New Clinical Trial: Phase 1 Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 in Relapsed or Refractory CLL and LymphomasPosted: March 5, 2015
The Weill Cornell Lymphoma Program has recently opened a new clinical trial for men and women with mantle cell lymphoma. The study sponsor is Bristol-Myers Squibb Research & Development, and the principal investigator at Weill Cornell is John P. Leonard, M.D.. For more information about the study, please call Amelyn Rodgriguez, RN at (212) 746-1362 or e-mail Amelyn at email@example.com.
- Men and women age 18 and older
- Hodgkin’s lymphoma or B-cell malignancy
- Relapsed after, or refractory to, prior therapy for Hodgkin’s lymphoma or B-cell malignancy
- Detailed eligibility reviewed when you contact the study team
This clinical trial is for men and women with relapsed or refractory lymphomas including:
- Mantle cell lymphoma
The study is evaluating the experimental drug BMS-986016 (Anti-Lag-3), to demonstrate adequate safety and tolerability, as well as a favorable risk/benefit profile, to support further clinical testing.
The study will be conducted in 2 parts. Part A consists of a dose escalation design and Part B consists of cohort expansion in 4 disease-restricted populations. Treatment in Part B will be initiated when the maximum tolerated dose (or maximum administered dose) for Part A has been determined.
Subjects will complete up to 3 periods of the study: Screening (up to 28 days), Treatment (up to a maximum of twelve 8-week cycles of therapy), and Clinical Follow-up (135 days following last dose of study drug). Women of child bearing potential will have additional follow-up assessments through Day 165 for home pregnancy tests. Each treatment cycle comprises 4 doses of BMS-986016 administered intravenously on Days 1, 15, 29, and 43. Subjects will continue on treatment as long as they are responding to therapy and not experiencing unacceptable side effects.