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

Hematologic Malignancies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04538599
• Other study ID #: BHCT-RD13-01-02
• Status: Completed
• Phase: Phase 1
• Start date: September 10, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: September 2021
• Source: Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 30, 2021
• Est. primary completion date: February 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hematologic Malignancies
• Hematologic Neoplasms
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	The First Affiliated Hospital,College of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
He Huang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting toxicity (DLT)		4 weeks after infusion