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CD22 Targeting CAR-T Therapy Against B Cell Hematological Malignancies

Primary Purpose

Recurrent or Refractory B Cell Malignancy

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CD22 CAR-T
Sponsored by
Kai Lin Xu; Jun Nian Zheng
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent or Refractory B Cell Malignancy

Eligibility Criteria

4 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Affiliated hospital of Xuzhou medical collegeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CD22 CAR-T

Arm Description

Enrolled patients will receive three escalating doses of autologous CAR-T.

Outcomes

Primary Outcome Measures

Complete remission rate
The B cells in peripheral blood of all enrolled patients will be monitored every week

Secondary Outcome Measures

Full Information

First Posted
June 6, 2016
Last Updated
June 6, 2016
Sponsor
Kai Lin Xu; Jun Nian Zheng
Collaborators
iCarTAB BioMed Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02794961
Brief Title
CD22 Targeting CAR-T Therapy Against B Cell Hematological Malignancies
Official Title
Application of Humanized Anti-CD22 Antibody in CAR-T Therapy of B Cell Hematological Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kai Lin Xu; Jun Nian Zheng
Collaborators
iCarTAB BioMed Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent or Refractory B Cell Malignancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CD22 CAR-T
Arm Type
Experimental
Arm Description
Enrolled patients will receive three escalating doses of autologous CAR-T.
Intervention Type
Biological
Intervention Name(s)
CD22 CAR-T
Intervention Description
Autologous CAR-T cells with average 1*10^6 cells/kg body weight
Primary Outcome Measure Information:
Title
Complete remission rate
Description
The B cells in peripheral blood of all enrolled patients will be monitored every week
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiang Cao, M.D., Ph.D.
Phone
8651685802291
Email
zimu05067@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
JunNian Zheng, M.D., Ph.D.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KaiLin Xu, MD. Ph.D.
Organizational Affiliation
Xuzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated hospital of Xuzhou medical college
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiang Cao, M.D., Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
23243285
Citation
Haso W, Lee DW, Shah NN, Stetler-Stevenson M, Yuan CM, Pastan IH, Dimitrov DS, Morgan RA, FitzGerald DJ, Barrett DM, Wayne AS, Mackall CL, Orentas RJ. Anti-CD22-chimeric antigen receptors targeting B-cell precursor acute lymphoblastic leukemia. Blood. 2013 Feb 14;121(7):1165-74. doi: 10.1182/blood-2012-06-438002. Epub 2012 Dec 14.
Results Reference
result

Learn more about this trial

CD22 Targeting CAR-T Therapy Against B Cell Hematological Malignancies

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