Phase II Study to Assess AFM13 in Patients With R/R CD30-positive T-cell Lymphoma or Transformed Mycosis Fungoides

  • STATUS
    Recruiting
  • End date
    Feb 11, 2023
  • participants needed
    145
  • sponsor
    Affimed GmbH
Updated on 11 December 2020
ct scan
cancer
systemic therapy
measurable disease
fungal infection
avid
t-cell lymphoma
peripheral t-cell lymphoma
brentuximab vedotin
mycosis fungoides
anaplastic large cell lymphoma
brentuximab

Summary

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.

Details
Treatment AFM13
Clinical Study IdentifierNCT04101331
SponsorAffimed GmbH
Last Modified on11 December 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: T-Cell Lymphoma or Peripheral T-Cell Lymphoma or Transformed Mycosis Fungoides?
Do you have any of these conditions: T-Cell Lymphoma or Transformed Mycosis Fungoides or Peripheral T-Cell Lymphoma?
Do you have any of these conditions: Transformed Mycosis Fungoides or T-Cell Lymphoma or Peripheral T-Cell Lymphoma?
Do you have any of these conditions: Transformed Mycosis Fungoides or Peripheral T-Cell Lymphoma or T-Cell Lymphoma?
Do you have any of these conditions: Transformed Mycosis Fungoides or Peripheral T-Cell Lymphoma or T-Cell Lymphoma?
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

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
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