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NCT05444322 Clinical Trial

A Study of RD14-01 in Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma

Mantle Cell Lymphoma Clinical Trial

Official title:
A Study of RD14-01 in Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05444322
Other study ID # BHCT-RD14-01
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date July 5, 2022
Est. completion date July 10, 2025

Study information
Verified date July 2022
Source Zhejiang University
Contact He Huang, PhD
Phone 86-13605714822
Email hehuangyu@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is designed to explore the safety and tolerability of RD14-01 for patients with relapsed and/or refractory B-cell non-Hodgkin lymphoma. And to evaluate the efficacy and pharmacokinetics of RD14-01 in patients.

Recruitment information / eligibility
Status Recruiting
Enrollment 18
Est. completion date July 10, 2025
Est. primary completion date July 10, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 1. Aged 18 to 75 years. 2. Diagnosis of r/r MCL, DLBCL, or FL (Grade 1, 2 and 3a). 3. ECOG: 0-1. 4. Life expectancy greater than 3 months. 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 e-antigen (HBeAg) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal range; hepatitis C virus (HCV) antibody positive; human immunodeficiency virus (HIV) antibody positive; syphilis antibody positive; cytomegalovirus (CMV) DNA positive; Epstein-Barr virus (EBV) DNA positive. 3. Central nervous system (CNS) metastases. 4. Participated in other clinical studies within 4 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

Related Conditions & MeSH terms

Intervention

Drug:
• RD14-01 cell infusion
Autologous CAR T cells

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 Up to 2 years
Primary Maximum tolerable dose MTD Up to 2 years
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