CAR-T cell therapy after stem cell transplant for relapsed B-cell lymphoma

Clinical Study of the Efficacy and Safety of Chimeric Antigen Receptor T-cell Therapy Following Autologous Stem Cell Transplantation for Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma

This study is testing if giving CAR-T cell therapy after a stem cell transplant can help people with relapsed B-cell lymphoma feel better and stay in remission longer.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Soochow University (other)
• Drugs / interventions: CAR-T, chimeric antigen receptor, chemotherapy
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT06381830 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the safety and efficacy of chimeric antigen receptor T-cell (CAR-T) therapy administered after autologous stem cell transplantation (ASCT) in patients with relapsed or refractory B-cell Non-Hodgkin's lymphoma. The approach aims to enhance the effectiveness of CAR-T therapy and reduce relapse rates by first using ASCT to decrease tumor burden. Eligible participants are those aged 18-65 with measurable disease who have undergone prior treatments. The study will monitor patient responses and safety outcomes following the combined treatment regimen.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with relapsed or refractory large B-cell Non-Hodgkin's lymphoma who have measurable lesions and have received prior therapies.

Not a fit: Patients who have recently used immunosuppressants or hormones may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve treatment outcomes and reduce relapse rates for patients with relapsed B-cell lymphoma.

How similar studies have performed: Other studies have shown promising results with CAR-T therapy, but this specific combination with ASCT is a novel approach.

Eligibility criteria

Inclusion Criteria:

1. Age: 18-65 years.
2. Pathological immunohistochemistry or flow cytometry confirmed that R/ R Large B-cell Non-Hodgkin's Lymphoma with measurable (the longest diameter greater than 1.5cm and the longest vertical diameter greater than 1.0cm) lesions.
3. Previously treated with 1 or more lines of therapy.
4. ECOG≤2#.
5. The main organ functions need to meet the following conditions:LVEF≥50%;CCr≥30 ml/min; ALT and AST≤3 times normal range.
6. Hematopoietic function needs to meet the following conditions: platelet count≥45×10\^9/L; hemoglobin≥8.0 g/dL; absolute neutrophil count≥1.0×10\^9/L.
7. Subjects of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study until the follow-up one year period of the study.
8. Estimated survival time ≥3 months.
9. Voluntary signing of informed consent and good compliance.

Exclusion Criteria:

1. Have used immunosuppressants or hormones within 2 weeks prior to apheresis, or have to use immunosuppressants or hormones after signing informed consent.
2. The presence of bacterial, fungal, viral, mycoplasma or other types of infection that, in the judgment of the investigator, are difficult to control.
3. Active hepatitis B or active hepatitis C.
4. HIV infection.
5. Have received CAR-T cell therapy or allogeneic hematopoietic stem cell transplantation prior to signing the informed consent.
6. Prior malignancy (other than Relapsed Refractory B-cell Non-Hodgkin's Lymphoma).
7. Pregnant or breasting-feeding women.
8. There is evidence of complications or medical conditions that could interfere with the conduct of the study or put patients at serious risk, including but not limited to serious cardiovascular disease.
9. Conditions deemed by the researchers to be inappropriate for participation.

Where this trial is running

Suzhou, Jiangsu

• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (RECRUITING)

Study contacts

• Study coordinator: Caixia Li, M.D.

Conditions: Lymphoma, B-Cell, Autologous Stem Cell Transplantation, Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma, CAR-T Cell Therapy