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

Phase 1

Completed

• Conditions: 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

• Registration Number: NCT04450069
• Lead Sponsor: Calibr, a division of Scripps Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-6-23
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Inclusion Criteria:<br><br> - Patients with relapsed / refractory previously treated B cell malignancies<br> (according to the World Health Organization classification; 2017)<br><br> - Patients must have received adequate prior therapy including at least two lines of<br> prior therapies including anthracycline or bendamustine-containing chemotherapy,<br> anti-CD20 (cluster of differentiation antigen 20) therapies and/or Brutton's<br> tyrosine kinase (BTK) inhibitors<br><br> - Patients treated with prior CD19 targeted molecules (e.g., Blincyto) must have<br> confirmed CD19+ disease<br><br> - Patients must be ineligible for allogeneic stem cell transplant (SCT)<br><br> - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1<br><br> - Estimated life expectancy of = 12 weeks from the first day of SWI019 dose<br> administered<br><br> - Willing to undergo pre- and post-treatment core needle biopsy<br><br> - Adequate hematological, renal, pulmonary, cardiac, and liver function<br><br> - Resolved adverse events of any prior therapy to either baseline or CTCAE Grade =1<br><br> - Women of childbearing potential, a negative pregnancy test and must agree to<br> practice effective birth control<br><br> - Men sexually active with female partners of child bearing potential must agree to<br> practice effective contraception<br><br> - Willing and able to comply with scheduled visits, treatment plan, laboratory tests<br> and other procedures<br><br>Exclusion Criteria:<br><br> - Patients diagnosed with certain disease histologies including pediatric<br> lymphomas/leukemias, monoclonal gammopathy of undetermined significance (MGUS),<br> T-cell histiocyte large B cell lymphoma<br><br> - Pregnant or lactating women<br><br> - Active bacterial, viral, and fungal infections<br><br> - History of allogeneic stem cell transplantation<br><br> - Treatment with any prior lentiviral or retroviral based CAR-T<br><br> - Patients receiving live (attenuated) vaccines within 4 weeks of screening visit or<br> need for live vaccine on study<br><br> - Patients with known active central nervous system (CNS) disease. Patients with prior<br> CNS disease that has been effectively treated may be eligible<br><br> - History of Class III or IV New York Heart Association (NYHA) heart failure,<br> myocardial infarction, unstable angina or other significant cardiac disease within 6<br> months of screening<br><br> - Involvement of cardiac tissue by lymphoma<br><br> - Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura<br> (ITP)<br><br> - HIV-1 and HIV-2 antibody positive patients

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency, relatedness, severity and duration of treatment emergent and treatment related adverse events;Number of first cycle dose limiting toxicities (DLT) as assessed by Common Terminology Criteria for Adverse Events (CTCAE)

Secondary Outcome Measures

Name	Time	Method
Maximum drug concentration (Cmax) of SWI019;Area under the curve (AUC) of SWI019;Time to reach Cmax (Tmax) of SWI019;Clearance (CL) of SWI019;Apparent elimination half-life (t1/2) of SWI019;Quantification of CLBR001 cells in peripheral blood;Phenotype of CLBR001 in peripheral blood and/or tumor/bone marrow biopsies;Immunogenic response to CLBR001;Immunogenic response to SWI019;Serum cytokine concentrations;Overall (best) objective response by the Response Evaluation Criteria in Lymphoma (RECIL) and Lugano criteria;Duration of response (DOR);Progression free survival (PFS);Overall survival (OS)