Inaticabtagene Autoleucel Injection in the Treatment of Refractory Systemic Lupus Erythematosus-related Immune Thrombocytopenia

NCT06826430 | Recruiting Phase 1

• 1 other identifier: HY001105
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, open-label，phase I clinical study to evaluate the safety and tolerability of Inaticabtagene Autoleucel Injection in treatment of refractory systemic lupus erythematosus-related immune thrombocytopenia.

Conditions

Autoimmune Thrombocytopenia

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-related Adverse Events

  Therapy-related adverse events (AE), including severe adverse events (SAE) and laboratory outliers with clinical significance, will be recorded and assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)

  Up to 28 days post-infusion

• The safe dosage for a single infusion of Inaticabtagene Autoleucel Injection

  The safe dosage for ITP patients will be evaluated by comprehensively assessing the Overall Response Rate (ORR) and the incidence of adverse events (AEs).

  Up to 28 days post-infusion

Secondary Outcomes (9)

• Overall Remission Rate (ORR)

  Up to 6 months post-infusion

• Proportion of subjects who achieved disease remission (DORIS)

  Up to 6 months post-infusion

• Proportion of subjects who achieved lupus hypoactivity state (LLDAS)

  Up to 6 months post-infusion

• Improvement in systemic lupus erythematosus scores (SELENA-SLEDAI)

  Up to 24 months post-infusion

• Changes in MOS item short from health survey(SF-36)

  Up to 24 months post-infusion

Study Arms (1)

Single dose of Inaticabtagene Autoleucel Injection

EXPERIMENTAL

Subjects who meet the enrollment conditions will receive intravenous infusion of CAR-T cells after lymphodepletion.

Drug: Inaticabtagene autoleucel Injection

Interventions

Inaticabtagene autoleucel Injection DRUG

Inaticabtagene autoleucel Injection, the autologous 2nd generation CD19-directed CAR-T cells, will be administered by vein. Before CAR-T infusion，patients will get a 3-4 days lymphodepletion therapy with fludarabine and cyclophosphamide.

Single dose of Inaticabtagene Autoleucel Injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age range: 18-70 years (including 18 and 70 years), regardless of gender.
• Clinically diagnosed with Refractory Systemic Lupus Erythematosus-related Immune Thrombocytopenia according to the revised criteria of ACR in 1997 or EULAR/ACR in 2019. At least two consecutive blood routine tests showing platelet counts \<50×10\^9/L; Peripheral blood smear microscopy showed no significant abnormalities in the morphology of blood cells; The morphological characteristics of bone marrow cells are consistent with immune thrombocytopenia. Treated at least 1 course of MP shock therapy or high-dose steroids, combined with one or more immunosuppressive agents (including biologics) for at least 3 months but not achieving partial remission, or the efficacy cannot be maintained during the steroid reduction process.
• During the study period, the use of corticosteroids at a dose not exceeding 10mg prednisone or its equivalent, all immunosuppressants (excluding hydroxychloroquine) should be discontinued.
• Women of childbearing potential must have a negative blood pregnancy test 7 days prior to trial conditioning therapy; any male and female patients of childbearing potential must agree to use an effective method of contraception throughout the study and for at least 2 year following infusion of CAR-T cells. Childbearing potential is biologically capable of bearing a living baby and sexually active. Female patients who were not of childbearing potential (ie, met at least 1 of the following criteria):
• Hysterectomy or oophorectomy, or
• Medically confirmed ovarian failure, or medically confirmed postmenopausal (cessation of menses for at least 12 consecutive months in the absence of pathological or physiological causes).
• Adequate organ function according to the following criteria:
• Aspartate aminotransferase (AST) ≤ 3 times of upper limit of normal (ULN);
• Alanine aminotransferase (ALT) ≤ 3 times ULN;
• Total serum bilirubin ≤ 2 times ULN unless the patient has documented Gilbert's syndrome; patients with Gilbert's syndrome who have bilirubin ≤ 3.0 times ULN and direct bilirubin ≤ 1.5 times ULN may be included;
• Serum creatinine ≤ 1.5 times ULN, or creatinine clearance ≥ 60 mL/min (Cockcroft and Gault formula), Patients with lupus nephritis may relax the conditions appropriately according to the judgment of the investigator;
• Must have minimal pulmonary reserve and oxygen saturation \> 91% in a nonoxygenated state;
• Lymphocyte count \> 0.4 × 109/L.

You may not qualify if:

• Severe active central nervous system (CNS) lupus, including seizures, psychosis, cerebrovascular accidents, or CNS vasculitis requiring therapeutic intervention within 60 days after baseline.
• Dialysis patients or creatinine clearance rate less than 30mL/min.
• Pregnancy or breastfeeding.
• Merge active infections (such as sepsis, bacteremia, mycosis, uncontrolled lung infections, and active tuberculosis).
• Hepatitis B surface antigen (HBsAg) and/or hepatitis B e antigen (HBeAg) are positive; Hepatitis B e antibody (HBe Ab) and/or hepatitis B core antibody (HBcAb) are positive, and the number of HBV-DNA copies is greater than the measurable lower limit; Hepatitis C (HCV) antibody positive; positive for human immunodeficiency virus (HIV) antibodies; positive for syphilis antibody (TP Ab);
• Major surgery that was assessed as unsuitable by the investigators within 4 weeks before screening.
• Patients with concurrent active malignancy within the past five years, those with a history of malignancy but cuired are eligible.
• The patient's heart meets any of the following conditions:
• Patients with clinically significant pleural effusion during screening.
• Patients vaccinated with a live vaccine within 6 weeks prior to screening.
• Patients with deep vein thrombosis within 6 months prior to screening, or a history of pulmonary embolism.
• Patients with a life expectancy of less than 6 months.
• Patients participating in any other interventional clinical study or receiving treatment of an active investigational drug within 3 months or 5 half-lives for launched drugs prior to Inaticabtagene Autoleucel Injection infusion.
• Patients with a history of epilepsy, cerebral ischemia/hemorrhage, cerebellar diseases, or other active central nervous system disorders;
• Patients with hypersensitivity reactions to the components of Inaticabtagene Autoleucel Injection.

Sponsors & Collaborators

• Juventas Cell Therapy Ltd.: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Mengtao Li, Dr.

  Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Junyin Yu

CONTACT

+86 13920424844; yujunyin@juventas.cn

wenqiu Huang, Dr.

CONTACT

huangwenqiu@juventas.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 14, 2025
• Study Start: March 1, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 7, 2025

Record last verified: 2025-08

Locations

CN (1)