Irvine, California – September 10, 2026 -- PeproMene Bio, Inc. reported that seven of nine patients (80%) treated with its BAFF-R-targeted CAR-T therapy PMB-CT01 achieved complete remission in a Phase 1 trial, with results now published in The Lancet.
All complete responses remained relapse-free at data cutoff, with the longest sustained remission reaching 35 months
Four of six patients who had previously progressed after conventional CD19-directed CAR-T therapy also achieved complete response under the new BAFF-R approach, described in the study as "CAR after CAR" treatment. No relapses were observed among any of the seven complete responders as of the data cutoff.
Safety profile shows all cytokine release syndrome cases limited to Grade 1
All reported cases of cytokine release syndrome (CRS) and both cases of immune effector cell-associated neurotoxicity syndrome (ICANS) were confined to Grade 1 severity, a safety profile the company positions as more favorable than approved CD19 CAR-T therapies.
Trial expands from single site at City of Hope to multiple U.S. medical centers
Based on the Phase 1 results, the study has broadened beyond its original single-site location at City of Hope to additional medical centers across the United States. The first patient treated in the expansion phase, who had a high-grade triple-hit B-cell lymphoma that progressed after CD19-directed CAR-T therapy, also achieved complete response at first disease assessment.
"The publication of this peer-reviewed data in The Lancet represents significant recognition of this novel therapy," said Larry W. Kwak, M.D., Ph.D., scientific founder of PeproMene Bio. He said the absence of relapses supports the therapy's potential for blood cancers previously considered incurable, and noted its safety profile could enable outpatient administration, potentially expanding access for underserved patients and opening applications in autoimmune disease treatment.
Stephen Forman, M.D., co-author of the publication and director of the Hematologic Malignancies Institute at City of Hope, said the early results are promising particularly for patients whose disease progressed after CD19- or CD20-directed T-cell therapy. City of Hope will continue to serve as the study's coordinating center, manufacturing site, and patient recruitment hub.
IFLI committed up to $11 million in December 2024 to fund clinical development
The Institute for Follicular Lymphoma Innovation (IFLI) provided up to $11 million in December 2024 to support PMB-CT01's clinical development in patients with relapsed or refractory follicular lymphoma. Mehrdad Mobasher, M.D., M.P.H., managing partner at IFLI, said the early and durable response rates are encouraging for patients whose lymphoma returns after CD19-directed CAR-T therapy.
PMB-CT01 is an autologous CAR-T therapy targeting BAFF-R, a receptor expressed almost exclusively on B cells and essential for B-cell survival, reducing the likelihood of antigen-loss escape. The therapy is also under investigation in ongoing Phase 1 trials for relapsed/refractory B-cell acute lymphoblastic leukemia. PeproMene Bio has licensed intellectual property related to PMB-CT01 from City of Hope.