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

Primary Purpose

Leukemia, Lymphoma

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Anti-CD22-CAR-transduced T cells
Sponsored by
Affiliated Hospital to Academy of Military Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring CD22, CAR-T, Leukemia, Lymphoma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fengtai DistrictRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

anti-CD22 CAR-T

Arm Description

Patients will receive a full dose CART infusion at day 0.

Outcomes

Primary Outcome Measures

Incidence of adverse events related to treatment as assessed by NCI CTCAE version 4.03

Secondary Outcome Measures

Overall Complete Remission Rate (ORR)
Disease response(CR, CRi)
CART cells persistence in vivo

Full Information

First Posted
August 14, 2017
Last Updated
February 6, 2021
Sponsor
Affiliated Hospital to Academy of Military Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03262298
Brief Title
Anti-CD22 CAR-T Cell Therapy Targeting B Cell Malignancies
Official Title
Anti-CD22 Chimeric Antigen Receptor (CAR)-Modified T Cell Therapy Targeting CD22 in Treating Patients With B Cell Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 20, 2017 (Actual)
Primary Completion Date
August 20, 2021 (Anticipated)
Study Completion Date
August 20, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Affiliated Hospital to Academy of Military Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphoma
Keywords
CD22, CAR-T, Leukemia, Lymphoma

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
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
anti-CD22 CAR-T
Arm Type
Experimental
Arm Description
Patients will receive a full dose CART infusion at day 0.
Intervention Type
Biological
Intervention Name(s)
Anti-CD22-CAR-transduced T cells
Other Intervention Name(s)
anti-CD22 CART, CART22
Intervention Description
a single dose of Anti-CD22-CAR-transduced T cells will be infusion after preconditioning.
Primary Outcome Measure Information:
Title
Incidence of adverse events related to treatment as assessed by NCI CTCAE version 4.03
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Overall Complete Remission Rate (ORR)
Time Frame
2 years
Title
Disease response(CR, CRi)
Time Frame
2 years
Title
CART cells persistence in vivo
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: 18-65 years Patients with Cluster of Differentiation 22(CD22) positive B cell malignancies as confirmed by flow cytometry Refractory or relapsed B cell-acute lymphoblastic leukemia No available curative treatment options (such as hematopoietic stem cell transplantation) Stage III-IV disease Creatinine < 2.5 mg/dl Aspartate transaminase-alanine transaminase ratio < 3x normal Bilirubin < 2.0 mg/dl Karnofsky performance status >= 60 Expected survival time > 3 months Adequate venous access for apheresis Ability to understand and provide informed consent Exclusion Criteria: Pregnant or lactating women Patients requiring T cell immunosuppressive therapy Active central nervous system leukemia Any concurrent active malignancies Patients with a history of a seizure disorder or cardiac disorder Previous treatment with any immunotherapy products Patients with human immunodeficiency virus, hepatitis B or C infection Uncontrolled active infection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liangding Hu, M.D.
Phone
+86-010-6694-7107
Email
huliangding@sohu.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liangding Chen, M.D.
Organizational Affiliation
Affiliated Hospital to Academy of Military Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fengtai District
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100071
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
+8618501002450

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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