RD13-01 for Patients With r/r CD7+ T-ALL/T-LBL
1 other identifier
interventional
24
1 country
1
Brief Summary
This study is designed to explore the safety of RD13-01 for patients with CD7+ relapsed and/or refractory T cell acute lymphoblastic leukemia or lymphoblastic lymphoma. And to evaluate the efficacy and pharmacokinetics of RD13-01 in patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2020
Typical duration for not_applicable
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
November 3, 2020
CompletedFirst Posted
Study publicly available on registry
November 9, 2020
CompletedStudy Start
First participant enrolled
November 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2022
CompletedNovember 9, 2020
November 1, 2020
1 year
November 3, 2020
November 3, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Dose-limiting toxicity (DLT)
4 weeks after infusion
Study Arms (1)
RD13-01 cell infusion
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Aged 3 to 70 years.
- Diagnosis of r/r T-ALL/T-LBL.
- ECOG: 0-2.
- Life expectancy greater than 12 weeks.
- 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 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.
- Patients with graft-versus-host disease (GVHD) or who need to use immunosuppressive drugs.
- Participated in other clinical studies within 2 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
- Min Xianglead
Study Sites (1)
Hebei Yanda Ludaopei Hospital
Langfang, Hebei, 065200, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xian Zhang
Hebei Yanda Ludaopei Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 3, 2020
First Posted
November 9, 2020
Study Start
November 15, 2020
Primary Completion
November 15, 2021
Study Completion
November 15, 2022
Last Updated
November 9, 2020
Record last verified: 2020-11