Brief Title
Anti-CD30 CAR-T Therapy in Patients With Refractory/Relapsed Lymphocyte Malignancies
Official Title
Efficacy and Safety of Anti-CD30 CAR-T Therapy in Patients With Refractory/Relapsed Lymphocyte Malignancies：a Single-center, Open, Single-arm Clinical Study.
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.
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 Phase
Phase 1
Study Type
Interventional
Primary Outcome
Number of participants with adverse events
Secondary Outcome
One-month remission rate
Condition
Adult T-Cell Lymphoma/Leukaemia
Intervention
Anti-CD30 CAR T cells
Study Arms / Comparison Groups
Anti-CD30 CAR T cells
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Genetic
Estimated Enrollment
50
Start Date
July 3, 2019
Completion Date
January 1, 2023
Primary Completion Date
July 1, 2022
Eligibility Criteria
Inclusion Criteria:
1. Patient or his or her legal guardian voluntarily participates in and signs an informed
consent form.
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:
1. Women who are pregnant (urine/blood pregnancy test positive) or lactating.
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.
Gender
All
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
Heng Mei, M.D. Ph.D, 86-13986183871, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT04008394
Organization ID
WHUH-CART-CD30-01
Responsible Party
Principal Investigator
Study Sponsor
Wuhan Union Hospital, China
Collaborators
Wuhan Bio-Raid Biotechnology Co, Ltd. China
Study Sponsor
Heng Mei, M.D. Ph.D, Principal Investigator, Wuhan Union Hospital, China
Verification Date
August 2019