CAR-T Cells Combined With Peptide Specific Dendritic Cell in Relapsed/Refractory Leukemia/MDS
NCT ID: NCT03291444
Last Updated: 2024-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
30 participants
INTERVENTIONAL
2018-05-05
2025-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Chimeric antigen receptor T cells
After pretreatment, chimeric antigen receptor T cells will be transfused.
peptide specific dendritic cell
After transfusion of chimeric antigen receptor T cells, Eps8 or WT1 peptide specific dendritic cell were intradermal injected.
Chimeric antigen receptor T cells
After pretreatment, chimeric antigen receptor T cells will be transfused.
Chimeric antigen receptor T cells
After pretreatment, chimeric antigen receptor T cells will be transfused.
Interventions
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Chimeric antigen receptor T cells
After pretreatment, chimeric antigen receptor T cells will be transfused.
peptide specific dendritic cell
After transfusion of chimeric antigen receptor T cells, Eps8 or WT1 peptide specific dendritic cell were intradermal injected.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
No
Sponsors
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Shenzhen Geno-Immune Medical Institute
OTHER
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Zhujiang Hospital
OTHER
Responsible Party
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Principal Investigators
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Yuhua Li, M.D, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Zhujiang Hospital
Locations
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Zhujiang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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2017-XYNK-001
Identifier Type: -
Identifier Source: org_study_id
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