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

April 24, 2024 updated by: Affimed GmbH

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

154

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • O'Neal Comprehensive Cancer Center at UAB
        • Contact:
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope National Medical Center
        • Contact:
      • Orange, California, United States, 92868
    • Kentucky
      • Louisville, Kentucky, United States, 40207
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Karmanos Cancer Institute
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • Masonic Cancer Center, University of Minnesota
        • Contact:
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
    • Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 (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.
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 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
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)
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
Throughout study completion (estimated up to 24 months)
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)
From the time of first protocol-specific intervention until 30 days after the last administration
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
During treatment cycles (estimated up 6 months)
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.
Throughout study completion (estimated up to 24 months)
Overall survival (OS)
Time Frame: up to 24 months
Overall survival rate
up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Affimed GmbH

Collaborators

Artiva Biotherapeutics, Inc.

Investigators

  • Study Director: Karenza Alexis, MD, Affimed Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2023

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

November 30, 2027

Study Registration Dates

First Submitted

May 19, 2023

First Submitted That Met QC Criteria

May 30, 2023

First Posted (Actual)

June 1, 2023

Study Record Updates

Last Update Posted (Estimated)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFM13-203

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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