Phase 1 Study Of PF-06863135, A BCMA-CD3 Bispecific Antibody, In Relapsed/Refractory Multiple Myeloma

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Overview

The purpose of this trial is to determine which dose level of PF-06863135 is safest, best tolerated, and works best when given by itself and combined with pomalidomide or lenalidomide to patients with relapsed/refractory multiple myeloma.

SparkCures ID 930
Trial Phase Phase 1
Enrollment 80 Patients
Treatments
Tags
Trial Sponsors
  • Pfizer
NCT Identifier

NCT03269136

CLOSED

This trial has completed.

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

  • Relapsed/refractory multiple myeloma
  • Progressed or are intolerant of established therapies including proteasome inhibitor, immunomodulatory drug, and anti-CD38 antibody
  • Performance Status of 0- 1 ( Performance Score 2 is permitted only if due to underlying myeloma)
  • Adequate bone marrow, hematological, kidney and liver function
  • Resolved acute effects of any prior therapy to baseline severity
  • Not pregnant

Exclusion Criteria:

  • Recent history of other malignancies
  • History of active autoimmune disorders
  • Any form of primary immunodeficiency
  • Active and clinically significant bacterial, fungal, or viral infection
  • Evidence of active mucosal or internal bleeding
  • History of severe immune-mediated adverse event with prior immunomodulatory treatment
  • Major surgery within 4 weeks of study treatment start
  • Radiation therapy within 2 weeks of study treatment start
  • History of stem cell transplant (autologous or allogeneic) within 100 days prior to study enrollment
  • Donor Lymphocyte Infusion (DLI) within 30 days prior to study entry
  • Less than 30 days since last dose of antibody based therapies or less than 5 half-lives since last dose of previous therapy
  • Requirement for systemic immune suppressive medication except as permitted in the protocol
  • Current requirement for chronic blood product support

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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