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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 : July 21, 2021
Sponsor:
Information provided by (Responsible Party):
Affimed GmbH

Tracking Information
First Submitted Date  ICMJE September 20, 2019
First Posted Date  ICMJE September 24, 2019
Last Update Posted Date July 21, 2021
Actual Study Start Date  ICMJE November 13, 2019
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2019)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2019)
  • 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)
  • 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 )
  • 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.
  • Pharmacokinetics (PK) of AFM13 [ Time Frame: During Cycle 1 (each cycle is 56 days) ]
    Cmax (maximum measured concentration of the analyte in plasma)
  • 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)
  • PK of AFM13 [ Time Frame: During Cycle 1 (each cycle is 56 days) ]
    Vss (Volume of distribution at steady state)
  • PK of AFM13 [ Time Frame: During Cycle 1 (each cycle is 56 days) ]
    t1/2 (Terminal half-life)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II Study to Assess AFM13 in Patients With R/R CD30-positive T-cell Lymphoma or Transformed Mycosis Fungoides
Official Title  ICMJE 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)
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Peripheral T Cell Lymphoma
  • Transformed Mycosis Fungoides
Intervention  ICMJE Drug: AFM13
weekly intravenous infusions of 200mg
Study Arms  ICMJE
  • Experimental: Cohort A
    PTCL (peripheral T cell lymphoma) patients with CD30 expression ≥10%
    Intervention: Drug: AFM13
  • Experimental: Cohort B
    PTCL (peripheral T cell lymphoma) patients with CD30 expression ≥1% to <10%
    Intervention: Drug: AFM13
  • Experimental: Cohort C
    TMF (transformed mycosis fungoides) patients with CD30 expression ≥1%
    Intervention: Drug: AFM13
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 23, 2019)
145
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2023
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sylvia Schwarz, PhD + 49 6221 6743 ext 620 s.schwarz@affimed.com
Listed Location Countries  ICMJE Australia,   France,   Germany,   Italy,   Korea, Republic of,   Poland,   Russian Federation,   Spain,   Turkey,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04101331
Other Study ID Numbers  ICMJE AFM13-202
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Affimed GmbH
Study Sponsor  ICMJE Affimed GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Karenza Alexis, MD Affimed Inc.
Principal Investigator: Won Seog Kim, Dr Samsung Medical Center
Principal Investigator: Steven Horwitz, MD Memorial Sloan Kettering Cancer Center
PRS Account Affimed GmbH
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP