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Phase 2 Study of AFM13 in Combination With AB-101 in Subjects With R/R HL and CD30+ PTCL (LuminICE-203)

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ClinicalTrials.gov Identifier: NCT05883449
Recruitment Status : Recruiting
First Posted : June 1, 2023
Last Update Posted : April 25, 2024
Sponsor:
Collaborator:
Artiva Biotherapeutics, Inc.
Information provided by (Responsible Party):
Affimed GmbH

Study Description
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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.

Condition or disease Intervention/treatment Phase
Relapsed or Refractory Hodgkin Lymphoma Peripheral T Cell Lymphoma Drug: AFM13 Drug: AB-101 Drug: Cyclophosphamide Drug: Fludarabine Drug: Interleukin-2 Phase 2

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 10, 2023
Estimated Primary Completion Date : April 30, 2026
Estimated Study Completion Date : November 30, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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)
 Drug: AFM13
anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion

Drug: AB-101
NK cell therapy, intravenous infusion

Drug: Cyclophosphamide
Lymphodepleting chemotherapy, intravenous infusion

Drug: Fludarabine
Lymphodepleting chemotherapy, intravenous infusion

Drug: Interleukin-2
Immune cytokine, subcutaneously
Experimental: 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)
 Drug: AFM13
anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion

Drug: AB-101
NK cell therapy, intravenous infusion

Drug: Cyclophosphamide
Lymphodepleting chemotherapy, intravenous infusion

Drug: Fludarabine
Lymphodepleting chemotherapy, intravenous infusion

Drug: Interleukin-2
Immune cytokine, subcutaneously
Experimental: 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)
 Drug: AFM13
anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion

Drug: AB-101
NK cell therapy, intravenous infusion

Drug: Cyclophosphamide
Lymphodepleting chemotherapy, intravenous infusion

Drug: Fludarabine
Lymphodepleting chemotherapy, intravenous infusion

Drug: Interleukin-2
Immune cytokine, subcutaneously
Experimental: Exploratory: AFM13 + AB-101 on CD30-positive PTCL
AFM13 + AB-101 on select CD30-positive PTCL subtypes (Dose Level A or B)
 Drug: AFM13
anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion

Drug: AB-101
NK cell therapy, intravenous infusion

Drug: Cyclophosphamide
Lymphodepleting chemotherapy, intravenous infusion

Drug: Fludarabine
Lymphodepleting chemotherapy, intravenous infusion

Drug: Interleukin-2
Immune cytokine, subcutaneously


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response Rate by Independent Radiology Committee [ Time Frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months ]
    ORR (complete response (CR) + partial response [PR]) by Independent Radiology Committee (IRC) based on positron emission tomography-computed tomography (PET-CT) as assessed by the Lugano classification


Secondary Outcome Measures :
  1. Duration of Response by Investigator and Independent Radiology Committee [ Time Frame: Tumor assessment performed every 6 weeks for 3 cycles, if no disease progression on completion of treatment, then every 3 months for the first 12 months and then every 6 months (up to 24 months) ]
    Duration of response (DOR) defined as time from first assessment of PR or CR to the first assessment of progressive disease. Response based on positron emission tomography-computed tomography (PET-CT) as assessed by the Lugano classification.

  2. Complete response rate (CRR) by Investigator and Independent Radiology Committee [ Time Frame: Tumor assessment performed every 6 weeks for 3 cycles, if no disease progression on completion of treatment, then every 3 months for the first 12 months and then every 6 months (up to 24 months) ]
    Complete Response Rate based on positron emission tomography-computed tomography (PET-CT) as assessed by the Lugano classification.

  3. ORR by Investigator based on PET-CT as assessed by the Lugano classification [ Time Frame: Tumor assessment performed every 6 weeks for 3 cycles, if no disease progression on completion of treatment, then every 3 months for the first 12 months and then every 6 months (up to 24 months) ]
    ORR (CR + PR) by Investigator based on positron emission tomography-computed tomography (PET-CT) as assessed by the Lugano classification

  4. Incidence of subjects receiving subsequent transplant [ Time Frame: Throughout study completion (estimated up to 24 months) ]
    The incidence of subjects receiving subsequent transplant will be assessed and summarized by percentage rates and 95% Confidence Intervals

  5. Incidence of TEAEs and SAEs [ Time Frame: From the time of first protocol-specific intervention until 30 days after the last administration ]
    Frequency of subjects with study-drug related treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

  6. Immunogenicity assessment of AFM13 in combination with AB-101 [ Time Frame: During treatment cycles (estimated up 6 months) ]
    Frequency of subjects developing anti-drug antibodies (ADAs) against AFM13 or AB-101

  7. Progression-free survival (PFS) by Independent Radiology Committee [ Time Frame: Throughout study completion (estimated up to 24 months) ]
    Progression-free survival (PFS) defined as time from first treatment (AFM13/AB-101) received until PD/OS.

  8. Overall survival (OS) [ Time Frame: up to 24 months ]
    Overall survival rate


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with a diagnosis of FDG-avid relapsed or refractory classical HL OR select subtypes of FDG-avid CD30-positive relapsed or refractory PTCL
  • 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:

  • Active central nervous system (CNS) involvement (untreated or uncontrolled parenchymal 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 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05883449


Contacts
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Contact: Affimed GmbH 004962216743 ext 60 trials@affimed.com

Locations
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United States, Alabama
O'Neal Comprehensive Cancer Center at UAB Recruiting
Birmingham, Alabama, United States, 35294
Contact: Christopher Crawford Jr.       chriscrawford@uabmc.edu   
United States, California
City of Hope National Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Matthew Mei, MD       mamei@coh.org   
UC Irvine Health Recruiting
Orange, California, United States, 92868
Contact: Lauren Pinter-Brown, MD       lpinterb@hs.uci.edu   
United States, Kentucky
Norton Cancer Institute Recruiting
Louisville, Kentucky, United States, 40207
Contact: Tabby Thomas    502-899-3366    StudyStartup@NCIResearch.org   
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Grace Bae, MPH, CCRP    313-576-8030    baeg@karmanos.org   
United States, Minnesota
Masonic Cancer Center, University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Joseph Maakaron, MD       maaka001@umn.edu   
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Katherine Stricker       kstricker@wustl.edu   
United States, New Jersey
John Theurer Cancer Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Elizabeth McCarthy       elizabethl.mccarthy@hmhn.org   
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Anthony Zisa       zisaa@mskcc.org   
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Asala Issa       issaa@ccf.org   
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Allandria Straker-Edwards       allandria.straker-edwards@fccc.edu   
Sponsors and Collaborators
Affimed GmbH
Artiva Biotherapeutics, Inc.
Investigators
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Study Director: Karenza Alexis, MD Affimed Inc.
More Information
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Responsible Party: Affimed GmbH
ClinicalTrials.gov Identifier: NCT05883449    
Other Study ID Numbers: AFM13-203
First Posted: June 1, 2023    Key Record Dates
Last Update Posted: April 25, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Hodgkin Disease
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Cyclophosphamide
Fludarabine
Interleukin-2
 Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents