JY231 Injection for the Treatment of Relapsed/Refractory Neurologic Immune Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTongji Hospital
About this trial
his study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed/refractory neurologic immune disorders. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of relapsed/refractory neurologic immune disorders.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female subjects (both 18 and 75 years of age) aged 18 to 75 years who have signed an informed consent (ICF) that none of the available treatment options have been effective; and
Disqualifiers
have a contraindication or hypersensitivity to fludarabine, cyclophosphamide, and any component of the test drug;
have received intravenous immunoglobulin or plasma exchange therapy or immunosorbent therapy within 4 weeks prior to retrieval;
have used tacrolimus, cyclosporine, azathioprine, morphimecrolimus, mycophenolate mofetil, methotrexate, or methotrexate within 1 week prior to mono-harvesting;
Treatment with neonatal Fc receptor (FcRn) antagonists (e.g., Efgartigimod, etc.) within 1 week prior to single-take;
Trial design
Design model
Single group
Treatments tested in this trial
JY231 Injection
DrugJY231 injection is administered intravenously and produces autologous CAR-T cells in the patient's body some time after infusion. A total of 3 dose groups were established to conduct a 3+3 dose-escalation study. The doses were divided into two categories: non-lymphodepletion and lymphodepletion pretreatment. The three dose groups for lymphodepletion included: 2×10\^8 TU, 4×10\^8 TU, and 8×10\^8 TU. The three dose groups for non-lymphodepletion included: 2×10\^9 TU, 4×10\^9 TU, and 8×10\^9 TU. The decision to perform lymphodepletion was based on the lymphocyte count and function during the patient screening period.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: JY231 injection for the treatment of relapsed/refractory neurologic immune disordersExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of adverse events(AE) after infusion
The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.
Time frame
Day 28、Month 2、Month 3、Month 6、Month 12、Month 18、Month 242
Maximal Tolerated Dose(MTD)
MTD will be determined based on Dose-Limiting Toxicity(DLTs) observed during the first 28 days of study treatment.
Time frame
Up to 28 days after infusionSponsors and contacts
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Source ClinicalTrials.gov