Back to resultsCD30 Targeted CAR-T in Treating CD30-Expressing Lymphomas
Primary Purpose
Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
ICAR30 T cells
Sponsored by
About this trial
This is an interventional treatment trial for Hodgkin Lymphoma
Eligibility Criteria
Inclusion Criteria:
Hodgkin's lymphoma, anaplastic large cell lymphoma and other CD30 positive malignancies, relapsed or refractory:
- Karnofsky or Lansky score >50;
- Expected survival>12 weeks;
- Hgb > 8.0;
- 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 fold normal;
- Patients must sign an informed consent.
Exclusion Criteria:
- Pregnant or lactating;
- Uncontrolled active infection including hepatitis B or C;
- HIV positive;
- Active clinically significant CNS dysfunction;
- Current use of systemic steroids;
- Heterogenous lymphocyte treatments within recent 6 months;
Sites / Locations
- Weifang People's HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ICAR30 T cells
Arm Description
anti-CD30 CAR-T cells. Patients receive ICAR30 T cells infusion.
Outcomes
Primary Outcome Measures
Measure the safety of ICAR30 T cells
To assess the adverse events of ICAR30 T cells infusion in patients with Hodgkin's lymphoma and CD30+ anaplastic large cell lymphoma.
Secondary Outcome Measures
Measure the anti-tumor effect of ICAR30 T cells
To assess the anti-tumor effect of ICAR30 T cells infusion in patients with Hodgkin's lymphoma and CD30+ anaplastic large cell lymphoma.
Measure the survival time of ICAR30 T cells in vivo
To measure the survival time of ICAR30 T cells in vivo, extra blood will be drawn from patients receive ICAR30 T cells infusion in the follow-up time.
Full Information
NCT ID
NCT03383965
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
NCT03383965
Brief Title
CD30 Targeted CAR-T in Treating CD30-Expressing Lymphomas
Official Title
A Clinical Study of CD30 Targeted CAR-T in Treating CD30-Expressing Lymphomas
Study Type
Interventional
2. Study Status
Record Verification Date
March 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
CAR-T cells have been validated effective in treating CD19 positive B cell lymphoma. Other lymphomas like Hodgkin's lymphoma and anaplastic large cell lymphoma are CD30 positive. In this study, a newly CD30 targeted CART therapy ICAR30 is designed to specifically kill those CD30 expressing malignancies including Hodgkin's lymphoma and CD30+ anaplastic large cell lymphoma. The subjects will receive several doses of autologous ICAR30 T cells infusion and then the safety, treating effects and lasting period of these cells in vivo will be evaluated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ICAR30 T cells
Arm Type
Experimental
Arm Description
anti-CD30 CAR-T cells. Patients receive ICAR30 T cells infusion.
Intervention Type
Biological
Intervention Name(s)
ICAR30 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-CD30 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 ICAR30 T cells
Description
To assess the adverse events of ICAR30 T cells infusion in patients with Hodgkin's lymphoma and CD30+ anaplastic large cell lymphoma.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Measure the anti-tumor effect of ICAR30 T cells
Description
To assess the anti-tumor effect of ICAR30 T cells infusion in patients with Hodgkin's lymphoma and CD30+ anaplastic large cell lymphoma.
Time Frame
3 years
Title
Measure the survival time of ICAR30 T cells in vivo
Description
To measure the survival time of ICAR30 T cells in vivo, extra blood will be drawn from patients receive ICAR30 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:
Hodgkin's lymphoma, anaplastic large cell lymphoma and other CD30 positive malignancies, relapsed or refractory:
Karnofsky or Lansky score >50;
Expected survival>12 weeks;
Hgb > 8.0;
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 fold normal;
Patients must sign an informed consent.
Exclusion Criteria:
Pregnant or lactating;
Uncontrolled active infection including hepatitis B or C;
HIV positive;
Active clinically significant CNS dysfunction;
Current use of systemic steroids;
Heterogenous lymphocyte treatments within recent 6 months;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiulian Sun, MD.,Ph.D
Phone
(+86) 010-62420689
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, M.D., Ph.D
Phone
(+86) 010-62420689
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
Plan to Share IPD
No
Learn more about this trial
CD30 Targeted CAR-T in Treating CD30-Expressing Lymphomas
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