EHA2026 | What are the latest findings from the phase I CaMMouflage trial evaluating CB-011 in RRMM?

During the European Hematology Association (EHA) 2026 Congress, June 11–14, 2026, Stockholm, SE, the Multiple Myeloma Hub spoke with Binod Dhakal, Medical College of Wisconsin, Milwaukee, US. We asked, What are the latest findings from the phase I CaMMouflage trial evaluating CB-011 in relapsed/refractory multiple myeloma (RRMM).

Key points¹

• CB-011 is an allogeneic anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell therapy with immune cloaking that is manufactured from healthy donor T cells.
• The ongoing phase I CaMMouflage trial (NCT05722418) is evaluating the efficacy and safety of CB-011 in patients with RRMM who have received ≥3 prior lines of therapy; prior BCMA-targeted therapy is allowed provided the washout period is ≥90 days. 
• The CaMMouflage trial utilizes a standard 3+3 dose-escalation design, followed by an expansion phase at the maximum tolerated dose and/or the recommended phase II dose (RP2D). 
• Patients enrolled in the dose escalation phase receive a 3-day lymphodepletion (LD) regimen of either 300 mg/m² or 500 mg/m² cyclophosphamide with 30 mg/m² fludarabine, followed by a single infusion of CB-011 at one of five dose levels: 50M, 150M, 300M, 450M, or 800M.
  • The 450M dose was selected as the recommended dose for expansion based on preliminary data.²
• As of April 20, 2026, 48 patients had been enrolled.
  • The median age was 68.5 years and patients had received a median of 4 prior lines of therapy; high-risk cytogenetics were reported in 56% of patients and 33% had extramedullary disease.
• In patients naïve to BCMA-targeted therapy receiving 450M CB-011 CAR T-cell after LD with 500 mg/m² cyclophosphamide and 30 mg/m² fludarabine (RP2D; n = 12), the overall response rate was 92% and 83% of patients achieved a complete response or better. 
• No cases of graft-versus-host disease, parkinsonism, or cranial nerve palsies were observed in patients at the selected LD.
• Three Grade 5 adverse events (AEs) occurred at the 450M CAR T-cell dose (immune effector cell-associated hematotoxicity on Day 90 [related], pneumonia on Day 50 [unrelated], and respiratory acidosis on Day 466 [unrelated]); one Grade 5 adverse event occurred at the 300M dose (respiratory syncytial virus on Day 73 [unrelated]).
• At the 450M CAR T-cell dose, one Grade ≥3 cytokine release syndrome (CRS) event was reported and there were no Grade ≥3 immune effector cell-associated neurotoxicity syndrome events.
• CB-011 expansion was enriched in the CD8⁺ T-cell compartment, where a balance of effector and central memory T-cell phenotypes was observed, reinforcing the potent antitumor activity and functional persistence of CB-011.
• Overall, these findings support CB-011 as a promising treatment option for patients with high-risk, heavily pretreated RRMM.
• The dose expansion phase of CaMMouflage is enrolling BCMA-naïve and prior BCMA therapy-exposed patients with RRMM to continue the evaluation of 450 M CB-011 CAR T-cell therapy in these patient populations, with trial completion expected next year. 

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