CD19-targeted CAR T Cells for Relapsed or Refractory (R/R) Large B-cell Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Ming Ju Biotechnology Co., Ltd.
About this trial
This is an open-label, single-arm study to treat the adult R/R Large B-cell Lymphoma subjects with Relmacabtagene autoleucel (relma-cel) in China.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥18 years old;
Sign on the informed consent;
Subjects must have histologically confirmed Large B-cell Lymphoma;
Subjects had been treated with anthracyclines and rituximab(or other CD20-targeted antibodies) and had relapsed, failed to respond, or progressed after at least two lines of therapy including autologous hematopoietic stem cell transplantation(auto-HSCT);
Disqualifiers
Primary CNS lymphoma;
History of another primary malignancy that has not been in remission for at least 2 years;
Subjects has HBV,HCV,HIV or syphilis infection at the time of screening;
Active deep venous thrombosis(DVT)/Pulmonary embolism(PE),or active DVT/PE requires anti-coagulation within 3 months prior to signing the ICF;
Trial design
Design model
Single group
Treatments tested in this trial
Relma-cel
Biological/VaccineRelma-cel will be administered at one dose level:1×10\^8 CAR+T cells
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Relma-celExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective response rate (ORR) in LBCL subjects
Objective response rate (ORR) in 3 month evaluated by investigator of LBCL subjects
Time frame
3 monthsSecondary outcomes
1
Objective response rate (ORR)
Objective response rate (ORR) in 3 month evaluated by IRC of LBCL subjects
Time frame
3 months2
Best objective response rate ( Best ORR) in LBCL subjects
Best objective response rate (ORR) evaluated by the investigator and IRC of LBCL subjects
Time frame
up to 1 year after Relma-cel infusion3
Complete response rate (CRR) in LBCL subjects
Complete response rate (CRR) at any time points evaluated by the investigator
Time frame
up to 1 year after Relma-cel infusion4
Progression-free survival (PFS)
Progression-free survival
Time frame
up to 1 year after Relma-cel infusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov