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CD30-directed Chimeric Antigen Receptor T (CART30) Therapy in Relapsed and Refractory CD30 Positive Lymphomas (CART30)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02259556
Recruitment Status : Recruiting
First Posted : October 8, 2014
Last Update Posted : January 28, 2016
Sponsor:
Information provided by (Responsible Party):
Han weidong, Chinese PLA General Hospital

Study Description
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Brief Summary:
Chimeric antigen receptor-modified T cells (CART) holds great promise for treatment of tumors. In this trial, CD30 positive Hodgkin's lymphoma and Non-Hodgkin's lymphoma will be treated by CD30-specific CART cells (CART30).

Condition or disease Intervention/treatment Phase
Hodgkin's Lymphoma Non-Hodgkin's Lymphoma Biological: CART30 Phase 1 Phase 2

Detailed Description:

When patients enroll on this trial, autologous CART-33 cells were generated from the mononuclear cells of 50 to 90 ml of the patient's peripheral blood (PB). During the term of cell preparation of CART30, patients will receive a conditioning regimen including cyclophosphamide and fludarabine. One day after completing conditioning regimen, the patient will be given infusions of CART30 cells into the vein in escalating doses over a period of 3 to 5 consecutive days.

Extra blood will be drawn to measure the persistence of CART30 in vivo.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CD30-directed Chimeric Antigen Receptor T (CART30) Therapy in Relapsed and Refractory CD30 Positive Lymphomas
Study Start Date : October 2014
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: anti-CD30 CAR T cells
Patients receive CART30 cell infusions with an escalation dose.
 Biological: CART30
Cells will be infused 1 day after the completion of conditioning regimen.
Other Name: anti-CD30 CAR T cells


Outcome Measures
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Primary Outcome Measures :
  1. Occurrence of related adverse events [ Time Frame: untill week 24 ]

Secondary Outcome Measures :
  1. Anti-tumor response to CART30 cell infusions [ Time Frame: Up to 24 weeks ]
    Evaluated mainly by computed tomography scanning


Other Outcome Measures:
  1. in vivo existence of CART30 [ Time Frame: 1 year ]
    Measure mainly by the changes of CAR molecule levels in blood


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects with CD30+ Hodgkin lymphoma and Non-Hodgkin lymphoma relapsing after autologous stem-cell transplantation (ASCT), or refractory to 2 multidrug regimens and/or anti-CD30 antibody treatment.
  • Newly diagnosed CD30+ Hodgkin lymphoma and Non-Hodgkin lymphoma patients who are unable to receive or complete standard chemotherapy.
  • Karnofsky or Lansky score greater than 60%.
  • Expected survival>12 weeks.
  • Creatinine<2.5mg/dl.
  • ALT (alanine aminotransferase)/AST (aspartate aminotransferase)<3 fold normal.
  • Bilirubin<2.5mg/dl.
  • Pulse oximetry of >90% on room air.
  • Adequate pulmonary function with FEV1, FVC and DLCO greater than or equal to 50% of expected corrected for hemoglobin.
  • Available autologous T cells with 10% or more expression of CD30 CAR determined by flow-cytometry.
  • Patients or legal guardians must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects. Patients or their guardians will be given a copy of the consent form.

Exclusion Criteria:

  • Active infection such as hepatitis B or C.
  • Receive anti-CD30 antibody-based therapy within recent 6 weeks.
  • Current use of systemic corticosteroids.
  • Pregnant or lactating.
  • Confirmed tumor in pulmonary and archenteric tissues.
Contacts and Locations
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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): NCT02259556


Contacts
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Contact: Weidong Han, Ph.D 86-10-66937463 hanwdrsw@sina.com
Contact: Quanshun Wang, Ph.D 86-10-66939486 wqs63@sohu.com

Locations
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China, Beijing
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Weidong Han, Ph.D    86-10-66937463    hanwdrsw@sina.com   
Contact: Quanshun Wang, Ph.D    86-10-66939486    wqs63@sohu.com   
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
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Study Chair: Weidong Han, Ph.D Chinese PLA General Hospital
More Information
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Responsible Party: Han weidong, Director, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT02259556    
Other Study ID Numbers: CHN-PLAGH-BT-011
First Posted: October 8, 2014    Key Record Dates
Last Update Posted: January 28, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases