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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 25, 2017
Last Update Posted: September 25, 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
  Purpose
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.

Condition Intervention Phase
Leukemia, Acute Lymphocytic (ALL) Leukemia, Acute Myelogenous (AML) Myelodysplastic Syndromes Biological: Chimeric antigen receptor T cells Biological: Eps8 peptide specific dendritic cell Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Study of Chimeric Antigen Receptor T Cells Combined With Eps8 Peptide Specific Dendritic Cell for Patients With Relapsed/Refractory Leukemia

Resource links provided by NLM:


Further study details as provided by Zhujiang Hospital:

Primary Outcome Measures:
  • Occurrence of study related adverse events, according to NCI CTCAE Version 4.0 [ Time Frame: up to 12 months ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Anticipated Study Start Date: September 23, 2017
Estimated Study Completion Date: March 1, 2022
Estimated Primary Completion Date: March 1, 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CAR-T cells combined with Eps8 peptide specific dendritic cell 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.
Active Comparator: Chimeric antigen receptor T cells Biological: Chimeric antigen receptor T cells
After pretreatment, chimeric antigen receptor T cells will be transfused.

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03291444


Contacts
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

Locations
China, Guangdong
Zhujiang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510282
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   
Principal Investigator: Yuhua Li, M.D, Ph.D         
Sponsors and Collaborators
Zhujiang Hospital
Shenzhen Geno-Immune Medical Institute
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Investigators
Principal Investigator: Yuhua Li, M.D, Ph.D Zhujiang Hospital
  More Information

Responsible Party: Zhujiang Hospital
ClinicalTrials.gov Identifier: NCT03291444     History of Changes
Other Study ID Numbers: 11111111
First Submitted: September 20, 2017
First Posted: September 25, 2017
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Leukemia
Myelodysplastic Syndromes
Preleukemia
Acute Disease
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Disease Attributes
Pathologic Processes
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Myeloid