A PHASE I, OPEN LABEL STUDY TO EVALUATE THE SAFETY, PHARMACOKINETIC, PHARMACODYNAMIC AND CLINICAL ACTIVITY OF PF-06863135, A B-CELL MATURATION ANTIGEN (BCMA)-CD3 BISPECIFIC ANTIBODY, IN PATIENTS WITH RELAPSED/REFRACTORY ADVANCED MULTIPLE MYELOMA (MM)
To assess the safety and tolerability at increasing dose levels of PF-06863135 in patients with relapse/ refractory multiple myeloma in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.
18 Years and up
Accepting Healthy Volunteers?
- Patients with relapse/ refractory multiple myeloma
- Performance Status of 0- 2 (unless due to bone pain)
- Adequate bone marrow, kidney and liver function
- History of active autoimmune disorders
- Active and clinically significant bacterial, fungal, or viral infection
- Major surgery within 4 weeks of study treatment start
- Radiation therapy within 2 weeks of study treatment start
- Less than 30 days since last dose of anti CD38 therapy, elotuzumab or other anti-CD319 therapy or less than 5 half-lives since last dose of previous systemic therapy.
- Stem cell transplant (autologous or allogeneic) within 100 days of study treatment start