Status:
RECRUITING
CAR-T Cells Combined With Peptide Specific Dendritic Cell in Relapsed/Refractory Leukemia/MDS
Lead Sponsor:
Zhujiang Hospital
Collaborating Sponsors:
Shenzhen Geno-Immune Medical Institute
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions:
Leukemia, Acute Lymphocytic (ALL)
Leukemia, Acute Myelogenous (AML)
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
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.
Detailed 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/refract...
Eligibility Criteria
Inclusion
- 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.
- 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, platelet count \>= 80,000/mm3, \<= 600,000/mm3.
- Pulmonary function: Peripheral blood oxygen saturation greater than 90%; Cardiac function: Left ventricular ejection fraction \>60%.
- Prior and concomitant associated diseases allowed with the exception of underlying autoimmune 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 condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
- Women of child-bearing potential should use adequate contraception prior to study entry and for the duration of study participation.
- Written informed consent obtained.
Exclusion
- 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 immunosuppressive agents.
- 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.
Key Trial Info
Start Date :
May 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03291444
Start Date
May 5 2018
End Date
June 1 2025
Last Update
March 15 2024
Active Locations (1)
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1
Zhujiang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510282