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Sequential CD19 and CD22 CAR-T Therapy for Newly Diagnosed Ph- B-ALL

Primary Purpose

B-Cell Acute Lymphoblastic Leukemia, Adult

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CAR-T cells targeting CD19 and CD22
Sponsored by
Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B-Cell Acute Lymphoblastic Leukemia, Adult focused on measuring CD19 CAR-T, CD22 CAR-T, Ph Chromosome Negative, B-ALL, Newly diagnosed

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age≥15 years old
  • Newly diagnosed B-cell acute lymphoblastic leukemia according to the 2016 WHO classification
  • The immunophenotype of leukemia cells were CD19 and CD22 positive
  • Ph- or Ph- like negative
  • Anticipated survival time more than 12 weeks;
  • Those who voluntarily participated in this trial and provided informed consent.

Exclusion Criteria:

  • History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
  • Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
  • Pregnant (or lactating) women;
  • Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
  • Active infection of hepatitis B virus or hepatitis C virus;
  • Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving inhaled steroids;
  • Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;
  • Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl;
  • Other uncontrolled diseases that were not suitable for this trial;
  • Patients with HIV infection;
  • Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.

Sites / Locations

  • The First Affiliated Hospital, College of Medicine, Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CAR-T therapy

Arm Description

Administration of CD19 and CD22 CAR T-cells

Outcomes

Primary Outcome Measures

Dose-limiting toxicity (DLT)
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events [Safety and Tolerability]

Secondary Outcome Measures

Complete Remission Rate
Complete Remission Rate after CAR-T cell therapy
Overall survival (OS)
From the first infusion of CD19 CAR-T cells to death or the last visit
Leukemia-free survival (LFS)
From the complete remission to the occurrence of any event, including death, relapse (any one occurs first), and the last visit
Quality of life
Assessment using European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scale [For item1-28: max score: 112, min score: 28, higher scores mean a better outcome; for item 28-29: max score: 14, min score: 2, higher scores mean a worse outcome] to measure Quality of life at Baseline, Month 1, 3, 6, 9 and 12

Full Information

First Posted
January 31, 2021
Last Updated
February 4, 2021
Sponsor
Zhejiang University
Collaborators
Yake Biotechnology Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04740203
Brief Title
Sequential CD19 and CD22 CAR-T Therapy for Newly Diagnosed Ph- B-ALL
Official Title
Clinical Trial for the Safety and Efficacy of Sequential CD19 and CD22 CAR-T Therapy for Adult Patients With Newly Diagnosed Ph Chromosome Negative B-cell Acute Lymphoblastic Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2021 (Anticipated)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang University
Collaborators
Yake Biotechnology Ltd.

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
Clinical Trial for the Safety and Efficacy of Sequential CD19 and CD22 CAR-T Therapy for Adult Patients With Newly Diagnosed Ph Chromosome Negative B-cell Acute Lymphoblastic Leukemia
Detailed Description
This is a prospective, single arm study. To evaluate the safety and efficacy of sequential CD19 and CD22 CAR-T cells in the treatment of adult newly diagnosed Ph chromosome negative B-cell acute lymphoblastic leukemia. The main endpoints were dose limiting toxicity (DLT) and incidence of adverse events (TEAEs).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-Cell Acute Lymphoblastic Leukemia, Adult
Keywords
CD19 CAR-T, CD22 CAR-T, Ph Chromosome Negative, B-ALL, Newly diagnosed

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
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CAR-T therapy
Arm Type
Experimental
Arm Description
Administration of CD19 and CD22 CAR T-cells
Intervention Type
Drug
Intervention Name(s)
CAR-T cells targeting CD19 and CD22
Intervention Description
Each subject receives sequential CD19 and CD22 CAR-T cells by intravenous infusion
Primary Outcome Measure Information:
Title
Dose-limiting toxicity (DLT)
Description
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Time Frame
Baseline up to 28 days after CAR-T cells infusion
Title
Incidence of treatment-emergent adverse events (TEAEs)
Description
Incidence of treatment-emergent adverse events [Safety and Tolerability]
Time Frame
Up to 2 years after CAR-T cells infusion
Secondary Outcome Measure Information:
Title
Complete Remission Rate
Description
Complete Remission Rate after CAR-T cell therapy
Time Frame
up to 28 days after CAR-T cells infusion
Title
Overall survival (OS)
Description
From the first infusion of CD19 CAR-T cells to death or the last visit
Time Frame
Up to 2 years after CD19 CAR-T cells infusion
Title
Leukemia-free survival (LFS)
Description
From the complete remission to the occurrence of any event, including death, relapse (any one occurs first), and the last visit
Time Frame
Up to 2 years after CD19 CAR-T cells infusion
Title
Quality of life
Description
Assessment using European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scale [For item1-28: max score: 112, min score: 28, higher scores mean a better outcome; for item 28-29: max score: 14, min score: 2, higher scores mean a worse outcome] to measure Quality of life at Baseline, Month 1, 3, 6, 9 and 12
Time Frame
At Baseline, Month 1, 3, 6, 9 and 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age≥15 years old Newly diagnosed B-cell acute lymphoblastic leukemia according to the 2016 WHO classification The immunophenotype of leukemia cells were CD19 and CD22 positive Ph- or Ph- like negative Anticipated survival time more than 12 weeks; Those who voluntarily participated in this trial and provided informed consent. Exclusion Criteria: History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases; Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past; Pregnant (or lactating) women; Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis); Active infection of hepatitis B virus or hepatitis C virus; Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving inhaled steroids; Previously treated with any CAR-T cell product or other genetically-modified T cell therapies; Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl; Other uncontrolled diseases that were not suitable for this trial; Patients with HIV infection; Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
He Huang, PhD
Phone
86-13605714822
Email
hehuangyu@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mingming Zhang, PhD
Phone
86-13656674208
Email
mingmingzhang@zju.edu.cn
Facility Information:
Facility Name
The First Affiliated Hospital, College of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
He Huang, PhD
Phone
86-13605714822
Email
hehuangyu@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Sequential CD19 and CD22 CAR-T Therapy for Newly Diagnosed Ph- B-ALL

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