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On November 14, 2022, Nature sub-journal Signal Transduction and Targeted Therapy (IF=38.
1) officially accepted the interim results
of the Phase I clinical trial of Reindeer Biologics BCMA CAR-T CT103A (Iquilencel injection) for the treatment of neuromyelitis optica spectrum disease (NMOSD).
。 This study is the world's first clinical trial of CAR-T therapy in the field of aquaporin 4 (AQP4)-mediated relapsed/refractory NMOSD diseases, which preliminarily proves the good tolerability and safety, long-lasting pathogenic antibody clearance and potential clinical efficacy of BCMA CAR-T therapy in NMOSD, and provides a new therapeutic idea
for antibody-mediated autoimmune diseases.
NMOSD is a rare, lifelong, progressive central nervous system autoimmune disease characterized by inflammatory demyelinating and axonal damage to the optic nerve and spinal cord, which can cause blindness, paralysis, and incontinence
.
The first onset of NMOSD occurred in all age groups, mostly young adults, with a median age of 39 years, and a higher incidence in Asian people than in the Casuvian population
.
The incidence rate in China is about 0.
41 per 100,000 and the prevalence is about 3.
31 per 100,000
.
NMOSD is a highly recurrent and disabling disease, and most participants have severe sequelae
.
This study is an open-label exploratory clinical study (NCT04561557) initiated by a researcher to evaluate the safety and efficacy of Iquilencel cell infusion in the treatment of relapsed/refractory antibody-mediated neuropathic inflammatory diseases (NCT04561557), conducted by the team
of Professor Wang Wei of Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology.
The study enrolled plasmacyte-positive AQP4 antibody refractory NMOSD patients treated with at least one immunosuppressant for more than one year but poor symptom control
.
As of March 20, 2022, 12 subjects received CT103A injection infusion, including 3 subjects in the 0.
5×106 CAR-T cells/kg dose group, 3 subjects in the climbing stage and 1.
0×106 CAR-T cells/kg dose group in the climbing stage and expansion stage, and 6 subjects received CAR-T cell infusion
with Iquilencel injection injection, respectively.
Safety: In the dose-exploration phase of this study, 6 subjects in the dose-ramping phase completed 28 days of DLT visits, and none of them observed DLT (Dose-Limiting Toxicity) events pre-specified by the protocol
.
All 12 subjects developed grade 1 to 2 CRS (Cytokine Release Syndrome).
All 12 participants did not develop any ICANS (Immune Effector Cell-Associated Neurologic Syndrome).
Compared to the safety profile that has been established in multiple myeloma indication studies, no new safety risks
have been identified.
Effectiveness: After a median follow-up of 5.
5 months, no recurrence
of NMOSD was observed in 11 (92%) participants.
Compared with before the reinfusion, Iquilencel generally reduced the EDSS (Expanded Disability Status Scale) score of NMOSD subjects, including 6 (50%) subjects with improved visual acuity, 8 (67%) subjects improved their walking ability, and 9 (75%) subjects improved
rectal bladder function.
Corresponding improvements
were also observed on other quality of life and pain scales.
PK/PD: Iquilencel cells were well amplified in subjects after reinfusion, accompanied by a significant decrease in serum AQP4 antibody levels and continued to maintain very low levels
.
The above data show that Iquilencel has initially shown safe and controllable and potential efficacy
in the treatment of relapsed/refractory NMOSD.
In addition to the results of this publication, reindeer biology and the team of researchers continue to explore the cellular and molecular biological mechanisms of iquilencel in the treatment of NMOSD, and the safety and efficacy of iquilencel in the treatment of other antibody-mediated autoimmune diseases including myasthenia gravis, chronic inflammatory demyelinating polyneuropathy, and immune-mediated necrotizing myopathy.
