Study Evaluating Safety Pharmacokinetics and Pharmacodynamics of AUR112 in Patients With Relapsed Advanced Lymphoma

Inclusion Criteria:

1. Males and females ≥ 18 years of age

2. Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1

3. Acceptable bone marrow and organ function at screening as described below:

4. ANC ≥ 1000/μL (without WBC growth factor support)

5. Platelet count: For patients with CLL ≥ 50,000/μL; For patients with lymphomas ≥ 75,000/μL without bone marrow involvement and ≥ 50,000/μL with bone marrowinvolvement. These thresholds should be qualified without platelet transfusionsupport.

6. Hemoglobin ≥ 9 g/dL (RBC Transfusion is allowed to achieve this Hb)

7. Total Bilirubin ≤ 1.5 x ULN; (Patients with known Gilbert's syndrome areallowed with a Total Bilirubin ≤ 2.5 x ULN)

8. AST (SGOT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases)

9. ALT (SGPT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases)

10. Creatinine clearance (CrCl) ≥ 60 mL/min (either measured or estimated by theCockcroft-Gault formula). (Cockcroft-Gault formula for estimated creatinineclearance [eCrCl]: eCrCl = [140- Age] × Weight [kg] × [0.85 if Female] / [72 ×serum creatinine (mg/dL)]).

11. Ability to swallow and retain oral medications

12. Histopathological diagnosis of Non-Hodgkin Lymphoma (NHL) or Chronic LymphocyticLeukemia (CLL) or Hodgkin disease. Note:

5a. The lymphoma should be either in Stage III or IV according to Lugano classification (Cheson et al. 2014) at screening. 5b. The lymphomas included in this study must fall within one of the following 2017 World Health Organization categories except lymphoma mentioned in Exclusion criterion #5:

• Mature B-cell neoplasms (excluding plasma cell neoplasms, heavy chain disease, andprimary central nervous system [CNS] lymphoma).

• Mature T- and NK-cell neoplasms.

• Hodgkin lymphomas 5c. The CLL should be Binet Stage C/Rai stage III or IV, as perthe International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines (Hallek et al. 2018).

6. In the case of subjects who have lymphoma for which high-dose chemotherapy andautologous stem cell transplantation (HDASCT) is considered a standard curativetherapy, eligibility for this study requires that the subject's disease has relapsedafter HDASCT, or the subject is not eligible for HD-ASCT, or that the subject hasrefused HD-ASCT.

7. In the case of patients who have lymphoid malignancies for which CAR-T therapy isindicated, eligibility for this study requires that the disease has relapsed afterCAR-T, or the patient is not eligible for CAR-T, or the patient has refused CAR-T,or the CAR-T is not available locally.

8. Evidence of measurable disease as per Lugano Criteria for Lymphoma (Cheson et al.

2014. or evidence of measurable disease as per iwCLL Criteria for CLL (Hallek et al. 2018). Note: Patients with Small Lymphocytic Lymphoma (SLL) alone or in combinationwith CLL are allowed.

9. Standard curative measures do not exist, and the patient must have exhausted alleffective therapies available locally. The patients must have relapsed or refractoryto at least 2 prior lines of systemic therapies for NHL or CLL, or Hodgkin disease.

Note:

• Any cancer patient with access to any effective therapy locally must not beenrolled.

• Patients with CLL should have documented evidence for progressive or symptomaticdisease (active disease) and must have indications for treatment (Hallek et al 2018).

• Patients with indolent lymphomas also must have indications for treatment, such asthe GELF (Brice et al 1997) or BNLI criterion (Ardeshna et al 2003)

Exclusion Criteria:

1. Systemic anti-cancer therapy, such as chemotherapy, biological therapy, orimmunomodulatory drug therapy received within the past 28 days or 5 half-lives,whichever is longer, from the Cycle 1 Day 1 of the study. Note: Concomitant use oflow dose prednisone (up to 10 mg/day) is allowed

2. Presence of an acute or chronic toxicity resulting from prior anticancer treatment,with the exception of alopecia or nail changes, that has not resolved to Grade ≤ 1,as determined by NCI CTCAE v 5.0. 1

3. Definitive Radiotherapy within the last 21 days of Cycle 1 Day 1 (limited fieldpalliative radiation is allowed and no restrictions during the screening period orduring the trial).

4. Use of any investigational agent within 28 days or 5 half-lives (whichever islonger) prior to Cycle 1 Day 1

5. Patients with Burkitt's lymphoma, Burkitt-like lymphoma, posttransplantlymphoproliferative disease, primary mediastinal large-B cell lymphoma, cutaneouslymphomas, mycosis fungoides (MF), or Sezary syndrome (SS).

6. Known symptomatic or untreated or recently treated (≤ 6 months of screening) centralnervous system (CNS) lymphoma. Patients with previously treated (> 6 months ofscreening) CNS lymphoma and are now stable and asymptomatic, from CNS perspective,are allowed.

7. Patients with lymphoma that requires immediate cytoreductive therapy.

8. Patients with low-grade lymphoma or indolent lymphoma that does not meetconventional criteria (Jeong SH, 2022) for requiring treatment.

9. Patients on drugs which are inhibitors of P-gp or BCRP or UGT1A1 and when thesedrugs cannot be discontinued from at least one week prior to Cycle 1 Day 1. Note:These drugs will be prohibited during Cycle 1 of therapy.

10. Major surgery ≤ 28 days from Cycle 1 Day 1 (major surgery is defined as a procedurerequiring general anesthesia)

11. Active infection requiring systemic therapy. Note: Prophylactic use of antibioticsis allowed. Any infection detected during screening period which is resolvedadequately according to investigator before the Cycle 1 Day 1, is allowed.

12. Known to be human immunodeficiency virus (HIV) positive or have an acquiredimmunodeficiency syndrome-related illness.

13. Known active or chronic hepatitis B (HBsAg +ve) or hepatitis C infection (HCVantibody +ve).

14. The patient who is expected to require any other form of antineoplastic therapy ortargeted therapy while on study

15. . Uncontrolled congestive heart failure (New York Heart Association [NYHA] Class 2-4), angina, myocardial infarction, cerebrovascular accident, coronary/peripheralartery bypass graft surgery, or transient ischemic attack, or pulmonary embolismwithin 3 months prior to Cycle 1 Day 1.

16. Ongoing cardiac dysrhythmias requiring treatment of any grade or treatment ofcardiac dysrhythmias in past 3 months, before Cycle 1 Day 1.

17. QTcF (Fridericia) interval >470 ms on ECG at screening and/or at Cycle 1 Day 1pre-dose.

18. Uncontrolled intercurrent illness including, but not limited to, symptomaticcongestive heart failure, uncontrolled hypertension, unstable angina pectoris,cardiac arrhythmia, active peptic ulcer disease or significant gastritis, activebleeding diatheses, presence of any major medical illness (e.g. renal, hepatic,hematologic, gastrointestinal, endocrine, pulmonary, or psychiatric illness/socialsituations or clinically significant laboratory / ECG abnormalities at screening,any or a combination of illnesses, which, in the opinion of the PI, may either putthe patient at risk because of participation in the study, or influence the resultsor the patient's ability to participate in the study.

19. Current swab-positive or suspected (under investigation) Covid19 infection or feverand other signs or symptoms suggestive of Covid-19 infection with recent contact ofperson(s) with confirmed Covid-19 infection, at screening or Cycle 1 Day 1.

20. History of another primary malignancy within 5 years prior to starting study drug,except for adequately treated basal or squamous cell carcinoma of the skin or cancerof the cervix in situ and the disease under study.

21. Positive pregnancy test for women of child-bearing potential (WOCBP) at thescreening or enrolment visit.

22. Lactating women or WOCBP or a man with a partner who has childbearing potential, whoare neither surgically sterilized nor willing to use reliable contraceptivemethods(hormonal contraceptive, IUD, or any double combination of male or femalecondom, spermicidal gel, diaphragm, sponge, cervical cap) during the screeningperiod, while on AUR112 and at least 28 days after last dose