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Multiple MyelomaPhase 1/2MM FPBMCNCT04864522

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

A Phase 1/2 study testing SLAMF7 FPBMC in people with Multiple Myeloma, run by University of Virginia at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
SLAMF7 FPBMC
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Aug 2023to Nov 2023
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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) ≥ 45% 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

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ashley Donihee

    Charlottesville, Virginia, 22903

Other trials in United States

About this study

Official title: Phase I/II Study of Anti-CD3 x Anti-SLAMF7 (Anti-CS-1) Bispecific Antibody Armed Fresh Peripheral Blood Mononuclear Cells (SLAMF7 FPBMC) in Relapsed/Refractory Multiple Myeloma

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. Patients receive 8 weekly doses and then 8 more doses every 2 weeks of SLAMF7 FPBMC by intravenous infusion.

Read the detailed description

Once subjects are determined eligible, white blood cells (lymphocytes) are collected via leukapheresis procedure. The white blood cells, specifically T cells, are then mixed with two proteins, OKT3 and IL-2, which activate the cells to multiply.

The "activated" T cells are coated with the OKT3 and elotuzumab (an anti-SLAMF7 drug) to produce bispecific fresh peripheral blood mononuclear cells (FPBMC).

About 72 hours after the leukapheresis procedure, SLAMF7 FPBMC infusions will start. After about 8-9 weeks, participants will have another leukapheresis procedure and then receive doses every 2 weeks for 8 more doses. Before, throughout and following SLAMF7 FPBMC, research blood will be collected to better understand immune response. Disease status will be checked regularly during and after study treatment.

Being tested
SLAMF7 FPBMC
Keywords
Multiple myeloma, Relapsed, Refractory, Fresh Peripheral Blood Mononuclear Cells (FPBMC), Bispecific antibodies
Medical subject headings
Multiple Myeloma, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SLAMF7 FPBMCDrug

    Also called CS-1 FPBMC

    Participants will receive 8 weekly infusions of SLAMF7 FPBMC, then 8 additional infusions every 2 weeks.

Study groups in NCT04864522
Study groupRoleWhat they receive
SLAMF7 FPBMCExperimentalParticipants will undergo apheresis to collect cells to make SLAMF7 fresh peripheral blood mononuclear cells (FPBMC). These cells will be activated in the lab to fight against multiple myeloma. About 3-4 days after apheresis, participants will start receiving infusions of SLAMF7 FPBMC. Throughout treatment, participants will have blood taken for labs, to check disease status and also to look at immune response. Study treatment will stop if the participant has disease progression.
Receives: Drug: SLAMF7 FPBMC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-limiting toxicities (DLTs)

    An adverse event that is considered at least possibly related to SLAMF7 FPBMC and meets at least one of the protocol-defined criteria

    Measured: From time of informed consent through one week following 8th FPBMC infusion

  2. Adverse event profile

    Severity, frequency, category, seriousness and duration of adverse events

    Measured: From time of informed consent through 30 days following last FPBMC infusion

Secondary outcomes (7)

  1. Overall response rate (ORR)

    As defined by International Myeloma Working Group (IMWG) response criteria (partial response (PR), very good partial response (VGPR), complete response (CR), stringent CR (sCR)

    Measured: About once a month during study treatment (for about 6 months), then about every 3 months for 3 years or until first progression

  2. Minimal Residual Disease (MRD) status

    Assessed by ClonoSeq, only for patients who achieve stringent CR or CR

    Measured: Through first progression of disease (maximum of 3 years from first infusion)

  3. Overall Survival (OS)

    Duration of time from consent through death or 3 years after first FPBMC infusion

    Measured: Through 3 years after first FPBMC infusion

  4. Cellular anti-myeloma responses

    IFN-gamma Elispots stimulated by a multiple myeloma cell line

    Measured: Multiple timepoints through 12 months after last FPBMC infusion

  5. Progression-free survival (PFS)

    Duration of time from consent through first progression (or end of follow-up)

    Measured: From informed consent through first progression or 3 years after enrollment

  6. Humoral anti-myeloma responses

    Anti-SOX2 IgG antibodies in the serum by specific ELISA

    Measured: Multiple timepoints through 12 months after last FPBMC infusion

  7. Lymphocyte response following infusions of SLAMF7 FPBMC

    T cell count and count for T cell subpopulations

    Measured: Blood samples collected prior to first infusion and then before the second through fifth infusions

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2021
  2. Study startAug 2023 (estimated)
  3. Primary completionNov 2023 (estimated)
  4. Study completionNov 2023 (estimated)

Why it stopped: Slow accrual due to a crowded field of effective drugs by the time the study opened

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
SLAMF7 FPBMC
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04864522
Sponsor's protocol ID
HSR200107
Acronym
MM FPBMC
Status last verified
Nov 2023
First submitted
30 Mar 2021
Last updated
21 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SLAMF7 FPBMC in people with Multiple Myeloma, run by University of Virginia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicities (DLTs) (time frame: From time of informed consent through one week following 8th FPBMC infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04864522.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.

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