UnknownPhase 2

CD19-targeted CAR T Cells for Relapsed and Refractory (R/R) Large B-cell Lymphoma

China10 participantsStarted 2023-08-17

Plain-language 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.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. ≥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;

✕. 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;

Pharmacokinetic(PK)-Cmax of Relma-cel

Timeframe: up to 1 year after Relma-cel infusion

Pharmacokinetic(PK)-Tmax of Relma-cel

Timeframe: up to 1 year after Relma-cel infusion

Pharmacokinetic(PK)-AUC of Relma-cel

Timeframe: up to 1 year after Relma-cel infusion

NCT IDNCT06149169

SponsorShanghai Ming Ju Biotechnology Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-30

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. ≥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;

✕. 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;