Anti-CD30 CAR-T Therapy in Patients With Refractory/Relapsed Lymphocyte Malignancies
NCT ID: NCT04008394
Last Updated: 2019-08-07
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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UNKNOWN
PHASE1
50 participants
INTERVENTIONAL
2019-07-03
2023-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Male or female patients aged 18 to 70 years (including 18 and 70 years old).
3. 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.
4. CD30+ lymphocyte malignancies:
1. Adult T-cell leukemia/lymphoma
2. Anaplastic large cell lymphoma (ALCL);
3. Angioimmunoblastic T-cell Lymphoma (AITL);
4. NK/T-cell lymphoma;
5. Peripheral T-cell lymphoma (PTCL);
6. Hodgkin lymphoma;
5. Subjects:
1. There are still residual lesions after major treatment, and they are not suitable for HSCT (auto/allo-HSCT);
2. Recurrence occurs after CR1, and HSCT (auto/allo-HSCT) is not selected or suitable because of self-willingness;
3. After hematopoietic stem cell transplantation or cellular immunotherapy, the patient suffered relapse or did not remission.
6. Having a measurable or evaluable lesion.
7. Patient's main organs function well：
1. Liver function: ALT/AST \< 3 times the upper limit of normal (ULN) and
2. total bilirubin≤34.2μmol/L
3. Renal function: Creatinine \< 220μmol/L.
4. Pulmonary function: Indoor oxygen saturation≥95%.
5. Cardiac Function: Left ventricular ejection fraction (LVEF) ≥40%.
8. 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).
9. The patient's peripheral superficial venous blood flow smoothly, which can meet the needs of intravenous drip.
10. Patient ECOG score≤2, Estimated survival time≥3 months.
Exclusion Criteria
2. Male or female with a conception plan in the past 1 years.
3. Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 years after enrollment.
4. Uncontrolled infectious disease within 4 weeks prior to enrollment.
5. Active hepatitis B/C virus.
6. HIV infected patients.
7. Suffering from a serious autoimmune disease or immunodeficiency disease.
8. The patient is allergic and is allergic to macromolecular biopharmaceuticals such as antibodies or cytokines.
9. The patient participated in other clinical trials within 6 weeks prior to enrollment.
10. Systemic use of hormones within 4 weeks prior to enrollment (except for patients with inhaled corticosteroids).
11. Have a history of epilepsy or other central nervous system diseases.
12. Having drug abuse/addiction.
13. According to the researcher's judgment, the patient has other unsuitable grouping conditions.
18 Years
70 Years
ALL
No
Sponsors
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Wuhan Bio-Raid Biotechnology Co, Ltd. China
UNKNOWN
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Responsible Party
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MEI HENG
Principal Investigator
Principal Investigators
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Heng Mei, M.D. Ph.D
Role: PRINCIPAL_INVESTIGATOR
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Locations
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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WHUH-CART-CD30-01
Identifier Type: -
Identifier Source: org_study_id
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