Exploratory Clinical Study of Anti-CD19/BCMA Universal CAR-T Cell Injection for the Treatment of … (NCT07558850) | Clinical Trial Compass
RecruitingNot Applicable
Exploratory Clinical Study of Anti-CD19/BCMA Universal CAR-T Cell Injection for the Treatment of Refractory Autoimmune Diseases
China72 participantsStarted 2026-05-10
Plain-language summary
A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19/BCMA-UCAR-T cells in patients with autoimmune diseases.
36-72 patients are planned to be enrolled in the dose-escalation trial.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Voluntarily sign an informed consent form, understand the study, and be willing and capable of completing all trial procedures.
✓. Aged 18 to 70 years, regardless of gender.
✓. At screening, the number of peripheral blood CD19-positive B cells determined by flow cytometry \> 5 cells/μL.
✓. For subjects previously treated with B-cell targeted therapy, peripheral blood B cell counts have returned to normal or above pre-treatment levels at the screening visit.
✓. Complete blood counts within 7 days prior to lymphodepleting chemotherapy meet the following requirements in patients with Sjögren's disease (SjD):
✓. Subjects have adequate hepatic, renal, pulmonary and cardiac function at screening visit, defined as:
✓. During the screening period, serum pregnancy test must be negative for fertile female subjects. Females who have undergone surgical sterilization or natural menopause for at least 2 years are considered non-fertile. Fertile female and male subjects must adopt highly effective contraceptive methods throughout the clinical study and for 1 year after the last study treatment. They shall also agree not to donate oocytes or sperm for assisted reproductive technology within 1 year following the final study treatment.
✓. Meet the 2010 ACR/EULAR classification diagnostic criteria, diagnosed with moderate to severe active rheumatoid arthritis, with a confirmed RA diagnosis for ≥ 6 months.
Exclusion criteria
✕. Moderate or higher disease activity (DAS28-ESR \> 3.2 or CDAI \> 10);
What they're measuring
1
Incidence of Dose-Limiting Toxicity (DLT)
Timeframe: up to 48 weeks after infusion
2
Incidence of Treatment Emergent Adverse Events (TEAEs)
Timeframe: up to 48 weeks after infusion
Trial details
NCT IDNCT07558850
SponsorThe First Affiliated Hospital with Nanjing Medical University
✕. Clinical signs and/or symptoms indicative of active disease;
✕. Inability to taper glucocorticoids to ≤ 7.5 mg/day prednisone or equivalent dose;
✕. Rapid radiographic progression (increase in modified van der Heijde Sharp score ≥ 5 points within 1 year);
✕. Impaired quality of life secondary to RA, despite seemingly adequate disease control.
✕2. Diagnosed with Dermatomyositis (DM) in accordance with the 2017 EULAR/ACR criteria for at least 24 weeks prior to informed consent (ICF) signing.
✕3. Meet the classification criteria for refractory DM, and satisfy criterion ①plus any one of criteria ②-⑤:①Insufficient response to glucocorticoids (prednisone 1-2 mg/kg/day or equivalent dose of other corticosteroids) combined or sequential treatment with at least two immunosuppressants, with glucocorticoid treatment lasting for no less than 3 months;② Rapid disease progression, and/or involvement of extrapulmonary organs including the heart and gastrointestinal tract, and/or significant interstitial lung disease;③ Calcification in subcutaneous, muscular and articular tissues;④ Recurrent rashes or cutaneous ulcers;⑤ Recurrent or persistent muscle weakness. MRI shows extensive diffuse muscle edema during the disease course, or CMAS score \< 48. At least two abnormal results among the five core parameters: Physician Global Assessment (PhGA) ≥ 2 cm, Patient Global Assessment (PtGA) ≥ 2 cm, Manual Muscle Test MDAAT ≥ 2, Health Assessment Questionnaire (HAQ) total score ≥ 0.25, muscle enzyme levels \> 1.5 × upper limit of normal (ULN).
✕4. Patients with anti-synthetase syndrome and positive anti-synthetase antibodies meet DM criteria and may be enrolled directly.