Itacitinib with CAR T-cell therapy for DLBCL
This study is looking at whether adding a drug called itacitinib can help people with diffuse large B-cell lymphoma (DLBCL) who are also receiving CAR T-cell therapy (Yescarta). Itacitinib is given by mouth once a day, starting about 4-6 weeks before your CAR T-cell infusion and continuing for 30 days after. CAR T-cell therapy uses your own immune cells, reprogrammed to fight cancer. To join, you must have DLBCL, be 18 or older, and be planning to receive treatment at Moffitt Cancer Center. You also need to have high levels of certain inflammation markers (ferritin and C-reactive protein). The main goal is to see if this combination improves how long people live without their cancer growing (Progression Free Survival) at 6 months. The study plans to enroll about 27 participants.
- Study design
- This is a Phase 2, single-arm, open-label study, meaning all participants receive the same treatment and everyone knows what treatment is being given. It plans to include about 27 adult participants.
- What's involved
- You would start taking itacitinib daily about 4-6 weeks before your CAR T-cell infusion and continue for 30 days after. You will receive a single infusion of CAR T-cell therapy.
- Compensation
- Not stated in the trial record.
- Follow-up
- The main outcome (Progression Free Survival) is measured at 6 months after treatment.
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NCT05757219
Itacitinib Pre-modulation in DLBCL Receiving CAR T Cell Therapy
Recruiting
PHASE2Ages 18+InterventionalTreatmentH. Lee Moffitt Cancer Center and Research InstituteInvestigator-initiated
~27 participants
Updated 2026-03-31 on ClinicalTrials.gov
What's tested:ItacitinibChimeric antigen receptor (CAR) T-cell therapy
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression Free Survival (PFS)
Measured over at 6 months
Conditions
Where it's being run
1 sites across 1 statesFlorida1
Study leadership
- Michael Jain, MD, PhD · PRINCIPAL_INVESTIGATOR · Moffitt Cancer Center
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Patients with a histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) who plan to receive treatment at the Moffitt Cancer Center/
Adult males or females who are 18 years of age or older at time of signing informed consent.
Must have ability to comprehend and the willingness to sign written informed consent for study participation.
Eligible to receive CAR-T cell therapy (axicabtagene ciloleucel) for DLBCL and histological variants.
Patients must have a serum ferritin level above 400 mg/mL and C-reactive protein level above 2 mg/dL (20 mg/L) at screening.
ECOG performance status 0 to 2.
The effects of Itacitinib on the developing human fetus are unknown. For this reason and because Janus kinase (JAK)1-selective inhibitors as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation as outlined in criteria below: (a) Men must agree to take appropriate precautions to avoid fathering children (with at least 99% certainty) from screening through safety follow up and must refrain from donating sperm during this period. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participants in their understanding confirmed.(b) Women of childbearing potential must have a negative serum pregnancy test at screening and before the first dose of Day 1 and must agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through safety follow up. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participants and their understanding confirmed. (c) Women of non-childbearing potential (ie, surgically sterile with a hysterectomy and/or bilateral oophorectomy OR \>= 12 months of amenorrhea) are eligible.
Patients must be ineligible for stem cell transplant at screening on the basis of active lymphoma.
Patients must meet laboratory parameters at screening as defined in protocol
Exclusion
Patients who are currently receiving or who have received any investigational study agent ≤4 weeks prior to screening visit are ineligible.
Prior treatment with chimeric antigen receptor (CAR) T-cell therapy.
Participants with clinically significant or uncontrolled cardiac disease, including unstable angina, acute myocardial infarction within 6 months from screening, New York Health Association III or IV heart failure, and circulatory collapse requiring vasopressor or inotropic support
Participants with arrhythmias that are not stable on a medical management program within 2 weeks of screening are also excluded.
Participants with arrhythmias that are not stable on a medical management program within 2 weeks of screening are also excluded.
Evidence of active uncontrolled/untreated infection (viral, bacterial, fungal, opportunistic) of any origin.
Participants with a known history or prior diagnosis of immunologic or inflammatory/autoimmune disease affecting the CNS, and unrelated to their disease under study or previous treatment.
Known positive Human immunodeficiency virus (HIV) status.
Participants with evidence of active and/or chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable on suppressive therapy, if indicated.
Participants with a history of hepatitis C virus (HCV) infection, HCV must have been treated and cured.
Participants who require the concurrent use of chronic systemic steroids or immunosuppressant medications. Steroids should not be given within 5 days prior to leukapheresis. Concomitant bridging steroids (section 6.6) are allowed after leukapheresis.
Known hypersensitivity or severe reaction to itacitinib, similar compounds, or excipients or itacitinib.
Participants who have not recovered from adverse events (AEs) due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1), with the exception of stable Grade 2 peripheral neuropathy and/or any grade alopecia.
Pregnant or nursing (breast-feeding) women are excluded from this study because there is an unknown but potential risk to using itacitinib in pregnant or nursing women.
Any condition that would, in the investigator's judgement, interfere with full participation in the study, including administration of itacitinib and attending required study visits (if outpatient); pose a significant risk to the participant; or interfere with interpretation of study data.
Inability of the participant to swallow and retain oral medication.
Participants receiving any medications or substances that are strong inhibitors of CYP3A4 are ineligible. As part of the enrollment/informed consent procedures, the participant will be counseled on the risk of interactions with other agents and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product.
What this trial measures
- Progression Free Survival (PFS)at 6 months
Progression Free Survival is defined as the time from start of treatment to the time of disease progression or death. Among patients treated with axi-cel who have a ferritin \>400 ng/ml and CRP\>2 mg/dl at the time of apheresis, the 6 month PFS was 25%. The primary endpoint of this study will be met if pre-modulation with itacitinib followed by axi-cel leads to a 6 month PFS of 45% or higher.