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
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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.
- 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.
- 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.
- Age greater than 18 year and less than 80 years.
- Objectively assessable parameters of life expectancy: more than 3 months.
- Performance status: WHO PS grade 0-1 (ECOG performance status 0 or 1).
- Meet the following criteria for apheresis:WBC >= 3,000/L, Hb >= 8.0 g/dL, plateletcount >= 80,000/mm3, <= 600,000/mm3.
- Pulmonary function: Peripheral blood oxygen saturation greater than 90%; Cardiacfunction: Left ventricular ejection fraction >60%.
- Prior and concomitant associated diseases allowed with the exception of underlyingautoimmune disease and positive serology for HIV/HBV/HCV.
- No concomitant use of immunosuppressive drugs.
- Adequate renal and liver function, i.e. creatinin, bilirubin, and aminotransferase =< 1.2 times the upper limit of normal.
- 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.
- Women of child-bearing potential should use adequate contraception prior to studyentry and for the duration of study participation.
- Written informed consent obtained.
Exclusion
Exclusion Criteria:
- Patients with severe complications: cardiovascular disorders, respiratory disorders,renal dysfunction, immunodeficiency, hematological disorders, autoimmune diseases,sever allergy and severe infectious disease.
- Patients who should receive systemic administration of steroid or immunosuppressiveagents.
- Presence of active brain metastases.
- Pregnant, lactating, or possibly pregnant women, or willing to be pregnant.
- Severe psychiatric disorder.
- Active multiple cancers.
- Patients have received other genetic therapy products.
- Transfection efficiency was less than 30%.
- Inappropriate for study entry judged by an attending physician.
- 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
Connect with a study center
Zhujiang Hospital, Southern Medical University
Guangzhou, Guangdong 510282
ChinaActive - Recruiting

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