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

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

NCT ID: NCT06381830

Condition: Lymphoma, B-Cell
Autologous Stem Cell Transplantation

Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell

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

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Apheresis
Description: Participants will undergo two separate apheresis procedures, including: G-CSF primed hematopoietic stem cell collection and peripheral blood mononuclear cell apheresis for CAR-T cell manufacturing.
Arm group label: ASCT+CAR-T

Intervention type: Other
Intervention name: Autologous Stem Cell Transplantation
Description: Participants are designed to receive myeloablative conditioning regimen prior to infusion of a minimum 2 x 10^6 CD34+ stem cells/kilogram.
Arm group label: ASCT+CAR-T

Intervention type: Drug
Intervention name: CAR-T Cell Therapy
Description: CAR-T cells will be infused within 7 days after autologous hematopoietic stem cell infusion (2-10×10^6 CAR-T/kg，ivgtt).
Arm group label: ASCT+CAR-T

Other name: Chimeric Antigen Receptor T-cell

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Locations:

Facility:
Name: The First Affiliated Hospital of Soochow University

Address:
City: Suzhou
Zip: 215000
Country: China

Status: Recruiting

Contact:
Last name: Caixia Li, M.D.

Phone: +86 512 67781856
Email: licaixia@suda.edu.cn

Start date: January 1, 2024

Completion date: January 1, 2027

Lead sponsor:
Agency: The First Affiliated Hospital of Soochow University
Agency class: Other

Collaborator:
Agency: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Agency class: Industry

Collaborator:
Agency: Suzhou Hongci Hematology Hospital, Suzhou, China
Agency class: Other

Source: The First Affiliated Hospital of Soochow University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06381830