Clinical trial NCT06149169: CD19-targeted CAR T Cells for Relapsed and Refractory (R/R) Large B-cell Lymphoma
Official title: An Open-Label, Single-Arm Study of Relma-cel, CD19-targeted Chimeric Antigen Receptor (CAR)T Cells for Relapsed and Refractory (R/R) LBCL
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Lymphoma, Non-Hodgkin
Diffuse Large B Cell Lymphoma
Keywords: JWCAR029
B-Cell Malignancies
CAR T cells
Chimeric antigen receptor
Relapsed/Refractory
Lead sponsor: Shanghai Ming Ju Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-11-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 relma-cel treatment.

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(supplement study) and the recommended dose is 1×10\^8 CAR+T cells.

Eligibility criteria: Inclusion Criteria:

1. ≥18 years old;
2. Sign on the informed consent;
3. Subjects must have histologically confirmed Large B-cell Lymphoma;
4. 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);
5. Subjects have accessible PET-positive lesion and have measurable CT-positive lesion according to Lugano Classification;
6. Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1;
7. Adequate organ function;
8. Adequate vascular access for leukapheresis procedur;
9. Subjects who have previously received CD19 targeted therapy must confirm that lymphoma lesions still expresss CD19;
10. Women of childbearing potential must agree to use highly effective methods of contraception for 1 year after the last dose of Relma-cel;
11. 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:

1. Central nervous system(CNS) only involvement by malignancy or primary CNS lymphoma;
2. History of another primary malignancyn that has not been in remission for at least 2 years;
3. Subjects has HBV,HCV,HIV or syphilis nefection at the time of screening;
4. Active deep venous thrombosis(DVT)/Pulmonary embolism(PE),or active DVT/PE requires anti-coagulation within 3 months prior to signing the ICF;
5. Subjects with uncontrolled systemic fungal,bacterial,viral or other infection;
6. Presence of acute or chronic graft-versus-host disease(GVHD);
7. History of any serious cardiovascular disease or presence of clinically relevant CNS pathology;
8. Pregnant or nursing woman;
9. 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;
10. Uncontrolled conditions or unwillingness or inability to follow the procedures required in the protocol;
11. Received CAR T-cell or other genetically-modified T-cell therapy previously.

Primary outcomes:
measure: Pharmacokinetic(PK)-Cmax of Relma-cel
timeFrame: up to 1 year after Relma-cel infusion
measure: Pharmacokinetic(PK)-Tmax of Relma-cel
timeFrame: up to 1 year after Relma-cel infusion
measure: Pharmacokinetic(PK)-AUC of Relma-cel
timeFrame: up to 1 year after Relma-cel infusion
Secondary outcomes:
measure: Objective response rate (ORR) in LBCL subjects
timeFrame: 3 months
measure: Best objective response rate ( Best ORR) in LBCL subjects
timeFrame: up to 1 year after Relma-cel infusion
measure: Complete response rate (CRR) in LBCL subjects
timeFrame: up to 1 year after Relma-cel infusion
measure: Adverse events (AEs)
timeFrame: up to 1 year after Relma-cel infusion
measure: Duration of response (DOR)
timeFrame: up to 1 year after Relma-cel infusion
measure: Progression-free survival (PFS)
timeFrame: up to 1 year after Relma-cel infusion
measure: Overall survival (OS)
timeFrame: up to 1 year after Relma-cel infusion
measure: Changes of serum cytokines-IL-2，IL-6，IL-8 and IFN- γ
timeFrame: up to 1 year after Relma-cel infusion
measure: Changes of inflammation biomarker-CRP
timeFrame: up to 1 year after Relma-cel infusion
measure: Changes of inflammation biomarker-serum ferritin
timeFrame: up to 1 year after Relma-cel infusion
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Cancer Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Cancer Hospital
name: Huilai Zhang
role: PRINCIPAL_INVESTIGATOR
References: