A Phase 2 Study to Assess the Efficacy and Safety of CAL-101 in Patients With Indolent B-Cell Non-Hodgkin Lymphoma Refractory to Rituximab and Alkylating Agents

Inclusion Criteria:

- Age ≥18 years.

- Karnofsky performance score of ≥60 (Eastern Cooperative Oncology Group [ECOG]
performance score of 0, 1, or 2).

- Histologically confirmed diagnosis of B-cell iNHL, with histological subtype limited
to the following:

- Follicular lymphoma (FL)

- Small lymphocytic lymphoma (SLL) with absolute lymphocyte count

- Lymphoplasmacytoid lymphoma (LPL)

- Marginal zone lymphoma (MZL) (splenic, nodal, or extranodal)

- Prior treatment with ≥2 prior chemotherapy- or immunotherapy-based regimens for iNHL.

- Prior treatment with rituximab and with an alkylating agent (eg, bendamustine,
cyclophosphamide, ifosfamide, chlorambucil, melphalan, busulfan, nitrosoureas) for
iNHL.

- Lymphoma that is refractory to rituximab and to an alkylating agent.

- For men and women of childbearing potential, willingness to abstain from sexual
intercourse or employ an effective method of contraception during the study drug
administration and follow-up periods.

- Willingness and ability to provide written informed consent and to comply with the
protocol requirements.

Exclusion Criteria:

- Central nervous system or leptomeningeal lymphoma.

- Known histological transformation from iNHL to diffuse large B-cell lymphoma.

- History of a non-lymphoma malignancy except for the following: adequately treated
local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ,
superficial bladder cancer, localized prostate cancer, other adequately treated Stage
1 or 2 cancer currently in complete remission, or any other cancer that has been in
complete remission for ≥5 years.

- Evidence of ongoing systemic bacterial, fungal, or viral infection (excluding viral
upper respiratory tract infections) at the time of initiation of study treatment.

- Pregnancy or breastfeeding.

- Ongoing alcohol or drug addiction.

- Known history of drug-induced liver injury, chronic active HCV, chronic active HBV,
alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis,
ongoing extrahepatic obstruction caused by stones, cirrhosis of the liver or portal
hypertension.

- History of prior allogeneic bone marrow progenitor cell or solid organ
transplantation.

- Ongoing immunosuppressive therapy, including systemic corticosteroids. Patients may
be using topical or inhaled corticosteroids.

- Prior therapy with CAL 101

- Exposure to another investigational drug within 3 weeks prior to start of study
treatment.

- Concurrent participation in another therapeutic treatment trial.

- Prior or ongoing clinically significant illness, medical condition, surgical history,
physical finding, ECG finding, or laboratory abnormality that, in the investigator's
opinion, could affect the safety of the patient; alter the absorption, distribution,
metabolism or excretion of the study drug; or impair the assessment of study results.