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

Sponsor
Min Xiang (Other)
Overall Status
Recruiting
CT.gov ID
NCT04620655
Collaborator
(none)
24
1
1
24
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: RD13-01 cell infusion
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
RD13-01 for Patients With r/r CD7+ T-ALL/T-LBL
Anticipated Study Start Date :
Nov 15, 2020
Anticipated Primary Completion Date :
Nov 15, 2021
Anticipated Study Completion Date :
Nov 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: RD13-01 cell infusion

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

Outcome Measures

Primary Outcome Measures

  1. Dose-limiting toxicity (DLT) [4 weeks after infusion]

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hebei Yanda Ludaopei Hospital Langfang Hebei China 065200

Sponsors and Collaborators

  • Min Xiang

Investigators

  • Principal Investigator: Xian Zhang, Hebei Yanda Ludaopei Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Min Xiang, Professor, Hebei Yanda Ludaopei Hospital
ClinicalTrials.gov Identifier:
NCT04620655
Other Study ID Numbers:
  • BHCT-RD13-01-03
First Posted:
Nov 9, 2020
Last Update Posted:
Nov 9, 2020
Last Verified:
Nov 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 9, 2020