BAFFR-targeting CAR T Cells for Patients With Relapsed or Refractory B-NHL

November 17, 2025 updated by: PeproMene Bio, Inc.

A Phase 1 Study Evaluating BAFFR-targeting CAR T Cells for Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL)

A Phase 1 Study Evaluating BAFFR-targeting CAR T Cells for Patients with Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This phase I trial evaluates the side effects and best dose of BAFFR-CAR T cells in treating patients with B-cell Non-Hodgkin's Lymphoma (B-NHL) that has come back (recurrent) or does not respond to treatment (refractory). T cells are infection fighting blood cells that can kill cancer cells. The T cells given in this study will come from the patient and will have a new gene put in them that makes them able to recognize BAFFR, a protein on the surface of cancer cells. These BAFFR-specific T cells may help the body's immune system identify and kill BAFFR+ cancer cells.

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope Medical Center
        • Contact:
          • Elizabeth Budde, MD
        • Contact:
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford University
        • Principal Investigator:
          • Matthew Frank
        • Contact:
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Hospital
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Contact:
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • Providence Swedish Cancer Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Informed Consent: Signed informed consent by the participant or legally authorized representative.

  2. Age & Performance Status:

    • Age ≥ 18 years
    • ECOG performance status ≤ 2

  3. Diagnosis & Disease Criteria:

    • Histologically confirmed B-NHL, including LBCL, MCL, and FL/MZL subtypes meeting specified prior treatment conditions.
    • BAFF-R expression on lymphoma cells required.
  4. Measurable Disease: Tumor ≥1.5 cm on CT/PET scan or evidence of disease in blood, BM, GI, skin, or spleen.
  5. Prior CAR T-cell Therapy: Allowed if ≥ 3 months since last treatment and CD19 CAR-T persistence < 5% before leukapheresis.

  6. Organ Function & Laboratory Criteria:

    • Hematologic: ANC ≥ 1000/μL, Platelets ≥ 75,000/μL (exceptions for BM involvement).
    • Liver Function: Bilirubin ≤ 1.5x ULN (except Gilbert's), AST/ALT < 3x ULN.
    • Renal Function: CrCl ≥ 50 mL/min.
    • Cardiac & Pulmonary: LVEF ≥ 45%, QTcF ≤ 480 ms, O₂ saturation > 91% on room air.
  7. Infectious Disease Screening: Seronegative for HIV, active HBV, active HCV (or undetectable viral load if positive).

  8. Reproductive Considerations:

    • Negative pregnancy test for females of childbearing potential.
    • Use of effective contraception or abstinence through 3 months post-treatment.

Exclusion Criteria:

  1. Prior Therapies & Transplants:

    • Prior allogeneic SCT.
    • Autologous SCT < 6 months before leukapheresis.
    • Concurrent systemic steroids or chronic immunosuppressant use.

  2. Disease-Specific Exclusions:

    • Cardiac lymphoma involvement.
    • Need for urgent therapy due to tumor-related complications (e.g., bowel obstruction).

  3. Medical Conditions:

    • Active autoimmune disease requiring immunosuppressants.
    • Primary immunodeficiency.
    • Cardiac conditions, including NYHA Class III/IV heart disease, arrhythmia, recent MI (≤ 6 months), stroke (≤ 6 months), or significant VTE (≤ 6 months).
    • Neurologic conditions, including prior optic neuritis, CNS inflammatory diseases, or seizure disorders.
    • History of malignancy, unless resected/treated with curative intent or in remission for ≥ 3 years.
    • Uncontrolled systemic infections or active CNS lymphoma.
  4. Pregnancy & Breastfeeding: Females who are pregnant or nursing.

  5. Other Considerations:

    • Investigator-determined safety concerns.
    • Potential noncompliance with study procedures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: B-cell activating factor receptor-Chimeric antigen receptor T cells [BAFFR-CAR T cells]
BAFFR-CAR T cells in participants with r/r B-NHL
Biological: BAFFR-CAR T cells
First-in-human trial examining the safety and preliminary efficacy of BAFFR-CAR T cells in participants with r/r B-NHL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: Up to 1 year post treatment
Assess the safety of administering BAFFR-CAR T cells in participants with relapsed or refractory (r/r) B-cell Non-Hodgkin's Lymphoma (B-NHL) and it's subtypes. Toxicity will be graded per Common Terminology Criteria for Adverse Events version 5.0, Cytokine Release Syndrome (CRS) and neurotoxicity which use the American Society for Transplantation and Cellular Therapy Consensus Criteria (ASTCT) and Graft versus Host Disease (GVHD) criteria. Toxicities will be followed from the start of lymphodepletion until the end of the study.
Up to 1 year post treatment
Maximum Tolerated Dose (MTD)
Time Frame: The DLT evaluation period is defined as 28 days following BAFFR CAR-T infusion.
Determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of BAFFR-CAR T cells. The highest dose with ≤ 1/6 participants with DLT will be considered the MTD.
The DLT evaluation period is defined as 28 days following BAFFR CAR-T infusion.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Response
Time Frame: Up to 1 year post treatment
Defined as achieving a best response of complete response or partial response per Lugano Criteria
Up to 1 year post treatment
Minimal Residual Disease (MRD)
Time Frame: Up to 1 year post treatment
Negative MRD is defined by malignant cells < 0.01% by flow cytometry or clonoSEQ.
Up to 1 year post treatment
B Cell Quantification
Time Frame: Up to 1 year post treatment
Measured by flow cytometry
Up to 1 year post treatment
Progression-free survival (PFS)
Time Frame: From CAR T cell infusion to the first observation of disease relapse/progression or death from any cause, whichever occurs first, assessed up to 15 years.
Kaplan-Meier product limit method with log-log transformation for the confidence interval will be used to estimate PFS.
From CAR T cell infusion to the first observation of disease relapse/progression or death from any cause, whichever occurs first, assessed up to 15 years.
Overall Survival (OS)
Time Frame: From the day of BAFFR-CAR T cell infusion to death from any cause assessed, up to 15 years.
Kaplan-Meier product limit method with log-log transformation for the confidence interval will be used to estimate OS.
From the day of BAFFR-CAR T cell infusion to death from any cause assessed, up to 15 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PeproMene Bio, Inc.

Collaborators

City of Hope Medical Center

Investigators

  • Study Chair: Elizabeth Budde, MD, City of Hope Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2022

Primary Completion (Estimated)

July 13, 2027

Study Completion (Estimated)

June 13, 2028

Study Registration Dates

First Submitted

May 6, 2022

First Submitted That Met QC Criteria

May 6, 2022

First Posted (Actual)

May 11, 2022

Study Record Updates

Last Update Posted (Actual)

November 20, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMB-102
  • PMB-BAFFR-102 (Other Identifier: PeproMeneBio)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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