Clinical Study of CAR-T Cell Therapy Following ASCT for R/R B-cell Non-Hodgkin's Lymphoma

Phase 2

Recruiting

• Conditions: Lymphoma, B-Cell; Autologous Stem Cell Transplantation
• Interventions: Other: Apheresis; Other: Autologous Stem Cell Transplantation; Drug: CAR-T Cell Therapy

• Registration Number: NCT06381830
• Lead Sponsor: The First Affiliated Hospital of Soochow University

Brief Summary

The study is designed to evaluate 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.

Detailed Description

Chimeric antigen receptor T (CAR-T) cell therapy has emerged as a promising approach for relapsed or refractory B-cell Non-Hodgkin's lymphoma (R/R B-NHL), with a complete response (CR) rate of about 50%. It is also considered to be a reasonable consolidation option in low or unmeasurable disease states recently. Unfortunately, 40%-70% of patients experienced relapse after CAR-T cell therapy in the long-term follow up. Autologous stem cell transplantation (ASCT) with myeloablative chemotherapy can enhance the efficiency of CAR-T cells and alleviate tumor load, leading to a lower relapse rate. As a result, CAR-T cell therapy following ASCT may be a promising method for R/R LBCL patients.

Study Timeline

• Study Start: 2024-01-01
• Status Verified: 2024-03
• Study First Submitted: 2024-04-19
• Study First Submitted QC: 2024-04-19
• Last Update Submitted: 2024-04-19
• Study First Posted: 2024-04-24
• Last Update Posted: 2024-04-24
• Primary Completion: 2027-01-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ASCT+CAR-T	Apheresis	Participants will receive autologous stem cell transplantation followed by chimeric antigen receptor T (CAR-T) cell therapy.
ASCT+CAR-T	Autologous Stem Cell Transplantation	Participants will receive autologous stem cell transplantation followed by chimeric antigen receptor T (CAR-T) cell therapy.
ASCT+CAR-T	CAR-T Cell Therapy	Participants will receive autologous stem cell transplantation followed by chimeric antigen receptor T (CAR-T) cell therapy.

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)	Up to 24 months	Number of participants who will have achieved response after ASCT plus CAR-T cell Therapy.
Progression-free Survival（PFS）	Up to 24 months	PFS is defined as the time from ASCT to progression, death or the last follow-up point

Secondary Outcome Measures

Name	Time	Method
Duration of Response(DOR)	Up to 24 months	To measure the duration of response to ASCT Plus CAR-T Cell Therapy over a follow-up period of 24 months
Complete Response Rate	Up to 24 months	Number of participants who will have achieved complete response after ASCT plus CAR-T cell Therapy.
Overall Survival（OS）	Up to 24 months	OS will be assessed from ASCT plus CAR-T cell therapy to death or last follow-up.
Adverse events profile	Up to 24 months	Number of participants with adverse events. Frequencies of toxicities based on the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 will be tabulated.

Trial Locations

Locations (1)

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China