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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04508842
Recruitment Status : Suspended (Adjustment plan)
First Posted : August 11, 2020
Last Update Posted : February 14, 2022
Sponsor:
Collaborator:
China Immunotech (Beijing) Biotechnology Co., Ltd.
Information provided by (Responsible Party):
Hebei Yanda Ludaopei Hospital

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
Refractory and Relapsed B Cell Acute Leukemia Biological: CD19/CD22-Dual-STAR-T 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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Phase I Efficacy and Safety Clinical Study of CD19/CD22-Dual-STAR-T Cells in Relapsed and Refractory B-ALL.
Estimated Study Start Date : May 1, 2022
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : December 10, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

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.




Primary Outcome Measures :
  1. Percentage of participants with adverse events. [ Time Frame: 12 months ]
    Percentage of participants with adverse events.


Secondary Outcome Measures :
  1. Objective Remission Rate(ORR) [ Time Frame: 12 months ]
    The percentage of participants who achieved complete remission(CR) and CR in over all participants.

  2. Proliferation ratio of Dual-STAR-T cells [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04508842


Locations
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China, Hebei
Hebei Yanda Ludaopei Hospital
Sanhe, Hebei, China, 065200
Sponsors and Collaborators
Hebei Yanda Ludaopei Hospital
China Immunotech (Beijing) Biotechnology Co., Ltd.
Investigators
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Study Director: Xian Zhang, PhD Hebei Yanda Ludaopei Hospital
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Responsible Party: Hebei Yanda Ludaopei Hospital
ClinicalTrials.gov Identifier: NCT04508842    
Other Study ID Numbers: HXYT-011
First Posted: August 11, 2020    Key Record Dates
Last Update Posted: February 14, 2022
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Neoplasms by Histologic Type
Neoplasms