Chronic Lymphocytic Leukemia Clinical Trial

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

Summary

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.

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Full Description

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.

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Eligibility Criteria

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

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 1

Estimated Enrollment:

18

Study ID:

NCT04450069

Recruitment Status:

Active, not recruiting

Sponsor:

Calibr, a division of Scripps Research

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There are 8 Locations for this study

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City of Hope National Medical Center
Duarte California, 91010, United States
University of California at San Diego
San Diego California, 92093, United States
University of Chicago
Chicago Illinois, 60637, United States
Masonic Cancer Center, University of Minnesota
Minneapolis Minnesota, 55455, United States
Weill Cornell Medical College - New York Presbyterian Hospital
New York New York, 10065, United States
Wake Forest Baptist Health
Winston-Salem North Carolina, 27157, United States
Sarah Cannon Research Institute - Tennessee Oncology
Nashville Tennessee, 37203, United States
Sarah Cannon Research Institute - Texas Transplant Institute
San Antonio Texas, 78229, United States

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 1

Estimated Enrollment:

18

Study ID:

NCT04450069

Recruitment Status:

Active, not recruiting

Sponsor:


Calibr, a division of Scripps Research

How clear is this clinincal trial information?

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