A Study of STRO-001 in Patients with Advanced B-Cell Malignancies

Overview

About this study

The purpose of this first-in-human study is to evaluate the safety, pharmacokinetics and preliminary effectiveness of STRO-001 given intravenously every 2 weeks to patients with advanced b-cell malignancies.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Confirmation of diagnosis.
  • Relapsed or relapsed/refractory disease.
  • Age ≥ 18 years old.
  • ECOG performance status (0-2).
  • Life expectancy > 3 months.
  • Adequate bone marrow and renal functions.
  • QTcF <500 msec.
  • Ability to comply with treatment, PK and test schedules.
  • NHL only - at least one measurable lesion.

Exclusion Criteria: 

  • Active plasma cell leukemia and/or leukemic manifestations of lymphoma.
  • Known amyloidosis (MM patients).
  • Chronic lymphocytic leukemia and Richter's transformation, and prolymphocytic leukemia (NHL subjects).
  • T-cell malignancy.
  • Sensory or motor neuropathy ≥ grade 2.
  • Chronic or ongoing active infectious disease requiring systemic treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active hepatitis C.
  • Ongoing immunosuppressive therapy, including systemic corticosteroids.
  • Note: Subjects may be using topical or inhaled corticosteroids. 
  • Clinically significant cardiac disease.
  • Significant concurrent, uncontrolled medical condition.
  • History or clinical signs of meningeal or active CNS involvement.
  • Known severe chronic obstructive pulmonary disease or asthma.
  • History of significant cerebrovascular disease.
  • . Known Human Immunodeficiency Virus seropositivity.
  • Positive serology for hepatitis B defined by a positive test for HBsAg.
  • Concurrent participation in another therapeutic treatment trial.
  • High screening liver function tests.
  • Prior treatment with CD74 targeting therapy.
  • Patients requiring anti-coagulant therapy

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Asher Alban Chanan Khan, M.B.B.S., M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20542550

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