Actively Recruiting
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
Eligibility Criteria
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
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
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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