CD22 Targeting CAR-T Therapy Against B Cell Hematological Malignancies

June 6, 2016 updated by: Kai Lin Xu; Jun Nian Zheng

Application of Humanized Anti-CD22 Antibody in CAR-T Therapy of B Cell Hematological Malignancies

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Xuzhou, Jiangsu, China, 221000
        • Recruiting
        • Affiliated Hospital of Xuzhou Medical College
        • Contact:
          • Jiang Cao, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 60 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete remission rate
Time Frame: 12 months
The B cells in peripheral blood of all enrolled patients will be monitored every week
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kai Lin Xu; Jun Nian Zheng

Collaborators

iCarTAB BioMed Inc.

Investigators

  • Principal Investigator: KaiLin Xu, MD. Ph.D., Xuzhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (ANTICIPATED)

June 1, 2018

Study Completion (ANTICIPATED)

June 1, 2019

Study Registration Dates

First Submitted

June 6, 2016

First Submitted That Met QC Criteria

June 6, 2016

First Posted (ESTIMATE)

June 9, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

June 9, 2016

Last Update Submitted That Met QC Criteria

June 6, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AF-08/04.2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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