Clinical Trials /

CD19/CD22-Dual-STAR-T for Patients With B Cell Acute Leukemia(B-ALL)

NCT04508842

Description:

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 .

Related Conditions:
  • B-Cell Acute Lymphoblastic Leukemia
Recruiting Status:

Not yet recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • 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.

Clinical Trial IDs

  • ORG STUDY ID: HXYT-011
  • NCT ID: NCT04508842

Conditions

  • Refractory and Relapsed B Cell Acute Leukemia

Interventions

DrugSynonymsArms
CD19/CD22-Dual-STAR-TCD19/CD22-Dual-STAR-T

Purpose

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).
    

Trial Arms

NameTypeDescriptionInterventions
CD19/CD22-Dual-STAR-TExperimentalCD19/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.
  • CD19/CD22-Dual-STAR-T

Eligibility Criteria

        Inclusion Criteria:

          1. Ages 1 to 70 years.

          2. 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.

          3. CD19 and/or CD22 positive within 3 months.

          4. ECOG 0-2.

          5. Estimated life expectancy ≥ 3 months.

          6. 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.

          7. Patients who voluntarily sign informed consent and are willing to comply with
             treatment plans, visit arrangements, laboratory tests and other research procedures.

        Exclusion Criteria:

          1. Active infections that are difficult to control

          2. HBV-DNA HCV-RNA and HIV ,either of which is positive

          3. Central nervous system leukemias that is symptomatic or uncontrolled by systemic
             chemotherapy and intrathecal chemotherapy

          4. Patients are receiving anti-GVHD treatment within 4 weeks of before screening.

          5. Performed major surgery within 4 weeks before screening.

          6. Patients have received chemotherapy within 7 days of screening.

          7. Experimental drugs were used within 4 weeks before screening.

          8. Received allogeneic cell therapy within 6 weeks prior to cell infusion.

          9. Patients have history of epilepsy or central nervous system diseases.

         10. Severe thyroid dysfunction

         11. Patients with active autoimmune disease.

         12. Pregnant or lactating women.

         13. The patient does not agree to use effective contraception during treatment and for the
             following 12 months;

         14. The researchers found that it was unsuitable for the recipients to be enrolled.
      
Maximum Eligible Age:70 Years
Minimum Eligible Age:1 Year
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Percentage of participants with adverse events.
Time Frame:12 months
Safety Issue:
Description:Percentage of participants with adverse events.

Secondary Outcome Measures

Measure:Objective Remission Rate(ORR)
Time Frame:12 months
Safety Issue:
Description:The percentage of participants who achieved complete remission(CR) and CR in over all participants.
Measure:Proliferation ratio of Dual-STAR-T cells
Time Frame:12 months
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Hebei Yanda Ludaopei Hospital

Last Updated

August 11, 2020