A Study Evaluating the Safety and Tolerability of QRL-201 in ALS

Inclusion Criteria:

• Male or female participants aged 18 to 80 years diagnosed with ALS

• ALS symptom onset within 24 months of Screening

• Slow vital capacity >50%

• Clinical or electrodiagnostic evidence of lower motor neuron involvement

• Not pregnant and not nursing

• Willing and able to practice effective contraception

• Able to tolerate lumbar puncture

• If on approved therapies for the treatment of ALS during the course of the study,must be on a stable dose (at the Sponsor's discretion)

Exclusion Criteria:

• Pathogenic variant, likely pathogenic variant, or variant of uncertain significancein the superoxide dismutase 1 (SOD1) and/or fused in sarcoma (FUS) genes

• Currently enrolled in any other clinical study involving either an investigationalproduct (IP) or off-label use of a drug or device

• Prior exposure to stem cell or gene therapy products

• Any contraindication to intrathecal drug administration

• Abnormal laboratory values deemed clinically significant by the Investigator

• Significant infection or known inflammatory process

• Any sign and/or history of neurological conditions and other neuromuscular disordersthat could affect the electrophysiological recordings.

• An EEG that shows signs of abnormal electrical activity (e.g., epilepsy)