A Study of MT-0169 in Participants With Relapsed or Refractory Multiple Myeloma

Stopped early · Phase 1

Conditions studied: Relapsed and/or Refractory Multiple Myeloma

In brief

This will be a Phase 1 Open-Label, dose escalation of MT-0169 (an Engineered toxin body (ETB) in patients with relapsed or refractory multiple myeloma. MT-0169 is an investigational drug that recognizes and binds to the CD38 receptor, which may be found on the surface of multiple myeloma cancer cells. It delivers a dose of a modified toxin that kills these cells.

Key facts

Study ID

NCT04017130

Run by

Molecular Templates, Inc.

People needed

14

Starts

2020-02-05

Expected to finish

2023-12-13

Last updated by the study team

2024-01-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed diagnosis of MM per revised IMWG diagnostic criteria
• Patients with RRMM who have failed treatment with, are intolerant to, or are not candidates for available therapies that are known to confer clinical benefit
• Must meet all of the following criteria for prior therapy:
• Must be refractory to ≥1 proteasome inhibitor (PI), ≥1 immunomodulatory drug (IMiD), and ≥1 steroid
• Must either have received ≥3 prior lines of therapy or ≥2 prior lines of therapy if 1 line included a combination of PI and IMiD (prior treatment with anti-CD38 therapy is permitted).
• With measurable disease, defined as ≥1 of the following:
• Serum M-protein ≥500 mg/dL (≥5 g/L) on serum protein electrophoresis (SPEP).
• Urine M-protein ≥200 mg/24 h on urine protein electrophoresis (UPEP).
• Serum FLC assay result with an involved FLC level ≥10 mg/dL (≥100 mg/L) if serum FLC ratio is abnormal.
• Patients with serum M-protein, urine M-protein, or involved immunoglobulin FLC not meeting the measurable disease criteria above will be eligible if they have ≥1 of the following:
• Bone marrow (BM) aspirate/biopsy with plasma cell percentage ≥30%
• PET imaging with ≥1 plasmacytoma lesion with a single diameter of ≥2cm.
• With Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.
• With the following cardiovascular parameters:
• Left ventricular ejection fraction (LVEF) > 50% by echocardiogram or cardiac MRI.
• Cardiac troponin (high sensitivity or conventional) and NT-proBNP or BNP values within the institutional normal range
• QT interval corrected by the Fridericia method (QTcF) on screening electrocardiogram (ECG)[ QTcF of ≤450 millisecond (ms) in males or ≤470 ms in females]
• Must meet the following clinical laboratory criteria at entry:
• Total bilirubin ≤1.5*the upper limit of the normal range (ULN), except for Gilbert's syndrome (direct bilirubin must be <2.0*ULN)
• Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤2.5*ULN.
• Estimated glomerular filtration rate (eGFR) ≥30 (mL/min/1.73 square meter [m2]), using the modification of diet in renal disease (MDRD) equation
• Absolute neutrophil count (ANC) ≥1000 per cubic millimeter (/mm3) (≥1.0*109 per liter [/L]); ≥750/mm3 (≥0.75*109/L) may be acceptable for participants with >50% of plasma cells in BM
• Platelet count ≥75,000/ mm3 (≥75*109/L); ≥50,000/ mm3 (≥50*109/L) may be acceptable for participants with ≤ 50% of plasma cells in BM
• Hemoglobin ≥7.5 g/dL without transfusion within 7 days before the lab test.
• Serum albumin ≥2.5 g/dL.

You may not qualify if…

• With polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin changes (POEMS) syndrome, monoclonal gammopathy of unknown significance, smoldering myeloma, amyloidosis, Waldenström macroglobulinemia, or Immunoglobulin M (IgM) myeloma.
• With sensory or motor neuropathy of NCI CTCAE V5 Grade ≥3.
• Have received final dose of any of the following treatments/procedures within the following interval before the first dose of MT-0169:
• Myeloma-specific therapy, including PIs and IMiDs: 14 days
• Anti-CD38 (a) therapy: Isatuximab 90 days; daratumumab 60 days
• Corticosteroid therapy for myeloma: 7 days
• Radiation therapy for localized bone lesions: 14 days
• Major surgery:30 days
• Autologous stem cell transplant: 90 days
• Investigational therapy: 30 days
• Have received an allogeneic stem cell transplant or organ transplantation.
• Have not recovered to Grade ≤1 or baseline, from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy) excluding alopecia and Grade 2 neuropathy.
• With clinical signs of central nervous system (CNS) involvement of MM.
• With a history of myelodysplastic syndrome or another malignancy other than MM except for the following: any malignancy in complete remission for 3 years, adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, or asymptomatic prostate cancer without known metastatic disease and not requiring therapy or requiring only hormonal therapy and with normal prostate-specific antigen level for ≥1 year before the start of study therapy.
• With known or suspected light chain amyloidosis of any organ (amyloid on the BM biopsy without other evidence of amyloidosis is acceptable).
• With any of the following cardiovascular conditions:
• Congestive heart failure (NYHA) class ≥II or cardiomyopathy, active ischemia, or any other uncontrolled cardiac condition or myocardial infarction or clinically significant arrhythmia requiring therapy including anticoagulants within the past 6 months or at screening (stable therapy for > 6 months is acceptable).
• Resting tachycardia (heart rate of > 100 bpm) at screening
• Clinically significant uncontrolled hypertension at screening
• Cardiac MRI at screening demonstrates evidence of amyloid cardiomyopathy or myocarditis
• With a history of documented significant pleural or pericardial effusions of at least CTCAE Grade 3 within 3 months before the start of treatment. This will also exclude patients with:
• Pericarditis (any Grade)
• Non-malignant pleural effusion (Grade ≥2)
• Patients with a history of noncardiogenic pulmonary edema associated with diffuse peripheral edema and history of intravascular hypovolemia associated with systemic antineoplastic therapy.
• With chronic or active infection requiring systemic therapy, history of symptomatic viral infection that has not been fully cured. The following exceptions apply for those with positive serologies of HIV, HBV, or HCV:

Where it is running

• University of Southern California — Los Angeles, California, United States
• Mayo Clinic - Jacksonville — Jacksonville, Florida, United States
• Miami University — Miami, Florida, United States
• Northside Hospital — Atlanta, Georgia, United States
• Mayo Clinic - Rochester — Rochester, Minnesota, United States
• The Ohio State University — Columbus, Ohio, United States
• Vanderbilt University Medical Center- Ingram Cancer Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.