PeproMene Bio's BAFF-R CAR-T Therapy Shows 78% Complete Response Rate in B-Cell Lymphoma Patients After CD19 CAR-T Failure
Key Insights
PeproMene Bio (search)'s PMB-CT01, a first-in-class BAFF-R (search)-targeted CAR-T therapy, achieved a 78% complete response rate in nine patients with relapsed/refractory B-cell non-Hodgkin lymphoma (search).
The therapy demonstrated a favorable safety profile with no dose-limiting toxicities, no grade >1 cytokine release syndrome, and no grade >1 immune effector cell-associated neurotoxicity syndrome.
All seven responding patients achieved minimal residual disease-negative status with durable responses, including the longest response exceeding three years without any relapses.
PeproMene Bio (search) announced promising clinical results from its Phase 1 study of PMB-CT01, an investigational B-cell activating factor receptor (BAFF-R (search))-targeted CAR T-cell therapy, demonstrating significant efficacy in patients with relapsed/refractory B-cell non-Hodgkin lymphoma (search) (B-NHL) who had limited treatment options. The updated data will be presented at the 2026 Congress of the European Hematology Association (EHA).
Strong Efficacy in Challenging Patient Population
In the completed dose-escalation portion of the study, PMB-CT01 achieved a 78% complete response (CR) rate, with seven of nine patients achieving complete remission. Notably, the study included patients whose cancer had progressed following standard CD19 (search)-directed CAR T-cell therapy, representing a population with significant unmet medical needs.
All responding patients achieved minimal residual disease (MRD)-negative status, indicating deep remissions with no detectable residual cancer cells. At the last data cutoff, no relapses had occurred and all responses remained ongoing, with the longest response exceeding three years.
Favorable Safety Profile
PMB-CT01 demonstrated a promising safety profile across all nine patients treated in the dose-escalation phase. The therapy showed no dose-limiting toxicities, no grade >1 cytokine release syndrome (CRS), and no grade >1 immune effector cell-associated neurotoxicity syndrome (ICANS). This safety profile may support future use in outpatient community oncology settings.
Expansion Into Multiple Lymphoma Subtypes
Building on these initial results, the trial is actively enrolling patients into expansion cohorts targeting mantle cell lymphoma (search), large B-cell lymphoma (search), and follicular lymphoma (search) (FL). The first patient treated in the expansion phase—a patient with transformed FL (tFL) who had progressed following CD19 (search) CAR-T therapy—achieved a complete response at their first disease assessment. Transformed FL is described as an aggressive form of lymphoma with limited established treatment options.
Novel Therapeutic Target
"When cancer progresses following CD19 (search) CAR T therapy, patients face a significant unmet medical need, with very limited treatment options remaining," said Larry W. Kwak, M.D., Ph.D., scientific founder of PeproMene Bio (search). "These durable CRs clinically validate BAFF-R (search) as a novel target, while the favorable safety profile observed to date may support future use in outpatient community oncology settings and further exploration in refractory autoimmune diseases."
PMB-CT01 represents a first-in-class BAFF-R (search)-targeted autologous CAR T-cell therapy. BAFF-R is expressed almost exclusively on B cells and is essential for B-cell survival, potentially reducing the likelihood of antigen-loss escape that can occur with other CAR-T therapies.
Clinical Development Program
The therapy is being evaluated in ongoing Phase 1 trials for both relapsed/refractory B-NHL and relapsed/refractory B-cell acute lymphoblastic leukemia (search) (B-ALL) under clinical trial identifier NCT05370430. The EHA presentation will provide comprehensive data from the dose-escalation portion of the study, scheduled for June 14, 2026.