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

NCT06381830 | Recruiting Phase 2

• 1 other identifier: ASCT+CART
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma, B-Cell; Autologous Stem Cell Transplantation

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Duration of Response(DOR)

  Up to 24 months

• Complete Response Rate

  Up to 24 months

• Overall Survival（OS）

  Up to 24 months

• Adverse events profile

  Up to 24 months

Study Arms (1)

ASCT+CAR-T

EXPERIMENTAL

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

Other: Apheresis; Other: Autologous Stem Cell Transplantation; Drug: CAR-T Cell Therapy

Interventions

Apheresis 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.

ASCT+CAR-T

Autologous Stem Cell Transplantation OTHER

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

ASCT+CAR-T

CAR-T Cell Therapy DRUG

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

Also known as: Chimeric Antigen Receptor T-cell

ASCT+CAR-T

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-65 years.
• 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.
• Previously treated with 1 or more lines of therapy.
• ECOG≤2#.
• The main organ functions need to meet the following conditions:LVEF≥50%;CCr≥30 ml/min; ALT and AST≤3 times normal range.
• 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.
• 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.
• Estimated survival time ≥3 months.
• Voluntary signing of informed consent and good compliance.

You may not qualify if:

• Have used immunosuppressants or hormones within 2 weeks prior to apheresis, or have to use immunosuppressants or hormones after signing informed consent.
• The presence of bacterial, fungal, viral, mycoplasma or other types of infection that, in the judgment of the investigator, are difficult to control.
• Active hepatitis B or active hepatitis C.
• HIV infection.
• Have received CAR-T cell therapy or allogeneic hematopoietic stem cell transplantation prior to signing the informed consent.
• Prior malignancy (other than Relapsed Refractory B-cell Non-Hodgkin's Lymphoma).
• Pregnant or breasting-feeding women.
• 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.
• Conditions deemed by the researchers to be inappropriate for participation.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead
• Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd: collaborator
• Suzhou Hongci Hematology Hospital, Suzhou, China: collaborator

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell

Interventions

Blood Component Removal; Immunotherapy, Adoptive

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Immunologic Techniques; Investigative Techniques

Study Officials

• Deipei Wu, M.D.

  The First Affiliated Hospital of Soochow University

  STUDY CHAIR

Central Study Contacts

Caixia Li, M.D.

CONTACT

+86 512 67781856; licaixia@suda.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: April 24, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 24, 2024

Record last verified: 2024-03

Locations

CN (1)