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

• Sponsor: He Huang (Other)
• Overall Status: Completed
• CT.gov ID: NCT04538599
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Actual Duration (Months): 14.7
• Patients Per Site Per Month: 0.8

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/NK-cell hematologic malignancies. And to evaluate the efficacy and pharmacokinetics of RD13-01 in patients.

Condition or Disease	Intervention/Treatment	Phase
Hematologic Malignancies	Drug: RD13-01 cell infusion	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 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/NK Cell Hematologic Malignancies
• Actual Study Start Date: Sep 10, 2020
• Actual Primary Completion Date: Feb 17, 2021
• Actual Study Completion Date: Nov 30, 2021

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/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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital，College of Medicine, Zhejiang University	Hangzhou	Zhejiang	China	310003

Sponsors and Collaborators

• He Huang

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: He Huang, PhD, Zhejiang University
• ClinicalTrials.gov Identifier: NCT04538599
• Other Study ID Numbers: BHCT-RD13-01-02
• First Posted: Sep 4, 2020
• Last Update Posted: Jan 25, 2022
• Last Verified: Sep 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasms; Hematologic Neoplasms

Study Results

No Results Posted as of Jan 25, 2022