Irvine, California, U.S., September 8, 2026

PeproMene Bio, Inc. has announced publication in The Lancet of results from a Phase 1 clinical trial evaluating PMB-CT01, the company’s first-in-class BAFF-R-targeted autologous CAR T-cell therapy, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL). The peer-reviewed findings showed deep and durable complete responses, including responses in patients whose disease had progressed following previous CD19-directed CAR T-cell therapy. The results provide early clinical evidence for targeting B-cell activating factor receptor (BAFF-R) as an alternative strategy in heavily pretreated B-cell malignancies.

PMB-CT01 Produces High Complete Response Rate

The Phase 1 study evaluated nine patients with relapsed or refractory B-cell lymphomas treated with PMB-CT01. According to the published results, seven of nine patients, or 80%, achieved a complete response (CR). Importantly, four of six patients whose disease had previously progressed after conventional CD19-directed CAR T-cell therapy also achieved complete responses, highlighting the potential of BAFF-R targeting in patients who have exhausted an established cellular therapy approach. The durability of the responses was another notable finding. At the reported data cutoff, all complete responses remained ongoing, with no relapses observed among the patients who achieved CR. The longest ongoing complete response had reached 35 months. These early observations are particularly relevant in relapsed/refractory lymphoma, where patients who progress following CAR T-cell treatment can face limited therapeutic options and poor outcomes. However, the small Phase 1 population means the findings require confirmation in larger and more controlled clinical studies.

BAFF-R CAR T Shows Favorable Early Safety Profile

The investigators also reported an encouraging safety profile for PMB-CT01. All observed cases of cytokine release syndrome (CRS) were limited to Grade 1, while the two reported cases of immune effector cell-associated neurotoxicity syndrome (ICANS) were also Grade 1. The company said the safety findings compare favorably with the safety considerations associated with currently approved CAR T-cell therapies. The potential safety profile could have implications for how the therapy is administered in future development. PeproMene Bio said the findings may support exploration of outpatient administration, which could potentially improve accessibility and reduce treatment-related burdens for selected patients. Such an approach would require appropriate clinical validation and regulatory assessment before becoming part of routine treatment. PMB-CT01 is designed to target BAFF-R, a receptor expressed almost exclusively on B cells and considered essential for B-cell survival. The company believes this restricted expression profile and the importance of BAFF-R for B-cell biology could reduce the likelihood of antigen-loss escape, a mechanism that can contribute to resistance against targeted cellular therapies.

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Clinical Program Expands Beyond Initial Study Site

The publication in The Lancet follows expansion of the PMB-CT01 Phase 1 program from its original site at City of Hope to additional medical centers across the United States. The first patient treated during the expansion phase had triple-hit high-grade B-cell lymphoma following progression after CD19-directed CAR T-cell therapy and achieved a complete response at the first disease assessment, according to the company. PMB-CT01 is currently being evaluated in ongoing Phase 1 studies for relapsed/refractory B-NHL and relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL). The program represents an effort to broaden the potential role of CAR T-cell therapy beyond conventional CD19 targeting and address patients whose cancers have become resistant to prior cellular therapies. While the Lancet findings are encouraging, PMB-CT01 remains investigational, and larger clinical studies will be necessary to establish its long-term efficacy, safety and potential role in treatment.

Source: PeproMene Bio press release