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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: Recruiting Phase 1 study of Multiple Myeloma and Acute Lymphoblastic Leukemia, sponsored by Joshua Sasine, MD, PhD.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Target dose collection of autologous HSCs (2 to 5 x 106 CD34+ cells/kg) defined as collection from at least 50% of patients enrolled in this study by Day 10.
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 |
What NCT05887167 shows while recruiting
NCT05887167 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (96% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT05887167's enrollment target sits among peer trials
20 381st of 438 higher than 47 of 438 other Multiple Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Myeloma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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