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

NCT ID: NCT04788472

Last Updated: 2024-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-05
• Study Completion Date: 2024-08-31

Brief Summary

Clinical Trial for the Efficacy and Safety 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 study was designed as a prospective, open-label, single-center study. It aims to evaluate the efficacy and safety of CD19 CAR-T cells in combination with dasatinib for the treatment of newly diagnosed Ph-positive B-cell acute lymphoblastic leukemia in adult.

Conditions

B-Cell Acute Lymphoblastic Leukemia, Adult

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CAR-T therapy

Administration of CD19 and CD22 CAR T-cells

Group Type: EXPERIMENTAL

CAR-T cells targeting CD19 and CD22

Intervention Type: DRUG

Each subject receives sequential CD19 and CD22 CAR-T cells by intravenous infusion

Interventions

CAR-T cells targeting CD19 and CD22

Each subject receives sequential CD19 and CD22 CAR-T cells by intravenous infusion

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years old;

2. Subjects with a diagnosis of B-cell acute lymphoblastic leukemia according to the 2016 edition of the WHO classification criteria for acute leukemia;

3. Subjects whose chromosomal and fusion gene analysis showed positivity for the Ph chromosome, BCR/ABL1 fusion gene;

4. Leukemia cells were CD19 and CD22 positive;

5. Patients with newly diagnosed B-ALL were not treated with standard chemotherapy regimens;

6. Serum total bilirubin ≤ 51 mol/L, serum ALT and AST both ≤ 3 times the upper limit of the normal range, blood creatinine ≤ 176.8 mol/L;

7. Echocardiography showed a left ventricular ejection fraction (LVEF) ≥50%;

8. Subjects had no active pulmonary infection and oxygen saturation ≥92% without oxygen;

9. The prognosis for survival is more than 3 months;

10. ECOG score 0-2;

11. Subjects volunteered to participate in this trial and signed an informed consent form.

Exclusion Criteria

1. Those with a history of epilepsy or other central nervous system disorders;

2. Those with a history of prolonged QT period or severe cardiac disease;

3. Women who are pregnant or breastfeeding (the safety of this therapy for the unborn child is not known);

4. Those with uncontrolled active infection;

5. Active hepatitis B or hepatitis C virus infection;

6. Those who have previously used any gene therapy product;

7. Those with insufficient amplification (<5-fold) in response to CD3/CD28 co-stimulatory signals;

8. Creatinine > 2.5 mg/dl or ALT / AST > 3 times the upper limit of the normal range or bilirubin > 2.0 mg/dl;

9. Those who suffer from other uncontrolled medical conditions that, in the opinion of the investigator, make them unsuitable for enrollment;

10. HIV-infected persons;

11. Any condition that, in the opinion of the investigator, may increase the risk to the subject or interfere with the results of the test.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yake Biotechnology Ltd.

INDUSTRY

Sponsor Role: collaborator

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

He Huang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Countries

China

References

Zhang M, Fu S, Feng J, Hong R, Wei G, Zhao H, Zhao M, Xu H, Cui J, Huang S, Wu X, Liu L, Sun J, Wu W, Zhu Y, He J, Zhao Y, Cai Z, Zheng W, Ye X, Shi J, Luo Y, Wang D, Chang AH, Hu Y, Huang H. Dasatinib and CAR T-Cell Therapy in Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: A Nonrandomized Clinical Trial. JAMA Oncol. 2025 Jun 1;11(6):625-629. doi: 10.1001/jamaoncol.2025.0674.

Reference Type: DERIVED

PMID: 40244598 (View on PubMed)

Other Identifiers

CD19-006

Identifier Type: -

Identifier Source: org_study_id