CAR-T Cells Combined With Peptide Specific Dendritic Cell in Relapsed/Refractory Leukemia/MDS

Last updated: March 14, 2024
Sponsor: Zhujiang Hospital
Overall Status: Active - Recruiting

Phase

1

Condition

White Cell Disorders

Leukemia

Myelodysplastic Syndromes (Mds)

Treatment

Chimeric antigen receptor T cells

peptide specific dendritic cell

Clinical Study ID

NCT03291444
2017-XYNK-001
  • Ages 18-80
  • All Genders

Study Summary

The main purpose of this study is to verify the safety and potential effectiveness of CART cells combined with peptide specific dendritic cell in relapsed/refractory leukemia.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Tumor type: Acute Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia (ALL)according to the WHO criteria (at least 20% blasts in the marrow). All FAB subtypesexcept M3. Patients with Myelodysplastic Syndrome, category of Refractory Anemia withExcess Blasts (RAEB): RAEB I (WHO: medullary blast count ≤ 10% and a peripheral blastcount ≤ 5%) and RAEB II (WHO: medullary blast count > 10% and/or > 5% peripheralblasts) can be included in the study in absence of other non-experimental treatmentmodalities.
  2. Positive antigen for any of CD19, CD20, CD22, CD10, CD33, CD38, CD56, CD117, CD123,CD34, or Muc1.Simultaneously ,high expression of EPS8 or WT1 in acute leukemia.
  3. Relapsed/Refractory leukemia patients:
  • Did not achieve complete remission after 2 times of standard plan chemotherapy.
  • Relapsed after first induction chemotherapy.
  • Did not response to chemotherapy before HSCT or relapsed after HSCT.
  • Cannot receive allo-HSCT or refuse to receive allo-HSCT.
  • Relapsed after CAR-T cell infusion.
  1. Age greater than 18 year and less than 80 years.
  2. Objectively assessable parameters of life expectancy: more than 3 months.
  3. Performance status: WHO PS grade 0-1 (ECOG performance status 0 or 1).
  4. Meet the following criteria for apheresis:WBC >= 3,000/L, Hb >= 8.0 g/dL, plateletcount >= 80,000/mm3, <= 600,000/mm3.
  5. Pulmonary function: Peripheral blood oxygen saturation greater than 90%; Cardiacfunction: Left ventricular ejection fraction >60%.
  6. Prior and concomitant associated diseases allowed with the exception of underlyingautoimmune disease and positive serology for HIV/HBV/HCV.
  7. No concomitant use of immunosuppressive drugs.
  8. Adequate renal and liver function, i.e. creatinin, bilirubin, and aminotransferase =< 1.2 times the upper limit of normal.
  9. Absence of any psychological, familial, sociological or geographical conditionpotentially hampering compliance with the study protocol and follow-up schedule; thoseconditions should be discussed with the patient before registration in the trial.
  10. Women of child-bearing potential should use adequate contraception prior to studyentry and for the duration of study participation.
  11. Written informed consent obtained.

Exclusion

Exclusion Criteria:

  1. Patients with severe complications: cardiovascular disorders, respiratory disorders,renal dysfunction, immunodeficiency, hematological disorders, autoimmune diseases,sever allergy and severe infectious disease.
  2. Patients who should receive systemic administration of steroid or immunosuppressiveagents.
  3. Presence of active brain metastases.
  4. Pregnant, lactating, or possibly pregnant women, or willing to be pregnant.
  5. Severe psychiatric disorder.
  6. Active multiple cancers.
  7. Patients have received other genetic therapy products.
  8. Transfection efficiency was less than 30%.
  9. Inappropriate for study entry judged by an attending physician.
  10. patients who have sensitivity to drugs that provide local anesthesia.

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Chimeric antigen receptor T cells
Phase: 1
Study Start date:
May 05, 2018
Estimated Completion Date:
June 01, 2025

Study Description

A prospective study to evaluate the safety and efficacy of Chimeric antigen receptor T cells combined with Eps8 or WT1(Wilms tumor 1) peptide specific dendritic cell for patients with relapsed/refractory leukemia. There are options for CAR-targets: CD19, CD20, CD22 and CD10 for acute lymphoblastic leukemia; CD33, CD38 CD56, CD117, CD123, CD34 and Muc1 for acute myeloid leukemia and Myelodysplastic Syndrome. Progression free survival, overall Survival, overall response rate, and duration of response were monitored.

Connect with a study center

  • Zhujiang Hospital, Southern Medical University

    Guangzhou, Guangdong 510282
    China

    Active - Recruiting

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