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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
The First Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Contact Information
Primary
Caixia Li, M.D.
licaixia@suda.edu.cn
+86 512 67781856
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2027-01-01
Participants
Target number of participants: 64
Treatments
Experimental: ASCT+CAR-T
Participants will receive autologous stem cell transplantation followed by chimeric antigen receptor T (CAR-T) cell therapy.
Sponsors
Leads: The First Affiliated Hospital of Soochow University
Collaborators: Suzhou Hongci Hematology Hospital, Suzhou, China, Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

This content was sourced from clinicaltrials.gov