A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy

Phase 2

Active, not recruiting

• Conditions: B Cell ALL; B-Cell Lymphoma; B-cell Non Hodgkin Lymphoma
• Interventions: Drug: Anakinra

• Registration Number: NCT04148430
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

This study is being done to see if the investigational drug, anakinra, prevent or reverse the severe side effects caused by CAR-T cell therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-30
• Study First Submitted: 2019-10-30
• Study First Submitted QC: 2019-10-31
• Study First Posted: 2019-11-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-01
• Last Update Posted: 2024-11-04
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• Patients (age >/= 18) with a diagnosis of relapsed CD19+ B-cell ALL, MCL, or NHL receiving commercially approved CD19-specific CAR T cells (e.g. tisagenleuleucel, axicabtagene, brexucabtagene autoleucel, etc) are eligible for the study

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Exclusion Criteria

• Patients with uncontrolled systemic fungal and bacterial infections
• Patients with known hypersensitivity to E. coli-derived proteins
• Women of childbearing potential must have a negative serum or urine pregnancy test (women who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential)
• Women who are pregnant or breastfeeding

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Arm 1 (CART Cell Group)	Anakinra	Cohort 1 Patients will receive anakinra 100mg s.c. every 12 hours starting on day 2 post CAR T cell infusion, or after 2 documented fevers of ≥38.5° C prior to day 2, whichever time point is earlier. Anakinra will be continued for 10 days. Cohort 2 Patients will receive anakinra 100mg s.c. daily on day 0 of T cell infusion, and continue anakinra daily for 7 days

Primary Outcome Measures

Name	Time	Method
Arm 1 (CAR T Cell Group) Rate of Severe Neurotoxicities	4 weeks	Determine the rate of severe neurotoxicities, \>/= Grade 3 or any grade seizure, within the first 4 weeks of treatment with prophylactic use of anakinra in participants receiving CD19-specific CAR T cells
Arm 2 (COVID-19 Group) proportion of patients able to avoid death or mechanical ventilation	28 days from the start of treatment	proportion of patients able to avoid death or mechanical ventilation within 28 days from the start of the treatment.

Trial Locations

Locations (2)

Hackensack Meridian Health (Data collection only); 🇺🇸 Hackensack, New Jersey, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States