Anti-CD30 CAR-T Therapy in Patients With Refractory/Relapsed Lymphocyte Malignancies

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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