- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04508842
CD19/CD22-Dual-STAR-T for Patients With B Cell Acute Leukemia(B-ALL)
September 27, 2022 updated by: Hebei Yanda Ludaopei Hospital
The Phase I Efficacy and Safety Clinical Study of CD19/CD22-Dual-STAR-T Cells in Relapsed and Refractory B-ALL.
This is a single center, single arm, open-lable phase I study to determine the safety and efficacy of CD19/CD22-Dual-STAR-T cells in patients with refractory and relapsed B cell acute leukemia .
Study Overview
Status
Terminated
Intervention / Treatment
Detailed Description
Patients with B cell acute leukemia will be enrolled, and Subjects will receive cytoreductive chemotherapy with cyclophosphamide and fludarabine on days -5, -4 and -3 followed by infusion of Dual-STAR-T cells.Dual-STAR-T cells will be intravenously infused with a escalated dose of 6E5、1E6、2E6、3E6 cells/kg.The purpose of current study is to evaluate the clinical safety and efficacy of CD19/CD22-Dual-STAR-T cells therapy in patients with refractory and relapsed B-ALL.Safety and efficacy of Dual-STAR-T cells therapy will be monitored.
The primary endpoint is the safety of Dual-STAR-T cells including the effect ratio of CRS and ICANS, ORR.
The secondary endpoint is the Dual-STAR-T cell proliferation ratio and Dual-STAR gene copied number in peripheral blood(PB), and progression free survival(PFS ), overall-survival(OS) and duration of overall response(DOR).
Study Type
Interventional
Enrollment (Actual)
2
Phase
- 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 Locations
-
-
Hebei
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Sanhe, Hebei, China, 065200
- Hebei yanda Ludaopei Hospital
-
-
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
1 year to 70 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Ages 1 to 70 years.
Prelapsed and refractorys B-ALL at least with one of the following conditions:
- Could not achieve CR after 2course of chemotherapy.
- Could not achieve CR or relapse after first-line or multi-line salvage chemotherapy, or MRD≥0.1%.
- Relapse within 12 months after first remission or MRD≥0.1%.
- Relapse after achieved CR in allogeneic hematopoietic stem cell transplantation (HSCT), or MRD≥0.1%.
- For Ph + patients: Failure to tolerate TKI or TKI treatment failure could be enrolled.
- CD19 and/or CD22 positive within 3 months.
- ECOG 0-2.
- Estimated life expectancy ≥ 3 months.
- Women of childbearing age must receive a pregnancy test within 7 days prior to initiation of treatment and the results are negative; male and female patients with fertility must use an effective contraceptive to ensure 12 months after discontinuation of treatment during the study period not pregnant inside.
- Patients who voluntarily sign informed consent and are willing to comply with treatment plans, visit arrangements, laboratory tests and other research procedures.
Exclusion Criteria:
- Active infections that are difficult to control
- HBV-DNA HCV-RNA and HIV ,either of which is positive
- Central nervous system leukemias that is symptomatic or uncontrolled by systemic chemotherapy and intrathecal chemotherapy
- Patients are receiving anti-GVHD treatment within 4 weeks of before screening.
- Performed major surgery within 4 weeks before screening.
- Patients have received chemotherapy within 7 days of screening.
- Experimental drugs were used within 4 weeks before screening.
- Received allogeneic cell therapy within 6 weeks prior to cell infusion.
- Patients have history of epilepsy or central nervous system diseases.
- Severe thyroid dysfunction
- Patients with active autoimmune disease.
- Pregnant or lactating women.
- The patient does not agree to use effective contraception during treatment and for the following 12 months;
- The researchers found that it was unsuitable for the recipients to be enrolled.
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: CD19/CD22-Dual-STAR-T
CD19/CD22-Dual-STAR-T cells are prepared via lentiviral infection.
5 days prior to infusion of Dual-STAR-T cells, subjects receive fludarabine at dose 30mg/m2/day and cyclophosphamide treatment at dose 500mg/m2 for 3 days and take a rest for 2 days before infusion.
Dual-STAR-T cells will be intravenously infused with a escalated dose of 6E5、1E6、2E6、3E6 cells/kg.
|
Patients with B cell acute leukemia will be enrolled, and Subjects will receive cytoreductive chemotherapy with cyclophosphamide and fludarabine on days -5, -4 and -3 followed by infusion of CD19/CD22-Dual-STAR-T cells.Dual-STAR-T cells will be intravenously infused with a escalated dose of 6E5、1E6、2E6、3E6 cells/kg.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of participants with adverse events.
Time Frame: 12 months
|
Percentage of participants with adverse events.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Remission Rate(ORR)
Time Frame: 12 months
|
The percentage of participants who achieved complete remission(CR) and CR in over all participants.
|
12 months
|
Proliferation ratio of Dual-STAR-T cells
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Xian Zhang, PhD, Hebei yanda Ludaopei Hospital
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)
October 10, 2020
Primary Completion (Actual)
May 1, 2022
Study Completion (Actual)
May 1, 2022
Study Registration Dates
First Submitted
August 9, 2020
First Submitted That Met QC Criteria
August 10, 2020
First Posted (Actual)
August 11, 2020
Study Record Updates
Last Update Posted (Actual)
September 28, 2022
Last Update Submitted That Met QC Criteria
September 27, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HXYT-011
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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