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

Overview

Información sobre este estudio

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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Jacksonville, Fla.

Investigador principal de Mayo Clinic

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

Cerrado para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publicaciones

Publications are currently not available
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CLS-20542550

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