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CAR T Cells Targeting CD30 Positive Lymphomas (4SCAR30273)

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ClinicalTrials.gov Identifier: NCT02274584
Recruitment Status : Unknown
Verified October 2014 by Jun Zhu, Peking University.
Recruitment status was:  Recruiting
First Posted : October 24, 2014
Last Update Posted : October 24, 2014
Sponsor:
Collaborator:
University of Florida
Information provided by (Responsible Party):
Jun Zhu, Peking University

Brief Summary:
Currently, a majority of lymphomas cannot be cured by standard chemo-radiotherapy. Cluster of differentiation antigen 30 (CD30) is expressed in many lymphoma subtypes, such as Hodgkin lymphoma (HL) and anaplastic large cell lymphoma (ALCL). CD30 represents a very attractive target for chimeric antigen receptor (CAR)-based immune cell therapy. This study will evaluate a novel 4th generation CD30 CAR engineered with a self-withdrawal mechanism (FKBP-iCasp9) for both efficacy and safety evaluation in lymphoma patients.

Condition or disease Intervention/treatment Phase
Lymphomas Genetic: Anti-CD30 CAR T cells Phase 1 Phase 2

Detailed Description:
A large number of lymphoma patients exhaust current treatment options and die from the disease. Innovative therapy is urgently needed. Chimeric antigen receptor (CAR)-modified T cells have demonstrated unprecedented successes in treating even late stage cluster of differentiation antigen 19 (CD19) positive B cell malignancies. Besides CD19 lymphomas, many lymphomas are CD30 positive and therefore, CD30-CAR T cells may prove to be effective in treating such patients. We have developed several generations of CD30 CARs. Preclinical studies have demonstrated effective killing of CD30 target cells. In this study, two versions of CD30 CARs, both of which are 4th generation CARs with a self-withdrawal mechanism (FKBP-iCasp9), will be evaluated in CD30 lymphoma patients. The primary goal is safety assessment including cytokine storm response and any other adverse effects. In addition, tumor targeting and disease status after treatment will also be evaluated.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy Evaluation of 4th Generation Safety-engineered CAR T Cells Targeting Relapsed and Refractory CD30 Positive Lymphomas
Study Start Date : March 2014
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2017


Arm Intervention/treatment
Experimental: CAR T cells
Autologous 4th generation anti-CD30 CAR T cells
Genetic: Anti-CD30 CAR T cells
Autologous 4th generation withdrawal lentiviral-transduced anti-CD30 CAR T cells




Primary Outcome Measures :
  1. Number of patients with adverse events. [ Time Frame: 2 years. ]
    Determine the toxicity profile of the 4th generation CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.


Secondary Outcome Measures :
  1. Survival time of Anti-CD30 CAR T cells in vivo. [ Time Frame: 2 years. ]
    Measure the survival of 4th generation CAR T cells transduced with the anti-CD30 lentiviral vector.

  2. Response rates to the 4th generation CAR T cells. [ Time Frame: 2 years. ]
    Describe the response rates of patients treated with 4th generation CAR T cells, including partial remission (PR), complete remission (CR), stable disease (SD) and progressive disease (PD).

  3. Survival time of the patients. [ Time Frame: 2 years. ]
    Evaluate the survival time of the patients treated with the 4th generation CAR T cells, including progression free survival (PFS) and overall survival (OS).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Relapsed or refractory CD30(+) lymphoma patients proved by immuno-histochemistry (IHC) or Flow-cytometry.
  • Not eligible for autologous stem-cell transplantation (ASCT) or relapsed after ASCT.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Age≥18.
  • Pulse oximetry of > 90% on room air.
  • Adequate hepatic function, defined as alanine transaminase (ALT) <3 x upper limit of normal (ULN), aspartate aminotransferase (AST) <3 x ULN; serum bilirubin and alkaline phosphatase <2 x ULN.
  • Adequate renal function, defined as serum creatinine <2.0mg/dl.
  • Adequate heart function with LVEF≥50%
  • Hb≥80g/L
  • Measurable disease can be identified.
  • Life expectancy ≥3 months.
  • Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 1 year after the study is concluded. The male partner should use a condom.
  • Patients must sign an informed consent.

Exclusion Criteria:

  • Uncontrolled active infection.
  • Active infection with hepatitis B virus (HBV), hepatitis C virus (HCV).
  • HIV positive
  • Pregnant or lactating.
  • Currently enrolled in another clinical trial.
  • Concurrent use of systemic steroids.

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): NCT02274584


Contacts
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Contact: Jun Zhu, MD +861088196596 zj@bjcancer.org

Locations
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United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Lung-Ji Chang, PhD    352-273-8949    lchang@mgm.ufl.edu   
Principal Investigator: Lung-Ji Chang, PhD         
China, Beijing
Peking University Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Contact: Jun Zhu, MD.    +8610-88196596    zhu-jun@bjcancer.org   
Contact: Zhitao Ying, MD.    +8610-88196109    yingzhitao001@163.com   
Principal Investigator: Jun Zhu, MD.         
Sponsors and Collaborators
Peking University
University of Florida
Investigators
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Principal Investigator: Jun Zhu, MD Peking University Cancer Hospital & Institute
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Responsible Party: Jun Zhu, Director, Peking University
ClinicalTrials.gov Identifier: NCT02274584    
Other Study ID Numbers: 30273-4SCAR
First Posted: October 24, 2014    Key Record Dates
Last Update Posted: October 24, 2014
Last Verified: October 2014
Keywords provided by Jun Zhu, Peking University:
Hodgkin's lymphoma
Anaplastic large cell lymphoma
CD30 positive lymphoma
Peripheral T/Natural Killer (NK) cell lymphoma
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases