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

This study is currently recruiting participants.
Verified September 2017 by Zhujiang Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT03291444
First Posted: September 22, 2017
Last Update Posted: September 22, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Shenzhen Geno-Immune Medical Institute
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Information provided by (Responsible Party):
Zhujiang Hospital
September 20, 2017
September 22, 2017
September 22, 2017
September 23, 2017
March 1, 2021   (Final data collection date for primary outcome measure)
Occurrence of study related adverse events, according to NCI CTCAE Version 4.0 [ Time Frame: up to 12 months ]
Same as current
No Changes Posted
  • Progression free survival time [ Time Frame: 2 years ]
  • Overall survival time [ Time Frame: 2 years ]
  • Overall response rate [ Time Frame: 2 years ]
  • Duration of response [ Time Frame: 2 years ]
Same as current
Not Provided
Not Provided
 
CAR-T Cells Combined With Peptide Specific Dendritic Cell in Relapsed/Refractory Leukemia
A Clinical Study of Chimeric Antigen Receptor T Cells Combined With Eps8 Peptide Specific Dendritic Cell for Patients With Relapsed/Refractory Leukemia
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.
A prospective study to evaluate the safety and efficacy of Chimeric antigen receptor T cells combined with Eps8 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.
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Leukemia, Acute Lymphocytic (ALL)
  • Leukemia, Acute Myelogenous (AML)
  • Myelodysplastic Syndromes
  • Biological: Chimeric antigen receptor T cells
    After pretreatment, chimeric antigen receptor T cells will be transfused.
  • Biological: Eps8 peptide specific dendritic cell
    After transfusion of chimeric antigen receptor T cells, Eps8 peptide specific dendritic cell were intradermal injected.
  • Experimental: CAR-T cells combined with Eps8 peptide specific dendritic cell
    Interventions:
    • Biological: Chimeric antigen receptor T cells
    • Biological: Eps8 peptide specific dendritic cell
  • Active Comparator: Chimeric antigen receptor T cells
    Intervention: Biological: Chimeric antigen receptor T cells
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
March 1, 2022
March 1, 2021   (Final data collection date for primary outcome measure)

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 for any of CD19, CD20, CD22, CD10, CD33, CD38, CD56, CD117, CD123, CD34, or Muc1.
  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.
  4. Age greater than 17 year and less than 61 years.
  5. Objectively assessable parameters of life expectancy: more than 3 months.
  6. Performance status: WHO PS grade 0-1 (ECOG performance status 0 or 1).
  7. Meet the following criteria for apheresis:WBC >= 3,000/L, Hb >= 8.0 g/dL, platelet count >= 80,000/mm3, <= 600,000/mm3.
  8. Objectively assessable parameters of life expectancy: more than 3 months.
  9. Prior and concomitant associated diseases allowed with the exception of underlying autoimmune disease and positive serology for HIV/HBV/HCV.
  10. No concomitant use of immunosuppressive drugs.
  11. Adequate renal and liver function, i.e. creatinin, bilirubin, and aminotransferase =< 1.2 times the upper limit of normal.
  12. 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.
  13. Women of child-bearing potential should use adequate contraception prior to study entry and for the duration of study participation.
  14. Written informed consent obtained.

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 immunosuppressive agents.
  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.
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact: Sanfang Tu, M.D, Ph.D 86-20-62782322 doctortutu@163.com
Contact: Yanjie He, M.D, Ph.D 86-20-61643190 hyjgzh2006@163.com
China
 
 
NCT03291444
11111111
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Zhujiang Hospital
Zhujiang Hospital
  • Shenzhen Geno-Immune Medical Institute
  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Principal Investigator: Yuhua Li, M.D, Ph.D Zhujiang Hospital
Zhujiang Hospital
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP