Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
24 participants
INTERVENTIONAL
2020-11-15
2022-11-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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RD13-01 cell infusion
RD13-01 cell infusion
Universal CAR-T cells targeting CD7
Interventions
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RD13-01 cell infusion
Universal CAR-T cells targeting CD7
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of r/r T-ALL/T-LBL.
3. ECOG: 0-2.
4. Life expectancy greater than 12 weeks.
5. Cardiac left ventricle ejection fraction ≥50%.
6. Informed consent explained to, understood by and signed by the patient/ guardian. Patient/guardian is given a copy of informed consent.
Exclusion Criteria
2. 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.
3. Patients with graft-versus-host disease (GVHD) or who need to use immunosuppressive drugs.
4. Participated in other clinical studies within 2 weeks prior to screening.
5. History of alcoholism, drug abuse or mental illness.
6. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
3 Years
70 Years
ALL
No
Sponsors
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Min Xiang
OTHER
Responsible Party
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Min Xiang
Professor
Principal Investigators
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Xian Zhang
Role: PRINCIPAL_INVESTIGATOR
Hebei Yanda Ludaopei Hospital
Locations
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Hebei Yanda Ludaopei Hospital
Langfang, Hebei, China
Countries
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Central Contacts
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Facility Contacts
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Xian Zhang
Role: primary
Other Identifiers
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BHCT-RD13-01-03
Identifier Type: -
Identifier Source: org_study_id