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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

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 Positive, 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

NCT ID

NCT04788472

First Posted

March 5, 2021

Last Updated

March 5, 2021

Sponsor

Zhejiang University

Collaborators

Yake Biotechnology Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04788472

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 Positive B-cell Acute Lymphoblastic Leukemia

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Recruiting

Study Start Date

March 5, 2021 (Anticipated)

Primary Completion Date

March 5, 2024 (Anticipated)

Study Completion Date

March 5, 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

Studies a U.S. FDA-regulated Device Product

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 Positive 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 positive 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 Positive, 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

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

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

hehuangyu@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Mingming Zhang, PhD

Phone

86-13656674208

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

hehuangyu@126.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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