Back to resultsPhase I Study of JWCAR029 in Subjects With R/R CLL/SLL
Primary Purpose
Leukemia, Lymphocytic, Chronic, B-Cell
Status
Not yet recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
JWCAR029 (Relmacabtagene Autoleucel)
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia, Lymphocytic, Chronic, B-Cell
Eligibility Criteria
Inclusion Criteria:
- ≥ 18 years old and ≤ 75 years old;
- Sign on the informed consent;
Diagnosis of:
- CLL with an indication for treatment based on iwCLL 2018 and measurable disease, or
- SLL (lymphadenopathy and/or splenomegaly and < 5×10^9 CD19+ CD5+ clonal B lymphocytes/L [< 5000/µL] in the peripheral blood at diagnosis with measurable disease that is biopsy-proven SLL);
- Relapsed/refractory patients, Subjects must have received and failed Bruton tyrosine kinase inhibitor (BTKi) treatment or have been deemed ineligible for BTKi therapy;
- 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;
- 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
- Jiangsu Province Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
JWCAR029 Treatment
Arm Description
Dose-finding for JWCAR029 monotherapy
Outcomes
Primary Outcome Measures
Treatment-related adverse events (AEs)
Type, Proportion, and Severity
Recommended dose of JWCAR029
Recommended dose of JWCAR029
Secondary Outcome Measures
Best Objective response (BOR) rate
iwCLL2018
Best Complete response (CR) rate
iwCLL2018
Objective response rate (ORR)
iwCLL2018
Complete response rate (CRR)
iwCLL2018
MRD-negative response rate
Proportion of subjects who achieve MRD-negative OR and CR
Progression free survival (PFS)
iwCLL2018
Overall survival (OS)
iwCLL2018
Duration of response
iwCLL2018
Pharmacokinetics- Maximum concentration (Cmax)
Flow cytometry and qPCR
Pharmacokinetics- Time of the maximum concentration (Tmax)
Flow cytometry and qPCR
Pharmacokinetics- area under the curve
Flow cytometry and qPCR
Serum cytokines associated with CRS
IL-6, IL-8, TGF-β1, TNF-α, etc.
Full Information
NCT ID
NCT05259813
First Posted
February 8, 2022
Last Updated
February 17, 2022
Sponsor
Shanghai Ming Ju Biotechnology Co., Ltd.
Collaborators
The First Affiliated Hospital with Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05259813
Brief Title
Phase I Study of JWCAR029 in Subjects With R/R CLL/SLL
Official Title
An Open Label, Single-arm, Phase I Study of JWCAR029 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 28, 2022 (Anticipated)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Ming Ju Biotechnology Co., Ltd.
Collaborators
The First Affiliated Hospital with Nanjing Medical University
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 I, open-label, single-arm, single center study to assess the safety and efficacy of JWCAR029 in subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Detailed Description
Upon the successful product generation of Relmacabtagene Autoleucel, subjects will enter the treatment phase of the study. Treatment will include lymphodepleting chemotherapy followed by Relmacabtagene Autoleucel administration. Subjects will then enter the post-treatment follow-up phase of the study and will be followed for approximately 24 months for safety, disease status, and survival. Long-term follow-up will continue under a separate long-term follow-up protocol, currently up to 15 years after the last Relmacabtagene Autoleucel administration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphocytic, Chronic, B-Cell
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
JWCAR029 Treatment
Arm Type
Experimental
Arm Description
Dose-finding for JWCAR029 monotherapy
Intervention Type
Genetic
Intervention Name(s)
JWCAR029 (Relmacabtagene Autoleucel)
Intervention Description
CD19-targeted Chimeric Antigen Receptor (CAR) T Cells
Primary Outcome Measure Information:
Title
Treatment-related adverse events (AEs)
Description
Type, Proportion, and Severity
Time Frame
2 years
Title
Recommended dose of JWCAR029
Description
Recommended dose of JWCAR029
Time Frame
28 days after JWCAR029 infusion
Secondary Outcome Measure Information:
Title
Best Objective response (BOR) rate
Description
iwCLL2018
Time Frame
3 months
Title
Best Complete response (CR) rate
Description
iwCLL2018
Time Frame
3 months
Title
Objective response rate (ORR)
Description
iwCLL2018
Time Frame
3 months
Title
Complete response rate (CRR)
Description
iwCLL2018
Time Frame
3 months
Title
MRD-negative response rate
Description
Proportion of subjects who achieve MRD-negative OR and CR
Time Frame
3 months
Title
Progression free survival (PFS)
Description
iwCLL2018
Time Frame
2 years
Title
Overall survival (OS)
Description
iwCLL2018
Time Frame
2 years
Title
Duration of response
Description
iwCLL2018
Time Frame
2 years
Title
Pharmacokinetics- Maximum concentration (Cmax)
Description
Flow cytometry and qPCR
Time Frame
2 years
Title
Pharmacokinetics- Time of the maximum concentration (Tmax)
Description
Flow cytometry and qPCR
Time Frame
2 years
Title
Pharmacokinetics- area under the curve
Description
Flow cytometry and qPCR
Time Frame
2 years
Title
Serum cytokines associated with CRS
Description
IL-6, IL-8, TGF-β1, TNF-α, etc.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥ 18 years old and ≤ 75 years old;
Sign on the informed consent;
Diagnosis of:
CLL with an indication for treatment based on iwCLL 2018 and measurable disease, or
SLL (lymphadenopathy and/or splenomegaly and < 5×10^9 CD19+ CD5+ clonal B lymphocytes/L [< 5000/µL] in the peripheral blood at diagnosis with measurable disease that is biopsy-proven SLL);
Relapsed/refractory patients, Subjects must have received and failed Bruton tyrosine kinase inhibitor (BTKi) treatment or have been deemed ineligible for BTKi therapy;
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;
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JianYong Li
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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Phase I Study of JWCAR029 in Subjects With R/R CLL/SLL
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