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 StatesActive - Recruiting
City of Hope National Medical Center
Duarte, California 91010
United StatesActive - Recruiting
UC Irvine Health
Orange, California 92868
United StatesActive - Recruiting
Sarah Cannon Research Institute
Denver, Colorado 80218
United StatesActive - Recruiting
Norton Cancer Institute
Louisville, Kentucky 40207
United StatesActive - Recruiting
Beth Israel Deaconess Medical
Boston, Massachusetts 02215
United StatesActive - Recruiting
Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesActive - Recruiting
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota 55455
United StatesActive - Recruiting
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesActive - Recruiting
John Theurer Cancer Center
Hackensack, New Jersey 07601
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesActive - Recruiting
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 StatesActive - Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United StatesActive - Recruiting
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
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