A Study of RD14-01 in Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Jul 2022
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2022
CompletedFirst Posted
Study publicly available on registry
July 5, 2022
CompletedStudy Start
First participant enrolled
July 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 10, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 10, 2025
CompletedJuly 11, 2022
July 1, 2022
2 years
June 29, 2022
July 6, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Dose-limiting toxicity
DLT
Up to 2 years
Maximum tolerable dose
MTD
Up to 2 years
Study Arms (1)
RD14-01 cell infusion
EXPERIMENTALInfused i.v. in a single dose
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- He Huanglead
Study Sites (1)
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
June 29, 2022
First Posted
July 5, 2022
Study Start
July 5, 2022
Primary Completion
July 10, 2024
Study Completion
July 10, 2025
Last Updated
July 11, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share