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NCT06623630 · ClinicalTrials.gov registry record · Phase 1
Lymphodepleting Total Body Irradiation (TBI) Plus Cyclophosphamide Prior to Ciltacabtagene Autoleucel (Carvykti; Cilta-cel) for Multiple Myeloma (MM) Patients With Impaired Renal Function
A Phase 1 study of Multiple Myeloma, sponsored by Washington University School of Medicine.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT06623630 is a Phase 1 study of Multiple Myeloma that is actively recruiting participants, run by Washington University School of Medicine. The registered enrollment target is 16 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06623630, a Phase 1 study of Multiple Myeloma, is actively recruiting participants, sponsored by Washington University School of Medicine.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
Treatment for relapsed/refractory multiple myeloma continues to evolve with the approval of highly effective anti-BCMA CAR T therapies in recent years. However, despite the high prevalence of renal insufficiency in this population, pivotal clinical trials have excluded patients with impaired renal function, leading to an urgent, unmet clinical need to develop safe and effective lymphodepleting regimens prior to CAR T administration for this population. In addition, renal insufficiency is linked to poor disease-related outcomes and is highly associated with several underserved populations. This study is testing the hypotheses that: 1. low-dose total body irradiation (TBI) in combination with cyclophosphamide (Cy) as lymphodepletion prior to administration of cilta-cel will be safe and tolerable in patients with multiple myeloma who have impaired renal function 2. low-dose TBI-Cy as lymphodepletion prior to cilta-cel will result in comparable CAR T expansion/persistence and disease response rates as those seen with standard lymphodepleting chemotherapy (fludarabine / cyclophosphamide).
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- RADIATION Total body irradiation
- DRUG Ciltacabtagene Autoleucel
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2024-12-04 |
| Est. Completion | 2028-05-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06623630
The ClinicalTrials.gov registry entry for NCT06623630 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 16 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 (97% lower). The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT06623630 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT06623630 about?
NCT06623630 is a clinical study titled "Lymphodepleting Total Body Irradiation (TBI) Plus Cyclophosphamide Prior to Ciltacabtagene Autoleucel (Carvykti; Cilta-cel) for Multiple Myeloma (MM) Patients With Impaired Renal Function". Treatment for relapsed/refractory multiple myeloma continues to evolve with the approval of highly effective anti-BCMA CAR T therapies in recent years. However, despite the high prevalence of renal insufficiency in this population, pivotal clinical trials have excluded patients with impaired renal f...
What is the current status of trial NCT06623630?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2024-12-04. Estimated completion is 2028-05-31.
What conditions does trial NCT06623630 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT06623630?
The interventions under investigation include: Cyclophosphamide (DRUG), Total body irradiation (RADIATION), Ciltacabtagene Autoleucel (DRUG).
Who is sponsoring clinical trial NCT06623630?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06623630 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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