CD19-directed CAR‑T therapy for relapsed or refractory B‑cell acute lymphoblastic leukemia

CD19-targeting Chimeric Antigen Receptor T-cell Therapy for Patients With Refractory and Relapsed B-cell Acute Lymphoblastic Leukemia

This trial tests locally manufactured CD19-targeting CAR‑T cells to try to induce remission in people with relapsed or refractory B‑cell ALL.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 196 (estimated)
• Sex: All
• Sponsor: The First Affiliated Hospital of Soochow University (Academic / other)
• Drugs / interventions: CAR T, Chimeric antigen receptor
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT03919240 on ClinicalTrials.gov

What this trial studies

Participants with CD19-positive relapsed or refractory B‑cell acute lymphoblastic leukemia will undergo leukapheresis to collect T cells that are then engineered locally to express a CD19-directed CAR and reinfused after lymphodepletion. The trial combines a Phase 1 dose-escalation component to define safety and a Phase 2 expansion to examine response rates and short-term outcomes. Key eligibility requires active disease or persistent residual disease after prior therapy and adequate organ function and performance status. Investigators will monitor for toxicity (including cytokine release syndrome and neurotoxicity) and measure remission rates and survival outcomes.

Who should consider this trial

Good fit: Ideal candidates are people with CD19-positive B‑cell ALL who have relapsed or failed to achieve remission after prior therapy, have adequate organ function and performance status, and an estimated survival over three months.

Not a fit: Patients unlikely to benefit include those without CD19 expression, with uncontrolled active infection, significant organ dysfunction, a history of seizure, active hepatitis B/C or HIV, or who are pregnant or unable to receive immunosuppressive chemotherapy.

Why it matters

Potential benefit: If successful, the therapy could induce remissions in patients who have not responded to prior treatments and may enable longer survival or bridge to transplant.

How similar studies have performed: CAR‑T therapies targeting CD19 have produced high remission rates in relapsed/refractory B‑ALL in prior international studies, though locally manufactured products vary and are less widely reported.

Eligibility criteria

Inclusion Criteria:

* Diagnosed as CD19+ B-cell acute lymphoblastic leukemia;
* Fail to achieve remission, or with persistent residual disease after at least 2 cycles of consolidation;
* With an estimated survival of higher than 3 months (according to investigator's judgement);
* Sufficient organ function: left ventricular ejection fractions≥ 0.5 by echocardiography, creatinine \< 1.6 mg/dL, aspartate aminotransferase/aspartateaminotransferase \< 3 x upper limit of normal, bilirubin \<2.0 mg/dL;
* Karnofsky performance status ≥ 60 or ECOG ≤ 2.

Exclusion Criteria:

* Intolerant to immunosuppressive chemotherapies;
* With active infection or other uncontrolled complications;
* With history of seizure;
* Active hepatitis B or hepatitis C infection and HIV infection;
* Pregnant or lactating women, or patients refusing to take effective contraception measures;
* Other contraindications that considered inappropriate to participate in this trial (according to investigator's judgement).

Where this trial is running

Suzhou, Jiangsu

• The Fisrt Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)

Study contacts

• Principal investigator: Depei Wu, M.D., Ph.D. — The First Affiliated Hospital of Soochow University
• Study coordinator: Jia Chen, M.D., Ph.D.

Conditions Acute Lymphoblastic Leukemia With Failed Remission; Acute Lymphoblastic Leukemia; Refractory and relapsed; Chimeric antigen receptor T-cell therapy