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CAR T-cell Therapy

Immune effector cell therapy for Cytokine Release Syndrome

Phase 2
Waitlist Available
Research Sponsored by Incyte Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from at day -3 through the duration of safety follow-up (up to day 56) for parts 1 and 2
Awards & highlights

Study Summary

This trial will test whether a drug called itacitinib can help prevent a side effect called cytokine release syndrome (CRS) in people who are about to receive treatment for blood cancer.

Eligible Conditions
  • Cytokine Release Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from at day -3 through the duration of safety follow-up (up to day 56) for parts 1 and 2
This trial's timeline: 3 weeks for screening, Varies for treatment, and from at day -3 through the duration of safety follow-up (up to day 56) for parts 1 and 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants Who Developed ≥Grade 2 Cytokine Release Syndrome (CRS) by Day 14 After Immune Effector Cell (IEC) Therapy, Assessed by Using American Society for Blood and Marrow Transplantation (ASBMT) CRS Consensus Grading
Secondary outcome measures
Duration of All Grades of CRS Occurring by Day 28 After IEC Therapy, Assessed by Using ASBMT CRS Consensus Grading
Duration of ICANS Occurring by Day 28 After IEC Therapy Using the ICANS Consensus Grading, Regardless of CRS
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Except CRS and ICANS
+8 more
Other outcome measures
Duration of Hospital Stay for Participants With CRS and/or ICANS by End of Study
Number of Hospital Admissions for Participants With CRS and/or ICANS by the End of the Study

Side effects data

From 2023 Phase 2 trial • 112 Patients • NCT04071366
50%
Fatigue
50%
Pyrexia
50%
Decreased appetite
50%
Diarrhoea
44%
Anaemia
44%
Headache
38%
Constipation
38%
Chills
31%
Nausea
31%
Oedema peripheral
25%
Platelet count decreased
25%
Hypertension
19%
Dizziness
19%
Cough
19%
Insomnia
19%
Weight decreased
19%
Pain
19%
Arthralgia
19%
Hypokalaemia
19%
Hyponatraemia
19%
Hypophosphataemia
19%
Hypotension
19%
Neutropenia
19%
Back pain
13%
Febrile neutropenia
13%
Electrocardiogram QT prolonged
13%
Thrombocytopenia
13%
Anxiety
13%
Hypoalbuminaemia
13%
Hypocalcaemia
13%
Hypogammaglobulinaemia
13%
Tremor
13%
Vomiting
13%
Rhinorrhoea
13%
Tachycardia
13%
Urinary incontinence
13%
Vision blurred
13%
Aspartate aminotransferase increased
13%
Dysuria
13%
Flushing
13%
Lymphocyte count decreased
13%
Lymphopenia
13%
Myalgia
13%
Myoclonus
13%
Neutrophil count decreased
13%
Muscular weakness
6%
Anal incontinence
6%
Catheter site haemorrhage
6%
Stomatitis
6%
Haematoma
6%
Dehydration
6%
Delirium febrile
6%
Malignant neoplasm progression
6%
Dysphagia
6%
Dyspnoea
6%
Hypomagnesaemia
6%
Abdominal discomfort
6%
Blood alkaline phosphatase increased
6%
Affect lability
6%
Confusional state
6%
Cytomegalovirus viraemia
6%
Deep vein thrombosis
6%
Epistaxis
6%
Hyperaesthesia
6%
Onychomycosis
6%
Oral pain
6%
Orthostatic hypotension
6%
Pain in extremity
6%
Penile ulceration
6%
Pleural effusion
6%
Polyomavirus viraemia
6%
Pruritus
6%
Purpura
6%
Rash
6%
Rash erythematous
6%
Seasonal allergy
6%
Sensitive skin
6%
Sinus bradycardia
6%
Skin ulcer
6%
Staphylococcal infection
6%
Urinary tract infection
6%
Fusarium infection
6%
Acute kidney injury
6%
Agitation
6%
Aphthous ulcer
6%
Atelectasis
6%
Blood lactate dehydrogenase increased
6%
Chronic sinusitis
6%
Depression
6%
Dyspepsia
6%
Dyspnoea exertional
6%
Erythema
6%
Facial pain
6%
Fall
6%
Fluid intake reduced
6%
Gait disturbance
6%
Hyperkalaemia
6%
Hypersensitivity
6%
Hypoaesthesia
6%
Hypoglycaemia
6%
Hypoxia
6%
Ingrowing nail
6%
Memory impairment
6%
Mental impairment
6%
Muscle spasms
6%
Neck pain
6%
Neurotoxicity
6%
Nocturia
6%
Non-cardiac chest pain
6%
Oedema
6%
Night sweats
6%
Infusion related reaction
6%
Hyperhidrosis
6%
Musculoskeletal stiffness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah
Part 2: Placebo BID + Yescarta
Part 1: Itacitinib 200 mg QD + Yescarta
Part 1: Itacitinib 200 mg + Any IEC
Part 2: Itacitinib 200 mg BID + Yescarta
Part 1: Itacitinib 200 mg QD + Tecartus

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part 2: Double-Blind Itacitinib Twice DailyExperimental Treatment4 Interventions
During Part 2, participants will be randomized to receive itacitinib 200mg or placebo twice daily for 30 days. The study population also includes participants who are receiving Yescarta for relapsed or refractory large B-cell lymphoma or follicular lymphoma.
Group II: Part 1: Open Label Itacitinib Once DailyExperimental Treatment3 Interventions
During Part 1, all participants receive itacitinib 200mg once daily (open label) for 30 days. The study population will include participants receiving any approved IEC for an approved indication.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Itacitinib
2020
Completed Phase 3
~910
Yescarta
2020
Completed Phase 2
~120
Placebo
1995
Completed Phase 3
~2670
Immune effector cell therapy
2020
Completed Phase 2
~120

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor
364 Previous Clinical Trials
55,053 Total Patients Enrolled
4 Trials studying Cytokine Release Syndrome
536 Patients Enrolled for Cytokine Release Syndrome
Peter Langmuir, MDStudy DirectorIncyte Corporation
10 Previous Clinical Trials
917 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the sample size for this medical experiment?

"The sponsor, Incyte Corporation, needs to enlist 108 suitable participants for the trial. Patient recruitment will be conducted in various sites including Washington University School of Medicine and the University of Miami Sylvester Comprehensive Cancer Center."

Answered by AI

Are new participants currently being enrolled for this research endeavor?

"According to the clinicaltrials.gov listing, this clinical trial is actively recruiting patients with an initial post date of February 7th 2020 and most recent update on October 25th 2022."

Answered by AI

What potential adversities are associated with Immune effector cell therapy?

"Our team at Power judged the safety of immune effector cell therapy to be a 2 due to limited clinical evidence attesting to its efficacy. Nevertheless, there is adequate data that supports its security."

Answered by AI

Are there any related studies on the efficacy of Immune effector cell therapy?

"Presently, there are 23 studies on Immune effector cell therapy in progress. One of these is currently at Phase 3 while the remaining trials are conducted from 397 different locations situated primarily in Houston, Texas."

Answered by AI

Is this investigation the first of its kind?

"Analyzing the efficacy of Immune effector cell therapy has been an ongoing process since 2013, when Incyte Corporation founded its first trial involving 121 participants. Following that initial investigation, Phase 1 drug approval was granted and today there are 23 studies encompassing 76 cities in 20 countries."

Answered by AI

Are there a considerable number of Canadian medical centers participating in this research endeavor?

"Currently, 11 sites across the United States are enrolling patients into this medical study. Major cities inlcude Saint Louis, Miami and Cincinnati as well as 8 other places. To reduce travel commitments, it is advised to select a site closest to you for participation."

Answered by AI
Recent research and studies
Clinical Cancer ResearchJournal
Itacitinib (INCB039110), a JAK1 Inhibitor, Reduces Cytokines Associated with Cytokine Release Syndrome Induced by CAR T-cell Therapy
Huarte, Eduardo, Roddy S. O'Connor, Michael T. Peel, Selene Nunez-Cruz, John Leferovich, Ashish Juvekar, Yan-ou Yang, et al.. 2020. “Itacitinib (INCB039110), a JAK1 Inhibitor, Reduces Cytokines Associated with Cytokine Release Syndrome Induced by CAR T-cell Therapy”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-20-1739.
clinicaltrials.govStudy
A Study of Itacitinib for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy
2020. "A Study of Itacitinib for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04071366.
~22 spots leftby Apr 2025
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