Back to resultsCD19/CD22-Dual-STAR-T for Patients With B Cell Acute Leukemia(B-ALL)
Primary Purpose
Refractory and Relapsed B Cell Acute Leukemia
Status
Terminated
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CD19/CD22-Dual-STAR-T
Sponsored by
About this trial
This is an interventional treatment trial for Refractory and Relapsed B Cell Acute Leukemia
Eligibility Criteria
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.
Sites / Locations
- Hebei Yanda Ludaopei Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CD19/CD22-Dual-STAR-T
Arm Description
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.
Outcomes
Primary Outcome Measures
Percentage of participants with adverse events.
Percentage of participants with adverse events.
Secondary Outcome Measures
Objective Remission Rate(ORR)
The percentage of participants who achieved complete remission(CR) and CR in over all participants.
Proliferation ratio of Dual-STAR-T cells
Full Information
NCT ID
NCT04508842
First Posted
August 9, 2020
Last Updated
September 27, 2022
Sponsor
Hebei Yanda Ludaopei Hospital
Collaborators
China Immunotech (Beijing) Biotechnology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04508842
Brief Title
CD19/CD22-Dual-STAR-T for Patients With B Cell Acute Leukemia(B-ALL)
Official Title
The Phase I Efficacy and Safety Clinical Study of CD19/CD22-Dual-STAR-T Cells in Relapsed and Refractory B-ALL.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
Adjustment plan
Study Start Date
October 10, 2020 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hebei Yanda Ludaopei Hospital
Collaborators
China Immunotech (Beijing) Biotechnology Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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 .
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory and Relapsed B Cell Acute Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CD19/CD22-Dual-STAR-T
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
CD19/CD22-Dual-STAR-T
Intervention 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 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.
Primary Outcome Measure Information:
Title
Percentage of participants with adverse events.
Description
Percentage of participants with adverse events.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Objective Remission Rate(ORR)
Description
The percentage of participants who achieved complete remission(CR) and CR in over all participants.
Time Frame
12 months
Title
Proliferation ratio of Dual-STAR-T cells
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xian Zhang, PhD
Organizational Affiliation
Hebei Yanda Ludaopei Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Hebei Yanda Ludaopei Hospital
City
Sanhe
State/Province
Hebei
ZIP/Postal Code
065200
Country
China
12. IPD Sharing Statement
Learn more about this trial
CD19/CD22-Dual-STAR-T for Patients With B Cell Acute Leukemia(B-ALL)
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