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NCT02291848 · ClinicalTrials.gov registry record · Phase 1

Tumor-Associated Antigen-Specific Cytotoxic T-Lymphocytes for Multiple Myeloma

A Phase 1 study of Multiple Myeloma, sponsored by Baylor College of Medicine.

Recruiting
Registry status
Phase 1
Development phase
36
Enrollment target
3
Study locations

NCT02291848 is a Phase 1 study of Multiple Myeloma that is actively recruiting participants, run by Baylor College of Medicine. The registered enrollment target is 36 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (93% lower). The trial reports 3 study locations across 1 state.

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The verdict

NCT02291848, a Phase 1 study of Multiple Myeloma, is actively recruiting participants, sponsored by Baylor College of Medicine.

RECRUITING
Registry status
Phase 1
Development phase
36 participants
Enrollment target
3
Study locations

Study Summary

This study is for patients that have a cancer called Multiple Myeloma, monoclonal gammopathy of undetermined significance (MGUS) or smoldering myeloma (SM). MGUS and SM have tumor cells that possess nearly identical properties to the cancer cells seen in patients with multiple myeloma. The investigators would like to target proteins that are expressed by these cells using the patient's own immune cells known as T lymphocytes.This research study uses special immune system cells called tumor associated antigen (TAA)-specific cytotoxic T lymphocytes (CTLs), a new experimental therapy. The proteins that investigators are targeting in this study are called tumor associated antigens (TAAs). These are cell proteins that are specific to the cancer cell.They either do not show or show up in low quantities on normal human cells. In this study the investigators are targeting five common TAAs called NY-ESO-1, MAGEA4, PRAME, Survivin and SSX. On a different protocol, patients have been treated and so far this treatment has shown to be safe. Investigators now want to try this treatment in patients with multiple myeloma or if the investigators can arrest the progression of the patient's condition condition (described above) to multiple myeloma. These TAA-specific CTLs are an investigational product not approved by the Food and Drug Administration. The purpose of this study is to find the largest safe dose of TAA-specific CTLs, to learn what the side effects are, and to see whether this therapy might help patients with multiple myeloma monoclonal gammopathy of undetermined significance (MGUS) or smoldering myeloma (SM) .

Conditions Studied

Interventions

  • BIOLOGICAL TAA-specific CTLs
  • BIOLOGICAL TAA-specific CTLs- fixed dose

Study Locations (3)

Texas

  • Harris Health Ben Taub Hospital - Houston
  • Harris Health Smith Clinic - Houston
  • Houston Methodist Hospital - Houston

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2015-04
Est. Completion 2027-12-22
Phase Phase 1

Sponsor

Baylor College of Medicine

616 total trials

What the Registry Record Tells You About NCT02291848

The ClinicalTrials.gov registry entry for NCT02291848 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 36 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 Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 2 interventions - of which TAA-specific CTLs is the first listed.

NCT02291848 reports 3 study locations spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT02291848 about?

NCT02291848 is a clinical study titled "Tumor-Associated Antigen-Specific Cytotoxic T-Lymphocytes for Multiple Myeloma". This study is for patients that have a cancer called Multiple Myeloma, monoclonal gammopathy of undetermined significance (MGUS) or smoldering myeloma (SM). MGUS and SM have tumor cells that possess nearly identical properties to the cancer cells seen in patients with multiple myeloma. The investig...

What is the current status of trial NCT02291848?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2015-04. Estimated completion is 2027-12-22.

What conditions does trial NCT02291848 study?

This clinical trial studies the following conditions: Multiple Myeloma.

What interventions are being tested in trial NCT02291848?

The interventions under investigation include: TAA-specific CTLs (BIOLOGICAL), TAA-specific CTLs- fixed dose (BIOLOGICAL).

Who is sponsoring clinical trial NCT02291848?

This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02291848 being conducted?

This trial has 3 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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