experienced an overall response rate (ORR) of 92%, including 75% who had a complete response (CR) or better. Among 11 evaluable patients in this group, 91% experienced minimal residual disease negativity at a 10-5 sensitivity. As of the September 24, 2025, data cutoff, 7 of the 12 patients remained on the study in a very good partial response or better at least 6 months after receiving a single dose of CB-011.
Regarding safety (n = 48), no instances of graft-vs-host disease, immune effector cell–associated enterocolitis, parkinsonism, or cranial nerve palsies were reported. Treatment emergent adverse effects (TEAEs) reported in at least 25% of patients treated with CB-011 and the selected lymphodepletion regimen of cyclophosphamide at 500 mg/m2 and fludarabine at 30 mg/m2 per day for 3 days (n = 35) included neutropenia (80%), anemia (60%), thrombocytopenia (49%), infections (49%), dizziness (31%), cytokine release syndrome (31%), fatigue (31%), leukopenia (29%), decreased appetite (29%), constipation (26%), and pyrexia (26%).
“Despite a rapidly advancing landscape of treatment options for multiple myeloma, challenges remain with only 10% of eligible patients receiving an autologous CAR [T-cell therapy],” Adriana Rossi, MD, director of CAR-T and Stem Cell Transplant Clinical Program at the Center of Excellence for Multiple Myeloma at Mount Sinai, and an investigator on the CaMMouflage trial, stated in a news release. “I believe the promising responses we are seeing with CB-011 combined with the off-the-shelf nature of this therapy could represent a paradigm shift for patients with relapsed or refractory multiple myeloma. I am excited about the potential this holds for the large number of multiple myeloma patients who simply cannot wait for autologous CAR-T manufacturing and prefer a single dose approach.”
The multicenter, open-label study is enrolling patients at least 18 years of age with relapsed/refractory multiple myeloma and measurable disease who received at least 3 prior lines of therapy including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody as part of a prior line of therapy, either in monotherapy or in combination.2 Patients also need to have an ECOG performance status of 0 or 1, and adequate hematologic, renal, hepatic, pulmonary, and cardiac function.
Investigators are excluding patients who received any prior CAR T-cell therapy; those who underwent autologous stem cell transplant within 6 weeks of lymphodepletion; patients who received allogeneic stem cell transplant within 6 months of lymphodepletion; and those with known active or prior history of central nervous system involvement.
In the first part of the study, CB-011 was evaluated at ascending doses in a 3+3 fashion: 150x106 CAR T cells (n = 6), 300x106 CAR T cells (n = 13), 450x106 CAR T cells (n = 13), and 800x106 CAR T cells (n = 3).1,2 The RDE is being further evaluated in the second part of the study.2
The incidence of dose-limiting toxicities was the primary end point in part 1, and ORR is serving as the primary end point in part 2.
“We are very encouraged by the compelling results from the CaMMouflage phase 1 trial, which demonstrate that CB-011 is delivering deep, durable responses in [patients with] high-risk, heavily pretreated multiple myeloma with a manageable safety profile. These data establish CB-011’s potential to be a best-in-class allogeneic CAR-T cell therapy that could expand access and bring meaningful benefit to patients who urgently need a readily available, single-dose option,” Rachel Haurwitz, PhD, president and chief executive officer of Caribou Biosciences, added in a news release.1 “We plan to initiate dose expansion before year end and to report dose expansion data, along with longer follow up on dose escalation data, in 2026.”
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