Relmacabtagene Autoleucel As Second-Line Therapy in Adult Patients with Aggressive B-cell NHL (NCT06093841) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Relmacabtagene Autoleucel As Second-Line Therapy in Adult Patients with Aggressive B-cell NHL
China46 participantsStarted 2023-11-03
Plain-language summary
The primary objective of this study is to asess the efficacy of Relmacabtagene autoleucel as second-line therapy in adult patients with aggressive B-cell Non-Hodgkins Lymphoma who are ineligible for haematopoietic stem cell transplantation.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age≥18 years;
✓. Signed written informed consent obtained prior to any study procedures;
✓. Histologically confirmed relapsed or refractory (R/R) aggressive B-cell NHL of the following histologiesLBCL as defined by the World Health Organization (WHO) Classification 2022:Diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), high-grade B-cell lymphoma (HGL) with MYC and BCL2 rearrangements,HGL-NOS, Primary mediastinal large B-cell lymphoma, Follicular lymphoma Grade 3B (FL3B),Indolent B-NHL-transformed large B-cell lymphoma with adequate prior treatment with anthracycline-containing agents and rituximab or other CD20-targeted agents;
✓. Subjects must meet the definition of refractory or relapsed;
✓. Subjects were not eligible for HDCT/ASCT based on the investigator's assessment ;
✓. Adequate organ function;
✓. Presence of positive PET assessable lesions as determined by the Lugano criteria ;
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
Exclusion criteria
✕. Subjects with non-Hodgkin's lymphoma who have received second or more line therapy;
✕. Lymphoma of the primary center (subjects with secondary central nervous system lymphoma are allowed to enroll;
✕. History of another primary malignancy that has not been in remission for at least 2 years;