Feasibility and Safety of Collecting and Combining Autologous Hematopoietic Stem Cells Wit
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 en
| Condition(s) | Hematologic Malignancy, Large B-cell Lymphoma, Acute Lymphoblastic Leukemia, Mantle Cell Lymphoma, Multiple Myeloma, Diffuse Large B Cell Lymphoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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 sub |
| Who can participate | 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 s |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Lead sponsor | Joshua Sasine, MD, PhD |
| Locations | Los Angeles, California, United States |
| Start date | 2024-03-02 |
| NCT ID | NCT05887167 |
| Official listing | https://clinicaltrials.gov/study/NCT05887167 |