PeproMene Bio, Inc. has announced the publication in The Lancet of results from its phase 1 clinical trial evaluating PMB-CT01, the company’s first-in-class BAFF-R-targeted CAR T-cell therapy, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma.
The publication reports durable complete clinical responses, together with a more favourable safety profile compared with approved CAR T-cell therapies. Seven of nine treated patients achieved a complete response (CR), including four of six patients who had progressed after conventional CD19-directed CAR T-cell therapy (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.
PMB-CT01 was safe, as all cytokine release syndrome (CRS) events and the two reported immune effector cell-associated neurotoxicity syndrome (ICANS) events were limited to Grade 1.
Based on the results, the phase 1 trial has expanded from a single clinical trial site at City of Hope, a cancer research and treatment organisation, to multiple additional medical centres across the US. The publication also reports 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.
“Publishing these peer-reviewed data in The Lancet represents a significant recognition of this novel therapy,” said Larry W. Kwak, scientific founder of PeproMene Bio.
“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, paper co-author and director of the Hematologic Malignancies Institute at City of Hope.
“City of Hope will continue to support the trial as the coordinating center and manufacturing site in addition to patient enrolment.”
In December 2024, the Institute for Follicular Lymphoma Innovation (IFLI) committed up to $11m 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 in advancing BAFF-R CAR T-cell therapy and encouraged by these early, durable responses,” said Mehrdad Mobasher, executive partner at the Institute for Follicular Lymphoma Innovation.