CLBR001 and SWI019 in Patients With Relapsed / Refractory B-cell Malignancies
CLBR001 and SWI019 in Patients With Relapsed / Refractory B-cell Malignancies
CLBR001 + SWI019 is an combination investigational immunotherapy being evaluated as a
 potential treatment for patients diagnosed with B cell malignancies who are refractory or
 unresponsive to salvage therapy or who cannot be considered for or have progressed after
 autologous hematopoietic cell transplantation. This first-in-human study will assess the
 safety and tolerability of CLBR001 + SWI019 and is designed to determine the maximum
 tolerated dose (MTD) or optimal SWI019 dose (OSD). Patients will be administered a single
 infusion of CLBR001 cells followed by cycles of SWI019. The study will also assess the
 pharmacokinetics and pharmacodynamics of CLBR001 + SWI019.
CLBR001 + SWI019 is a two-component therapy comprising an autologous chimeric antigen
 receptor T (CAR-T) cell product (CLBR001, the switchable CAR-T cell (sCAR-T)) and an
 anti-CD19 (cluster of differentiation antigen 19) antibody (SWI019, the switch, a biologic).
 In combination, SWI019 acts as an adapter molecule that controls the activity of the CLBR001
 CAR-T cell product.
Inclusion Criteria:

 -  Patients with relapsed / refractory previously treated B cell malignancies (according
 to the World Health Organization classification; 2017)

 -  Chemotherapy-refractory disease

 -  Patients must have received adequate prior therapy including at least two lines of
 prior therapies including anthracycline-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 disease histologies including pediatric lymphomas/leukemias,
 Burkitt lymphoma, lymphoplasmacytic lymphomas, 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 CD19 or CD20 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