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

Primary Purpose

Hematologic Malignancies

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

RD13-01 cell infusion

About this trial

This is an interventional treatment trial for Hematologic Malignancies

Eligibility Criteria

3 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The First Affiliated Hospital，College of Medicine, Zhejiang University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RD13-01 cell infusion

Arm Description

Outcomes

Primary Outcome Measures

Dose-limiting toxicity (DLT)

Secondary Outcome Measures

Full Information

NCT ID

NCT04538599

First Posted

August 30, 2020

Last Updated

January 8, 2022

Sponsor

He Huang

1. Study Identification

Unique Protocol Identification Number

NCT04538599

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

September 10, 2020 (Actual)

Primary Completion Date

February 17, 2021 (Actual)

Study Completion Date

November 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

He Huang

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hematologic Malignancies

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RD13-01 cell infusion

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

RD13-01 cell infusion

Intervention Description

Universal CAR-T cells targeting CD7

Primary Outcome Measure Information:

Title

Dose-limiting toxicity (DLT)

Time Frame

4 weeks after infusion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

The First Affiliated Hospital，College of Medicine, Zhejiang University

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310003

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

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