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Trial record 57 of 877 for:    "Reticulum Cell Sarcoma"

CD30 Targeted CAR-T in Treating CD30-Expressing Lymphomas

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ClinicalTrials.gov Identifier: NCT03383965
Recruitment Status : Recruiting
First Posted : December 27, 2017
Last Update Posted : December 27, 2017
Sponsor:
Collaborator:
Weifang People's Hospital
Information provided by (Responsible Party):
Xiulian Sun, Immune Cell, Inc.

Brief Summary:
CAR-T cells have been validated effective in treating CD19 positive B cell lymphoma. Other lymphomas like Hodgkin's lymphoma and anaplastic large cell lymphoma are CD30 positive. In this study, a newly CD30 targeted CART therapy ICAR30 is designed to specifically kill those CD30 expressing malignancies including Hodgkin's lymphoma and CD30+ anaplastic large cell lymphoma. The subjects will receive several doses of autologous ICAR30 T cells infusion and then the safety, treating effects and lasting period of these cells in vivo will be evaluated.

Condition or disease Intervention/treatment Phase
Hodgkin Lymphoma Anaplastic Large Cell Lymphoma Biological: ICAR30 T cells Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Study of CD30 Targeted CAR-T in Treating CD30-Expressing Lymphomas
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2025


Arm Intervention/treatment
Experimental: ICAR30 T cells
anti-CD30 CAR-T cells. Patients receive ICAR30 T cells infusion.
Biological: ICAR30 T cells
T cells were isolated from peripheral blood from patients enrolled. T cells were transduced with lentivirus bearing anti-CD30 antibody scFV and the activation signals of second generation CART designation. The CART cells were infused into the patients by IV with an escalating dosage.
Other Name: Biological drug




Primary Outcome Measures :
  1. Measure the safety of ICAR30 T cells [ Time Frame: 2 years ]
    To assess the adverse events of ICAR30 T cells infusion in patients with Hodgkin's lymphoma and CD30+ anaplastic large cell lymphoma.


Secondary Outcome Measures :
  1. Measure the anti-tumor effect of ICAR30 T cells [ Time Frame: 3 years ]
    To assess the anti-tumor effect of ICAR30 T cells infusion in patients with Hodgkin's lymphoma and CD30+ anaplastic large cell lymphoma.

  2. Measure the survival time of ICAR30 T cells in vivo [ Time Frame: 5 years ]
    To measure the survival time of ICAR30 T cells in vivo, extra blood will be drawn from patients receive ICAR30 T cells infusion in the follow-up time.



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Ages Eligible for Study:   2 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Hodgkin's lymphoma, anaplastic large cell lymphoma and other CD30 positive malignancies, relapsed or refractory:

  • Karnofsky or Lansky score >50;
  • Expected survival>12 weeks;
  • Hgb > 8.0;
  • FEV1, FVC and DLCO ≥50% of expected corrected for hemoglobin;
  • LVEF≥50%;
  • Creatinine<2.5mg/dl;
  • Bilirubin<2.5mg/dl;
  • ALT (alanine aminotransferase)/AST (aspartate aminotransferase)<3 fold normal;
  • Patients must sign an informed consent.

Exclusion Criteria:

  • Pregnant or lactating;
  • Uncontrolled active infection including hepatitis B or C;
  • HIV positive;
  • Active clinically significant CNS dysfunction;
  • Current use of systemic steroids;
  • Heterogenous lymphocyte treatments within recent 6 months;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03383965


Contacts
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Contact: Xiulian Sun, MD.,Ph.D (+86) 010-62420689 xiuliansun@ymcell.com

Locations
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China, Shandong
Weifang People's Hospital Recruiting
Weifang, Shandong, China, 261000
Contact: Xiulian Sun, M.D., Ph.D    (+86) 010-62420689    xiuliansun@ymcell.com   
Contact: Xuehong Ran, Doctor    0536-8192117    ranxuehong1967@163.com   
Sponsors and Collaborators
Immune Cell, Inc.
Weifang People's Hospital

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Responsible Party: Xiulian Sun, Principal Investigator, Immune Cell, Inc.
ClinicalTrials.gov Identifier: NCT03383965     History of Changes
Other Study ID Numbers: CD30-targeting CAR-T
First Posted: December 27, 2017    Key Record Dates
Last Update Posted: December 27, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lymphoma
Hodgkin Disease
Lymphoma, Large-Cell, Anaplastic
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin