A Phase 1/2 interventional study of CD24 Extracellular Domain-IgG1 Fc Domain Recombinant Fusion Protein CD24Fc and Placebo Administration in Advanced Malignant Solid Neoplasm, sponsored by Tianhong Li. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Tianhong Li · Phase 1/2, Interventional, and Treatment
This phase I/II trial investigates the side effects and how well CD24Fc works in treating immune related adverse events in patients with solid tumors that have spread to other places in the body (advanced). CD24Fc may prevent autoimmune reactions due to the tissue damage induced by cancer treatment. CD24Fc binds to injured cell components and prevents inflammatory responses. CD24Fc also acts to turn off the immune system after it has been activated ("immune checkpoint"). Adding CD24Fc to standard treatment may shorten the recovery time and reduce the severity of side effects from immunotherapy.
PRIMARY OBJECTIVES:
I. To determine the safety and tolerability of CD24 extracellular domain-IgG1 Fc domain recombinant fusion protein CD24Fc (CD24Fc) in patients with advanced solid tumors who developed debilitating immune-related adverse events (irAEs) from immune check point inhibitors (ICIs). (Phase I) II. To determine if CD24Fc shortens the recovery time of irAE and increases the recovery rate of irAE in cancer patients with grade (G)2 or 3 irAEs. (Randomized phase II)
SECONDARY OBJECTIVES:
I. Time to irAE reduction by at least 1 grade. (Phase I) II. Time to all irAEs reduced to grade =\< 1. (Phase I) III. Time to resume ICI treatment. (Phase I) IV. Recovery rate (as defined by reduction of irAE by one grade) at day (D)42. (Phase I) V. To estimate the time to all irAEs reduced to =\< 1. (Randomized phase II) VI. To record the use of steroids (drug, dose, duration) and other treatment for irAE. (Randomized phase II) VII. To record the time to resume ICI treatment. (Randomized phase II) VIII. To estimate the preliminary overall response rate (ORR), progression free survival (PFS), and 1-year overall survival (OS) after treatment with or without CD24Fc. (Randomized phase II) IX. To determine if CD24Fc treatment changes the levels of inflammatory markers in the plasma. (Randomized phase II)
OUTLINE:
PHASE I: Patients receive CD24Fc intravenously (IV) over 60 minutes on days 1, 14, and 28 with standard of care (i.e., steroids per treating physician and best supportive care) in the absence of disease progression or unacceptable toxicity.
PHASE II: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive CD24Fc IV over 60 minutes on days 1, 14, and 28 in addition to standard of care treatment for irAE in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive placebo IV over 60 minutes on days 1, 14, and 28 in addition to standard of care treatment for irAE in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at days 42 and 60 and then every 3 months for up to 1 year.
This is the only study on the registry with Tianhong Li as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
Patients receive CD24Fc IV over 60 minutes on days 1, 14, and 28 with standard of care (i.e., steroids per treating physician and best supportive care) in the absence of disease progression or unacceptable toxicity.
Biological: CD24 Extracellular Domain-IgG1 Fc Domain Recombinant Fusion Protein CD24Fc
Patients receive CD24Fc IV over 60 minutes on days 1, 14, and 28 in addition to standard of care treatment for irAE in the absence of disease progression or unacceptable toxicity.
Biological: CD24 Extracellular Domain-IgG1 Fc Domain Recombinant Fusion Protein CD24Fc
Patients receive placebo IV over 60 minutes on days 1, 14, and 28 in addition to standard of care treatment for irAE in the absence of disease progression or unacceptable toxicity.
Drug: Placebo Administration
Given IV
Also known as: CD24Fc, CD24Fc CD24IgG
Given IV
Number of Participants With New Adverse Event (AE) of Grade >= 3 (Phase I)
Number of Participants with New Adverse Event (AE) of Grade \>= 3 (Phase I)
Time frame: At day 60
Recovery Rate (Phase II)
Defined by reduction of irAE by one grade. Kaplan-Meier plots and confidence intervals will be used to summarize outcomes. Medians and associated 95% confidence intervals will be calculated, and comparisons between groups will be performed by log-rank tests. Cox proportional hazard models will be used to explore association between covariates and outcomes.
Time frame: At day 42
Time to Recovery From Grade 2 or 3 irAE (Phase II)
Will assess time to recovery from grade 2 or 3 irAE (as defined by reduction of at least 1 grade in irAE severity) from the initiation of CD24Fc treatment. Patients who have not been documented to have event (reduction of at least 1 grade) will be censored at the date of the latest clinical assessment that documented as being free of event.
Time frame: Up to 1 year
Time to irAE Reduction by at Least 1 Grade From the Initiation of CD24Fc Treatment (Phase I)
Time to irAE reduction by at least 1 grade from the initiation of CD24Fc treatment.
Time frame: Up to 1 year
Time to All irAEs Reduced to =< 1 From the Initiation of CD24Fc Treatment (Phase I)
Time to all irAEs reduced to =\< 1 from the initiation of CD24Fc treatment (Phase I)
Time frame: Up to 2 weeks
Time to Resume Immune Check Point Inhibitor (ICI) Treatment From the Initiation of CD24Fc Treatment (Phase I)
Time to resume immune check point inhibitor (ICI) treatment from the initiation of CD24Fc treatment (Phase I)
Time frame: Up to about 3.5 months
Recovery Rate (Reduction of irAE by One Grade) (Phase I)
The fraction of patients who experience a partial response (PR) or complete response (CR) will be determined by dividing the number of responders by the total evaluable patients.
Time frame: At day 42
Time to All irAEs Reduced to =< 1 From the Initiation of CD24Fc Treatment (Phase II)
Time to all irAEs reduced to =\< 1 from the initiation of CD24Fc treatment (Phase II)
Time frame: Up to 1 year
Use of Steroids and Other Drugs (Phase II)
Summary of use of steroids and other treatment for irAE.
Time frame: Up to 1 year
Overall Response Rate After Retreatment With ICI With or Without CD24Fc After Resolution of irAE (Phase II)
The fraction of patients who experience a PR or CR will be determined by dividing the number of responders by the total evaluable patients.
Time frame: Up to 1 year
Progression Free Survival (PFS) (Phase II)
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: From initiation of ICI to first documented evidence of disease progression or death, whichever comes first, assessed up to 1 year
Overall Survival (OS) (Phase II)
Count of participants known to be alive up to 1 year from the time from start of treatment.
Time frame: From start of treatment to death, assessed up to 1 year
The study was terminated by the sponsor after 3 out of 6 patients enrolled in phase I study.
| Milestone | Phase I |
|---|---|
| Started | 3 |
| Completed | 3 |
| Not completed | 0 |
Number of Participants with New Adverse Event (AE) of Grade \>= 3 (Phase I)
| Participants | Phase I |
|---|---|
| Number of Participants With New Adverse Event (AE) of Grade >= 3 (Phase I) | 1 |
Defined by reduction of irAE by one grade. Kaplan-Meier plots and confidence intervals will be used to summarize outcomes. Medians and associated 95% confidence intervals will be calculated, and comparisons between groups will be performed by log-rank tests. Cox proportional hazard models will be used to explore association between covariates and outcomes.
No measurements were reported for this outcome.
Will assess time to recovery from grade 2 or 3 irAE (as defined by reduction of at least 1 grade in irAE severity) from the initiation of CD24Fc treatment. Patients who have not been documented to have event (reduction of at least 1 grade) will be censored at the date of the latest clinical assessment that documented as being free of event.
No measurements were reported for this outcome.
Time to irAE reduction by at least 1 grade from the initiation of CD24Fc treatment.
| days | Phase I |
|---|---|
| Time to irAE Reduction by at Least 1 Grade From the Initiation of CD24Fc Treatment (Phase I) | 14 (14 to 14) |
Time to all irAEs reduced to =\< 1 from the initiation of CD24Fc treatment (Phase I)
| days | Phase I |
|---|---|
| Time to All irAEs Reduced to =< 1 From the Initiation of CD24Fc Treatment (Phase I) | 14 (14 to 14) |
Time to resume immune check point inhibitor (ICI) treatment from the initiation of CD24Fc treatment (Phase I)
| days | Phase I |
|---|---|
| Time to Resume Immune Check Point Inhibitor (ICI) Treatment From the Initiation of CD24Fc Treatment (Phase I) | 84.5 (61 to 108) |
The fraction of patients who experience a partial response (PR) or complete response (CR) will be determined by dividing the number of responders by the total evaluable patients.
| percentage of participants | Phase I |
|---|---|
| Recovery Rate (Reduction of irAE by One Grade) (Phase I) | 100 |
Time to all irAEs reduced to =\< 1 from the initiation of CD24Fc treatment (Phase II)
No measurements were reported for this outcome.
Summary of use of steroids and other treatment for irAE.
No measurements were reported for this outcome.
The fraction of patients who experience a PR or CR will be determined by dividing the number of responders by the total evaluable patients.
No measurements were reported for this outcome.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
No measurements were reported for this outcome.
Count of participants known to be alive up to 1 year from the time from start of treatment.
No measurements were reported for this outcome.
Collected over Up to 60 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phase I | 1/3 (33.3%) | 1/3 (33.3%) | 3/3 (100%) |
| Event | Phase I |
|---|---|
| DyspneaRespiratory, thoracic and mediastinal disorders | 1/3 |
| DysphagiaGastrointestinal disorders | 1/3 |
| OdynophagiaGastrointestinal disorders | 1/3 |
| FeverGeneral disorders | 1/3 |
| PneumoniaRespiratory, thoracic and mediastinal disorders | 1/3 |
| Event | Phase I |
|---|---|
| Blood bicarbonate decreasedInvestigations | 3/3 |
| HyperglycemiaMetabolism and nutrition disorders | 2/3 |
| HyponatremiaMetabolism and nutrition disorders | 2/3 |
| HypoxiaRespiratory, thoracic and mediastinal disorders | 2/3 |
| Alanine aminotransferase increasedInvestigations | 2/3 |
| Aspartate aminotransferase increasedInvestigations | 2/3 |
| AnemiaBlood and lymphatic system disorders | 1/3 |
| Blood bilirubin increasedInvestigations | 1/3 |
| FatigueGeneral disorders | 1/3 |
| Hepatic infectionInfections and infestations | 1/3 |
The study was terminated by the sponsor after 3 out of 6 patients enrolled in phase I study.
| Age, Categorical(Participants) | Phase I (CD24Fc) | Phase II, Arm I (CD24Fc) | Phase II, Arm II (Placebo) | Total |
|---|---|---|---|---|
| <=18 years | 0 | — | — | 0 |
| Between 18 and 65 years | 0 | — | — | 0 |
| >=65 years | 3 | — | — | 3 |
| Sex: Female, Male(Participants) | Phase I (CD24Fc) | Phase II, Arm I (CD24Fc) | Phase II, Arm II (Placebo) | Total |
|---|---|---|---|---|
| Female | 1 | — | — | 1 |
| Male | 2 | — | — | 2 |
| Race (NIH/OMB)(Participants) | Phase I (CD24Fc) | Phase II, Arm I (CD24Fc) | Phase II, Arm II (Placebo) | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | — | — | 0 |
| Asian | 0 | — | — | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | — | — | 0 |
| Black or African American | 0 | — | — | 0 |
| White | 3 | — | — | 3 |
| More than one race | 0 | — | — | 0 |
| Unknown or Not Reported | 0 | — | — | 0 |
| Region of Enrollment(participants) | Phase I (CD24Fc) | Phase II, Arm I (CD24Fc) | Phase II, Arm II (Placebo) | Total |
|---|---|---|---|---|
| United States | 3 | — | — | 3 |
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