Phase II Study of Pacritinib in Kaposi Sarcoma Herpesvirus (KSHV)-Associated Multicentric Castleman Disease and KSHV-Associated Inflammatory Cytokine Syndrome (KICS)

Phase II Study of Pacritinib in Kaposi Sarcoma Herpesvirus (KSHV)-Associated Multicentric Castleman Disease and KSHV-Associated Inflammatory Cytokine Syndrome (KICS) (NCT06052618) is a Phase 2 interventional studying KSHV Inflammatory Cytokine Syndrome (KICS) and Kaposi Sarcoma Herpesvirus -Associated Multicentric Castleman Disease, sponsored by National Cancer Institute (NCI). RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

Background: Kaposi sarcoma herpesvirus (KSHV)-associated inflammatory cytokine syndrome (KICS) and KSHV-multicentric Castleman disease (MCD) occur in people living with HIV. These diseases cause severe inflammation that can be fatal if not treated. Objective: To test a drug (pacritinib) in people with KSHV-associated KICS or MCD. Eligibility: People aged 18 years and older with KSHV-associated KICS or MCD. They must have at least one symptom. Design: Participants will be screened. They will have a physical exam with blood tests and tests of their heart function. They will have imaging scans. Their ability to perform everyday tasks will be reviewed. In some participants who have Kaposi sarcoma (KS) with KICS or MCD, these individuals may need a bronchoscopy and/or endoscopy of the upper or lower intestine: A flexible tube with a camera and a light source will be inserted through the mouth or anus to see these structures and assess any KS. Pacritinib is a capsule taken by mouth. Participants will take the drug twice a day, every day, for up to 24 weeks. They will write down each dose in a diary. Participants will visit the clinic 3 times in the first 4 weeks. Their visits will taper to once every 4 weeks. Imaging scans, blood tests, and other tests will be repeated during these visits. Participants will give samples of saliva. They may opt to allow tissues samples to be taken from their skin and lymph nodes. Participants will have follow-up visits 7 days and 30 days after their last dose of pacritinib. After that, they will visit the clinic every 3 months for up to 1 year. The physical exam and blood, heart, and imaging tests will be repeated at these visits.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against KSHV Inflammatory Cytokine Syndrome (KICS) and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 75 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused KSHV Inflammatory Cytokine Syndrome (KICS) subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

* Who May Qualify: - Participants must meet KSHV-associated Inflammatory Cytokine Syndrome (KICS) criteria or have diagnosed by tissue sample (biopsy-confirmed) Kaposi sarcoma herpesvirus -multicentric Castleman disease (KSHV-MCD) confirmed by the CCR, Laboratory of Pathology (LP), NCI - Age \>= 18 years - At least one clinical symptom attributed to KSHV-MCD or KICS, as follows: - Intermittent or persistent fever for at least 1 week (\>38 degrees C) - Fatigue (CTCAE - Grade \>=2) - Gastrointestinal symptoms (e.g., nausea and anorexia - CTCAE Grade \>=1) - Respiratory symptoms (e.g., cough and airway hyperreactivity - CTCAE Grade \>=1) - At least one laboratory abnormality attributed to KSHV-MCD or KICS, as follows: - Anemia (hemoglobin \[Hgb\] 7.0 - 12.5gm/dL) - Thrombocytopenia (50,000 - 150,000/mm3) - Hypoalbuminemia (\<3.4 g/dL) - Elevated C-reactive protein \[CRP\] (\>3mg/L) - No life or organ-threatening manifestations of KSHV-MCD, KICS or Kaposi Sarcoma (KS) - Eastern Cooperative Oncology Group \[ECOG\] performance status \<= 3 (Karnofsky \>=60%) - Participants must have laboratory parameters as defined below: - Total bilirubin \<=3 X upper limit of normal (ULN) or \<6X ULN for diagnosis of Gilbert's - AST(SGOT)/ALT(SGPT) \<=2.5 X ULN - PT/PTT/INR \<=1.5 X ULN - Creatinine within normal institutional limits OR Creatinine clearance \>=30mL/min/1.73 m\^2 as estimated by either Cockcroft-Gault or 24-hour urine collection for participants with creatinine levels above ULN - Participants with HIV should be receiving and willing to continue or willing to initiate an effective antiretroviral therapy (ART) regimen that excludes strong/ moderate CYP3A4 inducer or inhibitors. - For participants with evidence of chronic hepatitis B virus (HBV) infection, participants must be on suppressive therapy. - Participants with a history hepatitis C virus (HCV) infection must have completed treatment with evidence of sustained virologic response for a period of at least 3 months. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

* INCLUSION CRITERIA: * Participants must meet KSHV-associated Inflammatory Cytokine Syndrome (KICS) criteria or have histologically or cytologically confirmed Kaposi sarcoma herpesvirus -multicentric Castleman disease (KSHV-MCD) confirmed by the CCR, Laboratory of Pathology (LP), NCI * Age \>= 18 years * At least one clinical symptom attributed to KSHV-MCD or KICS, as follows: * Intermittent or persistent fever for at least 1 week (\>38 degrees C) * Fatigue (CTCAE - Grade \>=2) * Gastrointestinal symptoms (e.g., nausea and anorexia - CTCAE Grade \>=1) * Respiratory symptoms (e.g., cough and airway hyperreactivity - CTCAE Grade \>=1) * At least one laboratory abnormality attributed to KSHV-MCD or KICS, as follows: * Anemia (hemoglobin \[Hgb\] 7.0 - 12.5gm/dL) * Thrombocytopenia (50,000 - 150,000/mm3) * Hypoalbuminemia (\<3.4 g/dL) * Elevated C-reactive protein \[CRP\] (\>3mg/L) * No life or organ-threatening manifestations of KSHV-MCD, KICS or Kaposi Sarcoma (KS) * Eastern Cooperative Oncology Group \[ECOG\] performance status \<= 3 (Karnofsky \>=60%) * Participants must have laboratory parameters as defined below: * Total bilirubin \<=3 X upper limit of normal (ULN) or \<6X ULN for diagnosis of Gilbert's * AST(SGOT)/ALT(SGPT) \<=2.5 X ULN * PT/PTT/INR \<=1.5 X ULN * Creatinine within normal institutional limits OR Creatinine clearance \>=30mL/min/1.73 m\^2 as estimated by either Cockcroft-Gault or 24-hour urine collection for participants with creatinine levels above ULN * Participants with HIV should be receiving and willing to continue or willing to initiate an effective antiretroviral therapy (ART) regimen that excludes strong/ moderate CYP3A4 inducer or inhibitors. * For participants with evidence of chronic hepatitis B virus (HBV) infection, participants must be on suppressive therapy. * Participants with a history hepatitis C virus (HCV) infection must have completed treatment with evidence of sustained virologic response for a period of at least 3 months. * Participants with KSHV-MCD (Cohort 2) or KICS (Cohort 3) who have received prior therapy, such as rituximab or other monoclonal antibodies, must have a wash out period of at least 3 weeks. * Participants receiving medications or substances that are substitutes of strong CYP3A4 inhibitors must have a washout period of at least 5 half-lives of the drug prior to enrollment on study. * Individuals of child-bearing potential (IOCBP) must agree to use a highly effective method of contraception (e.g., intrauterine device \[IUD\], hormonal \[excluding hormonal contraceptives sensitive to CYP3A4 metabolism (i.e. progestin)\], surgical sterilization, abstinence) prior to study entry, for the duration of study participation, and for up to 30 days after discontinuation of the study drug. * Individuals of child-bearing potential (IOCBP) and individuals able to father a child with a partner able to become pregnant must agree to use a highly effective method of contraception (e.g., intrauterine device \[IUD\], hormonal \[excluding hormonal contraceptives sensitive to CYP3A4 metabolism (i.e. progestin, ethinylestradiol)\], surgical sterilization, abstinence) prior to study entry, for the duration of study participation, and for up to 30 days after discontinuation of the study drug. A participant may request that partner uses the highly effective form of contraception to fulfill this requirement. -Ability of participant to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA: * Grade \>2 symptomatic visceral KS (except for edema or non-ulcerating disease restricted to the oral cavity). * History of allergic reactions attributed to compounds of similar chemical or biologic composition to pacritinib. * Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A4. Lists including medications and substances known or with the potential to interact with the specified CYP3A4 isoenzymes. * Participants with evidence of ongoing hemorrhage, active signs/symptoms of bleeding, or history of severe bleeding complications in the one year prior to enrollment. * Any history of CTCAE Grade \>= 3 cardiac events within the last 3 months. * QTc(Fredericia) prolongation \>480 ms or other factors that increase the risk for QTc prolongation (i.e., heart failure, or a history of long QT interval syndrome). * Use of concomitant medications with significant potential for QTc prolongation * History of thrombosis, troponin-positive (Tpos) or myocardial infarction within the last 6 months * Participants with moderate (Child-Pugh Score B) or severe hepatic impairment (Child-Pugh Score C) * Diagnosis of primary effusion lymphoma \[PEL\] or another lymphoma. * Participants with a prior or concurrent malignancy whose natural history or treatment that has potential to interfere with the safety or efficacy assessment of the regimen. * Pregnant individuals as evaluated by a positive serum or urine beta-hCG at screening. * There is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the nursing person with pacritinib. Breastfeeding should be discontinued if the nursing person is treated with pacritinib. * Uncontrolled bacterial, mycobacterial, or fungal infection at screening. * Uncontrolled intercurrent illness that would limit compliance with study requirements, including results of hematology and chemistry testing, infection disease (etc.)

Treatments Being Tested

DRUG

Pacritinib

Pacritinib is administered orally as 200 mg twice daily for a total of 6, 28-day cycles

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06052618), the sponsor (National Cancer Institute (NCI)), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06052618 clinical trial studying?

Who can participate in NCT06052618?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06052618?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06052618. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06052618. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.