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
Recruiting
Phase 1
Interventional Study
Hematologic Malignancy
Large B-cell Lymphoma
Acute Lymphoblastic Leukemia
Mantle Cell Lymphoma
Multiple Myeloma
Diffuse Large B Cell Lymphoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 85
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 20 (estimated)
- Sponsor
- Joshua Sasine, MD, PhD · Other
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About This Trial
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…
Trial Locations
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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:
* D…
Contacts