PeproMene Bio's BAFF-R CAR T-Cell Therapy Shows 80% Complete Response Rate in Relapsed/Refractory B-Cell Lymphomas
核心洞察
PeproMene Bio (搜索)'s first-in-class BAFF-R (搜索)-targeted CAR T-cell therapy PMB-CT01 achieved an 80% complete response rate (7 of 9 patients) in a Phase 1 trial for relapsed/refractory B-cell non-Hodgkin lymphoma (搜索).
Four of six patients who had progressed after prior CD19-directed CAR T-cell therapy achieved complete responses, with no relapses observed and the longest ongoing response reaching 35 months.
All cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome events were limited to Grade 1, suggesting a more favorable safety profile than approved CAR T-cell therapies.
PeproMene Bio (搜索), Inc. announced publication in The Lancet of results from its Phase 1 clinical trial evaluating PMB-CT01, a first-in-class BAFF-R (搜索)-targeted CAR T-cell therapy, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (搜索) (B-NHL). The publication reports durable complete clinical responses together with a more favorable safety profile compared with approved CAR T-cell therapies.
Seven of nine treated patients (80%) achieved a complete response (CR), including four of six patients who had progressed after conventional CD19-directed CAR T-cell therapy, a setting referred to as "CAR after CAR." All complete responses remained ongoing at the time of data cutoff, with no relapses observed and the longest ongoing complete response reaching 35 months, suggesting the likelihood of cure.
Safety Profile
PMB-CT01 demonstrated a notably favorable safety profile. All cytokine release syndrome (CRS) events and the two reported immune effector cell-associated neurotoxicity syndrome (ICANS) events were limited to Grade 1.
Trial Expansion
Based on these results, the Phase 1 trial has expanded from a single clinical trial site at City of Hope (搜索) to multiple additional medical centers across the United States. The publication also reports that the first patient treated in the expansion phase—who had triple-hit high-grade B-cell lymphoma following progression after CD19-directed CAR T-cell therapy—also achieved a complete response at the first disease assessment.
Expert Commentary
"Publishing these peer-reviewed data in The Lancet represents a significant recognition of this novel therapy," said Larry W. Kwak, M.D., Ph.D., scientific founder of PeproMene Bio (搜索). "With the lack of any relapses, we believe PMB-CT01 is a paradigm-shifting CAR T-cell option for blood cancers which were previously thought to be incurable. Its elite safety may also enable outpatient administration—improving access for underserved patients—while also opening doors for treating autoimmune diseases where B-cell depletion is already proven."
"These early results are encouraging, particularly for patients whose disease progressed after CD19 or CD20-directed T-cell therapy," said Stephen Forman, M.D., paper co-author and director of the Hematologic Malignancies Institute at City of Hope (搜索). "City of Hope will continue to support the trial as the coordinating center and manufacturing site in addition to patient enrollment."
Funding and Development Support
In December 2024, the Institute for Follicular Lymphoma Innovation (搜索) (IFLI) committed up to $11 million to support the clinical development of PMB-CT01 in patients with relapsed or refractory follicular lymphoma. "For patients whose lymphoma returns after CD19-directed CAR T-cell therapy, a new target can mean a new chance. IFLI is proud to support PeproMene Bio (搜索) in advancing BAFF-R (搜索) CAR T-cell therapy and encouraged by these early, durable responses," said Mehrdad Mobasher, M.D., M.P.H., Executive Partner at the Institute for Follicular Lymphoma Innovation.
About PMB-CT01
PMB-CT01 is a first-in-class B-cell activating factor receptor (BAFF-R (搜索))-targeted autologous CAR T-cell therapy being evaluated in ongoing Phase 1 trials for relapsed/refractory B-NHL and relapsed/refractory B-ALL. BAFF-R is expressed almost exclusively on B cells and is essential for B-cell survival, reducing the likelihood of antigen-loss escape. PeproMene Bio (搜索) has licensed intellectual property relating to PMB-CT01 from City of Hope (搜索).
The publication, titled "BAFF-R (搜索) CAR T-cell therapy for relapsed or refractory B-cell lymphomas," appears in The Lancet as a Research Letter.