Clinical trial · Interventional
Study of IFN-α Combined With CAR-T Cell Therapy in Relapsed and Refractory Acute Lymphoblastic Leukemia（R/R-ALL）
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)
NCT04534634CI-TRIAL-00046877unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety and efficacy of IFN-α combined with CAR-T cell therapy in relapsed and refractory acute lymphoblastic leukemia (R/R ALL).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-cell Acute Lymphoblastic Leukemia | B Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IFN-α combined with CAR-T cell therapy | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- IFN-α combined with CAR T-cells therapy
- interventionNames
- Combination Product: IFN-α combined with CAR-T cell therapy
- type
- NO_INTERVENTION
- label
- Control group
- description
- CAR T-cells therapy
Primary outcomes (1)
- measure
- Overall response rate (ORR)
- timeFrame
- 2 years
- description
- ORR includes CR, CRi, MLFS and PR. Complete remission (CR)：Bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \>1.0x 10\^9/L; platelet count \>100x10\^9/L. CR with incomplete hematologic recovery (CRi)：All CR criteria except for residual neutropenia (\<1.0x10\^9/L) or thrombocytopenia (\<100x10\^9/L). Morphologic leukemia-free state (MLFS): Bone marrow blasts \<5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required. Partial remission (PR): All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.