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Humanized CAR-T Therapy for Treatment of B Cell Malignancy

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02782351
Recruitment Status : Unknown
Verified August 2017 by Kai Lin Xu; Jun Nian Zheng, Xuzhou Medical University.
Recruitment status was:  Recruiting
First Posted : May 25, 2016
Last Update Posted : August 4, 2017
Sponsor:
Collaborators:
iCarTAB BioMed Inc.
Huaian first people's hospital
Information provided by (Responsible Party):
Kai Lin Xu; Jun Nian Zheng, Xuzhou Medical University

Brief Summary:
The present study evaluates the safety and efficacy of humanized Chimeric antigen receptor T cells (CAR-T) in treating recurrent or refractory B cell malignancy targeting CD19 with a humanized scFv. All participants will receive autologous chimeric antigen receptor engineered T cells.

Condition or disease Intervention/treatment Phase
Leukemia, Lymphocytic, Chronic, B-Cell Biological: CAR-T Phase 1 Phase 2

Detailed Description:
CD19 has been extensively evaluated as a therapeutic target for recurrent or refractory B cell malignancy by chimeric antigen receptor T cell therapy, the single chain antibody sequence (scFv) against CD19 derived from a mouse hybridoma was widely employed. However, the immunogenicity of the mouse scFv sequence might be one of the reasons that CAR-T cells cannot persist in vivo for long. In present study investigators replace the mouse-derived scFv with a a humanized one and evaluate its safety and efficacy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Humanized CAR-T Therapy for Treatment of Recurrent or Refractory B Cell Malignancy by Targeting CD19
Study Start Date : May 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Experimental: CAR-T
In interventional studies, patients enrolled will receive autologous 2nd generation CAR-T cells, which contain a humanized single chain antibody sequence against CD19.
Biological: CAR-T
Patients will be infused with autologous CAR-T infusion in a dose escalating manner.




Primary Outcome Measures :
  1. CAR-T cells persistence in peripheral blood [ Time Frame: 12 months ]
    The presence of CAR T cells in patients' peripheral blood will be quantified with real time qPCR


Secondary Outcome Measures :
  1. B cell number and immunoglobulins in peripheral blood [ Time Frame: 12 months ]
    The number of B cells and immunoglobulins in peripheral blood will be evaluated by routine methods



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age≥3 at the time of consent
  • Survival time>12 weeks
  • B cell hematological malignancies by pathological examination
  • Chemotherapy failure or recurrent B cell malignancy
  • Creatinine< 2.5mg/dl
  • Glutamic-pyruvic transaminase, glutamic oxalacetic transaminase< 3 fold of normal level
  • Karnofsky Performance Status>50% at the time of screening
  • Bilirubin<2.0mg/dl
  • Adequate pulmonary, renal, hepatic, and cardiac function
  • Fail in autologous or allogenic haemopoietic stem cell transplantation
  • Free of leukocytes removal contraindications

Exclusion Criteria:

  • Pregnant or nursing women
  • Active hepatitis B, active hepatitis C, or any human immunodeficiency virus (HIV) infection at the time of screening
  • Previous treatment with any gene therapy product
  • Abnormal vital signs
  • Highly allergic constitution or history of severe allergies, especially allergy to interleukin-2
  • General infection or local severe infection, or other infection that is not controlled
  • Dysfunction in lung, heart, kidney and brain.
  • Severe autoimmune diseases
  • other symptoms that are not applicable for CAR-T

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): NCT02782351


Contacts
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Contact: Jiang Cao, M.D., Ph.D. 8651685802291 zimu05067@163.com
Contact: JunNian Zheng, M.D., Ph.D.

Locations
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China, Jiangsu
Huaian First People's Hospital Recruiting
Huai'an, Jiangsu, China, 223300
Contact: Chunling Wang, M.D., Ph.D.         
Affiliated hospital of Xuzhou medical college Recruiting
Xuzhou, Jiangsu, China, 221000
Contact: Jiang Cao, M.D., Ph.D.         
Sponsors and Collaborators
Kai Lin Xu; Jun Nian Zheng
iCarTAB BioMed Inc.
Huaian first people's hospital
Investigators
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Principal Investigator: KaiLin Xu, MD. Ph.D. Xuzhou Medical University
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kai Lin Xu; Jun Nian Zheng, President, Xuzhou Medical University
ClinicalTrials.gov Identifier: NCT02782351    
Other Study ID Numbers: XYFY2016-KL002-01
First Posted: May 25, 2016    Key Record Dates
Last Update Posted: August 4, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms
Leukemia
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell