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

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

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

Study Overview

• Status: Recruiting
• Conditions: ALL
• Intervention / Treatment: Drug: CD19 CAR-T cells

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: He Huang, MD; Phone Number: 13605714822; Email: hehuangyu@126.com
• Study Contact Backup: Name: Yongxian Hu; Phone Number: 057187233772; Email: huyongxian2000@aliyun.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Recruiting
      • The first affiliated hospital of medical college of zhejiang university
      • Contact: He Huang, MD; Phone Number: 13605714822; Email: hehuangyu@126.com
      • Contact: Yongxian Hu; Phone Number: 057187233772; Email: huyongxian2000@aliyun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

• Subjects meeting any of the following exclusion criteria are ineligible for enrollment in this study:

  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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CAR-T cells（ chimeric antigen receptor T cells）; CD19 CAR-T 2×10e6 CAR+ T cells/kg,	Drug: CD19 CAR-T cells; Each subject receive CD19/CD22 CAR T-cells by intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Molecular Response Rate after CD19 CAR-T Cell Therapy	Laboratory tests	28 days after infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Leukemia-Free Survival	Survival follow-up	2 years after infusion
Overall survival	Survival follow-up	2 years after infusion
Cumulative Incidence of Relapse	Laboratory tests	2 years after infusion
Complete Molecular Response Rate after CD22 CAR-T Cell Therapy	Laboratory tests	2 years after infusion

Collaborators and Investigators

• Sponsor: Zhejiang University
• Collaborators: Yake Biotechnology Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): November 30, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2028

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Estimated): November 26, 2025

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: CD19 CAR-T
• Other Study ID Numbers: TXB2025020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No