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

Phase 1

Completed

• Conditions: Hematologic Malignancies
• Interventions: Drug: RD13-01 cell infusion

• Registration Number: NCT04538599
• Lead Sponsor: He Huang

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-30
• Study First Submitted QC: 2020-08-30
• Study First Posted: 2020-09-04
• Study Start: 2020-09-10
• Primary Completion: 2021-02-17
• Status Verified: 2021-09
• Study Completion: 2021-11-30
• Last Update Submitted: 2022-01-08
• Last Update Posted: 2022-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. Aged 3 to 70 years.
2. Diagnosis of r/r T-ALL/NK-ALL, T-LBL, or T-NHL (including PTCL-NOS, AITL, ALCL, Extranodal NK/T cell lymphoma).
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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RD13-01 cell infusion	RD13-01 cell infusion	-

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicity (DLT)	4 weeks after infusion

Trial Locations

Locations (1)

The First Affiliated Hospital，College of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China