A Phase 1/2 Study of NRTX-1001 Neuronal Cell Therapy in Drug-Resistant Bilateral Mesial Temporal Lobe Epilepsy (MTLE)

Key Inclusion Criteria:

1. Male or female, age 18-75 years.

2. Subjects of childbearing potential will use highly effective contraception.

3. Proven history of focal seizures of hippocampal origin with bilateral seizure fociconfirmed by scalp or intracranial ictal EEG (including confirmation by recordingsfrom responsive neurostimulation [RNS] electrodes when applicable).

4. Either

5. bilateral hippocampal sclerosis on MRI (evidenced by increased FLAIR signalintensity in both hippocampi or by visual assessment showing reduced volumecompared to normal) or

6. bilateral temporal hypometabolism on 18-Flourodeoxyglucose Positron EmissionTomography (FDG PET) (assessed by visual assessment, comparing temporal regionsto frontal/parietal lobe neocortex). In this case, ictal EEG recordings mustalso include intracranial confirmation.or

7. a combination of unilateral instances of the evidence described in a. and b. (e.g., one side can be evidenced by criterion a. and the other side bycriterion b.) MRI or PET scans used for assessment must have been acquiredwithin 3 years of screening.

8. Subject has had at least four clinical focal seizures, including at least twoclinical focal seizures with objective manifestations, on average, per month for the 6 months prior to screening.

9. Subject has previously had adequate (in opinion of investigator) therapeutic trialsof at least two Anti-Seizure Medicines (ASMs).

10. Current ASM regimen, and doses of other drugs known to affect seizure frequency (e.g., antidepressants), have been stable for at least three months prior toenrollment.

11. Subject can converse and read in English or Spanish. Able to participate in requiredstudy procedures and provide signed informed consent.

Key Exclusion Criteria:

1. Epilepsy due to other and/or progressive neurologic disease.

2. Evidence of seizure focus outside hippocampus (either by seizure semiology or EEGfindings).

3. MRI indicating potential malignant lesion (low-grade glioma of any type is excluded)in any location or non-malignant potentially epileptogenic lesion outside thehippocampus. Small (<2 cm) non invasive meningioma, remote from the affectedtemporal lobe, is not exclusionary.

4. Seizures of non-focal origin.

5. History of status epilepticus in the year prior to screening, as guided by ILAEcriteria (Trinka 2015) in the judgement of the PI. A history of cluster seizures ispermitted.

6. Psychogenic Non-Epileptic Seizures (PNES) within the past 3 years.

7. Severe psychiatric disorders.

8. Primary or secondary immunodeficiency.

9. Pregnancy, or currently breastfeeding.

10. Suicide attempts in past year.

11. Significant other medical conditions which would impair safe participation.