Trial | NCT04620655  Report issue

Official Title

RD13-01 for Patients With r/r CD7+ T-ALL/T-LBL

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    24
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.
Study Started
Nov 15
2020
Anticipated
Primary Completion
Nov 15
2021
Anticipated
Study Completion
Nov 15
2022
Anticipated
Last Update
Nov 09
2020

Drug RD13-01 cell infusion

Universal CAR-T cells targeting CD7

RD13-01 cell infusion Experimental

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.
No Results Posted