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NCT04538599 Clinical Trial

RD13-01 for Patients With r/r CD7+ T/NK Cell Hematologic Malignancies

Hematologic Malignancies Clinical Trial

Official title:
RD13-01 for Patients With r/r CD7+ T/NK Cell Hematologic Malignancies

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04538599
Other study ID # BHCT-RD13-01-02
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 10, 2020
Est. completion date November 30, 2021

Study information
Verified date September 2021
Source Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is designed to explore the safety of RD13-01 for patients with CD7+ relapsed and/or refractory T/NK-cell hematologic malignancies. And to evaluate the efficacy and pharmacokinetics of RD13-01 in patients.

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date November 30, 2021
Est. primary completion date February 17, 2021
Accepts healthy volunteers No
Gender All
Age group 3 Years to 70 Years
Eligibility Inclusion Criteria: 1. Aged 3 to 70 years. 2. Diagnosis of r/r T-ALL/NK-ALL, T-LBL, or T-NHL (including PTCL-NOS, AITL, ALCL, Extranodal NK/T cell lymphoma). 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: 1. Pregnant or lactating. 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• RD13-01 cell infusion
Universal CAR-T cells targeting CD7

Locations
Country Name City State
China The First Affiliated Hospital,College of Medicine, Zhejiang University Hangzhou Zhejiang

Sponsors (1)
Lead Sponsor Collaborator
He Huang

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Dose-limiting toxicity (DLT) 4 weeks after infusion
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