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

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

• Complete Molecular Response Rate after CD19 CAR-T Cell Therapy [Time frame: 28 days after infusion]

Secondary outcome measures (4)

• Leukemia-Free Survival [Time frame: 2 years after infusion]
• Overall survival [Time frame: 2 years after infusion]
• Cumulative Incidence of Relapse [Time frame: 2 years after infusion]
• Complete Molecular Response Rate after CD22 CAR-T Cell Therapy [Time frame: 2 years after infusion]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

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

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• The first affiliated hospital of medical college of zhejiang university — Hangzhou

Identifiers

NCT: NCT07252336 · TXB2025020

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗