IRVINE, California, May 29, 2026
PeproMene Bio, Inc. has announced that updated clinical data from its ongoing Phase 1 trial of PMB-CT01, a first-in-class anti-BAFF-R CAR-T cell therapy, will be presented in an oral session at the 2026 European Hematology Association (EHA) Congress. The results highlight a highly encouraging combination of durable complete responses, favorable safety outcomes, and deep molecular remissions in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL), including individuals whose disease progressed following prior CD19-directed CAR-T therapy. The findings further validate BAFF-R as a promising new therapeutic target in hematologic cancers and support the continued development of PMB-CT01 for patients facing limited treatment options after standard therapies have failed.
PMB-CT01 Delivers High Complete Response Rates in Difficult-to-Treat Patients
The completed dose-escalation phase of the ongoing Phase 1 study evaluated PMB-CT01 in patients with heavily pretreated relapsed or refractory B-cell lymphomas, including those who had experienced disease progression following approved CD19 CAR-T therapies. Among the nine patients treated, investigators reported a remarkable 78% complete response rate, with seven patients achieving complete remission following treatment. Importantly, no disease relapses were observed at the time of data cutoff, and all responding patients remained in remission, with the longest ongoing response exceeding three years.
The durability of these responses is particularly significant given the challenging nature of the enrolled patient population. Patients who fail prior CD19-directed CAR-T therapies often have limited therapeutic alternatives and poor clinical outcomes. Researchers also reported that responding patients achieved minimal residual disease (MRD)-negative status, indicating the absence of detectable cancer cells using highly sensitive testing methods. These deep and sustained remissions suggest that PMB-CT01 may offer a meaningful therapeutic option for patients who have exhausted currently available treatments and continue to face aggressive disease progression.
Favorable Safety Profile Supports Broader Clinical Potential
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In addition to demonstrating strong efficacy, PMB-CT01 exhibited an encouraging safety profile throughout the dose-escalation study. Investigators reported no dose-limiting toxicities, no cases of Grade 2 or higher cytokine release syndrome (CRS), and no cases of Grade 2 or higher immune effector cell-associated neurotoxicity syndrome (ICANS), two of the most significant safety concerns commonly associated with CAR-T therapies. The absence of severe treatment-related toxicities may represent a key differentiating factor for PMB-CT01 compared with existing cellular immunotherapies.
According to study investigators, the favorable safety findings raise the possibility of expanding CAR-T treatment beyond highly specialized academic centers into broader community oncology settings in the future. Reduced toxicity could also facilitate investigation of BAFF-R-targeted CAR-T therapy in additional indications, including autoimmune diseases where B-cell depletion strategies are increasingly being explored. The safety profile observed to date strengthens confidence in the ongoing clinical development program and supports continued enrollment into expansion cohorts.
BAFF-R Emerges as a Promising New Target in Hematologic Oncology
PMB-CT01 is designed to target B-cell activating factor receptor (BAFF-R), a protein expressed almost exclusively on B cells and essential for their survival. Unlike CD19-targeted therapies, which can become ineffective when cancer cells lose CD19 expression, BAFF-R offers a potentially more stable therapeutic target that may reduce the risk of antigen escape and treatment resistance. The promising clinical data provide important validation for this novel approach and support broader exploration of BAFF-R-directed therapies across multiple hematologic malignancies.
The study is currently enrolling expansion cohorts in mantle cell lymphoma, large B-cell lymphoma, and follicular lymphoma, with early evidence already emerging from the first patient treated in the expansion phase. Notably, a patient with transformed follicular lymphoma who had previously failed CD19 CAR-T therapy achieved a complete response at the initial disease assessment. As the field of cellular immunotherapy continues to evolve, PMB-CT01 represents a potentially transformative next-generation CAR-T therapy capable of addressing significant unmet needs in relapsed and refractory B-cell cancers. The upcoming EHA 2026 presentation is expected to generate considerable interest among oncologists and hematology researchers seeking innovative treatment strategies for patients with advanced lymphoma.
Source: PeproMene Bio press release
