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

July 6, 2022 updated by: He Huang
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • The First Affiliated Hospital, College of Medicine, Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: RD14-01 cell infusion
Infused i.v. in a single dose
Drug: RD14-01 cell infusion
Autologous CAR T cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose-limiting toxicity
Time Frame: Up to 2 years
DLT
Up to 2 years
Maximum tolerable dose
Time Frame: Up to 2 years
MTD
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

He Huang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 5, 2022

Primary Completion (ANTICIPATED)

July 10, 2024

Study Completion (ANTICIPATED)

July 10, 2025

Study Registration Dates

First Submitted

June 29, 2022

First Submitted That Met QC Criteria

June 29, 2022

First Posted (ACTUAL)

July 5, 2022

Study Record Updates

Last Update Posted (ACTUAL)

July 11, 2022

Last Update Submitted That Met QC Criteria

July 6, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BHCT-RD14-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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