Anti-CD30 CAR-T Therapy in Patients With Refractory/Relapsed Lymphocyte Malignancies
Efficacy and Safety of Anti-CD30 CAR-T Therapy in Patients With Refractory/Relapsed Lymphocyte Malignancies：a Single-center, Open, Single-arm Clinical Study.
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jul 2019
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 2, 2019
CompletedStudy Start
First participant enrolled
July 3, 2019
CompletedFirst Posted
Study publicly available on registry
July 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2023
CompletedAugust 7, 2019
August 1, 2019
3 years
July 2, 2019
August 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
One-month remission rate
1 month
Overall survival
3 years
Event-free survival
3 years
Relapse-free survival
3 years
Quantity of anti-CD30 CAR-T cells in bone marrow cells and peripheral blood cells
3 years
- +1 more secondary outcomes
Study Arms (1)
Anti-CD30 CAR T cells
EXPERIMENTALPatients 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
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
You may qualify if:
- Patient or his or her legal guardian voluntarily participates in and signs an informed consent form.
- Male or female patients aged 18 to 70 years (including 18 and 70 years old).
- 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.
- CD30+ lymphocyte malignancies:
- Adult T-cell leukemia/lymphoma
- Anaplastic large cell lymphoma (ALCL);
- Angioimmunoblastic T-cell Lymphoma (AITL);
- NK/T-cell lymphoma;
- Peripheral T-cell lymphoma (PTCL);
- Hodgkin lymphoma;
- Subjects:
- There are still residual lesions after major treatment, and they are not suitable for HSCT (auto/allo-HSCT);
- Recurrence occurs after CR1, and HSCT (auto/allo-HSCT) is not selected or suitable because of self-willingness;
- After hematopoietic stem cell transplantation or cellular immunotherapy, the patient suffered relapse or did not remission.
- Having a measurable or evaluable lesion.
- +9 more criteria
You may not qualify if:
- Women who are pregnant (urine/blood pregnancy test positive) or lactating.
- Male or female with a conception plan in the past 1 years.
- Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 years after enrollment.
- Uncontrolled infectious disease within 4 weeks prior to enrollment.
- Active hepatitis B/C virus.
- HIV infected patients.
- Suffering from a serious autoimmune disease or immunodeficiency disease.
- The patient is allergic and is allergic to macromolecular biopharmaceuticals such as antibodies or cytokines.
- The patient participated in other clinical trials within 6 weeks prior to enrollment.
- Systemic use of hormones within 4 weeks prior to enrollment (except for patients with inhaled corticosteroids).
- Have a history of epilepsy or other central nervous system diseases.
- Having drug abuse/addiction.
- According to the researcher's judgment, the patient has other unsuitable grouping conditions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Heng Mei, M.D. Ph.D
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 2, 2019
First Posted
July 5, 2019
Study Start
July 3, 2019
Primary Completion
July 1, 2022
Study Completion
January 1, 2023
Last Updated
August 7, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share