For Healthcare Professionals

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


About the study

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.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


Inclusion Criteria:

  1. Patients with relapsed / refractory previously treated B cell malignancies (according to the World Health Organization classification; 2017)
  2. 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
  3. Patients treated with prior CD19 targeted molecules (e.g., Blincyto) must have confirmed CD19+ disease
  4. Patients must be ineligible for allogeneic stem cell transplant (SCT)
  5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
  6. Estimated life expectancy of ≥ 12 weeks from the first day of SWI019 dose administered
  7. Willing to undergo pre- and post-treatment core needle biopsy
  8. Adequate hematological, renal, pulmonary, cardiac, and liver function
  9. Resolved adverse events of any prior therapy to either baseline or CTCAE Grade ≤1
  10. Women of childbearing potential, a negative pregnancy test and must agree to practice effective birth control
  11. Men sexually active with female partners of child bearing potential must agree to practice effective contraception
  12. Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other procedures


Exclusion Criteria:

  1. Patients diagnosed with certain disease histologies including pediatric lymphomas/leukemias, monoclonal gammopathy of undetermined significance (MGUS), T-cell histiocyte large B cell lymphoma
  2. Pregnant or lactating women
  3. Active bacterial, viral, and fungal infections
  4. History of allogeneic stem cell transplantation
  5. Treatment with any prior lentiviral or retroviral based CAR-T
  6. Patients receiving live (attenuated) vaccines within 4 weeks of screening visit or need for live vaccine on study
  7. Patients with known active central nervous system (CNS) disease. Patients with prior CNS disease that has been effectively treated may be eligible
  8. 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
  9. Involvement of cardiac tissue by lymphoma
  10. Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura (ITP)
  11. HIV-1 and HIV-2 antibody positive patients

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details


Relapsed/Refractory B-cell Lymphomas,Diffuse Large B Cell Lymphoma (DLBCL),Follicular Lymphoma (FL),Chronic Lymphocytic Leukemia (CLL),Marginal Zone Lymphoma (MZL),Mantle Cell Lymphoma,Small Lymphocytic Lymphoma (SLL),Primary Mediastinal Large B Cell Lymphoma,Transformed Follicular Lymphoma,Waldenstrom Macroglobulinemia,Lymphoplasmacytic Lymphoma,Burkitt Lymphoma

Age (in years)



Phase 1

Participants needed


Est. Completion Date

Jun 30, 2024

Treatment type



Calibr, a division of Scripps Research identifier


Study number


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