CAP-100 for Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia

Inclusion Criteria:

1. Age ≥ 18 years.

2. Able to understand and sign a written informed consent document.

3. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.

4. Relapsed or refractory to at least two (2) prior standard systemic treatment regimenfor CLL or SLL (USA). Relapsed or refractory to at least two (2) prior standard systemic treatment regimenfor CLL or SLL and without available therapies known to provide clinical benefit (until new amendment implemented, Spain).

5. Prior CLL or SLL systemic therapy must have been discontinued for a duration of atleast five times its half-life (palliative low dose steroids are allowed to bridgethe time to CAP-100; major surgery or irradiation for CLL must have been completed > 4 weeks prior to the first trial dose of medication). Prior chimeric antigenreceptor (CAR)-T cell therapy is allowed.

6. Life expectancy > 16 weeks.

7. Subjects must have met the diagnostic criteria for CLL according to the iwCLL 2018guidelines (Hallek et al, 2018) or for SLL (NCCN guidelines, 2020) at some pointduring their disease course.

8. Subjects must meet iwCLL 2018 guideline criteria (Hallek et al, 2018) for activedisease.

9. Platelet count ≥ 50,000/ μL, unless decrease is attributable to bone marrowinfiltration of CLL.

10. Adequate liver function as indicated by aspartate transaminase (AST)/ alaninetransaminase (ALT) ≤ 2.5 times upper limit of normal (ULN), unless directlyattributable to the subject's tumor (in this case, acceptable levels are ≤ 5 x ULN).

11. Renal function as defined by creatinine clearance (CrCl)≥ 45 mL/min/1.73m2 (byCKD-EPI formula).

12. Women of childbearing potential and male subjects who have partners capable ofreproduction must agree to use an effective contraceptive method during the courseof the trial and for 4 months following the completion of their last treatment.Women of childbearing potential must have a negative serum β-subunit of hCGgonadotropin (β-hCG) pregnancy test result within 7 days of first trial dose. Femalesubjects who are surgically sterilized or who are > 45 years old and have notexperienced menses for > 2 years may have β-hCG pregnancy test waived.

Exclusion Criteria:

1. Allogeneic stem-cell transplantation within 6 months of trial entry.

2. Monoclonal antibody for anti-cancer therapy within 4 weeks of trial entry.

3. Side effects due to prior therapy not recovered to ≤Grade 1.

4. Oral targeted inhibitors (Bruton's tyrosine kinase [BTK]-inhibitors, B-cell lymphoma 2 [BCL-2] inhibitors, phosphoinositide 3-kinase [PI3K] inhibitors) within five timestheir half-life.

5. Active viral, bacterial or systemic fungal infection requiring treatment.

6. Subjects who are known to be human immunodeficiency virus (HIV)-positive.

7. Subjects with active known central nervous system (CNS) lymphoma.

8. Pregnant or lactating women.

9. History of previous cancer < 2 years before the trial, except controlled diseaseusing systemic therapy with curative intent, surgical therapy with curative intentor skin cancer, cancer in situ, and prostate cancer on the "watch and wait"approach.

10. Uncontrolled intercurrent illness including, but not limited to, New York HeartAssociation Class (NYHA) III and IV congestive heart failure, myocardial infractionwithin the previous 6 months, ejection fraction (EF) < 40%, life-threateningarrhythmias, or unstable angina brain metastasis or psychiatric illness that wouldlimit compliance with trial requirement.

11. Subjects with known hypersensitivity to any excipient contained in the drugformulation.

12. Subjects with a history of documented human anti-globulin antibodies.

13. Active autoimmune disease, motor neuropathy considered of autoimmune origin, andother CNS autoimmune disease.