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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04008394
Other study ID # WHUH-CART-CD30-01
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date July 3, 2019
Est. completion date January 1, 2023

Study information

Verified date August 2019
Source Wuhan Union Hospital, China
Contact Yu Hu, M.D. Ph.D
Phone 86-13986183871
Email dr_huyu@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date January 1, 2023
Est. primary completion date July 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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.

Study Design


Intervention

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.

Locations

Country Name City State
China Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei

Sponsors (2)

Lead Sponsor Collaborator
Wuhan Union Hospital, China Wuhan Bio-Raid Biotechnology Co, Ltd. China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with adverse events 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). 3 years
Secondary One-month remission rate Response to CAR-T therapy was assessed on day 30 (±2), against the National Comprehensive Cancer Network (NCCN, Version 1.2015). 1 month
Secondary Overall survival OS was calculated from the first CAR-T cell infusion to death or last follow-up (censored). 3 years
Secondary Event-free survival 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). 3 years
Secondary Relapse-free survival RFS was calculated from the first CAR-T cell infusion to relapse or last visit (censored). 3 years
Secondary Quantity of anti-CD30 CAR-T cells in bone marrow cells and peripheral blood cells In vivo (bone marrow and peripheral blood) quantity of CAR-T cells were determined by means of flow cytometry. 3 years
Secondary Quantity of anti-CD30 CAR copies in bone marrow cells and peripheral blood cells In vivo (bone marrow and peripheral blood) quantity of anti-CD30 CAR copies were determined by means of qPCR. 3 years
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