Status:
RECRUITING
Efficacy and Safety of Taitacept in Treatment of Refractory or Recurrent Anti-NMDAR/anti-LGI1 Encephalitis
Lead Sponsor:
Beijing Tongren Hospital
Conditions:
Anti-N-Methyl-D-Aspartate Receptor Encephalitis
Eligibility:
All Genders
14+ years
Phase:
PHASE2
Brief 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-...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06510283
Start Date
December 1 2024
End Date
July 1 2028
Last Update
November 20 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Beijing Tongren Hospital,Capital Medical University
Beijing, Beijing Municipality, China, 100730