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

Overview

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.

Interventions

• Drug Taitacept
  Telitacicept will be subcutaneously injected at a dose of 240mg per week, lasting for at least 24 weeks.

Primary outcome measures

• the change of mRS score [Time frame: from baseline at week 24]

Eligibility criteria

Inclusion criteria

• Age ≥14 years old, male or female;
• Symptoms of autoimmune encephalitis (AE) ≤ 9 months prior to enrollment;
• Diagnosed as autoimmune encephalitis, diagnostic criteria as follows:

• 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;
• 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);
• 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

• History of other autoimmunity such as SLE, RA, SS. Patients with hyperthyroidism and hypothyroidism cannot be excluded;
• 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

• Evidence of active infection such as shingles, HIV or active tuberculosis, etc.
• 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 ;
• Uncontrolled diabetes mellitus: Glycosylated hemoglobin>9.0% or fasting blood glucose≥11.1mmol/L;
• Received any live vaccine within 3 months prior to enrollment or planned to receive any vaccine during the study;
• Received rituximab or other biological therapies within 1 month prior to enrollment;
• Malignancy;
• Allergic to human biological products;
• 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
• Patients who plan to have children during the trial, or who are pregnant or breastfeeding;
• Alcohol or drug abuse/addiction is known to have an impact on compliance with trial requirements;
• Patients who are deemed unsuitable for the trial by the investigator (e.g., those with severe mental disorders).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Beijing Tongren Hospital,Capital Medical University — Beijing

Identifiers

NCT: NCT06510283 · TREC2024-KY061

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗