CD19 CAR-T for adults with newly diagnosed Philadelphia 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

This study will test CD19 CAR‑T cell therapy in adults newly diagnosed with Philadelphia chromosome–positive acute lymphoblastic leukemia to see if it can induce remission.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Zhejiang University (Academic / other)
• Drugs / interventions: chemotherapy, CAR-T
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT07252336 on ClinicalTrials.gov

What this trial studies

This single-arm, open-label Phase 2 multicenter study plans to enroll about 50 adults with newly diagnosed Ph‑positive B‑cell acute lymphoblastic leukemia who have not yet received standard chemotherapy. Participants will undergo leukapheresis and receive autologous CD19-directed CAR‑T cell infusions, followed by scheduled clinical and laboratory follow-up. The primary goal is to test efficacy, measured by remission rates, while secondary endpoints focus on safety and adverse events. Exploratory objectives include measuring CAR‑T cell expansion and persistence in vivo and the degree of B‑cell depletion.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18) with newly diagnosed Ph‑positive B‑ALL who are CD19-positive, treatment‑naïve to standard chemotherapy, have adequate organ function, and an ECOG performance status of 0–2.

Not a fit: Patients with CD19‑negative disease, those who have already received standard cytotoxic chemotherapy, or those with significant organ dysfunction, active uncontrolled infection, poor performance status, or pregnancy are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could offer a targeted cellular therapy that produces deep remissions and may reduce reliance on conventional chemotherapy for newly diagnosed Ph‑positive B‑ALL patients.

How similar studies have performed: CD19 CAR‑T therapies have shown high remission rates in relapsed or refractory B‑ALL, but using CAR‑T up front in newly diagnosed Ph‑positive patients is relatively novel and less well studied.

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:

* 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.

Where this trial is running

Hangzhou, Zhejiang

• The first affiliated hospital of medical college of zhejiang university — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: He Huang, MD

Conditions ALL; CD19 CAR-T