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| Name | Class |
|---|---|
| Shenzhen Geno-Immune Medical Institute | OTHER |
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | OTHER |
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Chimeric antigen receptor T cells | Active Comparator | After pretreatment, chimeric antigen receptor T cells will be transfused. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chimeric antigen receptor T cells | Biological | After pretreatment, chimeric antigen receptor T cells will be transfused. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival time | Time from random to the first occurrence of disease progression. | 2 years |
| Overall survival time | Time from randomization to death due to any cause |
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Inclusion Criteria:
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:
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.
Adequate renal and liver function, i.e. creatinin, bilirubin, and aminotransferase =< 1.2 times the upper limit of normal.
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.
Women of child-bearing potential should use adequate contraception prior to study entry and for the duration of study participation.
Written informed consent obtained.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sanfang Tu, M.D, Ph.D | Contact | 86-20-62782322 | doctortutu@163.com | |
| Yanjie He, M.D, Ph.D | Contact | 86-20-61643190 | hyjgzh2006@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yuhua Li, M.D, Ph.D | Zhujiang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhujiang Hospital, Southern Medical University | Recruiting | Guangzhou | Guangdong | 510282 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38712616 | Derived | 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. |
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|
| peptide specific dendritic cell | Biological | After transfusion of chimeric antigen receptor T cells, Eps8 or WT1 peptide specific dendritic cell were intradermal injected. |
|
|
| 2 years |
| Overall response rate | 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 | 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 |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D015470 | Leukemia, Myeloid, Acute |
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007951 | Leukemia, Myeloid |
| D001855 | Bone Marrow Diseases |
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| ID | Term |
|---|---|
| D016219 | Immunotherapy, Adoptive |
| ID | Term |
|---|---|
| D019264 | Adoptive Transfer |
| D007116 | Immunization, Passive |
| D007114 | Immunization |
| D007167 | Immunotherapy |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |
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