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

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Interventional

Phase

Phase 1

Age range

18 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

36 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not applicable

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (5)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

5 locations

Study team and timeline

Lead sponsor

PeproMene Bio, Inc.

Study start

Jun 13, 2022 Actual

Primary completion

Jul 13, 2027 Estimated

Study completion

Jun 13, 2028 Estimated

First posted

May 11, 2022 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts