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

November 3, 2020 updated by: Min Xiang
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hebei
      • Langfang, Hebei, China, 065200
        • Recruiting
        • Hebei yanda Ludaopei Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Aged 3 to 70 years.
  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:

  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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RD13-01 cell infusion
Drug: RD13-01 cell infusion
Universal CAR-T cells targeting CD7

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dose-limiting toxicity (DLT)
Time Frame: 4 weeks after infusion
4 weeks after infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Min Xiang

Investigators

  • Principal Investigator: Xian Zhang, Hebei yanda Ludaopei Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 15, 2020

Primary Completion (Anticipated)

November 15, 2021

Study Completion (Anticipated)

November 15, 2022

Study Registration Dates

First Submitted

November 3, 2020

First Submitted That Met QC Criteria

November 3, 2020

First Posted (Actual)

November 9, 2020

Study Record Updates

Last Update Posted (Actual)

November 9, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BHCT-RD13-01-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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