Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE October 5, 2014
First Posted Date  ICMJE October 8, 2014
Last Update Posted Date January 28, 2016
Study Start Date  ICMJE October 2014
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 7, 2014)
Occurrence of related adverse events [ Time Frame: untill week 24 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02259556 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2014)
Anti-tumor response to CART30 cell infusions [ Time Frame: Up to 24 weeks ]
Evaluated mainly by computed tomography scanning
Original Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2014)
Anti-tumor response to CART30 cell infusions [ Time Frame: Up to 24 weeks ]
Current Other Pre-specified Outcome Measures
 (submitted: October 7, 2014)
in vivo existence of CART30 [ Time Frame: 1 year ]
Measure mainly by the changes of CAR molecule levels in blood
Original Other Pre-specified Outcome Measures
 (submitted: October 7, 2014)
in vivo existence of CART30 [ Time Frame: 1 year ]
 
Descriptive Information
Brief Title  ICMJE CD30-directed Chimeric Antigen Receptor T (CART30) Therapy in Relapsed and Refractory CD30 Positive Lymphomas
Official Title  ICMJE CD30-directed Chimeric Antigen Receptor T (CART30) Therapy in Relapsed and Refractory CD30 Positive Lymphomas
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hodgkin's Lymphoma
  • Non-Hodgkin's Lymphoma
Intervention  ICMJE Biological: CART30
Cells will be infused 1 day after the completion of conditioning regimen.
Other Name: anti-CD30 CAR T cells
Study Arms  ICMJE Experimental: anti-CD30 CAR T cells
Patients receive CART30 cell infusions with an escalation dose.
Intervention: Biological: CART30
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 7, 2014)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2029
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Weidong Han, Ph.D 86-10-66937463 hanwdrsw@sina.com
Contact: Quanshun Wang, Ph.D 86-10-66939486 wqs63@sohu.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02259556
Other Study ID Numbers  ICMJE CHN-PLAGH-BT-011
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Han weidong, Chinese PLA General Hospital
Study Sponsor  ICMJE Chinese PLA General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Weidong Han, Ph.D Chinese PLA General Hospital
PRS Account Chinese PLA General Hospital
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP