Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT02291848

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

Led by Baylor College of Medicine · Updated on 2026-02-25

36

Participants Needed

3

Research Sites

664 weeks

Total Duration

On this page

Sponsors

B

Baylor College of Medicine

Lead Sponsor

T

The Methodist Hospital Research Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients at least 18 years old with high risk MGUS, smoldering myeloma, or Multiple Myeloma after at least one treatment regimen
  • Life expectancy of at least 6 weeks
  • Hemoglobin level of 7.0 or higher (transfusions allowed)
  • Able to give informed consent
  • Pulse oximetry above 93% on room air for patients with prior radiation therapy
  • Karnofsky score of 50 or higher
  • Bilirubin less than or equal to 2 times upper limit of normal
  • AST less than or equal to 3 times upper limit of normal
  • Creatinine less than or equal to 2 times upper limit of normal
  • Engrafted post transplant with absolute neutrophil count (ANC) above 500 at infusion if applicable
  • Off other investigational therapy for at least one month before study entry
  • Off conventional therapy for at least 48 hours before study entry except lenalidomide, thalidomide, pomalidomide, or immune checkpoint inhibitors
  • Female participants of childbearing potential must use effective birth control or have had hysterectomy or tubal ligation
  • Male partners must use condoms during the study
Not Eligible

You will not qualify if you...

  • Severe active infection
  • Active HIV infection at time of blood procurement
  • Receiving systemic corticosteroids within 48 hours before CTL infusion
  • Pregnant or breastfeeding

AI-Screening

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Trial Site Locations

Total: 3 locations

1

Harris Health Ben Taub Hospital

Houston, Texas, United States, 77030

Actively Recruiting

2

Harris Health Smith Clinic

Houston, Texas, United States, 77030

Actively Recruiting

3

Houston Methodist Hospital

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

P

Premal Lulla, MD

CONTACT

W

Wendy Callejas

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

3

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