Feasibility and Safety of Collecting and Combining Autologous Hematopoietic Stem Cells With Chimeric Antigen Receptor (CAR) T-Cell Therapy in Subjects With Relapsed/Refractory Hematological Malignancies
This study tests a new approach combining stem cells with CAR T-cell therapy for patients whose blood cancers have not responded to or have returned after previous treatments. Researchers will collect your own blood stem cells and combine them with specially designed immune cells (CAR T-cells) to potentially improve how well the treatment works.
Key Objective:This trial is testing whether combining autologous stem cells with CAR T-cell therapy is safe and feasible, potentially improving treatment outcomes for patients with hard-to-treat blood cancers.
Who to Consider:Patients with relapsed or refractory hematological malignancies (blood cancers that have returned or stopped responding to standard treatments) should consider enrolling in this study.
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Age 18 - 85 years. * Histologically proven hematological malignancy according to the World Health Organization 2016 classification criteria for which a commercially available, FDA-approved CAR T product exists. * Relapsed or refractory disease, defined by the following: * Disease progression after last regimen, or * Refractory disease: failure to achieve a partial response (PR) or complete remission (CR) to the last regimen * At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic therapy for the malignancy at the time the subject is planned for leukapheresis. * Toxicities due to prior therapy must be stable or recovered to ≤ Grade 1 with the exception of alopecia. * Subjects with an active uncontrolled infection should not start CAR T treatment until the infection has resolved. * Eastern cooperative oncology group (ECOG) performance status 0 - 2. * Adequate hematologic, hepatic, and cardiac function * Serum pregnancy tes