Phase 2 Study of AFM13 in Combination With AB-101 in Subjects With R/R HL and CD30+ PTCL
NCT ID: NCT05883449
Last Updated: 2025-08-20
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
25 participants
INTERVENTIONAL
2023-10-10
2025-06-13
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Safety run-in in Hodgkin Lymphoma
4 safety run-in cohorts:
* Cohort 1: 200 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15)
* Cohort 2: 300 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15)
* Cohort 3: 200 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15)
* Cohort 4: 300 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15)
AFM13
anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101
NK cell therapy, intravenous infusion
Cyclophosphamide
Lymphodepleting chemotherapy, intravenous infusion
Fludarabine
Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2
Immune cytokine, subcutaneously
Dose Level A in Hodgkin Lymphoma
Randomized Simon 2-stage design in Hodgkin Lymphoma Dose Level A (selected from cohort 1-4 of Safety run-in)
AFM13
anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101
NK cell therapy, intravenous infusion
Cyclophosphamide
Lymphodepleting chemotherapy, intravenous infusion
Fludarabine
Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2
Immune cytokine, subcutaneously
Dose Level B in Hodgkin Lymphoma
Randomized Simon 2-stage design in Hodgkin Lymphoma Dose Level B (selected from cohort 1-4 of Safety run-in)
AFM13
anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101
NK cell therapy, intravenous infusion
Cyclophosphamide
Lymphodepleting chemotherapy, intravenous infusion
Fludarabine
Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2
Immune cytokine, subcutaneously
Exploratory: AFM13 + AB-101 on CD30-positive PTCL
AFM13 + AB-101 on select CD30-positive PTCL subtypes (Dose Level A or B)
AFM13
anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101
NK cell therapy, intravenous infusion
Cyclophosphamide
Lymphodepleting chemotherapy, intravenous infusion
Fludarabine
Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2
Immune cytokine, subcutaneously
Interventions
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AFM13
anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101
NK cell therapy, intravenous infusion
Cyclophosphamide
Lymphodepleting chemotherapy, intravenous infusion
Fludarabine
Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2
Immune cytokine, subcutaneously
Eligibility Criteria
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Inclusion Criteria
* For subjects with R/R PTCL a pre-enrollment tumor biopsy positive for CD30 locally assessed 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 therapy including one prior line of combination chemotherapy. Prior therapy must also have included brentuximab vedotin and a PD1 check point inhibitor.
* Subjects with R/R PTCL must have received at least one prior line of combination chemotherapy. Subjects with ALCL subtype of PTCL must have received or been intolerant to brentuximab vedotin.
* Subjects with R/R classical HL AND R/R PTCL: Prior ASCT is permitted if completed at least 3 months prior to the first dose of study treatment. Prior allogeneic stem cell transplantation will be permitted if completed at least 1 year from study enrollment and there are no signs or symptoms of GVHD. Prior CAR-T therapy is permitted if last CAR-T dose completed at least 6 months prior to the first dose of study treatment.
* Ability to understand and sign the ICF
Exclusion Criteria
* Previous treatment with AFM13 or CBNK cells
* History of a solid organ allograft, or an inflammatory or autoimmune disease likely to be exacerbated by IL-2 (including subjects requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease that 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 curative intent and the subject has been disease free for 2 years or longer
* Active acute or chronic graft vs. host disease (GVHD) or GVHD requiring immunosuppressive treatment, clinically significant central nervous system (CNS) dysfunction
18 Years
ALL
No
Sponsors
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Artiva Biotherapeutics, Inc.
INDUSTRY
Affimed GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Wunderle Lydia, MD
Role: STUDY_DIRECTOR
Affimed Inc.
Locations
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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
Beth Israel Deaconess Medical
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
John Theurer Cancer Center
Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
UNC Immunotherapy Team, University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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AFM13-203
Identifier Type: -
Identifier Source: org_study_id
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