Back to resultsCD19-targeted CAR T Cells for Relapsed and Refractory (R/R) Mantle Cell Lymphoma
Primary Purpose
Mantle Cell Lymphoma
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
CD19-targeted Chimeric Antigen Receptor (CAR) T Cells
Sponsored by
About this trial
This is an interventional treatment trial for Mantle Cell Lymphoma focused on measuring JWCAR029, B-Cell Malignancies, Non-Hodgkin lymphoma, CAR T cells, Chimeric antigen receptor, Relapsed/Refractory, Mantle Cell Lymphoma
Eligibility Criteria
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.
Sites / Locations
- Peking University Cancer HospitalRecruiting
- Peking University Third HospitalRecruiting
- Fujian Medical University Consonancy HospitalRecruiting
- Guangdong Province people hospitalRecruiting
- Henan Province Cancer HospitalRecruiting
- Jiangsu Province People HospitalRecruiting
- Fudan University Shanghai Cancer CenterRecruiting
- Zhongshan Hospital affiliated to Fudan UniversityRecruiting
- Institute of Hematology, Chinese Academy of Medical SciencesRecruiting
- Tianjin Cancer HospitalRecruiting
- The First Affiliated Hospital of Zhejiang UniversityRecruiting
- Zhejiang province Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
JWCAR029 treatment
Arm Description
JWCAR029 be administrated at dose level: 1 x 10^8 CAR+T cells
Outcomes
Primary Outcome Measures
Objective response rate (ORR)
Objective response rate (ORR) in 3 month in relapsed and refractory (R/R) mantle cell lymphoma (MCL) subjects
Secondary Outcome Measures
Complete response rate (CRR)
Complete response rate (CRR) in 3 month in relapsed and refractory (R/R) mantle cell lymphoma (MCL) subjects
The best objective response rate
The best objective response rate in 3 month in relapsed and refractory (R/R) mantle cell lymphoma (MCL) subjects
The best complete response rate
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)
Number of participants with adverse events
Type of adverse events (AEs)
Type of adverse events
Severity of adverse events(AEs)
Severity of adverse events
Number of participants with laboratory abnormalities
Number of participants with laboratory abnormalities
Type of laboratory abnormalities
Type of laboratory abnormalities
Severity of laboratory abnormalities
Severity of laboratory abnormalities
Duration of response (DOR)
Time from first response(PR or CR) to disease progression or death from any cause
Duration of complete remission (DoCR)
Time from complete response (CR) to disease progression or death from any cause
Duration of partial remission (DoPR)
Time from partial response (PR) to disease progression or death from any cause.
Time to response (TTR)
Time from JWCAR029 infusion to first documentation of complete response (CR) or partial response (PR)
Time to complete response (TTCR)
Time from JWCAR029 infusion to first documentation of complete response (CR)
Cmax of JWCAR029
Maximum observed concentration of JWCAR029 in peripheral blood
Tmax of JWCAR029:
Time to maximum concentration of JWCAR029 in the peripheral blood
AUC of JWCAR029:
Area under the concentration vs time curve of JWCAR029 in the peripheral blood
Progression-free survival (PFS)
Progression-free survival
Overall survival (OS)
Overall survival
Anti-therapeutic JWCAR029 antibody
Anti-therapeutic JWCAR029 antibody
Changes of T cell counts
Changes of T cell counts
Changes of Subgroups of T cell
Changes of Subgroups of T cell
Changes of serum cytokines
Changes of serum cytokines
CD19 expression in tumor biopsy samples
CD19 expression in tumor biopsy samples
Changes in inflammatory biomarkers such as CRP
Changes in inflammatory biomarkers such as CRP
Changes in inflammatory biomarkers such as ferritin
Changes in inflammatory biomarkers such as CRP
Full Information
NCT ID
NCT04718883
First Posted
January 14, 2021
Last Updated
March 17, 2021
Sponsor
Shanghai Ming Ju Biotechnology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04718883
Brief Title
CD19-targeted CAR T Cells for Relapsed and Refractory (R/R) Mantle Cell Lymphoma
Official Title
A Phase II Open-Label, Single-Arm, Multicenter Study of JWCAR029, CD19-targeted Chimeric Antigen Receptor (CAR) T Cells for Relapsed and Refractory (R/R) Mantle Cell Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 13, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Ming Ju Biotechnology Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 2 years following JWCAR029 infusion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mantle Cell Lymphoma
Keywords
JWCAR029, B-Cell Malignancies, Non-Hodgkin lymphoma, CAR T cells, Chimeric antigen receptor, Relapsed/Refractory, Mantle Cell Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
JWCAR029 treatment
Arm Type
Experimental
Arm Description
JWCAR029 be administrated at dose level: 1 x 10^8 CAR+T cells
Intervention Type
Biological
Intervention Name(s)
CD19-targeted Chimeric Antigen Receptor (CAR) T Cells
Intervention Description
JWCAR029 will be administered at dose level: 1 x 10^8 CAR+T cells
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
Objective response rate (ORR) in 3 month in relapsed and refractory (R/R) mantle cell lymphoma (MCL) subjects
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Complete response rate (CRR)
Description
Complete response rate (CRR) in 3 month in relapsed and refractory (R/R) mantle cell lymphoma (MCL) subjects
Time Frame
3 months
Title
The best objective response rate
Description
The best objective response rate in 3 month in relapsed and refractory (R/R) mantle cell lymphoma (MCL) subjects
Time Frame
3 months
Title
The best complete response rate
Description
The best complete response rate in 3 month in relapsed and refractory (R/R) mantle cell lymphoma (MCL) subjects
Time Frame
3 months
Title
Number of participants with adverse events (AEs)
Description
Number of participants with adverse events
Time Frame
Up to 24 months after JWCAR029 infusion
Title
Type of adverse events (AEs)
Description
Type of adverse events
Time Frame
Up to 24 months after JWCAR029 infusion
Title
Severity of adverse events(AEs)
Description
Severity of adverse events
Time Frame
Up to 24 months after JWCAR029 infusion
Title
Number of participants with laboratory abnormalities
Description
Number of participants with laboratory abnormalities
Time Frame
Up to 24 months after JWCAR029 infusion
Title
Type of laboratory abnormalities
Description
Type of laboratory abnormalities
Time Frame
Up to 24 months after JWCAR029 infusion
Title
Severity of laboratory abnormalities
Description
Severity of laboratory abnormalities
Time Frame
Up to 24 months after JWCAR029 infusion
Title
Duration of response (DOR)
Description
Time from first response(PR or CR) to disease progression or death from any cause
Time Frame
Up to 24 months after JWCAR029 infusion
Title
Duration of complete remission (DoCR)
Description
Time from complete response (CR) to disease progression or death from any cause
Time Frame
Up to 24 months after JWCAR029 infusion
Title
Duration of partial remission (DoPR)
Description
Time from partial response (PR) to disease progression or death from any cause.
Time Frame
Up to 24 months after JWCAR029 infusion
Title
Time to response (TTR)
Description
Time from JWCAR029 infusion to first documentation of complete response (CR) or partial response (PR)
Time Frame
Up to 24 months after JWCAR029 infusion
Title
Time to complete response (TTCR)
Description
Time from JWCAR029 infusion to first documentation of complete response (CR)
Time Frame
Up to 24 months after JWCAR029 infusion
Title
Cmax of JWCAR029
Description
Maximum observed concentration of JWCAR029 in peripheral blood
Time Frame
Up to 1 year after JWCAR029 infusion
Title
Tmax of JWCAR029:
Description
Time to maximum concentration of JWCAR029 in the peripheral blood
Time Frame
Up to 1 year after JWCAR029 infusion
Title
AUC of JWCAR029:
Description
Area under the concentration vs time curve of JWCAR029 in the peripheral blood
Time Frame
Up to 1 year after JWCAR029 infusion
Title
Progression-free survival (PFS)
Description
Progression-free survival
Time Frame
Up to 2 year after JWCAR029 infusion
Title
Overall survival (OS)
Description
Overall survival
Time Frame
Up to 2 year after JWCAR029 infusion
Title
Anti-therapeutic JWCAR029 antibody
Description
Anti-therapeutic JWCAR029 antibody
Time Frame
Up to 2 year after JWCAR029 infusion
Title
Changes of T cell counts
Description
Changes of T cell counts
Time Frame
Up to 2 year after JWCAR029 infusion
Title
Changes of Subgroups of T cell
Description
Changes of Subgroups of T cell
Time Frame
Up to 2 year after JWCAR029 infusion
Title
Changes of serum cytokines
Description
Changes of serum cytokines
Time Frame
Up to 2 year after JWCAR029 infusion
Title
CD19 expression in tumor biopsy samples
Description
CD19 expression in tumor biopsy samples
Time Frame
Up to 2 year after JWCAR029 infusion
Title
Changes in inflammatory biomarkers such as CRP
Description
Changes in inflammatory biomarkers such as CRP
Time Frame
Up to 2 year after JWCAR029 infusion
Title
Changes in inflammatory biomarkers such as ferritin
Description
Changes in inflammatory biomarkers such as CRP
Time Frame
Up to 2 year after JWCAR029 infusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JWCAR029 Medical
Phone
+86 21 50464201
Email
JWCAR029Medical@jwtherapeutics.com
Facility Information:
Facility Name
Peking University Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Zhu
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongmei Jing
Facility Name
Fujian Medical University Consonancy Hospital
City
Fuzhou
State/Province
Fujiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianda Hu
Facility Name
Guangdong Province people hospital
City
Guanzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
WenYu Li
Facility Name
Henan Province Cancer Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keshu Zhou
Facility Name
Jiangsu Province People Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianyong Li
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junning Cao
Facility Name
Zhongshan Hospital affiliated to Fudan University
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peng Liu
Facility Name
Institute of Hematology, Chinese Academy of Medical Sciences
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dehui Zou
Facility Name
Tianjin Cancer Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lanfang Li
Facility Name
The First Affiliated Hospital of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Jin
Facility Name
Zhejiang province Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haiyan Yang
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
CD19-targeted CAR T Cells for Relapsed and Refractory (R/R) Mantle Cell Lymphoma
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