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

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.

Study Overview

• Status: Terminated
• Conditions: Lymphoma, B-Cell; Autologous Stem Cell Transplantation
• Intervention / Treatment: Other: Apheresis; Other: Autologous Stem Cell Transplantation; Drug: CAR-T Cell Therapy

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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215000
      • The First Affiliated Hospital of Soochow University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: ASCT+CAR-T; Participants will receive autologous stem cell transplantation followed by chimeric antigen receptor T (CAR-T) cell therapy.

Other: 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.; 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.; Drug: 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).; Other Names: Chimeric Antigen Receptor T-cell

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Response(DOR)	To measure the duration of response to ASCT Plus CAR-T Cell Therapy over a follow-up period of 24 months	Up to 24 months
Complete Response Rate	Number of participants who will have achieved complete response after ASCT plus CAR-T cell Therapy.	Up to 24 months
Overall Survival（OS）	OS will be assessed from ASCT plus CAR-T cell therapy to death or last follow-up.	Up to 24 months
Adverse events profile	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.	Up to 24 months

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Soochow University
• Collaborators: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd; Suzhou Hongci Hematology Hospital, Suzhou, China
• Investigators: Study Chair: Deipei Wu, M.D., The First Affiliated Hospital of Soochow University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): April 1, 2026
• Study Completion (Actual): April 1, 2026

Study Registration Dates

• First Submitted: April 19, 2024
• First Submitted That Met QC Criteria: April 19, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Autologous Stem Cell Transplantation; CAR-T Cell Therapy; Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Hemic and Lymphatic Diseases; Lymphoma, B-Cell; Investigative Techniques; Therapeutics; Biological Therapy; Immunologic Techniques; Immunomodulation; Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunotherapy, Adoptive; Blood Component Removal
• Other Study ID Numbers: ASCT+CART

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No