Condition: Hematologic Malignancy · Large B-cell Lymphoma · Acute Lymphoblastic Leukemia · Sponsor: Joshua Sasine, MD, PhD
The study is designed to examine the feasibility and safety of collecting autologous hematopoietic stem cells (HSCs) to be combined with CAR T-cell therapy for patients with relapsed/refractory (r/r) hematological disease. The study will evaluate feasibility of collecting the target dose of HSCs from at least 50% of enrolled patients. The study will assess safety based on incidence and severity of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) in the first 60 days post CAR T dosing, and also through the collection of adverse events (AEs) and serious adverse events (SAEs) as well as the durability of response after treatment with HSCs with CAR T. The study follows an open-label, single-center and single non-randomized cohort design. 20 subjects with r/r hematological malignancies will be enrolled and treated to evaluate the feasibility and preliminary safety of collecting autologous HSCs and combining them with CAR T-cell therapy.
This description comes directly from the study's public registry record.
Clinical Trial Recruitment Navigator · 310-423-2133 · GroupCancerTrialInformation@cshs.org
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| Cedars-Sinai Medical Center | Los Angeles, California, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05887167