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

NCT ID: NCT06381830

Last Updated: 2024-04-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2027-01-01

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.

Conditions

Lymphoma, B-Cell; Autologous Stem Cell Transplantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ASCT+CAR-T

Participants will receive autologous stem cell transplantation followed by chimeric antigen receptor T (CAR-T) cell therapy.

Group Type: EXPERIMENTAL

Apheresis

Intervention Type: OTHER

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.

Autologous Stem Cell Transplantation

Intervention Type: OTHER

Participants are designed to receive myeloablative conditioning regimen prior to infusion of a minimum 2 x 10\^6 CD34+ stem cells/kilogram.

CAR-T Cell Therapy

Intervention Type: DRUG

CAR-T cells will be infused within 7 days after autologous hematopoietic stem cell infusion (2-10×10\^6 CAR-T/kg，ivgtt).

Interventions

Apheresis

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.

Intervention Type: OTHER

Autologous Stem Cell Transplantation

Participants are designed to receive myeloablative conditioning regimen prior to infusion of a minimum 2 x 10\^6 CD34+ stem cells/kilogram.

Intervention Type: OTHER

CAR-T Cell Therapy

CAR-T cells will be infused within 7 days after autologous hematopoietic stem cell infusion (2-10×10\^6 CAR-T/kg，ivgtt).

Intervention Type: DRUG

Other Intervention Names

Chimeric Antigen Receptor T-cell

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

INDUSTRY

Sponsor Role: collaborator

Suzhou Hongci Hematology Hospital, Suzhou, China

UNKNOWN

Sponsor Role: collaborator

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Deipei Wu, M.D.

Role: STUDY_CHAIR

The First Affiliated Hospital of Soochow University

Locations

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Caixia Li, M.D.

Role: CONTACT

licaixia@suda.edu.cn

+86 512 67781856

Facility Contacts

Caixia Li, M.D.

Role: primary

licaixia@suda.edu.cn

+86 512 67781856

Other Identifiers

ASCT+CART

Identifier Type: -

Identifier Source: org_study_id