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Recruiting Phase 1 NCT03291444

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

Trial Parameters

Condition Leukemia, Acute Lymphocytic (ALL)
Sponsor Zhujiang Hospital
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 30
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2018-05-05
Completion 2024-12-31
Interventions
Chimeric antigen receptor T cellspeptide specific dendritic cell

Brief 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 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 subtypes except M3. Patients with Myelodysplastic Syndrome, category of Refractory Anemia with Excess Blasts (RAEB): RAEB I (WHO: medullary blast count ≤ 10% and a peripheral blast count ≤ 5%) and RAEB II (WHO: medullary blast count \> 10% and/or \> 5% peripheral blasts) can be included in the study in absence of other non-experimental treatment modalities. 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-

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