Phase I/II Study of SLAMF7 FPBMC/CS-1 FPBMC in Relapsed/Refractory Multiple Myeloma (MM FPBMC) SLAMF7 FPBMC

What's the purpose of this trial?

The purpose of this study is to understand the safety and estimate the efficacy of combining anti-CD3 x anti-SLAMF7 bispecific antibody fresh peripheral blood mononuclear cells (SLAMF7 FPBMC/CS1 FPBMC) for patients with relapsed and/or refractory multiple myeloma.

This trial is currently open and accepting patients.

What will happen during the trial?

Once subjects are determined eligible, white blood cells (lymphocytes) are collected via leukapheresis procedure at approximately 3 to 4 weeks prior to the first SLAMF7 BATs infusion. The white blood cells, specifically T cells, are then mixed with two proteins, OKT3 and IL-2, which activate the cells to multiply.

After approximately 14 days in culture, the activated T cells are coated with the OKT3 and elotuzumab (an anti-SLAMF7 drug) to produce bispecific antibody armed T cells (BATs). Cells are then frozen and stored until scheduled to be infused.

About 4 weeks after the leukapheresis procedure, SLAMF7 BATs infusions will start. At week 10 of SLAMF7 BATs infusions, disease status will be checked and patients who have stable disease or better may be eligible for additional SLAMF7 BATs infusions about every 4 weeks. Before, throughout and following SLAMF7 BATs, research blood will be collected to better understand immune response. Disease status will be checked regularly during and after study treatment.

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.

Inclusion Criteria:

  • Must have received ≥ 2 consecutive cycles of treatment which include an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 monoclonal antibody either used individually or in combination
  • Documented refractory or relapsed myeloma
    • Refractory is defined as progression while on treatment or within 60 days of last treatment
  • Measurable disease based on at least one of the following lab results within 28 days of enrollment
    • Serum IgG, IgA, or IgM M-protein ≥ 1.0 g/dL
    • Urine M-protein ≥ 200 mg excreted in a 24-hr collection sample
    • Involved serum free light chain (FLC) ≥ 100 mg/L provided the FLC ratio is abnormal
  • ECOG Performance Status 0 -2
  • Left Ventricular Ejection Fraction (LVEF) ≥ 55% at rest (MUGA or Echocardiogram)
  • Age ≥ 18 years at the time of consent (Written informed consent and HIPAA authorization for release of personal health information)
  • Females of childbearing potential, and males, must be willing to use an effective method of contraception for the duration of the treatment with study drug plus 90 days (duration of sperm turnover).
  • Adequate cardiac function as defined as:
    • No EKG evidence of acute ischemia
    • No EKG evidence of clinically significant conduction system abnormalities in the opinion of the treating investigator
    • No EKG evidence of > Grade 2 (> 480 ms) QTc prolongation
    • No uncontrolled angina or severe ventricular arrhythmias
    • No clinically significant pericardial disease
    • No history of myocardial infarction (MI) in the last 6 months
    • No Class 3 or higher New York Heart Association Congestive Heart Failure
  • Demonstrate adequate organ function as defined below; all screening labs should be performed within 14 days prior to enrollment.
    • Absolute lymphocyte count ≥ 400/mm3
    • Absolute neutrophil count ≥ 1,000/mm3
    • Platelets ≥ 75,000/mm3
    • Calculated Creatinine Clearance ≥ 30 ml/min
    • Serum total bilirubin ≤ 1.5 x upper limit of normal
    • AST and ALT < 2.5 times normal

Exclusion Criteria:

  • Known hypersensitivity to elotuzumab (Elo)
  • Amyloidosis, Waldenstrom's macroglobulinemia, POEMS syndrome, or known central nervous system (CNS) involvement
  • Receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to enrollment.
    • NOTE: Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Active autoimmune disease that has required systemic treatment in the past 2 years before enrollment (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
  • Serious non-healing wound, ulcer, bone fracture, major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to enrollment
  • Active liver disease (such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis)
  • HIV positive or known active Hepatitis C (e.g., HCV RNA [qualitative] is detected) or Hepatitis B (e.g. HBsAg reactive) virus
  • Active bleeding or a pathological condition that is associated with a high risk of bleeding (therapeutic anticoagulation is allowed)
  • Has an active infection requiring systemic therapy
  • History of active TB (Bacillus Tuberculosis)
  • Has received a live vaccine within 30 days of enrollment.
  • Anti-myeloma drug therapy (including radiation therapy) ≤ 14 days prior to apheresis
  • History of myocardial infarction (within 6 months of enrollment), stable or unstable angina
  • History of another malignancy within the past 3 years before enrollment. -- Exceptions include:
    • Basal cell carcinoma of the skin or squamous cell carcinoma of the skin,
    • In situ cancers that have undergone potentially curative therapy
  • Prisoners or patients who are incarcerated
  • Patients who are compulsorily detained for treatment of either a psychiatric or physical illness
  • Pregnant or breastfeeding females: Females of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.

Additional Trial Information

Phase 1/2

Enrollment: 18 patients (estimated)

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UVA Cancer Center University of Virginia Health System

Charlottesville, VA

Open and Accepting
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