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

• Status: Recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Treatments: Interleukin 1 Receptor Antagonist Protein

Criteria

Inclusion Criteria:

Arm 1 (CART Cell Group):

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

Arm 2 (COVID-19 Group):

Both Cohorts:

• Age ≥ 18 years old, with underlying solid tumor or hematologic malignancies

• A positive test for SARS-CoV2 virus in any specimen, or recent exposure to a known COVID-19 positive contact, or belonging to a high risk demographic group (living and/or working in high-risk setting)

Cohort 1:

• Infilgrate on CXR or CT scan, AND

• O2 saturation ≤ 93% on room air, or requiring supplemental oxygen, or respiratory rate ≥ 30 breaths/min

• Evidence of systemic inflammatory response as defined by presence of at least two of the following:

• Fever of ≥ 38C at any time point following suspected diagnosis, or

• CRP > 5 mg/dL, or

• Ferritin > 500 ng/mL

• AST/ALT ≤ 5x ULN

Cohort 2:

• On mechanical ventilation within 48 hours of starting study treatment

Exclusion Criteria:

Arm 1 and Arm 2:

• 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

Arm 2 (COVID-19 Group) only:

• Concurrent JAK inhibitors and/or IL-6 inhibitors (tocilizumab, siltuximab, etc.) for treatment of COVID-19 pneumonia are excluded but previous history or administration of these agents are allowed and no washout time is needed.

• History of or concurrent use of hydroxychloroquine, anti-viral drugs, antibiotics, corticosteroids and convalescent plasma is allowed.

• Patients receiving active chemotherapy or patients whose life expectancy is estimated to be <3 months in the opinion of investigators, strictly due to their cancer diagnosis (i.e. not due to COVID-19) are excluded

• Myelosuppressive chemotherapy is prohibited until clinical recovery (i.e. 1 or 2 on the 7-category ordinal scale)

• CrCl <30 mL/minute

• Treatment with any investigational agent is prohibited, except for investigational SAR-Co-V2 anti-viral agents, through 28 days after the last dose of anakinra