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

Overview

This study is for patients that have a cancer called Multiple Myeloma. 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 by normal human cells. In this study we target 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. 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.

SparkCures ID 695
Trial Phase Phase 1
Enrollment 36 Patients
Treatments
  • T Cells
  • Tumor Associated Antigen (TAA)-Specific Cytotoxic T Lymphocytes (CTLs)
Trial Sponsors
  • Baylor College of Medicine
NCT Identifier

NCT02291848

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Procurement Inclusion Criteria

  • Any patient, at least 18 yrs old regardless of sex, with a diagnosis of Myeloma after receiving at least one treatment regimen.
  • 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)

  • 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.
  • 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

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Houston Methodist Hospital

Houston, TX

Texas
Houston Methodist Hospital

Houston, TX

Resources