Can a protein calm the immune System's overreaction to cancer treatment?
NCT ID NCT04552704
First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time
Summary
This early-phase trial tests whether an experimental protein called CD24Fc can help people with advanced solid tumors recover from severe immune-related side effects caused by immunotherapy. These side effects occur when the immune system attacks healthy tissues. CD24Fc is designed to dampen this overactive immune response and reduce inflammation. The study aims to see if adding CD24Fc to standard care can shorten recovery time and lessen the severity of these side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CD24Fc, a lab-made protein that may calm the immune system and reduce inflammation caused by cancer immunotherapy
- What this could lead to
- If it works, CD24Fc could offer a faster, safer way to manage severe immune-related side effects, helping patients stay on their cancer treatment.
- What could go wrong
- This is an early, small trial, so results may not apply broadly. CD24Fc could also have its own side effects or fail to improve recovery.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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3 people
The number who actually took part.
- Started
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Oct 2020
- Finished
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Jan 2022
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Ability to understand and willingness to sign an informed consent form * At least 18 years of age * Histologically confirmed advanced solid tumors * Patients must have grade 2 or 3 irAEs from at least one ICI-containing regimen. Both newly emerging and persistent irAEs are allowed. Systemic steroid therapy or any other form of immunosuppressive therapy for irAEs is allowed. The specific irAEs are * Grade 2-3 diarrhea/colitis: Patients with \>= 4 stools per day or moderate-severe increase in ostomy output compared to baseline but not life-threatening diarrhea * Grade 2-3 pneumonitis: Mild to moderate (grade 2) or severe (grade 3) symptoms (including hypoxia, shortness of breath, requiring oxygen) but not life-threatening respiratory compromise requiring urgent intervention (e.g., tracheostomy or intubation) * Grade 2-3 renal irAE: Creatine increased between 1.6-6.0 x upper limit of normal (ULN) or =\< 3.0 x baseline if baseline was abnormal, estimated glomerular filtration rate (eGFR) or creatinine clearance \>= 15 ml/min/1.73m\^2 but not life-threatening consequences or requiring dialysis * Grade 2-3 Hepatic irAE: AST/ALT/ALP levels 3-20 x ULN, and T bilirubin increased \<5 x ULN * Grade 2-3 skin rash: moderate (10-30% body surface area, BSA) to severe (\> 30% BSA) but not life-threatening skin lesions or Stevens-Johnson syndrome * Eastern Cooperative Oncology Group (ECOG) performance status \< 2 * Life expectancy of \>= 3 months at the time of enrollment * Pretreatment absolute neutrophil count (ANC) \>= 1,000/uL obtained within 14 days prior to 1st dose of treatment * Pretreatment hemoglobin \>= 8 gm/dL obtained within 14 days prior to 1st dose of treatment * Pretreatment platelet count of \>= 75,000/uL obtained within 14 days prior to 1st dose of treatment * Female subjects who are of non-reproductive potential (i.e., post-menopausal by history - no menses for \>= 1 year; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy). Or, female subjects of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the first study drug administration * Male and female subjects who agree to use highly effective method of birth control (e.g., implants, injectables, birth control pills with two hormones, intrauterine devices \[IUDs\], complete abstinence or sterilized partner, and female sterilization) and a barrier method (e.g., condoms, vaginal ring, sponge, etc.) during the period of therapy and for 90 days after the last dose of study drug Exclusion Criteria: * Prior CD24Fc therapy * Any known active hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, including patients who have an active infection requiring systemic therapy. History of COVID-19 or known asymptomatic carrier of SARS-CoV-2 virus is allowed * Pregnant or lactating women * Any medical condition including additional laboratory abnormalities, or psychiatric illness that would, in the opinion of the investigator, prevent the subject from participating and adhering to study related procedures * Any known severe bacterial, fungal, or viral infection that in the opinion of the investigator would interfere with patient safety or compliance on trial within 2 weeks prior to enrollment * Patients with concomitant proarrhythmic medications * Patients with heart failure in New York (NY) Heart Association stage IV * Any grade 4 irAE symptoms and Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 grade 4 toxicity * AST, ALT, gamma glutamyl transpeptidase (GGT), or ALP \> 20.0 x ULN regardless of baseline * Blood bilirubin \>5.0 x ULN regardless of baseline * Creatinine \> 6.0 x ULN or creatinine clearance \<15 ml/min/1.73m2 * Urine: Anuria \< 140 ml in 24 hours * Electrolytes hyponatremia, sodium \< 120 mmol/L * Hypokalemia, potassium \< 2.5 mmol/L * Creatine kinase (CPK) \> 10.0 ULN * Electrocardiogram (ECG): Prolonged QT interval \>= 480 mS, corrected by Fridericia's formula. Torsade de pointes; polymorphic ventricular tachycardia; signs/symptoms of serious arrythmia
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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