Anti-CD19/CD22 Bispecific CAR-T Cell Therapy for CD19-positive ALL

March 9, 2020 updated by: The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine

A Phase I Clinical Trial of T-Cells Targeting CD19 and CD22 for Subjects With CD19-positive Acute Lymphoblastic Leukemia

The goal of this clinical trial is to study the feasibility and efficacy of anti-CD19/CD22 bispecific chimeric antigen receptors (CARs) T cell therapy for CD19-positive Acute Lymphoblastic Leukemia.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Primary Objectives

1. To determine the feasibility ad safety of anti-CD19/ CD22 CAR-T cells in treating patients with CD19-positive Acute Lymphoblastic Leukemia.

Secondary Objectives

  1. To determine in vivo expression, dynamics and persistency of anti-CD19/CD22 CAR-T cells.
  2. To determine in vivo expression of CD19-positive B cells.
  3. To access the complete remission rate (ORR) in patients with ALL with 3 months after CD19/CD22 CAR-T cells infusion.
  4. To investigate the favorable CD19/CD22 CAR-T cells dose and dosage regimen for the Phase II Clinical Trial.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • 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
    • Henan
      • Zhengzhou, Henan, China
        • Recruiting
        • Henan Province of TCM

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

13 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 13 Years to 70 Years, Male and female;
  2. Expected survival > 12 weeks;
  3. Clinical performance status of ECOG score 0-2;

  4. Histologically confirmed as CD19-positive lymphoma and who meet one of the following conditions:

    • Patients received at least 2 prior combination chemotherapy regimens (not including single agent monoclonal antibody therapy) and fail to achieve CR; or have disease recurrence; or not eligible for allogeneic stem cell transplantation; or disease responding or stable after most recent therapy but refused further treatment;
    • Disease recurrence after stem cell transplantation.
  5. Accessible to intravenous injection, and no white blood cell collection contraindications

  6. Patients who meet the following conditions:

    • Creatinine < 2.5 mmol/l;
    • Cardiac ejection fraction>50%, no pericardial effusion and no pleural effusion (ECHO examination);
    • Baseline oxygen saturation>92%;
    • Total bilirubin≤1.5xULN;
    • ALT/AST≤2.5x normal.
  7. Able to understand and sign the Informed Consent Document.

Exclusion Criteria:

  1. Accompanied by other malignant tumor
  2. Active hepatitis B, hepatitis C, syphilis, HIV infection
  3. Suffering severe cardiovascular or respiratory disease
  4. Any other diseases could affect the outcome of this trial
  5. Any affairs could affect the safety of the subjects or outcome of this trial
  6. Pregnant or lactating women, or patients who plan to be pregnancy during or after treatment
  7. Occurrence of infection uncontrolled or requiring systemic treatment 14 days prior to assignment
  8. Patients who are accounted by researchers to be not appropriate for this test
  9. Received CAR-T treatment or other gene therapies before assignment
  10. Patients with symptoms of central nervous system
  11. Subject suffering disease affects the understanding of informed consent or comply with study protocol.

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-CD19/CD22 CAR-T cells
Administration with anti-CD19/CD22 CAR-T cells in the CD19-positive ALL patients
Biological: anti-CD19/CD22 CAR-T cells
Retroviral vector-transduced autologous T cells to express anti-CD19 and anti-CD22 CARs
Drug: Fludarabine
30mg/m2/d
Drug: Cyclophosphamide
500mg/m2/d

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
Time Frame: 6 months
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm
Time Frame: 8 weeks
Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm
8 weeks
Duration of CAR-positive T cells in circulation
Time Frame: 6 months
Duration of CAR-positive T cells in circulation
6 months
Total number of CAR-positive T cells infiltrated into lymphoma tissue
Time Frame: 6 months
Total number of CAR-positive T cells infiltrated into lymphoma tissue
6 months

Collaborators and Investigators

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

Sponsor

The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine

Collaborators

First Affiliated Hospital of Wenzhou Medical University
Second Affiliated Hospital of Nanchang University
Hrain Biotechnology Co., Ltd.

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 (Actual)

May 3, 2018

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

February 1, 2021

Study Registration Dates

First Submitted

March 9, 2020

First Submitted That Met QC Criteria

March 9, 2020

First Posted (Actual)

March 11, 2020

Study Record Updates

Last Update Posted (Actual)

March 11, 2020

Last Update Submitted That Met QC Criteria

March 9, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Anti-CD19/CD22 CAR-T

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

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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