Spots Global Cancer Trial Database for Phase 2 Study of AFM13 in Combination With AB-101 in Subjects With R/R HL and CD30+ PTCL
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Trial Identification
Brief Title: Phase 2 Study of AFM13 in Combination With AB-101 in Subjects With R/R HL and CD30+ PTCL
Official Title: A Phase 2, Open-Label, Multi-Center Study of Innate Cell Engager AFM13 in Combination With Allogeneic Natural Killer Cells (AB-101) in Subjects With Recurrent or Refractory Hodgkin Lymphoma and CD-30 Positive Peripheral T-Cell Lymphoma
Study ID: NCT05883449
Study Description
Brief Summary: AFM13-203 is a phase 2, open-label, multi-center, multi-cohort study with a safety run-in followed by expansion cohorts. The study is evaluating the safety and efficacy of AFM13 in combination with AB-101 in subjects with R/R classical HL and CD30-positive PTCL.
Detailed Description: The study will start with a safety run-in exploring AFM13/AB-101 combination treatment in subjects with classical HL. Two dose levels of AFM13 and AB-101, respectively, will be tested in 4 cohorts. Cohort 1 and 2 will enroll in parallel. Enrolment into Cohort 3 and 4 will start only if the combination treatment has been well tolerated. Following the safety run-in observation period, a thorough risk-benefit analysis will be performed to determine 2 of the 4 cohorts/dose levels that will be further evaluated in the main part of the study which will also include subjects with classical HL and will follow a Simon two-stage design. An additional exploratory cohort (Cohort 5) will enroll subjects with select CD30-positive PTCL subtypes after completion of the safety run-in. All subjects will be treated with AFM13/AB-101 for a maximum of 3 cycles (cycle length is 48-days).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
O'Neal Comprehensive Cancer Center at UAB, Birmingham, Alabama, United States
City of Hope National Medical Center, Duarte, California, United States
UC Irvine Health, Orange, California, United States
Sarah Cannon Research Institute, Denver, Colorado, United States
Norton Cancer Institute, Louisville, Kentucky, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
John Theurer Cancer Center, Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Cleveland Clinic, Cleveland, Ohio, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Contact Details
Name: Wunderle Lydia, MD
Affiliation: Affimed Inc.
Role: STUDY_DIRECTOR
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