BAFFR-targeting CAR T Cells for Patients With Relapsed or Refractory B-NHL
NCT ID: NCT05370430
Last Updated: 2025-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
36 participants
INTERVENTIONAL
2022-06-13
2028-06-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
* 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.
18 Years
ALL
No
Sponsors
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City of Hope Medical Center
OTHER
PeproMene Bio, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Elizabeth Budde, MD
Role: STUDY_CHAIR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
Stanford University
Stanford, California, United States
University of Kansas Hospital
Kansas City, Kansas, United States
University of Minnesota
Minneapolis, Minnesota, United States
Atrium Health Levine Cancer Institute - Morehead
Charlotte, North Carolina, United States
Providence Swedish Cancer Institute
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Elizabeth Budde, MD
Role: primary
References
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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.
Other Identifiers
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PMB-BAFFR-102
Identifier Type: OTHER
Identifier Source: secondary_id
PMB-102
Identifier Type: -
Identifier Source: org_study_id
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