Irvine, California — November 20, 2025 — Leads & Copy — PeproMene Bio, Inc. has announced that two abstracts featuring data from its Phase 1 studies of PMB-CT01 (BAFFR-CAR T) will be presented at the 2025 American Society of Hematology (ASH) Annual Meeting.
The abstracts will highlight the safety and efficacy of PMB-CT01 in patients with relapsed or refractory B-cell Acute Lymphoblastic Leukemia (B-ALL) and B-cell Non-Hodgkin Lymphoma (B-NHL), including those who had not responded to prior CD19-directed therapy or those with CD19-negative disease. The interim results are derived from Phase 1 dose-escalation studies (NCT04690595, NCT05370430) and indicate that BAFF-R is a target that can overcome CD19 antigen escape, while maintaining durable activity and low toxicity.
Key findings for r/r B-NHL:
Safety: PMB-CT01 demonstrated a favorable tolerability profile, with no Grade ˃1 Cytokine Release Syndrome (CRS) and no Grade ˃1 Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS).
Efficacy: All seven patients in the study achieved Complete Response (CR) one to three months post-infusion, including those previously treated with CD19 CAR T therapy and those with CD19-negative disease.
Durability: Remissions have remained ongoing for up to 32+ months (median 17 months) at data cutoff.
Key findings for r/r B-ALL:
Efficacy: Four of six enrolled patients achieved an undetectable Minimal Residual Disease (MRD-) Complete Remission (CR).
High-Risk Population: Three of the four responders were CD19-negative at enrollment. All three successfully transitioned to allogeneic hematopoietic cell transplant (HCT) with curative intent.
Safety: No Dose-Limiting Toxicities (DLTs) were observed. One patient experienced Grade 2 CRS, with no Grade 3 CRS reported.
Hazel Cheng, Ph.D., COO of PeproMene Bio, stated that the consistent and durable activity observed across both B-ALL and B-NHL, particularly in patients who have exhausted CD19 CAR T options or present with CD19-negative disease, supports BAFF-R as a highly effective and safe alternative target. She added that the data highlights PMB-CT01’s potential to address critical unmet needs in high-risk relapsed disease.
ASH 2025 Oral Presentations:
Abstract Title: BAFFR-CAR T cells demonstrate durable responses and manageable toxicities in r/r B-cell lymphomas…
Abstract: abs25-7079
Date/Time: December 6, 2:45 PM
Presenter: Elizabeth Budde, M.D., Ph.D.
Abstract Title: BAFFR-CAR T cells show promising safety and anti-leukemia efficacy in r/r B-cell ALL patients…
Abstract: abs25-2035
Date/Time: December 8, 11:00 AM
Presenter: Ibrahim Aldoss, M.D.
(Dates/times are placeholders.)
About PMB-CT01:
PMB-CT01 is a first-in-class BAFF-R–targeted autologous CAR T cell therapy. BAFF-R is expressed almost exclusively on B cells and is essential for B-cell survival, reducing the likelihood of antigen-loss escape. PMB-CT01 is being evaluated in Phase 1 trials for r/r B-NHL and r/r B-ALL.
Hazel Cheng, Ph.D., COO, PeproMene Bio, Inc., Hazel.Cheng@pepromenebio.com
Source: PeproMene Bio, Inc.
