PI3K Delta Inhibitor in Relapsed / Refractory Autoimmune... | NCT05676697

Status Module

Name	Class
YL-Pharma	UNKNOWN

Arms/Interventions Module

Label	Type	Description	Intervention Names
PI3K Delta Inhibitor	Experimental		Drug: Linperlisib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Linperlisib	Drug	The phosphatidylinositol 3-kinase delta (PI3Kδ) signaling pathway plays a critical role in the activation, proliferation, and tissue homing of self-reactive B cells that contribute to autoimmune diseases. B cells play an essential role in immune system function and dysfunction (e.g., autoimmunity) by producing antibodies and by acting as antigen-presenting cells (APCs) for T cells. Signaling via PI3K controls many essential B cell functions and is therefore a promising target for preventing aberrant B cell activation.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall response rate	Percentage of patients with hematological response. Hematological response is evaluated by hemoglobin and other hemolysis-related laboratory indicators.	6-12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Incidence of the adverse event	Use Common Terminology Criteria for Adverse Events (CTCAE) Version 5 to assess the adverse event.	12 weeks
Complete response rate	Percentage of patients with hematological complete response. Hematological response is evaluated by hemoglobin and other hemolysis-related laboratory indicators.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female age ≥ 18 years
Diagnosis of primary warm antibody hemolytic anemia (AIHA).
Hemoglobin < 100g/L
Refractory to or relapsed after at least 2 prior treatment line.
ECOG performance status ≤ 2
Willing and able to comply with the requirements for this study and written informed consent.

Exclusion Criteria:

Neutrophils counts < 0.5×10^9/L or platelet counts < 50 x 10^9/L
Diagnosis of any of the following diseases: Cold agglutinin disease, cold agglutinin syndrome, mixed AIHA, paroxysmal cold hemoglobinuria (PCH).
Diagnosis of the active stage of the connective tissue or systemic autoimmune rheumatic diseases (SARDs)
History of lymphoproliferative neoplasms
Had other inherited or acquired hemolytic diseases.
Secondary AIHA caused by drugs or infection
Previously received organ or stem cell transplantation.
Had malignant tumor within 5 years before enrollment, exclusive of cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial tumor, cervical carcinoma in situ or other indolent tumors
Patients with HBV, HCV, HIV or other infections that require treatment.
Abnormal liver function: two consecutive examinations with an interval of ≥1 week suggest that ALT and AST are 2.5 times higher than the upper limit of normal values
Renal impairment: creatinine clearance <60ml/min
Any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study, including clinically significant cardiac diseases, refractory hypertension, metabolic disorders and other diseases that seriously affect the function of the gastrointestinal tract.
Had a history of any psychiatric diseases, cerebrovascular disease or cognitive sequelae of head injury.
Received rituximab in 6 weeks before enrollment.
Received attenuated vaccine 4 in weeks before enrollment
Participation in another clinical trial within 4 weeks before the start of this trial
Have an allergy to Linperlisib or any other part of this medicine.
Previously treated with other PI3Kδ inhibitor.
Pregnant or breast-feeding patients
Patients considered to be ineligible for the study by the investigator for reasons other than the above

Facility	Status	City	State	ZIP	Country	Contacts
Zhoukou Central Hospital		Zhoukou	Henan		China
Regenerative Medicine Center

ID	Term
D000743	Anemia, Hemolytic
D000740	Anemia
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases