Status:
ACTIVE_NOT_RECRUITING
CD19-targeted CAR T Cells for Relapsed and Refractory (R/R) Large B-cell Lymphoma
Lead Sponsor:
Shanghai Ming Ju Biotechnology Co., Ltd.
Conditions:
Lymphoma, Non-Hodgkin
Diffuse Large B Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
This is an open-label, single-arm study conducted in adult subjects with R/R LBCL in China to evaluate the pharmacokinetics(PK), safety and efficacy of relma-cel, monitor the immune response after rel...
Eligibility Criteria
Inclusion
- ≥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 include autologous hematopoietic stem cell transplantation(auto-HSCT);
- Subjects have accessible PET-positive lesion and have measurable CT-positive lesion according to Lugano Classification;
- Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1;
- Adequate organ function;
- Adequate vascular access for leukapheresis procedur;
- Subjects who have previously received CD19 targeted therapy must confirm that lymphoma lesions still expresss CD19;
- Women of childbearing potential must agree to use highly effective methods of contraception for 1 year after the last dose of Relma-cel;
- Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 1 year after the last dose of Relma-cel.
Exclusion
- Central nervous system(CNS) only involvement by malignancy or primary CNS lymphoma;
- History of another primary malignancyn that has not been in remission for at least 2 years;
- Subjects has HBV,HCV,HIV or syphilis nefection 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;
- Subjects with uncontrolled systemic fungal,bacterial,viral or other infection;
- Presence of acute or chronic graft-versus-host disease(GVHD);
- History of any serious cardiovascular disease or presence of clinically relevant CNS pathology;
- Pregnant or nursing woman;
- Subjects using of any chemotherapy,corticisteriod,experiment agents,GVHD therapies,radiation,allo-HSCT or any other therapies for lymphoma must go through a specific wash-out period before leukapheresis;
- Uncontrolled conditions or unwillingness or inability to follow the procedures required in the protocol;
- Received CAR T-cell or other genetically-modified T-cell therapy previously.
Key Trial Info
Start Date :
August 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06149169
Start Date
August 17 2023
End Date
March 31 2025
Last Update
August 21 2024
Active Locations (1)
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1
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China, 300060