- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05105867
CD19 Targeted Universal Chimeric Antigen Receptor T Cells Injection for CD19+ Refractory/Relapsed B-cell Malignancies
May 8, 2023 updated by: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
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
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The study consists of the following periods: screening, lymphodepletion, CAR-T cell infusion, safety follow up, and long term follow-up.
Study Type
Interventional
Enrollment (Anticipated)
15
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 Contact
- Name: Sanbin Wang, Professor
- Phone Number: +86 13187424131
- Email: Sanbin1011@163.com
Study Locations
-
-
Yunnan
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Kunming, Yunnan, China, 650000
- Recruiting
- 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
-
Contact:
- Sanbin Wang, Professor
- Phone Number: +86 13187424131
- Email: Sanbin1011@163.com
-
-
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
14 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Key Inclusion Criteria:
- 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.
Key Exclusion Criteria:
- 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.
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Anti-CD19 Universal CAR-T Cells injection
Anti-CD19 Universal CAR-T Cells injection will be administered by vein after lymphodepletion .
|
Anti-CD19 Universal CAR-T Cells injection will be administered by vein after lymphodepletion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose Limiting Toxicities
Time Frame: Up to 4 weeks after CAR-T infusion
|
Incidence of dose-limiting toxicities as protocol-defined
|
Up to 4 weeks after CAR-T infusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate (ORR)
Time Frame: At 4,12,24 weeks after CAR-T infusion
|
Objective response rate after CAR-T infusion
|
At 4,12,24 weeks after CAR-T infusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sanbin Wang, Professor, 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
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)
September 29, 2021
Primary Completion (Anticipated)
August 31, 2024
Study Completion (Anticipated)
November 30, 2024
Study Registration Dates
First Submitted
October 25, 2021
First Submitted That Met QC Criteria
October 25, 2021
First Posted (Actual)
November 3, 2021
Study Record Updates
Last Update Posted (Actual)
May 10, 2023
Last Update Submitted That Met QC Criteria
May 8, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GC011-411
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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