A Single-Arm Clinical Study of CD19 CAR-T Following ASCT for Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (R/R B-NHL) With High-Risk Prognostic Factors

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

Clinical trial for the safety and efficacy of CD19 CAR-T following autologous hematopoietic stem cell transplantation (ASCT) for Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (R/R B-NHL) with High-Risk Prognostic Factors

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically confirmed B-cell non-Hodgkin's lymphoma including the following types

‣ diffuse large B-cell lymphoma

⁃ high-grade B-cell lymphoma with or without MYC and BLC2 and/or BCL6 rearrangement

⁃ transformed lymphoma

⁃ primary mediastinal large B-cell lymphoma

⁃ follicular lymphoma (FL)

• Relapsed or refractory diseases fulfilling one of the following criteria (individuals must have received anti-CD20 monoclonal antibody and anthracycline-containing chemotherapy regimen)

‣ Primary refractory disease, defined as disease progression after first-line immunochemotherapy or disease progression within 6 weeks of the end of the last chemotherapy

⁃ Stable disease (SD) as best response after at least 4 cycles of first-line therapy

⁃ Partial response (PR) as best response after at least 6 cycles of first-line therapy (biopsy-proven residual disease is needed for individuals with Deauville score of 4)

⁃ PR as best response after at least 2 cycles of second-line therapy

⁃ Disease relapse ≤12 months after the completion of first-line immunochemotherapy

⁃ Relapsed or refractory disease after ≥2 lines of chemotherapy

• Presence of at least one of the following high-risk prognostic factors: (1) extranodal involvement; (2) maximum diameter of the bulky mass ≥5 cm; (3) TP53 gene alterations

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

• Eligible for HDCT/ASCT based on the investigator's assessment and are scheduled to undergo an ASCT sequential CAR-T treatment regimen

• Adequate renal and hepatic function defined as:

‣ Serum alanine aminotransferase (ALT/AST) ≤ 3 upper limit of normal (ULN)

⁃ Total bilirubin ≤1.5 mg/dL(\<3 times ULN in patients with Gilbert's syndrome, cholestasis due to hepatoportal compression adenopathy, biliary obstruction in patients with liver involvement or lymphoma)

⁃ Serum creatinine ≤1.5 ULN, or creatinine clearance (as estimated by Cockcroft Gault) ≥ 30 mL/min

• Cardiac ejection fraction ≥ 40%

• Baseline oxygen saturation \> 95% on room air

• Life expectancy ≥3 months

Locations
Other Locations
China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Contact Information
Primary
Weili Zhao
zwl_trial@163.com
+862164370045
Backup
Li Wang
+862164370045
Time Frame
Start Date: 2024-04-16
Estimated Completion Date: 2027-04
Participants
Target number of participants: 16
Treatments
Experimental: CAR-T following ASCT
Participants will receive high-dose chemotherapy followed by stem-cell infusion, and a fixed dose of CAR-T cells will be infused.
Related Therapeutic Areas
Sponsors
Leads: Ruijin Hospital

This content was sourced from clinicaltrials.gov

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