A Multicenter Study of CAR-T Cells in Primary Ph+All

NCT ID: NCT07252336

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2028-11-30

Brief Summary

A Multicenter Study of CD19 CAR-T Cells in the Treatment of Adult Patients With Primary Ph Chromosome Positive Acute Lymphoblastic Leukemia

Detailed Description

This study is a single-arm, open-label, multicenter clinical trial that plans to enroll approximately 50 adult patients with newly diagnosed Ph-positive acute lymphoblastic leukemia to undergo CD19 CAR-T cell therapy. The primary objective is to evaluate the efficacy of CD19 CAR-T therapy in adult patients with newly diagnosed Ph-positive acute lymphoblastic leukemia. The secondary objective is to assess the safety of CD19 CAR-T therapy in this patient population. The exploratory objectives include evaluating the in vivo expansion and persistence of CAR-T cells, as well as B-cell depletion.

Conditions

ALL

Study Design

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

Study Groups

CAR-T cells（ chimeric antigen receptor T cells）

CD19 CAR-T 2×10e6 CAR+ T cells/kg,

Group Type: EXPERIMENTAL

CD19 CAR-T cells

Intervention Type: DRUG

Each subject receive CD19/CD22 CAR T-cells by intravenous infusion

Interventions

CD19 CAR-T cells

Each subject receive CD19/CD22 CAR T-cells by intravenous infusion

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years old, gender not restricted;

2. Subjects diagnosed with B-cell acute lymphoblastic leukemia (B-ALL) in accordance with the 2016 WHO Classification of Acute Leukemias;

3. Abnormal B cells positive for CD19 and CD22 by immunophenotyping;

4. Subjects positive for Philadelphia chromosome (Ph chromosome) and BCR/ABL1 fusion gene by chromosomal and corresponding genetic testing;

5. Newly diagnosed B-ALL patients who have not received treatment with standard chemotherapy regimens;

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

7. Left ventricular ejection fraction (LVEF) ≥ 50% as assessed by echocardiography;

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

9. Estimated survival time ≥ 3 months;

10. ECOG performance status score 0-2;

11. Females and males of childbearing potential must agree to use appropriate contraceptive measures before enrollment, during study participation, and within 6 months after infusion;

12. Subjects voluntarily participate in this study and sign the informed consent form.

Exclusion Criteria

1. Subjects with a history of epilepsy or other central nervous system diseases;

2. Subjects with a prior history of QT interval prolongation or severe cardiac diseases;

3. Pregnant or lactating women (the safety of this therapy for unborn children is unknown);

4. Subjects with untreated active infections;

5. Subjects with serological evidence of chronic hepatitis B virus (HBV) infection who are unable or unwilling to receive standard prophylactic antiviral treatment, or have a detectable HBV viral DNA load; subjects with serological evidence of hepatitis C virus (HCV) infection who have not completed curative treatment or have a detectable HCV viral load;

6. Human immunodeficiency virus (HIV) antibody positive;

7. Syphilis antibody positive;

8. Subjects who have previously received any gene therapy products;

9. Subjects with other uncontrolled diseases who, in the investigator's judgment, are unsuitable for enrollment;

10. Any other conditions that, in the investigator's judgment, may increase the risk to the subject or interfere with the study results.

• 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

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The first affiliated hospital of medical college of zhejiang university

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

He Huang, MD

Role: CONTACT

hehuangyu@126.com

13605714822

Yongxian Hu

Role: CONTACT

huyongxian2000@aliyun.com

057187233772

Facility Contacts

He Huang, MD

Role: primary

hehuangyu@126.com

13605714822

Yongxian Hu

Role: backup

huyongxian2000@aliyun.com

057187233772

Other Identifiers

TXB2025020

Identifier Type: -

Identifier Source: org_study_id