Clinical trial NCT06381830: Clinical Study of CAR-T Cell Therapy Following ASCT for R/R B-cell Non-Hodgkin's Lymphoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
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
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
Collaborators: name: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
name: Suzhou Hongci Hematology Hospital, Suzhou, China
First posted: 2024-04-24
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Up to 24 months
measure: Progression-free Survival（PFS）
timeFrame: Up to 24 months
Secondary outcomes:
measure: Duration of Response(DOR)
timeFrame: Up to 24 months
measure: Complete Response Rate
timeFrame: Up to 24 months
measure: Overall Survival（OS）
timeFrame: Up to 24 months
measure: Adverse events profile
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital of Soochow University
name: Deipei Wu, M.D.
role: STUDY_CHAIR
References: