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New treatment option for Non-Hodgkin Lymphoma
Official title CD19-targeted CAR T Cells for Relapsed or Refractory (R/R) Large B-cell Lymphoma
ClinicalTrials.gov ID: NCT06479356
What this study is testing
What is Relma-cel?
Relma-cel is an investigational medicine, being studied as a potential treatment for non-hodgkin lymphoma.
Also referred to as CD19-targeted Chimeric Antigen Receptor(CAR) T Cells.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥18 years old;
- Sign on the informed consent;
- people must have histologically confirmed Large B-cell Lymphoma;
- people had been treated with anthracyclines and rituximab(or other CD20-targeted antibodies) and had relapsed, failed to respond, or progressed after...
- people have accessible PET-positive lesion and have measurable CT-positive lesion according to Lugano Classification;
You likely can't join if
- Primary CNS lymphoma;
- History of another primary malignancy that has not been in remission for at least 2 years;
- people 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;
- people with uncontrolled systemic fungal,bacterial,viral or other infection;
- Presence of acute or chronic graft-versus-host disease(GVHD);
See the full eligibility criteria
- ≥18 years old;
- Sign on the informed consent;
- people must have histologically confirmed Large B-cell Lymphoma;
- people 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...
- people 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;
- people 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.
- Primary CNS lymphoma;
- History of another primary malignancy that has not been in remission for at least 2 years;
- people 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;
- people 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;
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.