FIH Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy

Key Inclusion Criteria:

1. Male or Female, age ≥18 to 75

2. Focal seizures, clinically defined as unilateral MTLE

3. Has failed to achieve seizure control despite adequate trials of at least 2 ASDs atappropriate doses

4. Currently on stable doses (at least 1 month) of approved ASDs

5. Single seizure focus confirmed within one hippocampus

6. Seizure frequency averages ≥4 per 28-day period, including at least 2 clinical focalseizures per 28-day period with objective manifestations or more severe types, overthe 6 months prior to the Screening Visit.

7. Considered (by Investigator) to be a candidate for temporal lobectomy (TL) or LaserInterstitial Thermal Therapy (LITT) following evaluation at a qualified epilepsysurgery program (National Association of Epilepsy Centers [NAEC] Level 4).

Key Exclusion Criteria:

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

2. Evidence of seizure focus outside of the hippocampus or evidence of seizures of non-focal origin.

3. Significant other medical conditions which would impair safe participation

4. History of status epilepticus in the year prior to screening. A history of clusterseizures is permitted.

5. Primary or secondary immunodeficiency

6. Suicide attempts in the past year

7. Severe psychiatric disorders

8. Prior lobectomy or LITT procedure

9. MRI indicating potential malignant lesion

10. Pregnancy, or currently breastfeeding.