Back to resultsRD13-01 for Patients With r/r CD7+ T-ALL/T-LBL
Primary Purpose
T Acute Lymphoblastic Leukemia, T-lymphoblastic Lymphoma
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
RD13-01 cell infusion
Sponsored by
About this trial
This is an interventional treatment trial for T Acute Lymphoblastic Leukemia
Eligibility Criteria
Inclusion Criteria:
- Aged 3 to 70 years.
- Diagnosis of r/r T-ALL/T-LBL.
- ECOG: 0-2.
- Life expectancy greater than 12 weeks.
- Cardiac left ventricle ejection fraction ≥50%.
- Informed consent explained to, understood by and signed by the patient/ guardian. Patient/guardian is given a copy of informed consent.
Exclusion Criteria:
- Pregnant or lactating.
- Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal range; hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C Viral (HCV) RNA positive; human immunodeficiency virus (HIV) antibody positive; cytomegalovirus (CMV) DNA positive; syphilis positive.
- Patients with graft-versus-host disease (GVHD) or who need to use immunosuppressive drugs.
- Participated in other clinical studies within 2 weeks prior to screening.
- History of alcoholism, drug abuse or mental illness.
- Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
Sites / Locations
- Hebei Yanda Ludaopei HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
RD13-01 cell infusion
Arm Description
Outcomes
Primary Outcome Measures
Dose-limiting toxicity (DLT)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04620655
Brief Title
RD13-01 for Patients With r/r CD7+ T-ALL/T-LBL
Official Title
RD13-01 for Patients With r/r CD7+ T-ALL/T-LBL
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 15, 2020 (Anticipated)
Primary Completion Date
November 15, 2021 (Anticipated)
Study Completion Date
November 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Min Xiang
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
This study is designed to explore the safety of RD13-01 for patients with CD7+ relapsed and/or refractory T cell acute lymphoblastic leukemia or lymphoblastic lymphoma. And to evaluate the efficacy and pharmacokinetics of RD13-01 in patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
T Acute Lymphoblastic Leukemia, T-lymphoblastic Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RD13-01 cell infusion
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
RD13-01 cell infusion
Intervention Description
Universal CAR-T cells targeting CD7
Primary Outcome Measure Information:
Title
Dose-limiting toxicity (DLT)
Time Frame
4 weeks after infusion
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:
Aged 3 to 70 years.
Diagnosis of r/r T-ALL/T-LBL.
ECOG: 0-2.
Life expectancy greater than 12 weeks.
Cardiac left ventricle ejection fraction ≥50%.
Informed consent explained to, understood by and signed by the patient/ guardian. Patient/guardian is given a copy of informed consent.
Exclusion Criteria:
Pregnant or lactating.
Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal range; hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C Viral (HCV) RNA positive; human immunodeficiency virus (HIV) antibody positive; cytomegalovirus (CMV) DNA positive; syphilis positive.
Patients with graft-versus-host disease (GVHD) or who need to use immunosuppressive drugs.
Participated in other clinical studies within 2 weeks prior to screening.
History of alcoholism, drug abuse or mental illness.
Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xian Zhang
Phone
+86-13641041596
Email
zhxian2@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xian Zhang
Organizational Affiliation
Hebei Yanda Ludaopei Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hebei Yanda Ludaopei Hospital
City
Langfang
State/Province
Hebei
ZIP/Postal Code
065200
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xian Zhang
Phone
+86-13641041596
Email
zhxian2@126.com
12. IPD Sharing Statement
Learn more about this trial
RD13-01 for Patients With r/r CD7+ T-ALL/T-LBL
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