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

Launched by PEPROMENE BIO, INC. · May 6, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment using specially modified immune cells called CAR T cells to help patients with a type of blood cancer known as B-cell Non-Hodgkin's Lymphoma (B-NHL) that has either come back or has not responded to previous treatments. The study is currently recruiting participants aged 18 and older who have a confirmed diagnosis of specific types of B-NHL and have undergone at least two prior therapies. To qualify, patients must have some measurable disease and a certain level of a protein called BAFF-R on their cancer cells.

Participants in this trial can expect to receive the experimental CAR T cell therapy, which is designed to target the BAFF-R protein on their lymphoma cells. They will be closely monitored for safety and effectiveness throughout the study. It's important to note that this trial may not be suitable for everyone, as there are specific health criteria that must be met, including having no recent serious health issues or other significant medical conditions. If you or a loved one are interested in participating, discussing this with your healthcare provider can help determine if this trial is a good fit.

Gender

ALL

Eligibility criteria

• 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.