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

NCT07252336 | Recruiting Phase 2

• 1 other identifier: TXB2025020
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

ALL

Keywords

CD19 CAR-T

Outcome Measures

Primary Outcomes (1)

• Complete Molecular Response Rate after CD19 CAR-T Cell Therapy

  Laboratory tests

  28 days after infusion

Secondary Outcomes (4)

• Leukemia-Free Survival

  2 years after infusion

• Overall survival

  2 years after infusion

• Cumulative Incidence of Relapse

  2 years after infusion

• Complete Molecular Response Rate after CD22 CAR-T Cell Therapy

  2 years after infusion

Study Arms (1)

CAR-T cells（ chimeric antigen receptor T cells）

EXPERIMENTAL

CD19 CAR-T 2×10e6 CAR+ T cells/kg,

Drug: CD19 CAR-T cells

Interventions

CD19 CAR-T cells DRUG

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

CAR-T cells（ chimeric antigen receptor T cells）

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old, gender not restricted;
• Subjects diagnosed with B-cell acute lymphoblastic leukemia (B-ALL) in accordance with the 2016 WHO Classification of Acute Leukemias;
• Abnormal B cells positive for CD19 and CD22 by immunophenotyping;
• Subjects positive for Philadelphia chromosome (Ph chromosome) and BCR/ABL1 fusion gene by chromosomal and corresponding genetic testing;
• Newly diagnosed B-ALL patients who have not received treatment with standard chemotherapy regimens;
• 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;
• Left ventricular ejection fraction (LVEF) ≥ 50% as assessed by echocardiography;
• Subjects with no active pulmonary infection and oxygen saturation ≥ 92% without oxygen supplementation;
• Estimated survival time ≥ 3 months;
• ECOG performance status score 0-2;
• Females and males of childbearing potential must agree to use appropriate contraceptive measures before enrollment, during study participation, and within 6 months after infusion;
• Subjects voluntarily participate in this study and sign the informed consent form.

You may not qualify if:

• Subjects with a history of epilepsy or other central nervous system diseases;
• Subjects with a prior history of QT interval prolongation or severe cardiac diseases;
• Pregnant or lactating women (the safety of this therapy for unborn children is unknown);
• Subjects with untreated active infections;
• 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;
• Human immunodeficiency virus (HIV) antibody positive;
• Syphilis antibody positive;
• Subjects who have previously received any gene therapy products;
• Subjects with other uncontrolled diseases who, in the investigator's judgment, are unsuitable for enrollment;
• Any other conditions that, in the investigator's judgment, may increase the risk to the subject or interfere with the study results.

Sponsors & Collaborators

• Zhejiang University: lead
• Yake Biotechnology Ltd.: collaborator

Study Sites (1)

The first affiliated hospital of medical college of zhejiang university

Hangzhou, Zhejiang, 310003, China

RECRUITING

Central Study Contacts

He Huang, MD

CONTACT

13605714822; hehuangyu@126.com

Yongxian Hu

CONTACT

057187233772; huyongxian2000@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 26, 2025
• Study Start: November 30, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2028
• Last Updated: December 4, 2025

Record last verified: 2025-11

Locations

CN (1)