This phase I trial is evaluating the safety of a new antibody-targeting therapy (TG-1801) in patients with B-Cell LymphomaA Phase 1 First-in-Human Study of Bispecific Antibody TG-1801 in Subjects With B-Cell Lymphoma

Exclusion

1. Prior therapy with any agent blocking the CD47/SIRPα pathway or any previous CD19 targeting therapy, including but not limited to: antibodies, fragments, bispecific bodies, or chimeric antigen receptor (CAR) T-cells.

2. Subjects receiving cancer therapy (i.e. chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization) or any investigational drug within 21 days of Day 1 of Cycle 1 (42 days for prior mitomycin C or a nitrosourea).

   a. Corticosteroid therapy started at least 7 days prior to Cycle 1 Day 1 (prednisone ≤ 10 mg daily or equivalent) is allowed as clinically warranted. Topical or inhaled corticosteroids are permitted.

3. Prior autologous stem cell transplant within 6 months. Prior allogeneic hematologic stem cell transplant within 1 year and excluded if there is active graft versus host disease.

4. Subjects who have not recovered (≤ Grade 1 or at baseline) from adverse events due to previous therapy, except for alopecia and Grade 2 neuropathy due to previous cancer therapy.

   Note: Toxicity that has not recovered to ≤ Grade 1 is allowed if it meets the inclusion requirements for laboratory parameters defined above.

5. Any severe or uncontrolled illness or other conditions that could affect their participation in the study including, but not limited to:

   1. Symptomatic, or history of documented congestive heart failure (NY Heart Association functional classification III-IV).
   2. Myocardial infarction within 6 months of enrollment.
   3. Poorly controlled or clinically significant atherosclerotic vascular disease including cerebrovascular accident, transient ischemic attack, angioplasty, cardiac/vascular stenting within 6 months of enrollment, angina not well controlled by medication.
   4. Ongoing or active infection, except localized fungal infection of skin or nails.
6. Known active Hepatitis B (e.g. HBsAg reactive), Hepatitis C (e.g. HCV RNA [qualitative] is detected), cytomegalovirus (CMV DNA by PCR), or known history of HIV.
7. Malignancy within 2 years of study enrollment except for adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, superficial bladder cancer, or localized prostate cancer.
8. Known clinically active CNS involvement.
9. History of anaphylaxis or severe allergy to a monoclonal antibody; or known or suspected hypersensitivity to the excipients contained in the study drug formulation.
10. Lactating or pregnant.