Autologous Stem Cell Transplantation, Lymphoma, B-Cell
Conditions
Keywords
Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma, CAR-T Cell Therapy, Autologous Stem Cell Transplantation
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.
Interventions
OTHERApheresis
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.
OTHERAutologous 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.
DRUGCAR-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).
Sponsors
The First Affiliated Hospital of Soochow University
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Suzhou Hongci Hematology Hospital, Suzhou, China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | Up to 24 months | Number of participants who will have achieved response after ASCT plus CAR-T cell Therapy. |
| Progression-free Survival（PFS） | Up to 24 months | PFS is defined as the time from ASCT to progression, death or the last follow-up point |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response(DOR) | Up to 24 months | To measure the duration of response to ASCT Plus CAR-T Cell Therapy over a follow-up period of 24 months |
| Complete Response Rate | Up to 24 months | Number of participants who will have achieved complete response after ASCT plus CAR-T cell Therapy. |
| Overall Survival（OS） | Up to 24 months | OS will be assessed from ASCT plus CAR-T cell therapy to death or last follow-up. |
| Adverse events profile | Up to 24 months | 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. |
Countries
China
Contacts
STUDY_CHAIRDeipei Wu, M.D.
The First Affiliated Hospital of Soochow University
Outcome results
None listed