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

Trial Status: Active

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.

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

California

Duarte
City of Hope Comprehensive Cancer Center
Status: ACTIVE
Contact: Liana Nikolaenko
Phone: 833-310-2278
San Diego
University of California San Diego
Status: ACTIVE

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: ACTIVE

North Carolina

Winston-Salem
Wake Forest University Health Sciences
Status: APPROVED

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.

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Calibr, a division of Scripps Research

  • Primary ID CBR-sCAR19-3001
  • Secondary IDs NCI-2020-08466
  • Clinicaltrials.gov ID NCT04450069