A Phase 1 Dose Escalation Study of OMP-52M51 in Subjects with Lymphoid Malignancies
Study Status
Open to Enrollment
Study Description
This clinical trial is for men and women with relapsed or refractory lymphoid malignancies, including chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), transformed mycosis fungoides (MF), or Sezary Syndrome.
The purpose of this study is to evaluate the safety of a new experimental drug called OMP-52M51.
Many current cancer therapies often produce an initial reduction in tumor size, but they may not have long-term benefits. One possible explanation is the presence of a specific type of cancer cell known as a “cancer stem cell.” Cancer stem cells represent a small part of the tumor, but they are believed to be responsible for much of the growth and spread of the cancer. Cancer stem cells may also be more resistant to traditional types of treatment, like chemotherapy and radiation therapy.
OMP-52M51 is a humanized monoclonal antibody developed to target cancer stem cells, and it may block the growth of cancer stem cells. The study will test the safety of OMP-52M51 at different dose levels and will evaluate the effects the drug has on participants and their cancer. This is the first time OMP-52M51 is being tested in humans, so it is not known if it will provide benefit in treating lymphoid malignancies.
Study participants will be assigned a pre-determined dose level of OMP-52M51; the dose level will not change for the duration of the study. The dose a participant receives will depend on when he or she enrolls in the study.
Participants will receive OMP-52M51 via infusion every 3 or 4 weeks. If a participant’s tumor has not grown or has decreased in size after 8 weeks on study, the participant may continue to receive doses of OMP-52M51 until disease progression.
Disease Status and/or Stage
Relapsed or Refractory Lymphoid Malignancies, Including Chronic Lymphocytic Leukemia (CLL), Mantle Cell Lymphoma (MCL), Diffuse Large B-cell Lymphoma (DLBCL), Transformed Mycosis Fungoides (MF), or Sezary Syndrome
Sponsor
OncoMed
Key Eligibility
- Men and women age 18 and older
- Diagnosed with chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), transformed mycosis fungoides (MF), or Sezary Syndrome
- Relapsed or refractory disease after two or more standard treatments
- Detailed eligibility reviewed when you contact the study team
Principal Investigator
Contact
- Amelyn Rodriguez, RN
- (212) 746-1362
- [email protected]
- Weill Cornell Lymphoma Center
- (646) 962-2700
Protocol ID
52M51-001
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Contact Us
For general inquiries, or if you need assistance finding a study, please contact:
Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]