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CD22 Targeting CAR-T Therapy Against B Cell Hematological Malignancies

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: NCT02794961
Recruitment Status : Unknown
Verified June 2016 by Kai Lin Xu; Jun Nian Zheng, Xuzhou Medical University.
Recruitment status was:  Recruiting
First Posted : June 9, 2016
Last Update Posted : June 9, 2016
Sponsor:
Collaborator:
iCarTAB BioMed Inc.
Information provided by (Responsible Party):
Kai Lin Xu; Jun Nian Zheng, Xuzhou Medical University

Brief Summary:
CD19 expression on B cell frequently lost after CD19-targeting CAR-T therapy. In present study, we construct a CD22-targeting chimeric antigen receptor to overcome this issue.

Condition or disease Intervention/treatment Phase
Recurrent or Refractory B Cell Malignancy Biological: CD22 CAR-T Phase 1 Phase 2

Detailed Description:
CD19 is an ideal target with great potential for treating B-cell-derived hematological malignancies. Although the complete remission rate is as high as 93% by using CD19-targeting CAR-T technology, approximately 60% patients will have recurrent disease. Among all the recurrent patients, two thirds is revealed to loss their CD19 expression on B cell surface. For overcoming this issue, we establish a new chimeric antigen receptor containing humanized single chain antibody sequence to target CD22 molecule on B cells.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Application of Humanized Anti-CD22 Antibody in CAR-T Therapy of B Cell Hematological Malignancies
Study Start Date : June 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2019

Arm Intervention/treatment
Experimental: CD22 CAR-T
Enrolled patients will receive three escalating doses of autologous CAR-T.
Biological: CD22 CAR-T
Autologous CAR-T cells with average 1*10^6 cells/kg body weight




Primary Outcome Measures :
  1. Complete remission rate [ Time Frame: 12 months ]
    The B cells in peripheral blood of all enrolled patients will be monitored every week



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Greater than four years of age
  • 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
  • Bilirubin<2.0mg/dl
  • Karnofsky Performance Status>50% at the time of screening
  • Adequate pulmonary, renal, hepatic, and cardiac function
  • Fail in autologous or allogenic haemopoietic stem cell transplantation
  • Free of leukocytes removal contraindications
  • Voluntarily join CAR-T clinical trial
  • Understand and sign written informed consent

Exclusion Criteria:

  • Pregnant or nursing women
  • Active hepatitis B, active hepatitis C, or any human immunodeficiency virus (HIV) infection at the time of screening
  • Feasibility assessment proves that the efficiency of transduction of lymphocyte is below 10% or the lymphocyte cannot be propagated.
  • 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): NCT02794961


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
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.
Investigators
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Principal Investigator: KaiLin Xu, MD. Ph.D. Xuzhou Medical University
Publications of Results:
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Responsible Party: Kai Lin Xu; Jun Nian Zheng, President, Xuzhou Medical University
ClinicalTrials.gov Identifier: NCT02794961    
Other Study ID Numbers: AF-08/04.2
First Posted: June 9, 2016    Key Record Dates
Last Update Posted: June 9, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases