A Multi-center, Open-label, Single-arm Phase I Clinical Study to Evaluate the Safety and Tolerability of Inaticabtagene Autoleucel Injection in Treatment of Refractory Systemic Lupus Erythematosus-related Immune Thrombocytopenia

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Contact Information
Primary
Junyin Yu
yujunyin@juventas.cn
+86 13920424844
Backup
wenqiu Huang, Dr.
huangwenqiu@juventas.cn
Time Frame
Start Date: 2025-03-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 12
Treatments
Experimental: Single dose of Inaticabtagene Autoleucel Injection
Subjects who meet the enrollment conditions will receive intravenous infusion of CAR-T cells after lymphodepletion.
Sponsors
Leads: Juventas Cell Therapy Ltd.

This content was sourced from clinicaltrials.gov