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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRuijin Hospital

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • autologous stem-cell transplantation
  • Relmacabtagene autoleucel (relma-cel)

Treatment groups

16 Participants
are divided into 1 treatment group

Locations

1
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Shanghai China

Sponsors and collaborators

Ruijin Hospital

Lead sponsor