Back to resultsCD7 CAR-T for Patients With r/r CD7+ Hematologic Malignancies
Primary Purpose
Hematological Malignancies
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Anti-CD7 CAR-T
Sponsored by
About this trial
This is an interventional treatment trial for Hematological Malignancies focused on measuring T-ALL/LBL, AML
Eligibility Criteria
Inclusion Criteria:
- Diagnosed CD7 positive relapsed/refractory hematological malignancies.
- Echocardiography shows left ventricular ejection fraction (LVEF) ≥ 50%;
- There is no active pulmonary infection, and the oxygen saturation during air inhalation is more than 92%;
- The estimated survival time is more than 3 months;
- Eastern cooperative oncology group (ECOG) performance status of 0 to 2
- The patients or their legal guardians voluntarily participated in the trial and signed the informed consent.
Exclusion Criteria:
- Patients with history of epilepsy or other central nervous system diseases;
- Patients with prolonged QT or severe heart disease;
- Pregnant or lactating women
- Patients with uncontrolled active infection.
- Positive for any of the following etiological tests: HIV, HBV, HCV
- Any other conditions that researcher think it is inappropriate for the subject to anticipate the trial
Sites / Locations
- Institute of Hematology & Blood Diseases HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
anti-CD7 UCAR-T cells
Arm Description
Outcomes
Primary Outcome Measures
Overall Response Rate(ORR)
Number of patients who achieved response after treatment of CD7 CAR-T cell.
Secondary Outcome Measures
Duration of overall response (DOR)
Duration of overall response will be assessed from the CAR-T cell infusion to progression, death or last follow-up.
Overall survival(OS)
OS will be assessed from the CAR-T cell infusion to death or last follow-up.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05454241
Brief Title
CD7 CAR-T for Patients With r/r CD7+ Hematologic Malignancies
Official Title
Efficacy, Safety and PK of CD7 CAR-T in Patients With Relapsed or Refractory CD7+ Hematological Malignancies
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 7, 2022 (Actual)
Primary Completion Date
September 7, 2024 (Anticipated)
Study Completion Date
September 7, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ying Wang
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 open-label, phase 2 study to evaluate the efficacy, safety and PK of CD7 chimeric antigen receptors treatment for patients with refractory/relapsed CD7 positive hematological malignancies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematological Malignancies
Keywords
T-ALL/LBL, AML
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
anti-CD7 UCAR-T cells
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Anti-CD7 CAR-T
Intervention Description
Universal CAR-T cells targeting CD7
Primary Outcome Measure Information:
Title
Overall Response Rate(ORR)
Description
Number of patients who achieved response after treatment of CD7 CAR-T cell.
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
Duration of overall response (DOR)
Description
Duration of overall response will be assessed from the CAR-T cell infusion to progression, death or last follow-up.
Time Frame
1 Year
Title
Overall survival(OS)
Description
OS will be assessed from the CAR-T cell infusion to death or last follow-up.
Time Frame
1 Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed CD7 positive relapsed/refractory hematological malignancies.
Echocardiography shows left ventricular ejection fraction (LVEF) ≥ 50%;
There is no active pulmonary infection, and the oxygen saturation during air inhalation is more than 92%;
The estimated survival time is more than 3 months;
Eastern cooperative oncology group (ECOG) performance status of 0 to 2
The patients or their legal guardians voluntarily participated in the trial and signed the informed consent.
Exclusion Criteria:
Patients with history of epilepsy or other central nervous system diseases;
Patients with prolonged QT or severe heart disease;
Pregnant or lactating women
Patients with uncontrolled active infection.
Positive for any of the following etiological tests: HIV, HBV, HCV
Any other conditions that researcher think it is inappropriate for the subject to anticipate the trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Wang, doctor
Phone
+86-22-23909278
Email
wangying1@ihcams.ac.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying Wang, Dr.
Organizational Affiliation
Hematology Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Hematology & Blood Diseases Hospital
City
Tianjin
ZIP/Postal Code
300020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Wang, Dr.
Phone
86-22-23909278
Email
wangying1@ihcams.ac.cn
First Name & Middle Initial & Last Name & Degree
Jianxiang Wang, Dr.
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
When the research is completed, it will be shared in the form of a paper publication
Learn more about this trial
CD7 CAR-T for Patients With r/r CD7+ Hematologic Malignancies
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