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

March 14, 2024 updated by: Zhujiang Hospital

A Clinical Study of Chimeric Antigen Receptor T Cells Combined With Eps8 Peptide Specific Dendritic Cell for Patients With Relapsed/Refractory Leukemia and Myelodysplastic Syndromes

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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/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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510282
        • Recruiting
        • Zhujiang Hospital, Southern Medical University
        • Contact:
        • Principal Investigator:
          • Yuhua Li, M.D, Ph.D
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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-HSCT.
    • Relapsed after CAR-T cell infusion.
  4. Age greater than 18 year and less than 80 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. Pulmonary function: Peripheral blood oxygen saturation greater than 90%; Cardiac function: Left ventricular ejection fraction >60%.
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CAR-T cells combined with peptide specific dendritic cell
CAR-T cells combined with Eps8 peptide specific dendritic cell,or CAR-T cells combined with WT1 peptide specific dendritic cell
Biological: Chimeric antigen receptor T cells
After pretreatment, chimeric antigen receptor T cells will be transfused.
Other Names:
  • CAR-T
Biological: peptide specific dendritic cell
After transfusion of chimeric antigen receptor T cells, Eps8 or WT1 peptide specific dendritic cell were intradermal injected.
Other Names:
  • WT1 peptide specific dendritic cell
  • Eps8 peptide specific dendritic cell
Active Comparator: Chimeric antigen receptor T cells
After pretreatment, chimeric antigen receptor T cells will be transfused.
Biological: Chimeric antigen receptor T cells
After pretreatment, chimeric antigen receptor T cells will be transfused.
Other Names:
  • CAR-T

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of study related adverse events, according to NCI CTCAE Version 4.0
Time Frame: up to 12 months
Incidence and severity of cytokine release syndrome(CRS): The systemic inflammatory response in patients with significantly increased IL-6 and other cytokines during the observation period is defined as CRS, which is divided into 1-5 grades, 1-2 Grade is mild, grade 3-5 is severe
up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival time
Time Frame: 2 years
Time from random to the first occurrence of disease progression.
2 years
Overall survival time
Time Frame: 2 years
Time from randomization to death due to any cause
2 years
Overall response rate
Time Frame: 2 years
The proportion of the total number of patients with complete remission and partial remission (CR+PR) after treatment in the total number of evaluable cases
2 years
Duration of response
Time Frame: 2 years
During the observation period, the time between complete remission of bone marrow (the ratio of bone marrow blast cells is less than 5%) to the recurrence of bone marrow (the ratio of bone marrow blast cells is greater than 5%) is the continuous remission time.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhujiang Hospital

Collaborators

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Shenzhen Geno-Immune Medical Institute

Investigators

  • Principal Investigator: Yuhua Li, M.D, Ph.D, Zhujiang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2018

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

September 20, 2017

First Submitted That Met QC Criteria

September 21, 2017

First Posted (Actual)

September 25, 2017

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-XYNK-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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