First Patient with Follicular Lymphoma Achieves Complete Response with BAFF-R Targeting CAR-T Cells

Major Advancement in Follicular Lymphoma Treatment

On May 23, 2025, PeproMene Bio, Inc., a clinical-stage biotech company based in Irvine, California, made a groundbreaking announcement regarding its innovative treatment for follicular lymphoma (FL). The company revealed that the first patient in their Phase 1 clinical trial, PMB-102, received BAFF-R targeted CAR-T cells (designated as PMB-CT01) and achieved a complete response (CR) just one month following treatment.

Dr. Elizabeth Budde, the study's principal investigator and an associate professor of hematology at City of Hope, emphasized the significance of this event, stating, “We are excited to report that a patient with relapsed/refractory follicular lymphoma has achieved complete remission with PMB-CT01, raising the count of patients achieving a 100% CR rate to seven, all with sustainable responses and manageable safety profiles.” This highlights the potential of PMB-CT01 as a viable treatment option in an area where patients often experience limited success with current therapies.

Understanding Follicular Lymphoma

Follicular lymphoma is recognized as the most common indolent form of B-cell non-Hodgkin lymphoma, constituting approximately 20% of NHL cases in the U.S. Unfortunately, FL is deemed incurable with existing standard therapies. As patients undergo treatment, the likelihood of relapse increases, shortening the timeframes for remission and the intervals until the next necessary treatment. Hence, patients grappling with relapsed/refractory FL are in dire need of additional therapeutic options.

Dr. Michel Azoulay, marketing director at the Institute for Follicular Lymphoma Innovation (IFLI), expressed optimism regarding PMB-CT01's impact on FL patients: “IFLI aims to expedite the development of innovative treatment options for relapsed/refractory FL patients. The promising effectiveness and safety profile exhibited by PMB-CT01 serves as a beacon of hope.”

Clinical Trial Details and Safety Profile

The Phase 1 PMB-102 study has seen all seven enrolled patients with relapsed/refractory B-cell non-Hodgkin lymphoma—including those with mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), and FL—achieve complete and durable remissions after being treated with PMB-CT01. This remarkable success has been accompanied solely by Grade 1 cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).

For patients who faced relapses after receiving CD19 CAR-T therapy or had CD19-negative tumors, PMB-CT01 positions itself as a compelling alternative. With the center's commitment to advancing this first-in-class BAFF-R CAR-T therapy, PeproMene Bio aims to broaden the scope of their study by incorporating multiple sites and enrolling patients with relapsed or refractory MCL, DLBCL, and FL.

The Technology Behind PMB-CT01

PMB-CT01 represents the first of its kind targeting the BAFF-R, a receptor that is predominantly expressed on B-cells and plays a crucial role in their proliferation and survival. The targeted approach promises that cancer cells cannot elude therapy by downregulating the BAFF-R antigen, making it a hopeful avenue for addressing B-cell malignancies.

Clinical trials for PMB-CT01 are currently underway for both relapsed/refractory B-cell non-Hodgkin lymphoma (NCT05370430) and acute B-cell lymphoblastic leukemia (B-ALL; NCT04690595). Initial results have indicated that PMB-CT01 demonstrates high efficacy and a favorable safety profile in heavily pre-treated populations.

PeproMene Bio licenses the intellectual property of PMB-CT01 from City of Hope, which remains a leader in cancer research and treatment.

Looking Ahead

The ongoing research supported by PeproMene Bio and IFLI signifies a collaboration aimed at unlocking new frontiers in cancer treatment. As this clinical study progresses, it embodies hope for patients with few remaining treatment options. By pursuing innovative approaches and fostering collaboration among the research community, this partnership may usher in a new era of effective therapies for follicular lymphoma and related malignancies.

For further insights into PeproMene Bio’s efforts or to learn about involvement in this groundbreaking study, the public is encouraged to visit www.pepromenebio.com.