Tumor-associated Antigen-specific Cytotoxic T-lymphocytes for Multiple Myeloma

What's the purpose of this trial?

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.

This trial is currently open and accepting patients.


What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Procurement Inclusion Criteria

  • Any patient, at least 18 yrs old regardless of sex, with a diagnosis of high risk MGUS/smoldering myeloma or patients with a diagnosis of Multiple myeloma after receiving at least one treatment regimen OR
  • Any patient, ≥ 18 yrs old regardless of sex with a diagnosis of high risk MGUS (defined as have 2 of the following: 1. Non IgG MGUS, 2. M protein ≥ 1.5 g/dl, 3. Abnormal free light chain ratio (<0.26 for lambda restricted disease or >1.65 for kappa restricted disease) or a diagnosis of smoldering myeloma.
  • Patients with life expectancy greater than or equal to 6 weeks.
  • Hgb greater than or equal to 7.0 (transfusions allowed).
  • Patient able to give informed consent.

Treatment Inclusion Criteria

  • Any patient, at least 18 yrs old regardless of sex, with a diagnosis of Myeloma after receiving at least one treatment regimen. If patient has received an autologous or syngeneic SCT they must be >90 days post-transplant (Group A)
  • OR
  • Following autologous or syngeneic SCT (as adjuvant therapy) and <90 days post transplant (Group B)
  • OR
  • Any patient ≥ 18 yrs old regardless of sex with a diagnosis of high risk MGUS/Smoldering myeloma (definition of high risk MGUS/smoldering myeloma provided in protocol) (Group C)
    • Patients with life expectancy greater than or equal to 6 weeks.
    • Pulse oximetry of >93% on room air in patients who previously received radiation therapy.
    • Patients with a Karnofsky score of greater than or equal to 50.
    • Patients with bilirubin less than or equal to 2 times upper limit of normal, AST less than or equal to 3 times upper limit of normal, and Hgb greater than or equal to 7.0 (transfusion allowed).
    • Engrafted post transplant (ANC >500) and ANC >500 at the time of infusion if applicable.
    • Patients with a creatinine less than or equal to 2x upper limit of normal for age.
    • Patients should have been off other investigational therapy for one month prior to entry in this study.
    • Patients should have been off conventional therapy for at least 48 hours prior to entry in this study (except for lenalidomide, thalidomide, pomalidomide or immune checkpoint inhibitors such as CTLA4 and/or PD-1/PD-L1 inhibitors)
    • Patient able to give informed consent.
    • Due to unknown effects of this therapy on a fetus, pregnant women are excluded from this research. The male partner should use a condom. Females of child-bearing potential must be willing to utilize one of the more effective birth control methods during the study unless female has had a hysterectomy or tubal ligation.

Procurement Exclusion Criteria

  • Patients with severe active infection.
  • Patients with active HIV infection at time of procurement (can be pending at the time of blood draw).

Treatment Exclusion Criteria

  • Patients with severe active infection.
  • Patients receiving systemic corticosteroid within 48 hours of CTL infusion.
  • Pregnant or breastfeeding

Additional Trial Information

Phase 1

Enrollment: 36 patients (estimated)

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Trial Locations

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Texas

Houston Methodist Hospital

Houston, TX

Open and Accepting

Trial Links

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Interested in this trial?
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