Efficacy and Safety of Taitacept in Treatment of Refractory or Recurrent Anti-NMDAR/Anti-LGI1 Encephalitis

Trial Title: Efficacy and Safety of Taitacept in Treatment of Refractory or Recurrent Anti-NMDAR/Anti-LGI1 Encephalitis

NCT ID: NCT06510283

Condition: Anti-N-Methyl-D-Aspartate Receptor Encephalitis

Conditions: Official terms:
Anti-N-Methyl-D-Aspartate Receptor Encephalitis
Encephalitis

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Taitacept
Description: Taitacept
Arm group label: Taitacept

Summary: The main objective is to explore the efficacy and safety of Telitacicept in the treatment of refractory/recurrent anti-NMDAR and anti-LGI1 encephalitis. Through this prospective, single-center, open-label clinical trial, we aim to investigate the effectiveness and safety of Telitacicept in refractory/recurrent anti-NMDAR and anti-LGI1 encephalitis by add-on therapy of Telitacicept combined with traditional treatment.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Age ≥14 years old, male or female; 2. Symptoms of autoimmune encephalitis (AE) ≤ 9 months prior to enrollment; 3. Diagnosed as autoimmune encephalitis, diagnostic criteria as follows: 1. Rapid onset (<3 months) of at least four of the following six major symptoms: - Abnormal (mental) behavior or cognitive dysfunction - Speech dysfunction (verbal urgency, hypospeech, mutism) - Seizures - Movement disorders, dyskinesias, or postural rigidity/abnormalities - Decreased level of consciousness - Autonomic dysfunction or central hypoventilation in the presence of one or more of the six major symptoms; 2. Positive anti-NMDAR (GluN1) IgG antibody detected in CSF or positive serum and/or cerebrospinal fluid LGI1 antibody; c．Reasonable exclusion of other etiologies and other well-defined encephalitis syndromes (e.g., Bickerstaff brainstem encephalitis, acute disseminated encephalomyelitis, Hashimoto encephalopathy, primary CNS vasculitis, Rasmussen encephalitis); 4. Refractory AE: ineffective treatment with steroids and rituximab or other immunosuppressants, post-treatment mRS score≥2 (stable for at least 24 hours）;Recurrent AE: at least 2 months after 1st or 2nd line treatment, new symptoms or worsening of existing symptoms (mRS increase>1); 5）Doses of steroids and other immunosuppressants (e.g. azathioprine, mycophenolate mofetil, cyclophosphamide) should be stabilised for 4 weeks prior to enrolment; 6）Ability to obtain patient or proxy consent; 7）Women of childbearing potential should use effective contraception during treatment or avoid heterosexual intercourse for at least 3 months after the last dose of talitacicept; Exclusion Criteria: 1. History of other autoimmunity such as SLE, RA, SS. Patients with hyperthyroidism and hypothyroidism cannot be excluded; 2. Abnormal laboratory indicators, including but not limited to the following indicators: White blood cell count<3×10^9 /L Neutrophil count<1.5×10^9 /L Hemoglobin<85g/L Blood platelet count<80×10^9 /L Serum creatinine>1.5×ULN TBil(total bilirubin) >1.5×ULN ALT>3× ULN AST>3× ULN Alkaline phosphatase>2× ULN Creatine kinase>5× ULN 3. Evidence of active infection such as shingles, HIV or active tuberculosis, etc. 4. Currently have active hepatitis or have severe liver disease and a history of it. - Patiens with abnormal Hepatitis B test as follows should be excluded: HbsAg positive; HbsAg negative but HbcAb positive, and HBV-DNA positive. Whereas patients with HbsAg negative but HbcAb positive, and HBV-DNA negative can be included. - Exclude patients who are positive for hepatitis C antibodies ; 5. Uncontrolled diabetes mellitus: Glycosylated hemoglobin>9.0% or fasting blood glucose≥11.1mmol/L; 6. Received any live vaccine within 3 months prior to enrollment or planned to receive any vaccine during the study; 7. Received rituximab or other biological therapies within 1 month prior to enrollment; 8. Malignancy; 9. Allergic to human biological products; 10. Participated in any clinical trial within 28 days prior to enrollment or within 5 times the half-life of the investigational drug participating in the clinical trial 11. Patients who plan to have children during the trial, or who are pregnant or breastfeeding; 12. Alcohol or drug abuse/addiction is known to have an impact on compliance with trial requirements; 13. Patients who are deemed unsuitable for the trial by the investigator (e.g., those with severe mental disorders).

Gender: All

Minimum age: 14 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Beijing Tongren Hospital,Capital Medical University

Address:
City: Beijing
Zip: 100730
Country: China

Status: Recruiting

Contact:
Last name: Jiawei Wang, doctor

Phone: 18811612263
Email: pengyujing1206@163.com

Start date: August 1, 2024

Completion date: July 1, 2028

Lead sponsor:
Agency: Beijing Tongren Hospital
Agency class: Other

Source: Beijing Tongren Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06510283