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

NCT04864522 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: HSR200107
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Multiple Myeloma

Keywords

Multiple myeloma; Relapsed; Refractory; Fresh Peripheral Blood Mononuclear Cells (FPBMC); Bispecific antibodies

Outcome Measures

Primary Outcomes (2)

• 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

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

• Adverse event profile

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

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

Secondary Outcomes (7)

• Overall response rate (ORR)

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

• Minimal Residual Disease (MRD) status

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

• Overall Survival (OS)

  Through 3 years after first FPBMC infusion

• Cellular anti-myeloma responses

  Multiple timepoints through 12 months after last FPBMC infusion

• Progression-free survival (PFS)

  From informed consent through first progression or 3 years after enrollment

Study Arms (1)

SLAMF7 FPBMC

EXPERIMENTAL

Participants 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.

Drug: SLAMF7 FPBMC

Interventions

SLAMF7 FPBMC DRUG

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

Also known as: CS-1 FPBMC

SLAMF7 FPBMC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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) ≥ 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

Ashley Donihee

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Recurrence

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Laahn Foster, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Progessor

Model Details: SLAMF7 FPBMC

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 29, 2021
• Study Start: August 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)