Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy for CD19+CD22+ Relapsed and Refractory Lymphoma
Primary Purpose
Lymphoma
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma
Eligibility Criteria
Inclusion Criteria:
- Histological detection confirmed CD19/CD22 postive lymphoma;
- Recieved more than 2 lines of chemotherapy;
- Not eligible for hematopoietic stem cell transplantation or relapsed after hematopoietic stem cell transplantation;
- Life expectation for more than 3 months;
- ECOG ≥ 2;
- Adequate organ function: EF≥50%; normal ECG; CCR≥40ml/min; ALT and AST ≤ 3 × upper limitation of normal, T-BIL ≤ 2.0mg/dl; PT and APTT < 2 × upper limitation of normal; SpO2 > 92%;
- CBC results: Hb ≥ 80g/L, ANC > 1 × 10E9/L, Plt ≥ 50 × 10E9/L;
- Results of pregnant test should be negative, and agree to conception control during treatment and 1 year after CAR-T infusion;
- With measurable disease;
- Written informed consent could be acquired;
Exclusion Criteria:
- Immunosuppressive agents or steroids in recent 1 week before recruitment;
- Uncontrolled infection;
- HIV positive ;
- Active HBV or HCV infection;
- Women in pregnancy and lactation;
- Refuse to conception control during treatment and 1 year after CAR-T infusion;
- Uncured malignancies other than non-Hodgkin lymphoma;
- Have participated similar trial for treating relapse/refractory non-Hodgkin lymphoma;
- Inheritated immune deficiancy;
- Severe heart disease.
Sites / Locations
- Shanghai Ruijin HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CAR-T cell therapy
Arm Description
Patient-derived dual specificity CD19 and CD22 CAR-T
Outcomes
Primary Outcome Measures
Overall remission rate
Rate of complete remission and patial remission
Secondary Outcome Measures
Adverse toxicity
According to CTCAE 4.0 criteria
Full Information
NCT ID
NCT03468153
First Posted
March 11, 2018
Last Updated
March 16, 2018
Sponsor
Ruijin Hospital
Collaborators
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
1. Study Identification
Unique Protocol Identification Number
NCT03468153
Brief Title
Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy for CD19+CD22+ Relapsed and Refractory Lymphoma
Official Title
The Safety and Efficacy of Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy for CD19+CD22+ Relapsed and Refractory Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
January 1, 2019 (Anticipated)
Study Completion Date
January 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
Collaborators
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
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
Patients with relapsed or refractory lymphoma often develop resistance to chemotherapy. Chimeric antigen receptor-modified T cell (CART) therapy showed promising effect in B-cell malignancies these years. CD19 and CD22 are proteins expressed on the surface of the lymphoma cells in patients with CD19+CD22+ lymphoma. The CAR enables the T-cells to recognize and kill the tumor cell through recognition of CD19 and CD22. This is a phase 2 trial to study the safety and efficacy of dual specificity CD19 and CD22 CAR-T cell immunotherapy for CD19+CD22+ relapsed and refractory lymphoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CAR-T cell therapy
Arm Type
Experimental
Arm Description
Patient-derived dual specificity CD19 and CD22 CAR-T
Intervention Type
Biological
Intervention Name(s)
Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy
Intervention Description
Patient-derived dual specificity CD19 and CD22 CAR-T Cells
Primary Outcome Measure Information:
Title
Overall remission rate
Description
Rate of complete remission and patial remission
Time Frame
4 weeks after infusion
Secondary Outcome Measure Information:
Title
Adverse toxicity
Description
According to CTCAE 4.0 criteria
Time Frame
Day 0, day 4, week 1, week 3, week 4, month 2, month 12 after CAR-T cells were infused
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histological detection confirmed CD19/CD22 postive lymphoma;
Recieved more than 2 lines of chemotherapy;
Not eligible for hematopoietic stem cell transplantation or relapsed after hematopoietic stem cell transplantation;
Life expectation for more than 3 months;
ECOG ≥ 2;
Adequate organ function: EF≥50%; normal ECG; CCR≥40ml/min; ALT and AST ≤ 3 × upper limitation of normal, T-BIL ≤ 2.0mg/dl; PT and APTT < 2 × upper limitation of normal; SpO2 > 92%;
CBC results: Hb ≥ 80g/L, ANC > 1 × 10E9/L, Plt ≥ 50 × 10E9/L;
Results of pregnant test should be negative, and agree to conception control during treatment and 1 year after CAR-T infusion;
With measurable disease;
Written informed consent could be acquired;
Exclusion Criteria:
Immunosuppressive agents or steroids in recent 1 week before recruitment;
Uncontrolled infection;
HIV positive ;
Active HBV or HCV infection;
Women in pregnancy and lactation;
Refuse to conception control during treatment and 1 year after CAR-T infusion;
Uncured malignancies other than non-Hodgkin lymphoma;
Have participated similar trial for treating relapse/refractory non-Hodgkin lymphoma;
Inheritated immune deficiancy;
Severe heart disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weili Zhao, MD
Phone
64370045
Ext
610707
Email
zhao.weili@yahoo.com
Facility Information:
Facility Name
Shanghai Ruijin Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weili Zhao, MD
Phone
64370045
Ext
610707
Email
zhao.weili@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy for CD19+CD22+ Relapsed and Refractory Lymphoma
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