Status:
TERMINATED
CD19/CD22-Dual-STAR-T for Patients With B Cell Acute Leukemia(B-ALL)
Lead Sponsor:
Hebei Yanda Ludaopei Hospital
Collaborating Sponsors:
China Immunotech (Beijing) Biotechnology Co., Ltd.
Conditions:
Refractory and Relapsed B Cell Acute Leukemia
Eligibility:
All Genders
1-70 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2022
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04508842
Start Date
October 10 2020
End Date
May 1 2022
Last Update
September 28 2022
Active Locations (1)
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1
Hebei Yanda Ludaopei Hospital
Sanhe, Hebei, China, 065200