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

NCT05883449 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: AFM13-203
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 15

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.

Conditions

Relapsed or Refractory Hodgkin Lymphoma; Peripheral T Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) by Independent Radiology Committee

  Best 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. A participant will be assumed as a responder if he/she achieves complete or partial response at any postbaseline visit.

  Disease assessments were conducted on Day 43 (+- 3 days) of each cycle. All subjects were treated for a maximum of 3 cycles.

Secondary Outcomes (10)

• Duration of Response by Independent Radiology Committee

  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 20 months)

• Complete Response Rate (CRR) by Independent Radiology Committee

  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 20 months)

• ORR by Investigator Based on 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 20 months)

• Duration of Response by Investigator

  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 20 months)

• Incidence of Subjects Receiving Subsequent Transplant

  Throughout study completion (up to 20 months)

Study Arms (4)

Safety run-in in Hodgkin Lymphoma

EXPERIMENTAL

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; Drug: AB-101; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Interleukin-2

Dose Level A in Hodgkin Lymphoma

EXPERIMENTAL

Randomized Simon 2-stage design in Hodgkin Lymphoma Dose Level A (selected from cohort 1-4 of Safety run-in)

Drug: AFM13; Drug: AB-101; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Interleukin-2

Dose Level B in Hodgkin Lymphoma

EXPERIMENTAL

Randomized Simon 2-stage design in Hodgkin Lymphoma Dose Level B (selected from cohort 1-4 of Safety run-in)

Drug: AFM13; Drug: AB-101; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Interleukin-2

Exploratory: AFM13 + AB-101 on CD30-positive PTCL

EXPERIMENTAL

AFM13 + AB-101 on select CD30-positive PTCL subtypes (Dose Level A or B)

Drug: AFM13; Drug: AB-101; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Interleukin-2

Interventions

AFM13 DRUG

anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion

Dose Level A in Hodgkin Lymphoma; Dose Level B in Hodgkin Lymphoma; Exploratory: AFM13 + AB-101 on CD30-positive PTCL; Safety run-in in Hodgkin Lymphoma

AB-101 DRUG

NK cell therapy, intravenous infusion

Dose Level A in Hodgkin Lymphoma; Dose Level B in Hodgkin Lymphoma; Exploratory: AFM13 + AB-101 on CD30-positive PTCL; Safety run-in in Hodgkin Lymphoma

Cyclophosphamide DRUG

Lymphodepleting chemotherapy, intravenous infusion

Dose Level A in Hodgkin Lymphoma; Dose Level B in Hodgkin Lymphoma; Exploratory: AFM13 + AB-101 on CD30-positive PTCL; Safety run-in in Hodgkin Lymphoma

Fludarabine DRUG

Lymphodepleting chemotherapy, intravenous infusion

Dose Level A in Hodgkin Lymphoma; Dose Level B in Hodgkin Lymphoma; Exploratory: AFM13 + AB-101 on CD30-positive PTCL; Safety run-in in Hodgkin Lymphoma

Interleukin-2 DRUG

Immune cytokine, subcutaneously

Dose Level A in Hodgkin Lymphoma; Dose Level B in Hodgkin Lymphoma; Exploratory: AFM13 + AB-101 on CD30-positive PTCL; Safety run-in in Hodgkin Lymphoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Affimed GmbH: lead
• Artiva Biotherapeutics, Inc.: collaborator

Study Sites (15)

O'Neal Comprehensive Cancer Center at UAB

Birmingham, Alabama, 35294, United States

Location

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

UC Irvine Health

Orange, California, 92868, United States

Location

Sarah Cannon Research Institute

Denver, Colorado, 80218, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40207, United States

Location

Beth Israel Deaconess Medical

Boston, Massachusetts, 02215, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

John Theurer Cancer Center

Hackensack, New Jersey, 07601, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

UNC Immunotherapy Team, University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania, Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Conditions

Recurrence; Hodgkin Disease; Lymphoma, T-Cell, Peripheral

Interventions

AFM13; Cyclophosphamide; fludarabine; Interleukin-2

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Limitations and Caveats

The decision to terminate this study was based solely on the financial situation of the company and was not related to the safety or efficacy. Given this limitation, the results of the time to event endpoints are premature.

Results Point of Contact

• Title: Clinical Operations
• Organization: Affimed GmbH

trials@affimed.com

+49 621 560030

Study Officials

• Wunderle Lydia, MD

  Affimed Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: June 1, 2023
• Study Start: October 10, 2023
• Primary Completion: November 7, 2024
• Study Completion: June 13, 2025
• Last Updated: August 20, 2025
• Results First Posted: August 20, 2025

Record last verified: 2025-08

Locations

US (15)