Combining IFN-α with CAR-T cell therapy for treating relapsed B-cell leukemia

An Open-label, Phase 2, Single-Center Study to Assess the Efficacy and Safety of Interferon-α Combined With Chimeric Antigen Receptor (CAR) T-cell Therapy in Patients With Relapsed and Refractory Acute Lymphoblastic Leukemia（R/R-ALL)

This study is testing if adding a medication called IFN-α to CAR-T cell therapy can help people with relapsed acute lymphoblastic leukemia feel better and improve their treatment results.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 12 Years to 65 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Soochow University (Academic / other)
• Drugs / interventions: immunotherapy, CAR-T, CAR T
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT04534634 on ClinicalTrials.gov

What this trial studies

This phase 2 clinical trial evaluates the safety and efficacy of combining IFN-α with CAR-T cell therapy in patients with relapsed and refractory acute lymphoblastic leukemia (R/R ALL). The study is conducted at a single center and involves administering IFN-α alongside CAR-T cell infusions to eligible patients. Participants will be monitored over a 5-year period, which includes both treatment and follow-up phases to assess outcomes.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 12-65 diagnosed with refractory or relapsed acute B-lymphoblastic leukemia.

Not a fit: Patients who are pregnant, have central nervous system leukemia, or uncontrolled active infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new effective treatment option for patients with difficult-to-treat B-cell acute lymphoblastic leukemia.

How similar studies have performed: While there have been studies on CAR-T cell therapy, the combination with IFN-α in this specific context is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Diagnosed refractory and relapsed acute B-lymphoblastic leukemia.
2. Age 12-65.
3. Eastern Cooperative Oncology Group (ECOG) score 0-2.
4. Target on leukemia is \>20% positive detected with flowcytometry.
5. Patients with left ventricular ejection fraction ≥ 0.5 by echocardiography or grade I/II cardiovascular dysfunction according to the New York Heart Association Classification.

5.Patients with aspartate aminotransferase or glutamic-pyruvic transaminase \> 3x upper limit of normal or bilirubin \> 2.0 mg/dL.

6.No other immunotherapy was received within 3 months.

Exclusion Criteria:

1. Patients are pregnant or lactating.
2. Patients with congenital immunodeficiency.
3. Patients with central nervous system leukemia.
4. Patients with uncontrolled active infection.
5. Patients with active hepatitis B or hepatitis C infection.
6. Patients with HIV infection.
7. Patients with atrial or venous thrombosis or embolism.
8. Patients with myo-infarction or severe arrythmia in the recent 6 months.
9. Other comorbidities that investigators considered not suitable for this study.

Where this trial is running

Suzhou, Jiangsu

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

Study contacts

• Principal investigator: xiaowen tang, Ph.D — The First Affiliated Hospital of Soochow University
• Study coordinator: xiaowen tang, Ph.D

Conditions B-cell Acute Lymphoblastic Leukemia; IFN-α, CAR-T