Anti-CD19 Chimeric Antigen Receptor T Cells for Refractory Autoimmune Diseases
Recruiting now · Phase 1/Phase 2
Conditions studied: Autoimmune Diseases
In brief
The goal of this study is to evaluate the safety and effi cacy of CD19 CAR T cells in the treatment of Refractory Autoimmune Diseases.
Key facts
- Study ID
- NCT06688799
- Run by
- Beijing GoBroad Hospital
- People needed
- 18
- Starts
- 2024-11-23
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-03-10
Who can join
Age: 3 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Systemic lupus erythematosus (SLE) 1.1. Refractory systemic lupus erythematosus (SLE) and / or refractory lupus nephritis (LN)
- Male or female patients, aged 3-65 years (including 3 and 65 years);
- Systemic lupus erythematosus that meets the 2019 American Society of Rheumatology (ACR) / European Association of Rheumatology Consortium (EULAR) classification criteria (see Annex 2);
- Nuclear antibody (ANA) test is clearly positive, namely ANA titer 1:80 (based on the equivalent results of Hep-2 immunofluorescence or enzyme immunoassay) and / or the test at the screening visit (based on ELISA test, 30 IU / mL).
- Refractory systemic lupus erythematosus (SLE) and / or refractory lupus nephritis (LN):
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- Patients take at least 7.5 mg of prednisolone daily to maintain low disease activity or a SLEDAI 2K score (see attachment 3) of 8 or higher.
- Recurrence of disease activity after failure of conventional therapy or after remission. Definition of conventional treatment: using corticosteroids (1 mg / kg / day) and cyclophosphamide for 6 months; or any of the following immunomodulatory drugs for more than 3 months: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biological agents such as rituximab, belimumab, and teacept.
- Physical strength status score (ECOG): 0-2 points; 6) The estimated survival period of 90 days; 1.2. Immune thrombocytopenia in refractory lupus (SLE-ITP)
- Age range: 18-70 years (including 18 and 70 years), gender limitation.
- Patients with refractory systemic lupus erythematosus (immune thrombocytopenia): meeting SLE 2019 ACR / EULAR classification criteria, with at least 2 consecutive routine blood tests showing platelets lower ; no abnormal morphology of blood cells in peripheral blood smear; morphological characteristics of bone marrow cells meeting immune thrombocytopenia. Refractory systemic lupus erythematosus (immune thrombocytopenia) was defined as at least 1 course of MP shock (1g 3 days) or high-dose hormone (1mg / kg d equivalent dose of glucocorticoid) combined with 1 or more immunosuppressive agents. Thrombocytopenia except for other than non-SLE causes, such as infection, myelosuppression, macropleic, hypersplenism, etc.
- Clinician assessment of the patients condition allowed the use of 10mg prednisone or its equivalent dose during the study and allowed the discontinuation of all immunosuppressive agents (excluding hydroxychloroquine).
- 3. refractory lupus thrombotic microangiopathy (SLE-TMA)
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- Age range: 18-70 years (including 18 and 70 years), gender limitation.
- Meet SLE-TMA standard; meet one of the following criteria, associated with SLE Microvascular hemolytic anemia, associated with elevated lactate dehydrogenase and peripheral blood smear fragmentation; and thrombocytopenia, except for other reasons; Renal biopsy suggested a TMA.
- Refractory systemic lupus erythematosus was defined as no TMA response with at least 1 course of MP shock (1g 3 days) or high-dose hormone (1mg / kg d equivalent dose glucocorticoid) combined with 1 or more immunosuppressants.
- The clinician assessed the patients condition allowed a glucocorticoid dose of up to 10mg prednisone or its equivalent dose during the study and allowed discontinuation of all immunosuppressive agents (excluding hydroxychloroquine).
- 4.SLE Myelitis
- Age: 18-60 years old.
- Diagnosis: meet the diagnostic criteria for SLE.
- Myelitis: acute or subacute paraplegia, sensory plane, sphincter dysfunction, and tendon reflex or plantar reflex abnormalities; including but not limited to spinal cord lesions confirmed by MRI. And other causes of myelitis.
- Severity: lower limb muscle strength grade 3
- Refractory / recurrent nature:
- Refractory: ineffective against high-dose hormone shock therapy and / or combined with other immunosuppressants; Relapse: at least two recurrences in the past 12 months, or three times in the past 24 months, and one recurrence in the 12 months prior to screening.
Where it is running
- Beijing GoBroad Hospital — Beijing, Beijing Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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