Phase
Condition
Lymphoma
Non-hodgkin's Lymphoma
Treatment
AB-101
Interleukin-2
Fludarabine
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects with a diagnosis of FDG-avid relapsed or refractory classical HL OR selectsubtypes of FDG-avid CD30-positive relapsed or refractory PTCL
For subjects with R/R PTCL a pre-enrollment tumor biopsy positive for CD30 locallyassessed by Ber-H2 targeted immunohistochemistry at ≥1% is mandatory (PTCL subtypes:PTCL-NOS, Angioimmunoblastic T-cell lymphoma, ALCL, anaplastic lymphoma kinase (ALK)-positive, ALCL, ALK-negative)
Subjects with R/R classical HL must have received at least two lines of therapyincluding one prior line of combination chemotherapy. Prior therapy must also haveincluded brentuximab vedotin and a PD1 check point inhibitor.
Subjects with R/R PTCL must have received at least one prior line of combinationchemotherapy. Subjects with ALCL subtype of PTCL must have received or beenintolerant to brentuximab vedotin.
Subjects with R/R classical HL AND R/R PTCL: Prior ASCT is permitted if completed atleast 3 months prior to the first dose of study treatment. Prior allogeneic stemcell transplantation will be permitted if completed at least 1 year from studyenrollment and there are no signs or symptoms of GVHD. Prior CAR-T therapy ispermitted if last CAR-T dose completed at least 6 months prior to the first dose ofstudy treatment.
Ability to understand and sign the ICF
Exclusion
Exclusion Criteria:
Active central nervous system (CNS) involvement (untreated or uncontrolledparenchymal brain metastasis or positive cytology of cerebrospinal fluid)
Previous treatment with AFM13 or CBNK cells
History of a solid organ allograft, or an inflammatory or autoimmune disease likelyto be exacerbated by IL-2 (including subjects requiring systemic treatment withinthe past 3 months or a documented history of clinically severe autoimmune diseasethat may require systemic steroids or immunosuppressive agents
Treatment with any therapeutic mAb or immunosuppressive medications
Known active Hepatitis B or C defined per protocol
Active HIV Infection
History of any other systemic malignancy, unless previously treated with curativeintent and the subject has been disease free for 2 years or longer
Active acute or chronic graft vs. host disease (GVHD) or GVHD requiringimmunosuppressive treatment, clinically significant central nervous system (CNS)dysfunction
Study Design
Study Description
Connect with a study center
O'Neal Comprehensive Cancer Center at UAB
Birmingham, Alabama 35294
United StatesSite Not Available
City of Hope National Medical Center
Duarte, California 91010
United StatesSite Not Available
UC Irvine Health
Orange, California 92868
United StatesSite Not Available
Sarah Cannon Research Institute
Denver, Colorado 80218
United StatesSite Not Available
Norton Cancer Institute
Louisville, Kentucky 40207
United StatesSite Not Available
Beth Israel Deaconess Medical
Boston, Massachusetts 02215
United StatesSite Not Available
Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesSite Not Available
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota 55455
United StatesSite Not Available
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesSite Not Available
John Theurer Cancer Center
Hackensack, New Jersey 07601
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesSite Not Available
UNC Immunotherapy Team, University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
United StatesSite Not Available
Cleveland Clinic
Cleveland, Ohio 44195
United StatesSite Not Available
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United StatesSite Not Available
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania 19104
United StatesSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.