CD19 Targeted Universal Chimeric Antigen Receptor T Cells Injection for CD19+ Refractory/Relapsed B-cell Malignancies
A Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of Anti-CD19 Universal CAR-T Cells in the Treatment of CD19+ Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia and Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
1 other identifier
interventional
15
1 country
1
Brief Summary
It is a single-arm, open-label clinical study to assess the safety and efficacy of the Anti-CD19 Universal CAR-T Cells injection for patients with CD19+ refractory/relapsed B cell acute lymphoblastic leukemia and B cell non-Hodgkin lymphoma.
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 Sep 2021
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
Study Start
First participant enrolled
September 29, 2021
CompletedFirst Submitted
Initial submission to the registry
October 25, 2021
CompletedFirst Posted
Study publicly available on registry
November 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2024
CompletedMay 10, 2023
April 1, 2023
2.9 years
October 25, 2021
May 8, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Dose Limiting Toxicities
Incidence of dose-limiting toxicities as protocol-defined
Up to 4 weeks after CAR-T infusion
Secondary Outcomes (1)
Objective response rate (ORR)
At 4,12,24 weeks after CAR-T infusion
Study Arms (1)
Anti-CD19 Universal CAR-T Cells injection
EXPERIMENTALAnti-CD19 Universal CAR-T Cells injection will be administered by vein after lymphodepletion .
Interventions
Anti-CD19 Universal CAR-T Cells injection will be administered by vein after lymphodepletion.
Eligibility Criteria
You may qualify if:
- Eastern Cooperative Oncology Group Performance Status of 0 or 1；
- Expected survival time ≥12 weeks;
- Adequate hematological, renal and liver function;
- Subjects understand and voluntarily sign the informed consent form.
You may not qualify if:
- Positive for any of the following etiological tests: HIV, HBV, HCV, TPPA ;
- Cyclophosphamide or fludarabine is contraindicated for subjects ;
- Active central nervous system (CNS) involvement by malignancy；
- Active infection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Kunming, Yunnan, 650000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sanbin Wang, Professor
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
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
Study Record Dates
First Submitted
October 25, 2021
First Posted
November 3, 2021
Study Start
September 29, 2021
Primary Completion
August 31, 2024
Study Completion
November 30, 2024
Last Updated
May 10, 2023
Record last verified: 2023-04