Mantle Cell Lymphoma
Conditions
Keywords
JWCAR029, B-Cell Malignancies, Non-Hodgkin lymphoma, CAR T cells, Chimeric antigen receptor, Relapsed/Refractory, Mantle Cell Lymphoma
Brief summary
This is a phase II, open-label, single-arm, multicenter study to assess the efficacy and safety of JWCAR029 in adult R/R Mantle Cell Lymphoma subjects in China.
Detailed description
This is a phase II, open-label, single-arm, multicenter study conducted in adult subjects with relapsed and refractory (R/R) mantle cell lymphoma (MCL) in China to evaluate the safety, efficacy, pharmacokinetics(PK), pharmacodynamics(PD) of JWCAR029 and immune response after JWCAR029 treatment. R/R MCL patients will be enrolled in dose level of 1.0 x 10\^8 CAR+ T cells. All subjects will be followed for 5 years following JWCAR029 infusion.
Interventions
JWCAR029 will be administered at dose level: 1 x 10\^8 CAR+T cells
Sponsors
Shanghai Ming Ju Biotechnology Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥ 18 years old; * Sign on the informed consent; * Subject must have histologically confirmed mantle cell lymphoma; * Relapsed/refractory patients; * 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; * Expected survival is greater than 12 weeks; * 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 JWCAR029; * Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 1 year after the last dose of JWCAR029.
Exclusion criteria
* Central nervous system (CNS) only involvement by malignancy or 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; * Deep venous thrombosis (DVT)/Pulmonary embolism (PE), or 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 women; * Subjects using of any chemotherapy, corticosteriod, experiment agents, GVHD therapies, radiation or any other therapies for lymphoma must go through a specific wash-out period before leukapheresis; * Received allo-hematopoietic stem cell transplantation therapy previously. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | 3 months | Objective response rate (ORR) in 3 month in relapsed and refractory (R/R) mantle cell lymphoma (MCL) subjects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The best objective response rate | 3 months | The best objective response rate in 3 month in relapsed and refractory (R/R) mantle cell lymphoma (MCL) subjects |
| The best complete response rate | 3 months | The best complete response rate in 3 month in relapsed and refractory (R/R) mantle cell lymphoma (MCL) subjects |
| Number of participants with adverse events (AEs) | Up to 24 months after JWCAR029 infusion | Number of participants with adverse events |
| Type of adverse events (AEs) | Up to 24 months after JWCAR029 infusion | Type of adverse events |
| Severity of adverse events(AEs) | Up to 24 months after JWCAR029 infusion | Severity of adverse events |
| Number of participants with laboratory abnormalities | Up to 24 months after JWCAR029 infusion | Number of participants with laboratory abnormalities |
| Type of laboratory abnormalities | Up to 24 months after JWCAR029 infusion | Type of laboratory abnormalities |
| Severity of laboratory abnormalities | Up to 24 months after JWCAR029 infusion | Severity of laboratory abnormalities |
| Duration of response (DOR) | Up to 24 months after JWCAR029 infusion | Time from first response(PR or CR) to disease progression or death from any cause |
| Duration of complete remission (DoCR) | Up to 24 months after JWCAR029 infusion | Time from complete response (CR) to disease progression or death from any cause |
| Duration of partial remission (DoPR) | Up to 24 months after JWCAR029 infusion | Time from partial response (PR) to disease progression or death from any cause. |
| Time to response (TTR) | Up to 24 months after JWCAR029 infusion | Time from JWCAR029 infusion to first documentation of complete response (CR) or partial response (PR) |
| Complete response rate (CRR) | 3 months | Complete response rate (CRR) in 3 month in relapsed and refractory (R/R) mantle cell lymphoma (MCL) subjects |
| Cmax of JWCAR029 | Up to 1 year after JWCAR029 infusion | Maximum observed concentration of JWCAR029 in peripheral blood |
| Tmax of JWCAR029: | Up to 1 year after JWCAR029 infusion | Time to maximum concentration of JWCAR029 in the peripheral blood |
| AUC of JWCAR029: | Up to 1 year after JWCAR029 infusion | Area under the concentration vs time curve of JWCAR029 in the peripheral blood |
| Progression-free survival (PFS) | Up to 2 year after JWCAR029 infusion | Progression-free survival |
| Overall survival (OS) | Up to 5 year after JWCAR029 infusion | Overall survival |
| Anti-therapeutic JWCAR029 antibody | Up to 2 year after JWCAR029 infusion | Anti-therapeutic JWCAR029 antibody |
| Changes of T cell counts | Up to 2 year after JWCAR029 infusion | Changes of T cell counts |
| Changes of Subgroups of T cell | Up to 2 year after JWCAR029 infusion | Changes of Subgroups of T cell |
| Changes of serum cytokines | Up to 2 year after JWCAR029 infusion | Changes of serum cytokines |
| CD19 expression in tumor biopsy samples | Up to 2 year after JWCAR029 infusion | CD19 expression in tumor biopsy samples |
| Changes in inflammatory biomarkers such as CRP | Up to 2 year after JWCAR029 infusion | Changes in inflammatory biomarkers such as CRP |
| Changes in inflammatory biomarkers such as ferritin | Up to 2 year after JWCAR029 infusion | Changes in inflammatory biomarkers such as CRP |
| Time to complete response (TTCR) | Up to 24 months after JWCAR029 infusion | Time from JWCAR029 infusion to first documentation of complete response (CR) |
Countries
China
Outcome results
None listed