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

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.

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Key information

Conditions

Hematologic Malignancies Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

3 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The First Affiliated Hospital，College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Aged 3 to 70 years.
Diagnosis of r/r T-ALL/NK-ALL, T-LBL, or T-NHL (including PTCL-NOS, AITL, ALCL, Extranodal NK/T cell lymphoma).
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.

Treatment and study plan

RD13-01 cell infusion

Drug

Universal CAR-T cells targeting CD7

Primary outcomes

Dose-limiting toxicity (DLT)

Time frame: 4 weeks after infusion

Sponsors and collaborators

Lead sponsor

He Huang

Other

Registry information

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Sep 4, 2020
Registry last updated: Jan 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed