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NCT03549442 · ClinicalTrials.gov registry record · Phase 1
Up-front CART-BCMA With or Without huCART19 in High-risk Multiple Myeloma
A Phase 1 study of Multiple Myeloma, sponsored by University of Pennsylvania.
- Active
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT03549442: Active Phase 1 study of Multiple Myeloma, sponsored by University of Pennsylvania.
NCT03549442 is a Phase 1 study of Multiple Myeloma that is active but no longer recruiting, run by University of Pennsylvania. The registered enrollment target is 40 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03549442, a Phase 1 study of Multiple Myeloma, is active but no longer recruiting, sponsored by University of Pennsylvania.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open-label phase 1 study to assess the safety and pharmacodynamics of CART-BCMA, with or without huCART19, in patients responding to first- or second-line therapy for high-risk multiple myeloma. The regimen evaluated in this study is based on established safety of CARTBCMA demonstrated in UPCC 14415/IRB#822756 at dose of 5x108 cells, administered as split infusions, following cyclophosphamide 1.5 g/m2 in patients with relapsed/refractory myeloma. This study tests CART-BCMA (1) as consolidation of early therapy for multiple myeloma, (2) with addition of fludarabine to the lymphodepleting chemotherapy regimen, (3) in combination with huCART19, and (4) as a single rather than split-dose infusion.
Primary Outcome
The occurrence of adverse events that are possibly, probably or definitely related to CAR T cells.
Conditions Studied
Interventions
- COMBINATION_PRODUCT BCMA CART + huCART19
- COMBINATION_PRODUCT CART BCMA or CART BCMA + huCART19
- COMBINATION_PRODUCT Single-dose infusion of CART BCMA or CART BCMA + huCART19
Study Locations (1)
Pennsylvania
- Univ. of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2018-05-09 |
| Est. Completion | 2036-03 |
| Phase | Phase 1 |
What the registry record for NCT03549442 still lists
NCT03549442 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 3 interventions - of which BCMA CART + huCART19 is the first listed.
NCT03549442 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03549442 about?
NCT03549442 is a clinical study titled "Up-front CART-BCMA With or Without huCART19 in High-risk Multiple Myeloma". This is an open-label phase 1 study to assess the safety and pharmacodynamics of CART-BCMA, with or without huCART19, in patients responding to first- or second-line therapy for high-risk multiple myeloma. The regimen evaluated in this study is based on established safety of CARTBCMA demonstrated in...
What is the current status of trial NCT03549442?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2018-05-09. Estimated completion is 2036-03.
What conditions does trial NCT03549442 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT03549442?
The interventions under investigation include: BCMA CART + huCART19 (COMBINATION_PRODUCT), CART BCMA or CART BCMA + huCART19 (COMBINATION_PRODUCT), Single-dose infusion of CART BCMA or CART BCMA + huCART19 (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT03549442?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03549442 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Myeloma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03549442's enrollment target sits among peer trials
40 289th of 438 higher than 135 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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