RecruitingPhase 2NCT06014775

Anti-CD38 Antibody Treating Evans Syndrome

A Prospective, One-arm and Open Clinical Study to Assess Safety and Efficacy of Anti-CD38 Antibody in the Treatment of Evans Syndrome


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

10 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

A single-center, open-label, off-label use investigator-initiated clinical study with safety run-in to explore the clinical activity and safety of Anti-CD38 Antibody in adult ES patients who have not responded adequately or relapsed after first-line treatment and at least one second-line therapy including immunosuppressive agents, Anti-CD20 Antibody and/or TPO-RA, or those in whom no other second-line treatment options are suitable.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing an anti-CD38 antibody treatment for people with Evans syndrome — a rare autoimmune condition where the immune system attacks its own red blood cells and platelets at the same time, causing anemia and bleeding risk. This study targets people whose disease has not responded to standard treatments. **You may be eligible if...** - You are 18 or older - You have been diagnosed with primary Evans syndrome - Your blood counts are significantly low (platelets <30 or hemoglobin <100g/L, or you have symptomatic anemia) - You have not responded to or have relapsed after corticosteroids and at least one second-line treatment - Your immune system is actively attacking red blood cells (positive DAT test, active hemolysis) - Your liver, kidney, and heart function are within acceptable limits **You may NOT be eligible if...** - You have secondary Evans syndrome (caused by another condition) - You have previously received anti-CD38 antibody therapy - You have another serious uncontrolled disease (e.g., organ failure or active cancer) - You recently used certain immunosuppressive treatments without adequate washout time Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAnti-CD38 antibody Injection

intravenous Anti-CD38 antibody administration This study adopts a prospective, single arm, open design method. Ten subjects were enrolled in the study and were treated with Anti-CD38 antibody (16mg/kg/w) for 8 weeks. The first stage is the main research stage (d1-w8), which is the core treatment period. The subjects will receive intravenous infusion of 16mg/kg Anti-CD38 antibody once a week for 8 weeks to observe the safety and efficacy during treatment. The second stage (w9-w24) is the stage of withdrawal from the visit, mainly to observe the safety and continuous efficacy of Anti-CD38 antibody after treatment.


Locations(1)

Chinese Academy of Medical Science and Blood Disease Hospital

Tianjin, Tianjin Municipality, China

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NCT06014775


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