Back to resultsA Clinical Study of CD19 Targeted CAR-T for Patients With CD19+ Lymphoma and Leukemia
Primary Purpose
B Cell Leukemia, B Cell Lymphoma
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
ICAR19 CAR-T cells
Sponsored by
About this trial
This is an interventional treatment trial for B Cell Leukemia
Eligibility Criteria
Inclusion Criteria:
CD19 positive leukemia and lymphoma，relapsed and/or refractory：
- survival>12 weeks;
- FEV1, FVC and DLCO ≥50% of expected corrected for hemoglobin;
- LVEF≥50%;
- Creatinine<2.5mg/dl;
- Bilirubin<2.5mg/dl;
- ALT (alanine aminotransferase)/AST (aspartate aminotransferase)<3 x normal;
- At least 7 days after last chemotherapy;
- provide with informed consent.
Exclusion Criteria:
- Active clinically significant CNS dysfunction
- Pregnant or breast-feeding women.
- Uncontrolled active infection including hepatitis B or C.
- HIV positive.
- Use of systemic steroids within 72 hours.
- Allogeneic lymphocyte treatments within recent 6 months.
- Any uncontrolled active medical disorder.
Sites / Locations
- Weifang People's HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ICAR19 CAR-T cells
Arm Description
Immunotherapy offers an extremely precise approach with the potential to eliminate cancer cells specifically. The newly designed CD19 targeted ICAR19 T cells can specifically kill CD19+ tumor cells. ICAR19 CART used the second generation of CART designation. In this study, the participants will receive several doses of autologous ICAR19 CAR-T cells and the investigators will determine the safety and therapeutic effects of these cells.
Outcomes
Primary Outcome Measures
Measure the safety of ICAR19 CAR-T cells
To assess the adverse events of ICAR19 T cells infusion in patients with CD19+ malignancies
Secondary Outcome Measures
Measure the anti-tumor effect of ICAR19 CAR-T cells
Assess for the therapeutic effects of ICAR 19 CAR-T cells in CD19-expressing leukemia and lymphoma
Survival time of ICAR19 T cells in vivo.
To measure the survival time of ICAR19 CAR-T cells in vivo, extra blood will be drawn from patients receive ICAR19 T cells infusion in the follow-up time
Full Information
NCT ID
NCT03383952
First Posted
December 6, 2017
Last Updated
December 19, 2017
Sponsor
Immune Cell, Inc.
Collaborators
Weifang People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03383952
Brief Title
A Clinical Study of CD19 Targeted CAR-T for Patients With CD19+ Lymphoma and Leukemia
Official Title
A Phase I Trial of CD19 Targeted ICAR19 T Cells in Patients With CD19+ Leukemia and Lymphoma.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Immune Cell, Inc.
Collaborators
Weifang People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Immunotherapy offers an extremely precise approach with the potential to eliminate cancer cells specifically. The newly designed CD19 targeted ICAR19 T cells can specifically kill CD19+ tumor cells. ICAR19 CART used the second generation of CART designation. In this study, the participants will receive several doses of autologous ICAR19 T cells and the investigators will determine the safety and therapeutic effects of these cells.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B Cell Leukemia, B Cell Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ICAR19 CAR-T cells
Arm Type
Experimental
Arm Description
Immunotherapy offers an extremely precise approach with the potential to eliminate cancer cells specifically. The newly designed CD19 targeted ICAR19 T cells can specifically kill CD19+ tumor cells. ICAR19 CART used the second generation of CART designation. In this study, the participants will receive several doses of autologous ICAR19 CAR-T cells and the investigators will determine the safety and therapeutic effects of these cells.
Intervention Type
Biological
Intervention Name(s)
ICAR19 CAR-T cells
Other Intervention Name(s)
Biological drug
Intervention Description
T cells were isolated from peripheral blood from patients enrolled. T cells were transduced with lentivirus bearing anti-CD19 antibody scFV and the activation signals of second generation CART designation. The CART cells were infused into the patients by IV with an escalating dosage.
Primary Outcome Measure Information:
Title
Measure the safety of ICAR19 CAR-T cells
Description
To assess the adverse events of ICAR19 T cells infusion in patients with CD19+ malignancies
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Measure the anti-tumor effect of ICAR19 CAR-T cells
Description
Assess for the therapeutic effects of ICAR 19 CAR-T cells in CD19-expressing leukemia and lymphoma
Time Frame
3 years
Title
Survival time of ICAR19 T cells in vivo.
Description
To measure the survival time of ICAR19 CAR-T cells in vivo, extra blood will be drawn from patients receive ICAR19 T cells infusion in the follow-up time
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
CD19 positive leukemia and lymphoma，relapsed and/or refractory：
survival>12 weeks;
FEV1, FVC and DLCO ≥50% of expected corrected for hemoglobin;
LVEF≥50%;
Creatinine<2.5mg/dl;
Bilirubin<2.5mg/dl;
ALT (alanine aminotransferase)/AST (aspartate aminotransferase)<3 x normal;
At least 7 days after last chemotherapy;
provide with informed consent.
Exclusion Criteria:
Active clinically significant CNS dysfunction
Pregnant or breast-feeding women.
Uncontrolled active infection including hepatitis B or C.
HIV positive.
Use of systemic steroids within 72 hours.
Allogeneic lymphocyte treatments within recent 6 months.
Any uncontrolled active medical disorder.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiulian Sun, MD.,Ph.D
Phone
(+86) 010-62420659
Email
xiuliansun@ymcell.com
Facility Information:
Facility Name
Weifang People's Hospital
City
Weifang
State/Province
Shandong
ZIP/Postal Code
261000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiulian Sun, MD.,Ph.D
Phone
(+86) 010-62420659
Email
xiuliansun@ymcell.com
First Name & Middle Initial & Last Name & Degree
xuehong Ran, doctor
Phone
0536-8192117
Email
ranxuehong1967@163.com
12. IPD Sharing Statement
Learn more about this trial
A Clinical Study of CD19 Targeted CAR-T for Patients With CD19+ Lymphoma and Leukemia
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