Description:
This is a phase II study to evaluate the antitumor activity and safety of AFM13 given as
monotherapy in patients with CD30-positive T-cell lymphoma. The investigational medicinal
product AFM13 is a tetravalent bispecific chimeric (anti-human CD30 x anti-human CD16A)
recombinant antibody construct which is being developed to treat CD30-positive malignancies.
Patients who suffer from peripheral T-cell lymphoma or transformed mycosis fungoides, whose
tumor expresses the surface marker CD30, and who have relapsed after an earlier treatment or
have refractory disease will be enrolled into this study if all of the study entry criteria
are fulfilled. Dependent on their disease type and the magnitude of CD30 expression, study
participants will be assigned to one of 3 study cohorts, each cohort receiving the same
treatment of weekly AFM13 infusions (a 200mg dose per infusion).
The main goal of the study is to assess the efficacy of AFM13 treatment as judged by the rate
of objective responses. Further goals are to assess the safety of AFM13 treatment, the
immunogenicity of AFM13 (as measured by the potential formation of anti-AFM13 antibodies) and
the concentration of AFM13 in the blood.
Approx. 1 month after the last dose of AFM13 there will be a final study visit to assess the
patients' health status after therapy, followed by quarterly phone contacts to check on their
overall health status and long-term survival.
Title
- Brief Title: Phase II Study to Assess AFM13 in Patients With R/R CD30-positive T-cell Lymphoma or Transformed Mycosis Fungoides
- Official Title: A Phase II Open-label Multicenter Study to Assess the Efficacy and Safety of AFM13 in Patients With Relapsed or Refractory CD30-positive Peripheral T-cell Lymphoma or Transformed Mycosis Fungoides (REDIRECT)
Clinical Trial IDs
- ORG STUDY ID:
AFM13-202
- NCT ID:
NCT04101331
Conditions
- Peripheral T Cell Lymphoma
- Transformed Mycosis Fungoides
Interventions
| Drug | Synonyms | Arms |
|---|
| AFM13 | | Cohort A |
Purpose
This is a phase II study to evaluate the antitumor activity and safety of AFM13 given as
monotherapy in patients with CD30-positive T-cell lymphoma. The investigational medicinal
product AFM13 is a tetravalent bispecific chimeric (anti-human CD30 x anti-human CD16A)
recombinant antibody construct which is being developed to treat CD30-positive malignancies.
Patients who suffer from peripheral T-cell lymphoma or transformed mycosis fungoides, whose
tumor expresses the surface marker CD30, and who have relapsed after an earlier treatment or
have refractory disease will be enrolled into this study if all of the study entry criteria
are fulfilled. Dependent on their disease type and the magnitude of CD30 expression, study
participants will be assigned to one of 3 study cohorts, each cohort receiving the same
treatment of weekly AFM13 infusions (a 200mg dose per infusion).
The main goal of the study is to assess the efficacy of AFM13 treatment as judged by the rate
of objective responses. Further goals are to assess the safety of AFM13 treatment, the
immunogenicity of AFM13 (as measured by the potential formation of anti-AFM13 antibodies) and
the concentration of AFM13 in the blood.
Approx. 1 month after the last dose of AFM13 there will be a final study visit to assess the
patients' health status after therapy, followed by quarterly phone contacts to check on their
overall health status and long-term survival.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Cohort A | Experimental | PTCL (peripheral T cell lymphoma) patients with CD30 expression ≥10% | |
| Cohort B | Experimental | PTCL (peripheral T cell lymphoma) patients with CD30 expression ≥1% to <10% | |
| Cohort C | Experimental | TMF (transformed mycosis fungoides) patients with CD30 expression ≥1% | |
Eligibility Criteria
Main Inclusion Criteria:
- Histologically confirmed CD30-positive PTCL (most subtypes allowed) or TMF per the
revised World Health Organization 2016 classification (Swerdlow, 2016) by central
assessment.
- Cohorts A and B (PTCL cohorts): measurable by the modified Lugano Classification
(Cheson, 2014); measurable disease of ≥1.5 cm diameter by computed tomography (CT),
assessed locally for eligibility. Note: fluorodeoxyglucose (FDG) avid disease by
positron emission tomography (PET) recommended, if possible.
- Cohort C (TMF cohort): measurable by the Olsen Criteria (Olsen, 2011) including at
least 1 cutaneous lymphoma lesion ≥2 cm in diameter, assessed locally for eligibility.
- Patients must have relapsed or refractory disease AND the following:
- Cohorts A and B (PTCL): patients must have received at least 1 prior line of systemic
therapy. For patients with systemic ALCL, patients must have failed or be intolerant
to brentuximab vedotin [BV]; Adcetris®
- Cohort C (TMF): patients must have received at least 1 prior line of systemic therapy;
and have exhausted systemic therapies with regular approval for their disease
Main Exclusion Criteria:
- Patients with the following subtypes of lymphoma: T-cell prolymphocytic leukemia;
T-cell large granular lymphocytic leukemia; Chronic lymphoproliferative disorder of NK
cells; Aggressive NK-cell leukemia; Extranodal NK-/T-cell lymphoma; Indolent T-cell
lymphoproliferative disorder of the GI tract:
- Has had an allogenic tissue hematopoietic cell/solid organ transplant within the last
3 years. Note: Patients who have had a transplant >3 years ago are eligible as long as
there are no signs/symptoms of graft versus host disease (GvHD).
- Requirement for systemic immunosuppressive therapy, e.g. GvHD therapy, <12 weeks prior
to the first dose of study drug.
- Prior treatment with AFM13
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Antitumor activity of AFM13: Independent Review Committee (IRC)-confirmed objective response rate (ORR) |
| 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 |
| Safety Issue: | |
| Description: | Assessed by the modified Lugano Classification (Cheson, 2014) for Cohorts A and B (PTCL) and after at least 8 weeks from the first assessment as assessed by Olsen Criteria (Olsen, 2011) for Cohort C (TMF) |
Secondary Outcome Measures
| Measure: | Antitumor activity of AFM13: Investigator-assessed objective response rate (ORR-2) |
| 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 |
| Safety Issue: | |
| Description: | Assessed by the modified Lugano Classification (Cheson, 2014) for Cohorts A and B (PTCL) and after at least 8 weeks from the first assessment as assessed by Olsen Criteria (Olsen, 2011) for Cohort C (TMF) |
| Measure: | Duration of response to AFM13 (DOR) |
| 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 |
| Safety Issue: | |
| Description: | Assessed by the modified Lugano Classification (Cheson, 2014) for Cohorts A and B (PTCL) and after at least 8 weeks from the first assessment as assessed by Olsen Criteria (Olsen, 2011) for Cohort C (TMF ) |
| Measure: | Safety of AFM13 |
| Time Frame: | From screening till final study visit (30-37 days after last dose) |
| Safety Issue: | |
| Description: | Number and frequency of Adverse Events, which includes clinical significant abnormal findings in safety laboratory, vital signs and ECG assessments. |
| Measure: | Pharmacokinetics (PK) of AFM13 |
| Time Frame: | During Cycle 1 (each cycle is 56 days) |
| Safety Issue: | |
| Description: | Cmax (maximum measured concentration of the analyte in plasma) |
| Measure: | PK of AFM13 |
| Time Frame: | During Cycle 1 (each cycle is 56 days) |
| Safety Issue: | |
| Description: | AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) |
| Measure: | PK of AFM13 |
| Time Frame: | During Cycle 1 (each cycle is 56 days) |
| Safety Issue: | |
| Description: | Vss (Volume of distribution at steady state) |
| Measure: | PK of AFM13 |
| Time Frame: | During Cycle 1 (each cycle is 56 days) |
| Safety Issue: | |
| Description: | t1/2 (Terminal half-life) |
| Measure: | Immunogenicity of AFM13 |
| Time Frame: | From screening till final study visit (30-37 days after last dose) |
| Safety Issue: | |
| Description: | Maximum change from baseline of anti-drug antibodies (ADA) in blood and their neutralizing potential |
| Measure: | Quality of Life (QoL) |
| Time Frame: | Through study completion, up to 12 months |
| Safety Issue: | |
| Description: | QoL as measured by the European Quality of Life 5-dimensional questionnaire (EQ-5D) for Cohorts A and B; and by Skindex-29 for Cohort C |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Affimed GmbH |
Last Updated
July 21, 2021
