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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.

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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.

Conditions Studied

Multiple Myeloma

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

FieldValue
Enrollment Target 40 participants
Start Date 2018-05-09
Est. Completion 2036-03
Phase Phase 1

Sponsor

University of Pennsylvania

1,423 total trials

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What the Registry Record Tells You About NCT03549442

The ClinicalTrials.gov registry entry for NCT03549442 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 40 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 (93% lower). The listed sponsor is University of Pennsylvania, which has 1,423 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 BCMA CART + huCART19 is the first listed.

NCT03549442 reports 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.