NCT03291444

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2018

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 25, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

May 5, 2018

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

6.7 years

First QC Date

September 20, 2017

Last Update Submit

March 14, 2024

Conditions

Leukemia, Acute Lymphocytic (ALL)Leukemia, Acute Myelogenous (AML)Myelodysplastic Syndromes

Outcome Measures

Primary Outcomes (1)

  • Occurrence of study related adverse events, according to NCI CTCAE Version 4.0

    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 Outcomes (4)

  • Progression free survival time

    2 years

  • Overall survival time

    2 years

  • Overall response rate

    2 years

  • Duration of response

    2 years

Study Arms (2)

CAR-T cells combined with peptide specific dendritic cell

EXPERIMENTAL

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 cellsBiological: peptide specific dendritic cell

Chimeric antigen receptor T cells

ACTIVE COMPARATOR

After pretreatment, chimeric antigen receptor T cells will be transfused.

Biological: Chimeric antigen receptor T cells

Interventions

Chimeric antigen receptor T cellsBIOLOGICAL

After pretreatment, chimeric antigen receptor T cells will be transfused.

Also known as: CAR-T
CAR-T cells combined with peptide specific dendritic cellChimeric antigen receptor T cells
peptide specific dendritic cellBIOLOGICAL

After transfusion of chimeric antigen receptor T cells, Eps8 or WT1 peptide specific dendritic cell were intradermal injected.

Also known as: WT1 peptide specific dendritic cell, Eps8 peptide specific dendritic cell
CAR-T cells combined with peptide specific dendritic cell

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • +4 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhujiang Hospital, Southern Medical University

Guangzhou, Guangdong, 510282, China

RECRUITING

Related Publications (1)

  • Tu S, Zhou L, Huang R, Zhou X, Yang J, He Y, Hu Y, Zhang H, Xie X, Li Y. Dendritic cell vaccines extend CAR T-cell persistence and improve the efficacy of CD19 CAR T-cell therapy in refractory or relapsed adult B-ALL patients. Am J Hematol. 2024 Jul;99(7):1437-1440. doi: 10.1002/ajh.27349. Epub 2024 May 7. No abstract available.

    PMID: 38712616DERIVED

MeSH Terms

Conditions

LeukemiaLeukemia, Myeloid, AcuteMyelodysplastic Syndromes

Interventions

Immunotherapy, Adoptive

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidBone Marrow Diseases

Intervention Hierarchy (Ancestors)

Adoptive TransferImmunization, PassiveImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative Techniques

Study Officials

  • Yuhua Li, M.D, Ph.D

    Zhujiang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanfang Tu, M.D, Ph.D

CONTACT

86-20-62782322doctortutu@163.com

Yanjie He, M.D, Ph.D

CONTACT

86-20-61643190hyjgzh2006@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2017

First Posted

September 25, 2017

Study Start

May 5, 2018

Primary Completion

December 31, 2024

Study Completion

June 1, 2025

Last Updated

March 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)