Back to resultsA Study of RD14-01 in Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma
Primary Purpose
Mantle Cell Lymphoma, Diffuse Large B-cell Lymphoma, Follicular Lymphoma
Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
RD14-01 cell infusion
Sponsored by
About this trial
This is an interventional treatment trial for Mantle Cell Lymphoma
Eligibility Criteria
Inclusion Criteria:
- Aged 18 to 75 years.
- Diagnosis of r/r MCL, DLBCL, or FL (Grade 1, 2 and 3a).
- ECOG: 0-1.
- Life expectancy greater than 3 months.
- Cardiac left ventricle ejection fraction ≥50%.
- Informed consent explained to, understood by and signed by the patient/guardian. Patient/guardian is given a copy of informed consent.
Exclusion Criteria:
- Pregnant or lactating.
- 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.
- Central nervous system (CNS) metastases.
- Participated in other clinical studies within 4 weeks prior to screening.
- History of alcoholism, drug abuse or mental illness.
- Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
Sites / Locations
- The First Affiliated Hospital, College of Medicine, Zhejiang UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
RD14-01 cell infusion
Arm Description
Infused i.v. in a single dose
Outcomes
Primary Outcome Measures
Dose-limiting toxicity
DLT
Maximum tolerable dose
MTD
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05444322
Brief Title
A Study of RD14-01 in Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma
Official Title
A Study of RD14-01 in Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2022 (Actual)
Primary Completion Date
July 10, 2024 (Anticipated)
Study Completion Date
July 10, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
He Huang
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mantle Cell Lymphoma, Diffuse Large B-cell Lymphoma, Follicular Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RD14-01 cell infusion
Arm Type
Experimental
Arm Description
Infused i.v. in a single dose
Intervention Type
Drug
Intervention Name(s)
RD14-01 cell infusion
Intervention Description
Autologous CAR T cells
Primary Outcome Measure Information:
Title
Dose-limiting toxicity
Description
DLT
Time Frame
Up to 2 years
Title
Maximum tolerable dose
Description
MTD
Time Frame
Up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 18 to 75 years.
Diagnosis of r/r MCL, DLBCL, or FL (Grade 1, 2 and 3a).
ECOG: 0-1.
Life expectancy greater than 3 months.
Cardiac left ventricle ejection fraction ≥50%.
Informed consent explained to, understood by and signed by the patient/guardian. Patient/guardian is given a copy of informed consent.
Exclusion Criteria:
Pregnant or lactating.
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.
Central nervous system (CNS) metastases.
Participated in other clinical studies within 4 weeks prior to screening.
History of alcoholism, drug abuse or mental illness.
Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
He Huang, PhD
Phone
86-13605714822
Email
hehuangyu@126.com
Facility Information:
Facility Name
The First Affiliated Hospital, College of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
He Huang, PhD
Phone
86-13605714822
Email
hehuangyu@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of RD14-01 in Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma
We'll reach out to this number within 24 hrs