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

Sponsor
The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine (Other)
Overall Status
Unknown status
CT.gov ID
NCT04303520
Collaborator
Hrain Biotechnology Co., Ltd. (Industry), First Affiliated Hospital of Wenzhou Medical University (Other), Second Affiliated Hospital of Nanchang University (Other)
20
Enrollment
1
Location
1
Arm
33
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I Clinical Trial of T-Cells Targeting CD19 and CD22 for Subjects With CD19-positive Acute Lymphoblastic Leukemia
Actual Study Start Date :
May 3, 2018
Anticipated Primary Completion Date :
Sep 1, 2020
Anticipated Study Completion Date :
Feb 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0 [6 months]

    Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0

Secondary Outcome Measures

  1. Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm [8 weeks]

    Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm

  2. Duration of CAR-positive T cells in circulation [6 months]

    Duration of CAR-positive T cells in circulation

  3. Total number of CAR-positive T cells infiltrated into lymphoma tissue [6 months]

    Total number of CAR-positive T cells infiltrated into lymphoma tissue

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

  1. Accessible to intravenous injection, and no white blood cell collection contraindications

  2. 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.

  1. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Henan Province of TCM Zhengzhou Henan China

Sponsors and Collaborators

  • The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine
  • Hrain Biotechnology Co., Ltd.
  • First Affiliated Hospital of Wenzhou Medical University
  • Second Affiliated Hospital of Nanchang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT04303520
Other Study ID Numbers:
  • Anti-CD19/CD22 CAR-T
First Posted:
Mar 11, 2020
Last Update Posted:
Mar 11, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cyclophosphamide
Fludarabine

Study Results

No Results Posted as of Mar 11, 2020