CD19-targeted CAR T Cells for Relapsed or Refractory (R/R) Large B-cell Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Relma-cel.
- Who it may be relevant to
- Registry conditions: Non-Hodgkin Lymphoma, Large B-cell Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open-Label, Single-Arm Study of Relma-cel, CD19-targeted Chimeric Antigen Receptor (CAR)T Cells for Relapsed or Refractory (R/R) LBCL
Overview
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 efficacy，safety and pharmacokinetics(PK) of relma-cel.
Relma-cel was approved by the China National Medical Products Administration(NMPA)in September 2021(Acceptance No:CXSS2000036)for the treatment of adult patients with R/R LBCL after second-line or more systemic therapy.The recommended dose is 1×10\^8 CAR+T cells.The indication for this application is R/R LBCL and the recommended dose is 1×10\^8 CAR+T cells.
Interventions
- Biological Relma-cel
Relma-cel will be administered at one dose level:1×10\^8 CAR+T cells
Primary outcome measures
- Objective response rate (ORR) in LBCL subjects [Time frame: 3 months]
Secondary outcome measures (10)
- Objective response rate (ORR) [Time frame: 3 months]
- Best objective response rate ( Best ORR) in LBCL subjects [Time frame: up to 1 year after Relma-cel infusion]
- Complete response rate (CRR) in LBCL subjects [Time frame: up to 1 year after Relma-cel infusion]
- Progression-free survival (PFS) [Time frame: up to 1 year after Relma-cel infusion]
- Overall survival (OS) [Time frame: up to 1 year after Relma-cel infusion]
- Duration of response (DOR) [Time frame: up to 1 year after Relma-cel infusion]
- Pharmacokinetic(PK)-Cmax of Relma-cel [Time frame: up to 1 year after Relma-cel infusion]
- Pharmacokinetic(PK)-Tmax of Relma-cel [Time frame: up to 1 year after Relma-cel infusion]
- Pharmacokinetic(PK)-AUC of Relma-cel [Time frame: up to 1 year after Relma-cel infusion]
- Adverse events (AEs) [Time frame: up to 1 year after Relma-cel infusion]
Eligibility criteria
Inclusion criteria
- ≥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);
- 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 procedure;
- Subjects who have previously received CD19 targeted therapy must confirm that lymphoma lesions still express 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 criteria
- 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;
- 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,corticosteroid,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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Tianjin Cancer Hospital — Tianjin
Identifiers
NCT: NCT06479356 · JWCAR029-117