Relapsed or Refractory B-cell Non-Hodgkin's LymphomaPhase 1NCT05370430
BAFFR-targeting CAR T Cells for Patients With Relapsed or Refractory B-NHL
A Phase 1 study testing BAFFR-CAR T cells in people with Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma, run by PeproMene Bio, Inc. at 6 sites in United States.
Trial summary
A Phase 1 Study Evaluating BAFFR-targeting CAR T Cells for Patients with Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
- What is being tested?
- BAFFR-CAR T cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 6 sitesUnited States
- Study dates
- 13 Jun 2022to 13 Jun 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed Consent: Signed informed consent by the participant or legally authorized representative.
- Age \& Performance Status:
- Age ≥ 18 years
- ECOG performance status ≤ 2
- Diagnosis \& Disease Criteria:
- Histologically confirmed B-NHL, including LBCL, MCL, and FL/MZL subtypes meeting specified prior treatment conditions.
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- BAFF-R expression on lymphoma cells required.
- Measurable Disease: Tumor ≥1.5 cm on CT/PET scan or evidence of disease in blood, BM, GI, skin, or spleen.
- Prior CAR T-cell Therapy: Allowed if ≥ 3 months since last treatment and CD19 CAR-T persistence < 5% before leukapheresis.
- 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.
- Infectious Disease Screening: Seronegative for HIV, active HBV, active HCV (or undetectable viral load if positive).
- Reproductive Considerations:
- Negative pregnancy test for females of childbearing potential.
- Use of effective contraception or abstinence through 3 months post-treatment.
Who cannot join
- Prior Therapies \& Transplants:
- Prior allogeneic SCT.
- Autologous SCT < 6 months before leukapheresis.
- Concurrent systemic steroids or chronic immunosuppressant use.
- Disease-Specific Exclusions:
- Cardiac lymphoma involvement.
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- Need for urgent therapy due to tumor-related complications (e.g., bowel obstruction).
- 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.
- Pregnancy \& Breastfeeding: Females who are pregnant or nursing.
- Other Considerations:
- Investigator-determined safety concerns.
- Potential noncompliance with study procedures.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Atrium Health Levine Cancer Institute - Morehead
Charlotte, North Carolina, 28204
Alexandra M White, 800-821-1535, Alexandra.M.White@advocatehealth.org
- Recruiting
City of Hope Medical Center
Duarte, California, 91010
Elizabeth Budde, MD
Qing Liu-Michael, PhD, qliumichael@coh.org
- Recruiting
University of Kansas Hospital
Kansas City, Kansas, 66160
CTNurseNav, 913-945-7552, CTNurseNav@kumc.edu
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Kayla Wagenmann, CRC-RN, 612-624-2342, wage0074@umn.edu
- Recruiting
Providence Swedish Cancer Institute
Seattle, Washington, 98104
Tori Braun, 206-386-2525, tori.braun@swedish.org
- Recruiting
Stanford University
Stanford, California, 94305
Priya Sharma, 650-723-1776, priyas33@stanford.edu
Matthew Frank
About this study
Official title: 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)
Read the 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.
- Being tested
- BAFFR-CAR T cells
- Keywords
- Relapsed or Refractory, Mantle Cell Lymphoma, BAFFR-CAR T cells, B-cell Non-Hodgkin's Lymphoma, B-NHL, BAFFR, MCL, LBCL
- Medical subject headings
- Recurrence, Lymphoma, B-Cell, Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAFFR-CAR T cellsBiological
First-in-human trial examining the safety and preliminary efficacy of BAFFR-CAR T cells in participants with r/r B-NHL
| Study group | Role | What they receive |
|---|---|---|
| B-cell activating factor receptor-Chimeric antigen receptor T cells [BAFFR-CAR T cells] | Experimental | BAFFR-CAR T cells in participants with r/r B-NHL Receives: Biological: BAFFR-CAR T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
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.
Measured: Up to 1 year post treatment
Maximum Tolerated Dose (MTD)
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.
Measured: The DLT evaluation period is defined as 28 days following BAFFR CAR-T infusion.
Secondary outcomes (5)
Disease Response
Defined as achieving a best response of complete response or partial response per Lugano Criteria
Measured: Up to 1 year post treatment
Minimal Residual Disease (MRD)
Negative MRD is defined by malignant cells < 0.01% by flow cytometry or clonoSEQ.
Measured: Up to 1 year post treatment
B Cell Quantification
Measured by flow cytometry
Measured: Up to 1 year post treatment
Progression-free survival (PFS)
Kaplan-Meier product limit method with log-log transformation for the confidence interval will be used to estimate PFS.
Measured: 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)
Kaplan-Meier product limit method with log-log transformation for the confidence interval will be used to estimate OS.
Measured: From the day of BAFFR-CAR T cell infusion to death from any cause assessed, up to 15 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start13 Jun 2022
- Primary completion13 Jul 2027 (estimated)
- Study completion13 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsed or Refractory B-cell Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PeproMene Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- City of Hope Medical Center
- Responsible party
- Sponsor
- Investigators
- Elizabeth Budde, MD, Study chair, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370430
- Sponsor's protocol ID
- PMB-102
- Other IDs
- PMB-BAFFR-102
- Status last verified
- Nov 2025
- First submitted
- 6 May 2022
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Dong Z, Budde LE, Oh E, Szymura S, Anderson A, Del Real M, Cha SC, Forman SJ, Kwak LW, Wang X. Analysis of polyfunctionality for enhanced BAFF-R CAR T-cell therapy for hematologic malignancies. Blood Adv. 2024 Aug 13;8(15):4066-4076. doi: 10.1182/bloodadvances.2024013195.
PubMed 38885481
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study Evaluating BAFFR-targeting CAR T Cells for Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL)
- ClinicalTrials.gov ID
- NCT05370430
- Acronym / sponsor ID
- PMB-102
- Keywords
- Relapsed or Refractory, Mantle Cell Lymphoma, BAFFR-CAR T cells, B-cell Non-Hodgkin's Lymphoma, B-NHL, BAFFR, MCL, LBCL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- PeproMene Bio, Inc.Industry (pharma, biotech, devices)
- Collaborators
- City of Hope Medical Center
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 13 Jul 2027 (estimated)
- Study completion
- 13 Jun 2028 (estimated)
- First posted
- 11 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 1 Study Evaluating BAFFR-targeting CAR T Cells for Patients with Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL)
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| B-cell activating factor receptor-Chimeric antigen receptor T cells [BAFFR-CAR T cells] | Experimental | Biological: BAFFR-CAR T cellsBAFFR-CAR T cells in participants with r/r B-NHL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Informed Consent: Signed informed consent by the participant or legally authorized representative.
- Age \& Performance Status:
- Diagnosis \& Disease Criteria:
- Measurable Disease: Tumor ≥1.5 cm on CT/PET scan or evidence of disease in blood, BM, GI, skin, or spleen.
- Prior CAR T-cell Therapy: Allowed if ≥ 3 months since last treatment and CD19 CAR-T persistence < 5% before leukapheresis.
Key exclusion criteria (18 listed)
- Prior Therapies \& Transplants:
- Disease-Specific Exclusions:
- Medical Conditions:
- Pregnancy \& Breastfeeding: Females who are pregnant or nursing.
- Other Considerations:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAFFR-CAR T cellsFirst-in-human trial examining the safety and preliminary efficacy of BAFFR-CAR T cells in participants with r/r B-NHL | Biological | B-cell activating factor receptor-Chimeric antigen receptor T cells [BAFFR-CAR T cells] |
Primary outcome
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.
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.
5 secondary outcomes
Disease Response
Time frame: Up to 1 year post treatment
Minimal Residual Disease (MRD)
Time frame: Up to 1 year post treatment
B Cell Quantification
Time frame: 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.
Overall Survival (OS)
Time frame: From the day of BAFFR-CAR T cell infusion to death from any cause assessed, up to 15 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Derived from this study: PubMed 38885481Dong Z, Budde LE, Oh E, Szymura S, Anderson A, Del Real M, Cha SC, Forman SJ, Kwak LW, Wang X. Analysis of polyfunctionality for enhanced BAFF-R CAR T-cell therapy for hematologic malignancies. Blood Adv. 2024 Aug 13;8(15):4066-4076. doi: 10.1182/bloodadvances.2024013195.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabeth Budde, MD study chair
City of Hope Medical Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BAFFR-CAR T cells in people with Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma, run by PeproMene Bio, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hazel (Ting-Ying) Cheng, PhD (714-599-8077, hazel.cheng@pepromenebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: Up to 1 year post treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05370430, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.