CD19/CD22-Dual-STAR-T for Patients With B Cell Acute Leukemia(B-ALL)
Study Details
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 .
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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 Design
Arms and Interventions
| 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. |
Biological: CD19/CD22-Dual-STAR-T
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.
|
Outcome Measures
Primary Outcome Measures
- Percentage of participants with adverse events. [12 months]
Percentage of participants with adverse events.
Secondary Outcome Measures
- Objective Remission Rate(ORR) [12 months]
The percentage of participants who achieved complete remission(CR) and CR in over all participants.
- Proliferation ratio of Dual-STAR-T cells [12 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Ages 1 to 70 years.
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Prelapsed and refractorys B-ALL at least with one of the following conditions:
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Could not achieve CR after 2course of chemotherapy.
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Could not achieve CR or relapse after first-line or multi-line salvage chemotherapy, or MRD≥0.1%.
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Relapse within 12 months after first remission or MRD≥0.1%.
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Relapse after achieved CR in allogeneic hematopoietic stem cell transplantation (HSCT), or MRD≥0.1%.
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For Ph + patients: Failure to tolerate TKI or TKI treatment failure could be enrolled.
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CD19 and/or CD22 positive within 3 months.
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ECOG 0-2.
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Estimated life expectancy ≥ 3 months.
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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.
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Patients who voluntarily sign informed consent and are willing to comply with treatment plans, visit arrangements, laboratory tests and other research procedures.
Exclusion Criteria:
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Active infections that are difficult to control
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HBV-DNA HCV-RNA and HIV ,either of which is positive
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Central nervous system leukemias that is symptomatic or uncontrolled by systemic chemotherapy and intrathecal chemotherapy
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Patients are receiving anti-GVHD treatment within 4 weeks of before screening.
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Performed major surgery within 4 weeks before screening.
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Patients have received chemotherapy within 7 days of screening.
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Experimental drugs were used within 4 weeks before screening.
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Received allogeneic cell therapy within 6 weeks prior to cell infusion.
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Patients have history of epilepsy or central nervous system diseases.
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Severe thyroid dysfunction
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Patients with active autoimmune disease.
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Pregnant or lactating women.
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The patient does not agree to use effective contraception during treatment and for the following 12 months;
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The researchers found that it was unsuitable for the recipients to be enrolled.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hebei Yanda Ludaopei Hospital | Sanhe | Hebei | China | 065200 |
Sponsors and Collaborators
- Hebei Yanda Ludaopei Hospital
- China Immunotech (Beijing) Biotechnology Co., Ltd.
Investigators
- Study Director: Xian Zhang, PhD, Hebei Yanda Ludaopei Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HXYT-011