Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in T-cell Lymphoma

Safety: Treatment-Emergent AE; Treatment-Related AE, SAE and Clinical significant AE; Dose
Limiting Toxicities (DLT). PK: Peak Plasma Concentration (Cmax), Area under the plasma
concentration versus time curve (AUC), Time of Maximum concentration observed (Tmax).
Efficacy: Overall Response Rate (ORR), Progression Free Survival (PFS), Overall Survival (OS)
and Duration of Response.

Inclusion Criteria:

- Refractory to or relapsed after at least 1 prior treatment line.

- ECOG performance status ≤2

- Patients must be ≥18 years of age

- Able to give a written informed consent.

Exclusion Criteria:

- Any cancer therapy in the last 3 weeks or limited palliative radiation <2 weeks

- Patients with HBV, HCV or HIV infection

- Previous therapy with GS-1101 (CAL-101, Idelalisib), IPI-145 (Duvelisib), TGR-1202 or
any drug that specifically inhibits PI3K/ mTOR (including temsirolimus, everolimus),
AKT or BTK Inhibitor (including Ibrutinib) in last 6 months

- Patients on immunosuppressive therapy including systemic corticosteroids.

- Patients with known history of liver disorders.

- Patients with uncontrolled Diabetes Type I or Type II

- Any severe and/or uncontrolled medical conditions or other conditions that could
affect their participation in the study.

- Women who are pregnant or lactating.