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NCT05887167 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Multiple Myeloma and Acute Lymphoblastic Leukemia, sponsored by Joshua Sasine, MD, PhD.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT05887167 is a Phase 1 study of Multiple Myeloma and Acute Lymphoblastic Leukemia that is actively recruiting participants, run by Joshua Sasine, MD, PhD. The registered enrollment target is 20 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05887167, a Phase 1 study of Multiple Myeloma and Acute Lymphoblastic Leukemia, is actively recruiting participants, sponsored by Joshua Sasine, MD, PhD.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- BIOLOGICAL autologous hematopoietic stem cells added to planned CAR T
Study Locations (1)
California
- Cedars-Sinai Medical Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-03-02 |
| Est. Completion | 2027-12-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05887167
The ClinicalTrials.gov registry entry for NCT05887167 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (96% lower). The listed sponsor is Joshua Sasine, MD, PhD, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Multiple Myeloma appearing as the primary indexed condition, and to 1 intervention - of which autologous hematopoietic stem cells added to planned CAR T is the first listed.
NCT05887167 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT05887167 about?
NCT05887167 is a clinical study titled "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". 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 fro...
What is the current status of trial NCT05887167?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2024-03-02. Estimated completion is 2027-12-15.
What conditions does trial NCT05887167 study?
This clinical trial studies the following conditions: Multiple Myeloma, Acute Lymphoblastic Leukemia, Diffuse Large B Cell Lymphoma, Mantle Cell Lymphoma, Hematologic Malignancy.
What interventions are being tested in trial NCT05887167?
The interventions under investigation include: autologous hematopoietic stem cells added to planned CAR T (BIOLOGICAL).
Who is sponsoring clinical trial NCT05887167?
This trial is sponsored by Joshua Sasine, MD, PhD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05887167 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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