Anti-CD22 CAR-T Cell Therapy Targeting B Cell Malignancies

February 6, 2021 updated by: Affiliated Hospital to Academy of Military Medical Sciences

Anti-CD22 Chimeric Antigen Receptor (CAR)-Modified T Cell Therapy Targeting CD22 in Treating Patients With B Cell Malignancies

The study will evaluate safety and efficacy of the CD22-targeted chimeric antigen receptor modified-T cell(CAR-T) cells in the treatment of B-cell Malignancies.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Clinical success with chimeric antigen receptor (CAR)- based immunotherapy for leukemia has been accompanied by the associated finding that antigen-escape variants of the disease are responsible for relapse. Despite anti-CD19 CAR-T exhibited the ability to re-induce remissions for many patients with relapsed and refractory B cell malignancies, a part of those patients will relapse with CD19-negative malignancies. CD22 is a type I transmembrane protein expressed on most mature B lymphocyte in the B cell malignancies，and plays a significant role in signal transduction pathway. The investigators design and conduct this trial to test the safety and effectiveness of CD22-targeted CAR-T.

Study Type

Interventional

Enrollment (Anticipated)

20

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
    • Beijing
      • Beijing, Beijing, China, 100071
        • Recruiting
        • Fengtai District
        • Contact:
          • Phone Number: +8618501002450

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age: 18-65 years
  2. Patients with Cluster of Differentiation 22(CD22) positive B cell malignancies as confirmed by flow cytometry
  3. Refractory or relapsed B cell-acute lymphoblastic leukemia
  4. No available curative treatment options (such as hematopoietic stem cell transplantation)
  5. Stage III-IV disease
  6. Creatinine < 2.5 mg/dl
  7. Aspartate transaminase-alanine transaminase ratio < 3x normal
  8. Bilirubin < 2.0 mg/dl
  9. Karnofsky performance status >= 60
  10. Expected survival time > 3 months
  11. Adequate venous access for apheresis
  12. Ability to understand and provide informed consent

Exclusion Criteria:

  1. Pregnant or lactating women
  2. Patients requiring T cell immunosuppressive therapy
  3. Active central nervous system leukemia
  4. Any concurrent active malignancies
  5. Patients with a history of a seizure disorder or cardiac disorder
  6. Previous treatment with any immunotherapy products
  7. Patients with human immunodeficiency virus, hepatitis B or C infection
  8. Uncontrolled active infection

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: anti-CD22 CAR-T
Patients will receive a full dose CART infusion at day 0.
Biological: Anti-CD22-CAR-transduced T cells
a single dose of Anti-CD22-CAR-transduced T cells will be infusion after preconditioning.
Other Names:
  • anti-CD22 CART, CART22

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events related to treatment as assessed by NCI CTCAE version 4.03
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Complete Remission Rate (ORR)
Time Frame: 2 years
2 years
Disease response(CR, CRi)
Time Frame: 2 years
2 years
CART cells persistence in vivo
Time Frame: 2 years
2 years

Collaborators and Investigators

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

Sponsor

Affiliated Hospital to Academy of Military Medical Sciences

Investigators

  • Principal Investigator: Liangding Chen, M.D., Affiliated Hospital to Academy of Military Medical Sciences

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 (Actual)

August 20, 2017

Primary Completion (Anticipated)

August 20, 2021

Study Completion (Anticipated)

August 20, 2022

Study Registration Dates

First Submitted

August 14, 2017

First Submitted That Met QC Criteria

August 22, 2017

First Posted (Actual)

August 25, 2017

Study Record Updates

Last Update Posted (Actual)

February 9, 2021

Last Update Submitted That Met QC Criteria

February 6, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 307-B-22-CAR-T

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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