Baltimore, MDNCT07424222Now EnrollingIRB Ready

Immune Effector Associated Hemophagocytic Lymphohistiocytosis-like Syndrome (IEC-HS) Clinical Trial in Baltimore, MD

Access cutting-edge immune effector associated hemophagocytic lymphohistiocytosis-like syndrome (iec-hs) treatment through this phase 1 clinical trial at a research site in Baltimore. Study-provided care at no cost to qualified participants.

Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Quick Self-Assessment

See if you qualify for this Baltimore location

Preparing your pre-screening questions…

Expert Care in Baltimore

Access immune effector associated hemophagocytic lymphohistiocytosis-like syndrome (iec-hs) specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related immune effector associated hemophagocytic lymphohistiocytosis-like syndrome (iec-hs) treatment provided free

Apply for This Baltimore Location

Check if you qualify for this immune effector associated hemophagocytic lymphohistiocytosis-like syndrome (iec-hs) clinical trial in Baltimore, MD

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Baltimore

    Convenient for MD residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Baltimore site if eligible
  4. 4Begin participation

About This Immune Effector Associated Hemophagocytic Lymphohistiocytosis-like Syndrome (IEC-HS) Study in Baltimore

This is a pilot study to gather information about safety and efficacy of using ruxolitinib (RUX) to treat Immune Effector Cell Associated Hemophagocytic Lymphohistiocytosis-like Syndrome (IEC-HS) occurring after CAR-T therapy. In addition, correlative studies will be done to 1) estimate the optimal duration of RUX therapy, 2) to identify immunological biomarkers associated with response (3) To evaluate the dynamics of CAR T expansion following RUX treatment. Oral RUX will be administered twice daily, with dosing determined by the participant's baseline platelet count. Treatment will continue for up to 8 weeks unless significant adverse events occur or the treating physician concludes that the therapy is no longer providing clinical benefit. The study expects to accrue 16 evaluable patients diagnosed with IEC-HS over 2 years.

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Who Can Participate

Inclusion Criteria

Patients of age 18 or older
Diagnosis of for Immune Effector Cell Associated Hemophagocytic Lymphohistiocytosis-like Syndrome (IEC-HS) per ASTCT consensus criteria
Patients must have an elevated ferritin (\>2 × ULN) at time of infusion and/or have a ferritin count that is rapidly rising (per clinical assessment) and at least 2 of the following manifestations as described in the ASTCT consensus criteria:
Onset with resolving/resolved CRS or worsening inflammatory response after initial improvement with CRS-directed therapy
Hepatic transaminase elevation§ (\>5 × ULN (if baseline was normal) or \>5 × baseline if baseline was abnormal)
Hypofibrinogenemia (\<150 mg/dL or \<LLN)
Hemophagocytosis in bone marrow or other tissue
Grade 1 cytopenias (new onset, worsening, or refractory) defined as:
Anemia (Hgb) \<LLN\
- 10.0 g/dL(gr1)
Neutropenia (ANC) 1,000 - 1,499/µL (Gr1)
Thrombocytopenia \<LLN - 75,000/µL (Gr1)
Lactate dehydrogenase elevations (\>ULN)
Other coagulation abnormalities (e.g. elevated PT/PTT)
Direct hyperbilirubinemia
New-onset splenomegaly that is palpable ≥5 cm below costal margin or \>450cc on imaging
Fever of 100.4 or greater (new or persistent)
Neurologic changes greater than baseline that are consistent with a grade 1 Immune Effector Cell Encephalopathy (ICE) Score or greater
Pulmonary manifestations
Gr 2 Hypoxia with decreased oxygen saturation with exercise (e.g. pulse ox \<88%)
pulmonary infiltrates
pulmonary edema with radiologic findings and moderate dyspnea on exertion
New onset renal insufficiency defined by:
an absolute increase in serum creatinine of ≥0.3 mg/dL within 48 hours.
A baseline increase in serum creatinine of ≥1.5 times within the prior 7 days.
Oliguria defined as urine volume \<0.5 mL/kg/h for at least 6 hours.
Hypertriglyceridemia (fasting level, \>265 mg/dL‖)
Patients who have received a CAR T product, commercially available or investigational, will be allowed to enroll
Eastern Cooperative Oncology Group (ECOG) Performance Score43 of 0-2
Patients may be treatment naïve for the IECH-HS diagnosis or may have received prior or ongoing treatment. Corticosteroids can be continued along with RUX initiation as noted above.
Patient is able to take oral medication or is willing to have an NG tube placed if unable to take oral medication. Patients in whom NG tube was placed due to acute decompensation (resulting in an ECOG of \>2), will be excluded.
Willing and able to sign an informed consent form

Exclusion Criteria

Life expectancy greater than 6 months
Patients with known active malignancy or known progressive underlying disease
Women who are pregnant or breastfeeding. Women must also refrain from breastfeeding during the course of study and for 60 days after the last dose of study treatment.
Presence of chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment. Participants with acute infection requiring antibiotic, antifungal, or antiviral treatment use should delay screening/enrollment until the course of antibiotic antifungal, or antiviral therapy has been completed and the infection is not active anymore. Note: If a participant has a positive screening test result for SARS-CoV-2 infection, the participant should be excluded until test normalization and clinical recovery.
Any prior investigational agent used to treat IEC-HS
Patient on treatment with rifampin, St Johns wart or other JAK inhibitors
Patient is unable to tolerate medicine administration either orally or via NG tube.
Known history of allergic reaction to ruxolitinib
History of clinically significant or uncontrolled cardiac disease, including recent (within the last 12 months) unstable angina or acute myocardial infarction, or New York Heart Association Class III or IV congestive heart failure, or clinically significant arrhythmias not controlled by medication. Participants with a pacemaker and well-controlled rhythm for at least 1 month before the first dose of study treatment will be allowed.
Any major surgery within 28 days before the first dose of study treatment.
Active HBV (or at risk of reactivation), defined as follows: positive HBsAg result (laboratory test required at screening), and/or positive total anti-HBc result (laboratory test required at screening), and/or quantitative HBV DNA test result greater than the lower limits of detection of the assay (if known; laboratory test not required for eligibility purpose, but can be done as part of screening if available locally). Note: Participants with no prior history of HBV infection who have been vaccinated against HBV and who have a positive anti-HBs as the only evidence of prior exposure may participate in the study.
Active HCV, defined as follows: positive anti-HCV result (laboratory test required at screening) and quantitative HCV RNA test result greater than the lower limits of detection of the assay (laboratory test only required if anti-HCV-positive, can be done as part of screening if available locally). Note: Anti-HCV-positive participants who received and completed treatment for HCV that was intended to eradicate the virus may participate if HCV RNA levels are undetectable at least 12 weeks after the last dose of therapy. Anti-HCV-positive participants with no available confirmatory negative HCV RNA test results will be excluded.
Known history of HIV (1/2 antibodies).
Any condition or circumstance that would, in the investigator's judgment, interfere with full participation in the study (eg, unable, unlikely, or unwilling to comply with the dose schedule and study evaluations, active alcohol or drug addiction), including administration of study treatment and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Baltimore?

Yes, this clinical trial (NCT07424222) has an active research site in Baltimore, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Immune Effector Associated Hemophagocytic Lymphohistiocytosis-like Syndrome (IEC-HS) Treatment Options in Baltimore, MD

If you're searching for immune effector associated hemophagocytic lymphohistiocytosis-like syndrome (iec-hs) treatment options in Baltimore, MD, this clinical trial (NCT07424222) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Baltimore research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced immune effector associated hemophagocytic lymphohistiocytosis-like syndrome (iec-hs) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all immune effector associated hemophagocytic lymphohistiocytosis-like syndrome (iec-hs) clinical trials near you to find additional studies recruiting in your area.

More Multiple Myeloma Trials in Baltimore, MD

See all multiple myeloma clinical trials recruiting in Baltimore — not just this study.

Browse Multiple Myeloma Trials in Baltimore →

Browse More Trials by Condition

Multiple Myeloma TrialsAnkylosing Spondylitis TrialsPulmonary Hypertension TrialsHidradenitis Suppurativa TrialsErectile Dysfunction TrialsInterstitial Cystitis TrialsMyalgic Encephalomyelitis TrialsAll Conditions →

Ready to Join in Baltimore?

Take the first step toward participating in this groundbreaking clinical trial

Secure · Expert Care · Baltimore, MD