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

NCT ID: NCT04620655

Last Updated: 2020-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-15

Study Completion Date

2022-11-15

Brief Summary

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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.

Detailed Description

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Conditions

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T Acute Lymphoblastic Leukemia T-lymphoblastic Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RD13-01 cell infusion

Group Type EXPERIMENTAL

RD13-01 cell infusion

Intervention Type DRUG

Universal CAR-T cells targeting CD7

Interventions

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RD13-01 cell infusion

Universal CAR-T cells targeting CD7

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Min Xiang

OTHER

Sponsor Role lead

Responsible Party

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Min Xiang

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Xian Zhang

Role: PRINCIPAL_INVESTIGATOR

Hebei Yanda Ludaopei Hospital

Locations

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Hebei Yanda Ludaopei Hospital

Langfang, Hebei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xian Zhang

Role: CONTACT

Phone: +86-13641041596

Email: [email protected]

Facility Contacts

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Xian Zhang

Role: primary

Other Identifiers

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BHCT-RD13-01-03

Identifier Type: -

Identifier Source: org_study_id