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

A Phase II Study of IL-1 Receptor Antagonist Anakinra to Prevent Severe Neurotoxicity and Cytokine Release Syndrome in Patients Receiving CD19-Specific Chimeric Antigen Receptor (CAR) T Cells

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.

Study Overview

• Status: Active, not recruiting
• Conditions: B-Cell Lymphoma; B-cell Non Hodgkin Lymphoma; B Cell ALL
• Intervention / Treatment: Drug: Anakinra

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jae Park, MD; Phone Number: 212-639-4048; Email: parkj6@mskcc.org

Study Locations

• United States
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack Meridian Health (Data collection only)
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Arm 1 (CART Cell Group); 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

Drug: Anakinra; 100mg subcutaneous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arm 1 (CAR T Cell Group) Rate of Severe Neurotoxicities	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	4 weeks
Arm 2 (COVID-19 Group) proportion of patients able to avoid death or mechanical ventilation	proportion of patients able to avoid death or mechanical ventilation within 28 days from the start of the treatment.	28 days from the start of treatment

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Jae Park, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

General Publications

• Danish H, Santomasso BD. Neurotoxicity Biology and Management. Cancer J. 2021 Mar-Apr 01;27(2):126-133. doi: 10.1097/PPO.0000000000000507.

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2019
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: October 30, 2019
• First Submitted That Met QC Criteria: October 31, 2019
• First Posted (Actual): November 1, 2019

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Antirheumatic Agents; Interleukin 1 Receptor Antagonist Protein
• Other Study ID Numbers: 19-168

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: • Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No