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

Last updated: November 11, 2024
Sponsor: Affimed GmbH
Overall Status: Active - Recruiting

Phase

2

Condition

Lymphoma

Non-hodgkin's Lymphoma

Treatment

AB-101

Interleukin-2

Fludarabine

Clinical Study ID

NCT05883449
AFM13-203
  • Ages > 18
  • All Genders

Study 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.

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

Total Participants: 154
Treatment Group(s): 5
Primary Treatment: AB-101
Phase: 2
Study Start date:
October 10, 2023
Estimated Completion Date:
November 30, 2027

Study 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).

Connect with a study center

  • O'Neal Comprehensive Cancer Center at UAB

    Birmingham, Alabama 35294
    United States

    Active - Recruiting

  • City of Hope National Medical Center

    Duarte, California 91010
    United States

    Active - Recruiting

  • UC Irvine Health

    Orange, California 92868
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • Norton Cancer Institute

    Louisville, Kentucky 40207
    United States

    Active - Recruiting

  • Beth Israel Deaconess Medical

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Masonic Cancer Center, University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Active - Recruiting

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • John Theurer Cancer Center

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • UNC Immunotherapy Team, University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania 19111
    United States

    Active - Recruiting

  • University of Pennsylvania, Abramson Cancer Center

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

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