Study of IFN-α Combined With CAR-T Cell Therapy in Relapsed and Refractory Acute Lymphoblastic Leukemia（R/R-ALL）

Phase 2

Recruiting

• Conditions: B-cell Acute Lymphoblastic Leukemia
• Interventions: Combination Product: IFN-α combined with CAR-T cell therapy

• Registration Number: NCT04534634
• Lead Sponsor: The First Affiliated Hospital of Soochow University

Brief Summary

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).

Detailed Description

This is a phase 2, single-center study. The patients will receive IFN-α combined with infusion of CAR T-cells in R/R B-ALL patients. The study participation will be 5 years including treatment and follow-up periods.

Study Timeline

• Study Start: 2019-04-01
• Status Verified: 2020-08
• Study First Submitted: 2020-08-25
• Study First Submitted QC: 2020-08-28
• Last Update Submitted: 2020-08-28
• Study First Posted: 2020-09-01
• Last Update Posted: 2020-09-01
• Primary Completion: 2023-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	IFN-α combined with CAR-T cell therapy	IFN-α combined with CAR T-cells therapy

Primary Outcome Measures

Name	Time	Method
Overall response rate (ORR)	2 years	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%.

Secondary Outcome Measures

Name	Time	Method
Cumulative incidence of relapse(CIR)	2 years	time from the date of achievement of a remission until the date of relapse
Overall survival (OS)	2 years	time from enrollment to the date of death from any cause
Leukemia-free survival (LFS)	2 years	time from enrollment to the date of primary refractory disease, or relapse from CR, or death from any cause
the duration of CAR-T cells in patients	2 years	the time of CAR-T cells' persistence in blood and the copies of CAR-T cells
Number of adverse events	2 years	adverse events are evaluated with CTCAE V5.0

Trial Locations

Locations (1)

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China