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Trial record 4 of 6 for:    AFM13

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

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ClinicalTrials.gov Identifier: NCT04101331
Recruitment Status : Recruiting
First Posted : September 24, 2019
Last Update Posted : April 21, 2021
Sponsor:
Information provided by (Responsible Party):
Affimed GmbH

Brief 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.


Condition or disease Intervention/treatment Phase
Peripheral T Cell Lymphoma Transformed Mycosis Fungoides Drug: AFM13 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 145 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : November 13, 2019
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : February 2023


Arm Intervention/treatment
Experimental: Cohort A
PTCL (peripheral T cell lymphoma) patients with CD30 expression ≥10%
Drug: AFM13
weekly intravenous infusions of 200mg

Experimental: Cohort B
PTCL (peripheral T cell lymphoma) patients with CD30 expression ≥1% to <10%
Drug: AFM13
weekly intravenous infusions of 200mg

Experimental: Cohort C
TMF (transformed mycosis fungoides) patients with CD30 expression ≥1%
Drug: AFM13
weekly intravenous infusions of 200mg




Primary Outcome Measures :
  1. 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 ]
    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 :
  1. 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 ]
    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)

  2. 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 ]
    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 )

  3. Safety of AFM13 [ Time Frame: From screening till final study visit (30-37 days after last dose) ]
    Number and frequency of Adverse Events, which includes clinical significant abnormal findings in safety laboratory, vital signs and ECG assessments.

  4. Pharmacokinetics (PK) of AFM13 [ Time Frame: During Cycle 1 (each cycle is 56 days) ]
    Cmax (maximum measured concentration of the analyte in plasma)

  5. PK of AFM13 [ Time Frame: During Cycle 1 (each cycle is 56 days) ]
    AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

  6. PK of AFM13 [ Time Frame: During Cycle 1 (each cycle is 56 days) ]
    Vss (Volume of distribution at steady state)

  7. PK of AFM13 [ Time Frame: During Cycle 1 (each cycle is 56 days) ]
    t1/2 (Terminal half-life)

  8. Immunogenicity of AFM13 [ Time Frame: From screening till final study visit (30-37 days after last dose) ]
    Maximum change from baseline of anti-drug antibodies (ADA) in blood and their neutralizing potential

  9. Quality of Life (QoL) [ Time Frame: Through study completion, up to 12 months ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04101331


Contacts
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Contact: Sylvia Schwarz, PhD + 49 6221 6743 ext 620 s.schwarz@affimed.com

Locations
Show Show 66 study locations
Sponsors and Collaborators
Affimed GmbH
Investigators
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Study Director: Cassandra Choe-Juliak, MD Affimed Inc.
Principal Investigator: Won Seog Kim, Dr Samsung Medical Center
Principal Investigator: Steven Horwitz, MD Memorial Sloan Kettering Cancer Center
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Responsible Party: Affimed GmbH
ClinicalTrials.gov Identifier: NCT04101331    
Other Study ID Numbers: AFM13-202
First Posted: September 24, 2019    Key Record Dates
Last Update Posted: April 21, 2021
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mycoses
Lymphoma
Lymphoma, T-Cell
Mycosis Fungoides
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell, Cutaneous