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Recruiting Phase 2

CAR-T Following ASCT for Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (R/R B-NHL) With High-Risk Prognostic Factors

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About this study

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

Condition
B-cell Non Hodgkin Lymphoma
Tested
autologous stem-cell transplantation, Relmacabtagene autoleucel (relma-cel)
Sponsor
Ruijin Hospital

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 25

  • Minimum age: 18 years
  • Study condition: B-cell Non Hodgkin Lymphoma
  • 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

Exclusion 6

  • History of autologous or allogeneic stem cell transplantation
  • Active HBV or HCV infection, defined as HBV-DNA or HCV-DNA levels above the normal upper limit, with or without abnormal liver function. Individuals with positive HBsAg or HBcAb should receive antiviral prophylaxis for at least 12 months after CAR-T cells infusion.
  • Presence of uncontrolled infection, cardio-cerebrovascular disease，coagulopathy, or connective tissue disease.
  • History of HIV infection
  • Prior chimeric antigen receptor cellular immunotherapy targeting CD19
  • Pregnant or lactating patients

Where

1 site, 1 recruiting

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.