NCT04450069CompletedPhase 1
CLBR001 and SWI019 in Patients With Relapsed / Refractory B-cell Malignancies
A Phase 1, Open-label, Dose Escalating Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of the Combination of CLBR001 and SWI019 in Patients With Relapsed/Refractory B-cell Malignancies
Source: ClinicalTrials.gov · Last updated 20 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- First submitted
- 23 Jun 2020
- Start date
- 14 Aug 2020
- Primary completion date
- 6 May 2024
- Lead sponsor
- Calibr, a division of Scripps Research
- Diseases
- Diffuse large B-cell lymphoma, Follicular lymphoma, Mantle cell lymphoma, Chronic lymphocytic leukaemia
- NCT number
- NCT04450069
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 18
- From 14 Aug 2020 to the primary completion date, 6 May 2024
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Patients diagnosed with certain disease histologies including pediatric lymphomas/leukemias, monoclonal gammopathy of undetermined significance (MGUS), T-cell histiocyte large B cell lymphoma
- Active bacterial, viral, and fungal infections
- History of allogeneic stem cell transplantation
- 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
Other
- Pregnant or lactating women
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| City of Hope National Medical Center Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| Masonic Cancer Center, University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Sarah Cannon Research Institute (Tennessee Oncology) Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Weill Cornell Medical College-New York Presbyterian Hospital Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Sarah Cannon Research Institute - Texas Transplant Institute Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| University of California At San Diego Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| Wake Forest Baptist Health Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.