CLBR001 and SWI019 in Patients With Relapsed / Refractory B-cell Malignancies

Inclusion Criteria:

Patients with relapsed / refractory previously treated B cell malignancies (according to the World Health Organization classification; 2017)
Patients must have received adequate prior therapy including at least two lines of prior therapies including anthracycline or bendamustine-containing chemotherapy, anti-CD20 (cluster of differentiation antigen 20) therapies and/or Brutton's tyrosine kinase (BTK) inhibitors
Patients treated with prior CD19 targeted molecules (e.g., Blincyto) must have confirmed CD19+ disease
Patients must be ineligible for allogeneic stem cell transplant (SCT)
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
Estimated life expectancy of ≥ 12 weeks from the first day of SWI019 dose administered
Willing to undergo pre- and post-treatment core needle biopsy
Adequate hematological, renal, pulmonary, cardiac, and liver function
Resolved adverse events of any prior therapy to either baseline or CTCAE Grade ≤1
Women of childbearing potential, a negative pregnancy test and must agree to practice effective birth control
Men sexually active with female partners of child bearing potential must agree to practice effective contraception
Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other procedures

Exclusion Criteria:

Patients diagnosed with certain disease histologies including pediatric lymphomas/leukemias, monoclonal gammopathy of undetermined significance (MGUS), T-cell histiocyte large B cell lymphoma
Pregnant or lactating women
Active bacterial, viral, and fungal infections
History of allogeneic stem cell transplantation
Treatment with any prior lentiviral or retroviral based CAR-T
Patients receiving live (attenuated) vaccines within 4 weeks of screening visit or need for live vaccine on study
Patients with known active central nervous system (CNS) disease. Patients with prior CNS disease that has been effectively treated may be eligible
History of Class III or IV New York Heart Association (NYHA) heart failure, myocardial infarction, unstable angina or other significant cardiac disease within 6 months of screening
Involvement of cardiac tissue by lymphoma
Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura (ITP)
HIV-1 and HIV-2 antibody positive patients