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New treatment option for Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
Official title BAFFR-targeting CAR T Cells for Patients With Relapsed or Refractory B-NHL
ClinicalTrials.gov ID: NCT05370430
What this study is testing
What is BAFFR-CAR T cells?
BAFFR-CAR T cells is an investigational medicine, being studied as a potential treatment for relapsed or refractory b-cell non-hodgkin's lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Phase 1 Study Evaluating BAFFR-targeting CAR T Cells for Patients with Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL)
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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:
You likely can't join if
- 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.
See the full eligibility criteria
- 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.
- 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.
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Stanford, California, United States
- Kansas City, Kansas, United States
- Minneapolis, Minnesota, United States
- Charlotte, North Carolina, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Stanford, California, United States; Kansas City, Kansas, United States; Minneapolis, Minnesota, United States; Charlotte, North Carolina, United States; Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.