Anti-CD30 CAR-T Therapy in Patients With Refractory/Relapsed Lymphocyte Malignancies
Study Details
Study Description
Brief Summary
The overall purpose of this study is to explore the safety and therapeutic effect of CD30-targeted chimeric antigen receptor T(CAR-T) cells in the treatment of Refractory/Relapsed lymphocyte malignancies.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Detailed Description
Chimeric antigen receptor (CAR)-modified T cells (CAR-T cells) have the capabilities to recognize tumor associated antigen and kill tumor cells specifically. CD30 is originally described as a marker of Hodgkin's and R-S cells in Hodgkin's lymphoma. CD30 antibody has been applied to treat lymphocyte derived malignancies. To explore the potency of CD30 in CAR-T therapy, this trial is designed and conducted to test the safety and efficacy of CD30-targeted CAR-T in Refractory/Relapsed lymphocyte malignancies.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Anti-CD30 CAR T cells Patients receive CD30 CAR-T cells transduced with a lentiviral vector on day 0 in the absence of disease progression or unacceptable toxicity. Autologous 3th generation anti-CD30 CAR T cells. |
Genetic: Anti-CD30 CAR T cells
Patients receive CD30 CAR-T cells transduced with a lentiviral vector on day 0 in the absence of disease progression or unacceptable toxicity. Autologous 3th generation anti-CD30 CAR T cells.
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Outcome Measures
Primary Outcome Measures
- Number of participants with adverse events [3 years]
Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0).
Secondary Outcome Measures
- One-month remission rate [1 month]
Response to CAR-T therapy was assessed on day 30 (±2), against the National Comprehensive Cancer Network (NCCN, Version 1.2015).
- Overall survival [3 years]
OS was calculated from the first CAR-T cell infusion to death or last follow-up (censored).
- Event-free survival [3 years]
EFS was calculated from the first CAR-T cell infusion to death, progression of the disease, relapse or gene recurrence, whichever came first, or last visit (censored).
- Relapse-free survival [3 years]
RFS was calculated from the first CAR-T cell infusion to relapse or last visit (censored).
- Quantity of anti-CD30 CAR-T cells in bone marrow cells and peripheral blood cells [3 years]
In vivo (bone marrow and peripheral blood) quantity of CAR-T cells were determined by means of flow cytometry.
- Quantity of anti-CD30 CAR copies in bone marrow cells and peripheral blood cells [3 years]
In vivo (bone marrow and peripheral blood) quantity of anti-CD30 CAR copies were determined by means of qPCR.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient or his or her legal guardian voluntarily participates in and signs an informed consent form.
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Male or female patients aged 18 to 70 years (including 18 and 70 years old).
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Pathological and histological examination confirmed CD30+ lymphocyte malignancies, and patients currently have no effective treatment options, such as chemotherapy or recurrence after hematopoietic stem cell transplantation; or patients voluntarily choose Anti-CD30 CAR-T as rescue treatment.
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CD30+ lymphocyte malignancies:
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Adult T-cell leukemia/lymphoma
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Anaplastic large cell lymphoma (ALCL);
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Angioimmunoblastic T-cell Lymphoma (AITL);
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NK/T-cell lymphoma;
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Peripheral T-cell lymphoma (PTCL);
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Hodgkin lymphoma;
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Subjects:
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There are still residual lesions after major treatment, and they are not suitable for HSCT (auto/allo-HSCT);
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Recurrence occurs after CR1, and HSCT (auto/allo-HSCT) is not selected or suitable because of self-willingness;
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After hematopoietic stem cell transplantation or cellular immunotherapy, the patient suffered relapse or did not remission.
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Having a measurable or evaluable lesion.
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Patient's main organs function well:
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Liver function: ALT/AST < 3 times the upper limit of normal (ULN) and
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total bilirubin≤34.2μmol/L
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Renal function: Creatinine < 220μmol/L.
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Pulmonary function: Indoor oxygen saturation≥95%.
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Cardiac Function: Left ventricular ejection fraction (LVEF) ≥40%.
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The patients did not receive any anticancer treatments such as chemotherapy, radiotherapy and immunotherapy (such as immunosuppressive drugs) within 4 weeks before admission, and the toxicity related to previous treatments had returned to < 1 level at admission (except for low toxicity such as alopecia).
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The patient's peripheral superficial venous blood flow smoothly, which can meet the needs of intravenous drip.
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Patient ECOG score≤2, Estimated survival time≥3 months.
Exclusion Criteria:
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Women who are pregnant (urine/blood pregnancy test positive) or lactating.
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Male or female with a conception plan in the past 1 years.
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Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 years after enrollment.
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Uncontrolled infectious disease within 4 weeks prior to enrollment.
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Active hepatitis B/C virus.
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HIV infected patients.
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Suffering from a serious autoimmune disease or immunodeficiency disease.
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The patient is allergic and is allergic to macromolecular biopharmaceuticals such as antibodies or cytokines.
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The patient participated in other clinical trials within 6 weeks prior to enrollment.
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Systemic use of hormones within 4 weeks prior to enrollment (except for patients with inhaled corticosteroids).
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Have a history of epilepsy or other central nervous system diseases.
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Having drug abuse/addiction.
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According to the researcher's judgment, the patient has other unsuitable grouping conditions.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | China | 430022 |
Sponsors and Collaborators
- Wuhan Union Hospital, China
- Wuhan Bio-Raid Biotechnology Co, Ltd. China
Investigators
- Principal Investigator: Heng Mei, M.D. Ph.D, Wuhan Union Hospital, China
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- WHUH-CART-CD30-01