City of Hope and PeproMene Bio Report BAFF-R CAR T-Cell Therapy in Relapsed B-Cell Lymphomas

The Journal Entry Runs to a Byline and a Disclosure

PubMed's record for the item carries a title, five authors, a DOI and an unusually detailed conflict of interest statement, and nothing else. Europe PMC returns the same fields with the abstract slot empty. The journal's own page blocked an automated request from APO|APE News, and no repository copy exists. The disclosure that did publish states that Kwak consults for PeproMene Bio and InnoLifes and holds stock or stock options in both; that Budde received research support from PeproMene paid to her institution and consults for Gilead, Bristol Myers Squibb, AstraZeneca, CRISPR Therapeutics, Roche and Merck; that Chen and Real received research support from PeproMene paid to their institution; and that Song declares no competing interests. De-identified patient-level data are offered to researchers holding regulatory permissions under a data use agreement.

Four Weeks Earlier in the British Journal of Haematology

Four weeks before the Lancet item appeared, a City of Hope group put numbers on why the target is being pursued. Writing in the British Journal of Haematology on July 24, Tizro and colleagues from the Department of Pathology and Laboratory Medicine, working with hematology and with the Toni Stephenson Lymphoma Center, measured BAFF-R on diagnostic and relapsed fresh B-lymphoblastic leukemia samples by multiparameter flow cytometry. Expression was present in most cases, at lower levels than on mature B cells, and it was retained in the majority of CD19-negative relapses that followed CD19-directed therapy. TP53 alterations turned out to be concentrated in the CD19-negative immune escape group, 68.8 percent against 21.7 percent, with p = 0.0006 and an odds ratio of 7.9, and BAFF-R stayed on the surface in that high-risk population.

That work covers B-ALL, a different disease from the lymphomas in the Lancet report, and its authors stop at calling BAFF-R a stable immunotherapeutic target relevant to early-phase trials. Kwak and Song are authors on both papers.

NCT05370430 Runs to a July 2027 Primary Completion

NCT05370430 opened as a single-group phase 1 study sponsored by PeproMene Bio with City of Hope as collaborator, and its record was last updated on November 17, 2025 with primary completion estimated for July 13, 2027. Eligible histologies are large B-cell lymphoma, mantle cell lymphoma, and follicular or marginal zone lymphoma meeting specified prior-treatment conditions, in adults with ECOG performance status of 2 or better. Prior allogeneic transplant is disqualifying, and an autologous transplant inside six months of leukapheresis is too. The protocol schedules leukapheresis ahead of lymphodepletion, from which the toxicity clock starts running. PeproMene describes PMB-CT01 as an autologous product built from an anti-BAFF-R single-chain variable fragment with second-generation signaling domains carrying CD3 zeta and 4-1BB, and says it licensed the underlying intellectual property from City of Hope.

The company announced the program's first lymphoma response on December 20, 2022, in a patient with mantle cell lymphoma who had failed chemoimmunotherapy, a BTK inhibitor, venetoclax and CD19 CAR T therapy. "We are pleased to see a deep complete remission which is minimal residual disease negative," said Elizabeth Budde, the City of Hope associate professor in the Division of Lymphoma named as principal investigator on the trial. That release records grade 1 cytokine release syndrome with full recovery and no immune effector cell-associated neurotoxicity syndrome in the first month, and identifies Kwak as City of Hope's vice president and deputy director of its Comprehensive Cancer Center as well as PeproMene's scientific founder and the compensated chair of its scientific advisory board, holding an equity interest in the company.

Secondary measures include best response by Lugano criteria, measurable residual disease set at malignant cells below 0.01 percent by flow cytometry or clonoSEQ, serial B-cell quantification and progression-free survival. Six sites are listed: City of Hope in Duarte, Stanford, the University of Kansas Hospital, the University of Minnesota, Atrium Health Levine Cancer Institute Morehead in Charlotte, and Providence Swedish Cancer Institute in Seattle. Disclosure: City of Hope faculty serve as chairs within the APE|APO Event Series, run by Advancing Precision Medicine, which stands behind this publication.

Why This Matters to the APO|APE Reader

Patients who already had a CD19 CAR T product can enroll only if three months have passed and residual CD19 CAR-T persistence measures below 5 percent before leukapheresis, a threshold that has to be produced by a laboratory before apheresis can be scheduled. That converts CAR persistence from a research assay into a gating test with a manufacturing slot attached to it. Two of the six listed sites, Charlotte and Seattle, sit outside the original West Coast and Midwest set, which puts the same requirement in front of laboratories that have never run it. Until the correspondence itself becomes readable, the size of the treated lymphoma cohort remains a number only its authors have.