CD19-targeted CAR T Cells for Relapsed and Refractory (R/R) Mantle Cell Lymphoma
- Conditions
- Mantle Cell Lymphoma
- Registration Number
- NCT04718883
- Lead Sponsor
- Shanghai Ming Ju Biotechnology Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 59
- ≥ 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Cmax of JWCAR029 Up to 1 year after JWCAR029 infusion Maximum observed concentration of JWCAR029 in peripheral blood
Type of adverse events (AEs) Up to 24 months after JWCAR029 infusion Type of adverse events
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
Changes of serum cytokines Up to 2 year after JWCAR029 infusion Changes of serum cytokines
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
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 complete response (TTCR) Up to 24 months after JWCAR029 infusion Time from JWCAR029 infusion to first documentation of complete response (CR)
Overall survival (OS) Up to 5 year after JWCAR029 infusion Overall survival
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
Severity of adverse events(AEs) Up to 24 months after JWCAR029 infusion Severity of adverse events
Severity of laboratory abnormalities Up to 24 months after JWCAR029 infusion Severity of laboratory abnormalities
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)
Progression-free survival (PFS) Up to 2 year after JWCAR029 infusion Progression-free survival
CD19 expression in tumor biopsy samples Up to 2 year after JWCAR029 infusion CD19 expression in tumor biopsy samples
Number of participants with adverse events (AEs) Up to 24 months after JWCAR029 infusion Number of participants with adverse events
Type of laboratory abnormalities Up to 24 months after JWCAR029 infusion Type 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
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
Changes of Subgroups of T cell Up to 2 year after JWCAR029 infusion Changes of Subgroups of T cell
Complete response rate (CRR) 3 months Complete response rate (CRR) in 3 month in relapsed and refractory (R/R) mantle cell lymphoma (MCL) subjects
Number of participants with laboratory abnormalities Up to 24 months after JWCAR029 infusion Number of participants with laboratory abnormalities
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 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
Trial Locations
- Locations (12)
Peking University Cancer Hospital
🇨🇳Beijing, Beijing, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Fujian Medical University Consonancy Hospital
🇨🇳Fuzhou, Fujiang, China
Guangdong Province people hospital
🇨🇳Guanzhou, Guangdong, China
Henan Province Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Jiangsu Province People Hospital
🇨🇳Nanjing, Jiangsu, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
Zhongshan Hospital affiliated to Fudan University
🇨🇳Shanghai, Shanghai, China
Institute of Hematology, Chinese Academy of Medical Sciences
🇨🇳Tianjin, Tianjin, China
Tianjin Cancer Hospital
🇨🇳Tianjin, Tianjin, China
Scroll for more (2 remaining)Peking University Cancer Hospital🇨🇳Beijing, Beijing, China