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NCT05883449 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
TERMINATED
Registry last update
2025-08-20

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Objective Response Rate (ORR) by Independent Radiology Committee

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outcome · POSTED

Duration of Response by Independent Radiology Committee

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outcome · POSTED

Complete Response Rate (CRR) by Independent Radiology Committee

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outcome · POSTED

ORR by Investigator Based on PET-CT as Assessed by the Lugano Classification

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outcome · POSTED

Duration of Response by Investigator

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outcome · POSTED

Incidence of Subjects Receiving Subsequent Transplant

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outcome · POSTED

Frequency of Subjects With Study Drug Related TEAEs

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outcome · POSTED

Frequency of Subjects With Serious Treatment Emergent Adverse Events

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outcome · POSTED

Frequency of Subjects Developing Anti-drug Antibodies (ADAs) Against AFM13

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outcome · POSTED

Progression-free Survival (PFS) by Independent Radiology Committee

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outcome · POSTED

Overall Survival

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility 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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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)
    intervention Names
    1. Drug: AFM13
    2. Drug: AB-101
    3. Drug: Cyclophosphamide
    4. Drug: Fludarabine
    5. Drug: Interleukin-2
    label
    Safety run-in in Hodgkin Lymphoma
    type
    EXPERIMENTAL
  2. description
    Randomized Simon 2-stage design in Hodgkin Lymphoma Dose Level A (selected from cohort 1-4 of Safety run-in)
    intervention Names
    1. Drug: AFM13
    2. Drug: AB-101
    3. Drug: Cyclophosphamide
    4. Drug: Fludarabine
    5. Drug: Interleukin-2
    label
    Dose Level A in Hodgkin Lymphoma
    type
    EXPERIMENTAL
  3. description
    Randomized Simon 2-stage design in Hodgkin Lymphoma Dose Level B (selected from cohort 1-4 of Safety run-in)
    intervention Names
    1. Drug: AFM13
    2. Drug: AB-101
    3. Drug: Cyclophosphamide
    4. Drug: Fludarabine
    5. Drug: Interleukin-2
    label
    Dose Level B in Hodgkin Lymphoma
    type
    EXPERIMENTAL
  4. description
    AFM13 + AB-101 on select CD30-positive PTCL subtypes (Dose Level A or B)
    intervention Names
    1. Drug: AFM13
    2. Drug: AB-101
    3. Drug: Cyclophosphamide
    4. Drug: Fludarabine
    5. Drug: Interleukin-2
    label
    Exploratory: AFM13 + AB-101 on CD30-positive PTCL
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Dose Level A in Hodgkin Lymphoma
    2. Dose Level B in Hodgkin Lymphoma
    3. Exploratory: AFM13 + AB-101 on CD30-positive PTCL
    4. Safety run-in in Hodgkin Lymphoma
    description
    anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
    name
    AFM13
    type
    DRUG
  2. arm Group Labels
    1. Dose Level A in Hodgkin Lymphoma
    2. Dose Level B in Hodgkin Lymphoma
    3. Exploratory: AFM13 + AB-101 on CD30-positive PTCL
    4. Safety run-in in Hodgkin Lymphoma
    description
    NK cell therapy, intravenous infusion
    name
    AB-101
    type
    DRUG
  3. arm Group Labels
    1. Dose Level A in Hodgkin Lymphoma
    2. Dose Level B in Hodgkin Lymphoma
    3. Exploratory: AFM13 + AB-101 on CD30-positive PTCL
    4. Safety run-in in Hodgkin Lymphoma
    description
    Lymphodepleting chemotherapy, intravenous infusion
    name
    Cyclophosphamide
    type
    DRUG
  4. arm Group Labels
    1. Dose Level A in Hodgkin Lymphoma
    2. Dose Level B in Hodgkin Lymphoma
    3. Exploratory: AFM13 + AB-101 on CD30-positive PTCL
    4. Safety run-in in Hodgkin Lymphoma
    description
    Lymphodepleting chemotherapy, intravenous infusion
    name
    Fludarabine
    type
    DRUG
  5. arm Group Labels
    1. Dose Level A in Hodgkin Lymphoma
    2. Dose Level B in Hodgkin Lymphoma
    3. Exploratory: AFM13 + AB-101 on CD30-positive PTCL
    4. Safety run-in in Hodgkin Lymphoma
    description
    Immune cytokine, subcutaneously
    name
    Interleukin-2
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
SEQUENTIAL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
25
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Objective Response Rate (ORR) by Independent Radiology Committee
    time Frame
    Disease assessments were conducted on Day 43 (+- 3 days) of each cycle. All subjects were treated for a maximum of 3 cycles.
secondary Outcomes
  1. description
    Duration of response (DOR) defined as time from first assessment of PR or CR to the first assessment of progressive disease/death. Response based on positron emission tomography-computed tomography (PET-CT) as assessed by the Lugano classification assessed by Independent Radiology Committee.
    measure
    Duration of Response by 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 20 months)
  2. description
    Complete Response Rate based on positron emission tomography-computed tomography (PET-CT) as assessed by the Lugano classification.
    measure
    Complete Response Rate (CRR) by 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 20 months)
  3. description
    ORR (CR + PR) by Investigator based on positron emission tomography-computed tomography (PET-CT) as assessed by the Lugano classification
    measure
    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 20 months)
  4. description
    Duration of response (DOR) defined as time from first assessment of PR or CR to the first assessment of progressive disease/death. Response based on positron emission tomography-computed tomography (PET-CT) as assessed by the Lugano classification assessed locally by the Investigator.
    measure
    Duration of Response by Investigator
    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 20 months)
  5. description
    The number of subjects receiving subsequent transplant will be assessed and summarized by percentage rates
    measure
    Incidence of Subjects Receiving Subsequent Transplant
    time Frame
    Throughout study completion (up to 20 months)
  6. description
    The number of subjects with study-drug related (AFM13 or AB-101) treatment-emergent adverse events (TEAEs)
    measure
    Frequency of Subjects With Study Drug Related TEAEs
    time Frame
    From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
  7. description
    The number of subjects who had serious treatment emergent adverse events.
    measure
    Frequency of Subjects With Serious Treatment Emergent Adverse Events
    time Frame
    From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
  8. description
    The number of subjects developing anti-drug antibodies (ADAs) against AFM13
    measure
    Frequency of Subjects Developing Anti-drug Antibodies (ADAs) Against AFM13
    time Frame
    During treatment cycles (up to 6 months)
  9. description
    Progression-free survival (PFS) defined as time from first treatment (AFM13/AB-101) received until progressive disease (PD). Subjects who started a new anti-lymphoma therapy prior to a documented progressive disease were censored at the last disease assessment prior to initiation of new anti-lymphoma therapy. Subjects who discontinued the study before the first assessment of progressive disease or death were censored at their last disease assessment.
    measure
    Progression-free Survival (PFS) by Independent Radiology Committee
    time Frame
    From the first treatment received until the first progression disease assessed by IRC or death.
  10. description
    Overall Survival (OS) was defined as (date of death - date of first dose)/30.4375. Patients alive at the end of study will be censored on the last date of observation.
    measure
    Overall Survival
    time Frame
    From the first treatment received until the death.
Full study description
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.
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).
Source references
Source notices and limitations
    Discovery and provenance
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      occurrences
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        exact text
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        start
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      offset unit
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      query cond
      Peripheral T-Cell Non-Hodgkin Lymphoma
      query disease state id
      ds-peripheral-t-cell-non-hodgkin-lymphoma
      source file
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      source file sha256
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      source string sha256
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    Preserved source evidence · Not medical advice