RAPA-501 Therapy for ALS

Inclusion Criteria:

1. Male or female patients ≥ 18 years of age.

2. Patients with sporadic or familial amyotrophic lateral sclerosis (ALS) diagnosed aslaboratory-supported possible, probable, or definite according to World Federationof Neurology El Escorial Criteria.

3. . Less than or equal to 24 months since ALS symptom onset.

4. Total ALSFRS-R score between 34 and 45.

5. Must have a source of autologous T cells potentially sufficient to manufactureRAPA-501 cells, as defined by a peripheral CD3+ T cell count ≥ 500 cells per μl.

6. Patients may continue riluzole (Rilutek®), and/or edaravone (Radicava®), and/orsodium phenylbutyrate/taurusodial (Relyvrio™) if on a stable dose for at least 30days prior to the screening visit.

7. Patients must be ≥ 2 two weeks removed from major surgery or investigationaltherapy.

8. Patients must have recovered from clinical toxicities ([resolution of CTCAE(v5) [version 5] toxicity to a value of ≤ 2].).

9. Serum creatinine ≤ less than or equal to 2.0 mg/dL.

10. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x upperlimit of normal (ULN).

11. Bilirubin ≤ 1.5 (except if due to Gilbert's disease).

12. Pulmonary slow vital capacity (SVC) ≥ 70% of predicted normal.

13. No history of abnormal bleeding tendency.

14. Voluntary written consent must be given before performance of any study relatedprocedure not part of standard medical care, with the understanding that consent maybe withdrawn by the patient participant at any time without prejudice to futuremedical care.

Exclusion Criteria:

1. Active uncontrolled infection.

2. Hypertension not adequately controlled by ≤ 3 medications.

3. History of documented pulmonary embolus within 6 months of enrollment.

4. Clinically significant cardiac pathology, as defined by: myocardial infarctionwithin 6 months prior to enrollment, Class III or IV heart failure according toNYHA, uncontrolled angina, severe uncontrolled ventricular arrhythmias, orelectrocardiographic evidence of acute ischemia or active conduction systemabnormalities.

5. Patients with history of coronary artery bypass grafting or angioplasty will receivea cardiology evaluation and be considered on a case-by-case basis.

6. HIV, hepatitis B, or hepatitis C seropositive.

7. Pregnancy or breastfeeding patients.

8. Patients of Subjects of childbearing age, or males who have a partner ofchildbearing potential, who are unwilling to practice contraception.

9. Patients Subjects may be excluded at the Principal Investigator discretion of the PIor if it is deemed that allowing participation would represent an unacceptablemedical or psychiatric risk.