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Clinical Trials/NCT04620655
NCT04620655UnknownNot Applicable

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

Min Xiang1 site in 1 country24 target enrollmentStarted: November 15, 2020Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
24
Locations
1
Primary Endpoint
Dose-limiting toxicity (DLT)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
3 Years to 70 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Aged 3 to 70 years.
  • •Diagnosis of r/r T-ALL/T-LBL.
  • •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.

Arms & Interventions

RD13-01 cell infusion

Experimental

Intervention: RD13-01 cell infusion (Drug)

Outcomes

Primary Outcomes

Dose-limiting toxicity (DLT)

Time Frame: 4 weeks after infusion

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Min Xiang
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Min Xiang

Professor

Hebei Yanda Ludaopei Hospital

Study Sites (1)

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