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    Summary
    EudraCT Number:2019-001003-20
    Sponsor's Protocol Code Number:AFM13-202
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-10-17
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2019-001003-20
    A.3Full title of the trial
    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).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the safety and efficacy of AFM13 in patients with certain types of T-cell lymphoma
    A.4.1Sponsor's protocol code numberAFM13-202
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAffimed GmbH
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAffimed GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationICON Clinical Research (UK) Ltd
    B.5.2Functional name of contact pointMichelle Boone
    B.5.3 Address:
    B.5.3.1Street AddressBoeing Avenue 62-68
    B.5.3.2Town/ citySchiphol-Rijk
    B.5.3.3Post code1119 PE
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31206558957
    B.5.6E-mailmichelle.boone@iconplc.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAFM13
    D.3.2Product code AFM13
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot applicable
    D.3.9.2Current sponsor codeAFM13
    D.3.9.4EV Substance CodeSUB33352
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsed or Refractory CD30-positive Peripheral T-cell Lymphoma or Transformed Mycosis Fungoides
    E.1.1.1Medical condition in easily understood language
    Certain subgroups of blood cancers called T-cell lymphoma, where a gene or protein called CD30 is expressed
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10034622
    E.1.2Term Peripheral T-cell lymphomas NEC
    E.1.2System Organ Class 100000004851
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10028484
    E.1.2Term Mycoses fungoides
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To assess the antitumor activity of AFM13 by Independent Review Committee confirmed positron emission tomography-computed tomography (PET-CT)-based objective response rate (ORR)
    E.2.2Secondary objectives of the trial
    •To assess the antitumor activity of AFM13 by Independent Review Committee -confirmed complete response (CR) and partial response (PR) rates and CT scan-based ORR
    •To assess the antitumor activity of AFM13 by Investigator-assessed ORR (defined as ORR-2)
    • To assess the duration of response (DOR) to AFM13
    • To assess the safety and tolerability of AFM13
    • To assess the serum pharmacokinetics (PK) of AFM13
    • To assess the immunogenicity of AFM13
    • To assess Quality of Life of subjects while on treatment with AFM13

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Ability to understand the purpose and risks of the study, provide signed and dated written informed consent and authorization to use confidential health information in accordance with federal, local & institutional guidelines.
    2. Age ≥18 years at time of provision of informed consent.
    3. Histologically confirmed CD30-positive (via centrally assessed Ber-H2 targeted IHC; cut-offs listed in protocol) PTCL (allowed subtypes listed in protocol) or TMF per the revised WHO 2016 classification (Swerdlow, 2016) by central assessment (Note: Subjects must wait for central results before first dose of study drug).
    The required cut-offs for the CD30-positivity are:
    • Cohort A (PTCL): ≥10% by IHC • Cohort B (PTCL): ≥1 to <10% by IHC
    • Cohort C (TMF): ≥1% by IHC
    Measurable disease will be defined as below for each cohort:
    • 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.
    • 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. Note: After the planned Interim Analyses, Cohorts A and B may be combined with the CD30-positivity defined as ≥ 1% by centrally assessed IHC.
    4. Subjects must have relapsed or refractory disease AND the following:
    • Cohorts A and B (PTCL cohorts): Subjects must have received at least 1 prior line of systemic therapy. For subjects with systemic ALCL, subjects must have failed or be intolerant to brentuximab vedotin [BV]; Adcetris®.
    • Cohort C (TMF cohort): Subjects must have received at least 1 prior line of systemic therapy, and have exhausted systemic therapies with full approval for their treatment of transformed mycosis fungoides.
    Note: intolerance is defined as a discontinuation of a drug due to a ≥ Grade 2 treatment-related adverse event that is clearly documented.
    5. Completion of treatment with any radiotherapy, chemotherapy, antibody, immunoconjugates and/or another investigational drug ≥4 weeks (or 5 half-lives of the drug, whichever is shorter) prior to first dose of study drug.
    Note: Subjects may be enrolled after a minimum of 2 weeks post radiation if radiation was for palliative intent to a single cutaneous lesion or single nodal region after discussion with the Sponsor.
    6. Completion of an autologous hematopoietic stem cell transplantation at least 3 months prior to first dose of study drug (if applicable).
    7. Resolution of any clinically significant previous therapy-related toxicity to ≤Grade 1 or to baseline if pre-existing condition (exception: Subjects with all grade alopecia and ≤Grade 2 peripheral neuropathy).
    8. Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.
    9. Life expectancy ≥12 weeks.
    10. Adequate laboratory functional values. (Note: transfusions and growth factors allowed during Screening; however, transfusion dependency defined as requiring blood products > once per week not allowed):
    a) Platelet count ≥50,000/mm3;
    b) Hemoglobin ≥8.0 g/dL (≥4.96mmol/L);
    c) Absolute neutrophil count >1,000/mm3;
    d) Alanine transaminase/aspartate transaminase ≤ 3x the upper limit of normal (ULN) or ≤ 5x for subjects with documented hepatic involvement with lymphoma;
    e) Total bilirubin ≤1.5 x ULN or <3 x ULN for subjects with Gilbert's disease or documented hepatic involvement with lymphoma;
    f) Serum creatinine ≤1.5mg/dL or measured or calculated (per institutional standard) creatinine clearance ≥30mL/min for subjects with creatinine levels >1.5 x ULN;
    11. If female of child-bearing potential, must not be pregnant or be breastfeeding and required to have a negative urine or serum pregnancy
    test within 3 days prior to the first dose of study drug. Note: Urine pregnancy tests that cannot be confirmed as negative, require a confirmatory negative serum pregnancy test. In addition, females of childbearing potential must agree use of a highly effective method of contraception for the course of the study from 14 days prior to the first dose of study drug until 60 days after the last dose of study drug.
    Non-childbearing potential is defined as:
    • Postmenopausal: defined as no menses for 12 months without an alternative medical cause. A high follicle-stimulating hormone (FSH) level in the postmenopausal range may be used to confirm postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. In the absence of 12 months of amenorrhea, FSH measurements indicating post-menopausal status must be documented in subject's medical history.
    • Permanently sterile: documented permanent sterilization eg, hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
    12. If male, surgically sterile or agrees to use a highly effective method of contraception, prior to the first dose of study drug until 60 days after the last dose of study drug.
    E.4Principal exclusion criteria
    1. Subjects 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 gastrointestinal tract
    •Adult T-cell leukemia/lymphoma
    2. Current evidence of central nervous system involvement.
    3. Has had an allogenic tissue hematopoietic cell/solid organ transplant within the last 3 years. Note: Subjects who have had a transplant > 3 years ago are eligible as long as there are no signs/symptoms of graft versus host disease (GvHD).
    4. Requirement for chronic systemic immunosuppressive therapy <12 weeks prior to the first dose of study drug for prophylaxis or management of conditions such as GvHD (eg, mycophenolate, methotrexate, calcineurin inhibitor based therapy, steroid doses that would require prolonged tapering for discontinuation).
    5. Major surgery ≤4 weeks prior to first dose of study drug.
    6. Any active, concurrent, significant illness or disease (other than T-cell lymphoma) or clinically significant findings including psychiatric and behavioral problems, medical history and/or physical examination findings that would preclude the subject from participation in the study such as:
    a) active infection requiring systemic therapy ≤10 days before the first dose of study drug;
    b) unstable angina pectoris, symptomatic congestive heart failure (New York Heart Association II, III, IV; Appendix C of protocol), myocardial infarction 6 months prior to first study drug, uncontrolled cardiac arrhythmia eg, atrial fibrillation/flutter, cerebrovascular accidents ≤6 months before first dose of study drug;
    c) any severe or uncontrolled other disease or condition which might increase the risk associated with study participation;
    d) active Hepatitis B or Hepatitis C as defined in the protocol. Antiviral prophylaxis for chronic Hepatitis B virus infection may be used at the discretion of the investigator. Note: Subjects must meet criteria defined in the protocol to be allowed to be enrolled in the study).
    7. Diagnosis of Human Immunodeficiency Virus (HIV) i.e. presence of HIV 1/2 antibodies.
    8. Diagnosis of immunodeficiency or requirement for systemic steroid therapy or any other form of immunosuppressive therapy (outside of
    examples already mentioned in exclusion criterion number 4) <7 days prior to the first dose study drug. Topical steroid creams for symptomatic relief for subjects in Cohort C (TMF) are exceptions to this rule. Also, the use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor/Medical Monitor.
    9. Any other malignancy known to be active, with the exception of treated cervical intra-epithelial neoplasia and non-melanoma skin cancer.
    10. General intolerance of any protocol medication or its excipients.
    11. Subject´s inability to appreciate the nature, meaning and consequences of the trial and to formulate his/her own wishes correspondingly.
    12. Subject is unwilling to comply with the protocol; including the required biopsies and PK sampling.
    13. Prior treatment with AFM13.
    E.5 End points
    E.5.1Primary end point(s)
    To assess the antitumor activity of AFM13 by an Independent Review Committee positron emission tomography-computed tomography (IRC-PET-CT) based objective response rate (ORR)
    E.5.1.1Timepoint(s) of evaluation of this end point
    ORR (CR + PR) as confirmed by an IRC as assessed by the modified Lugano Classification (Cheson, 2014) for Cohorts A and B (PTCL) based on PET-CT and after at least 8 weeks from the first assessment as assessed by Olsen Criteria (Olsen, 2011) for Cohort C (TMF)(see Appendix F of protocol).
    E.5.2Secondary end point(s)
    1) To assess the antitumor activity of AFM13 by:
    o IRC-confirmed CR and PR rates and CT scan-based ORR
    o Investigator-assessed ORR (defined as ORR-2)


    2) To assess the duration of response (DOR) to AFM13

    3) To assess the safety and tolerability of AFM13

    4) To assess the pharmacokinetics (PK) of AFM13

    5) To assess the immunogenicity of AFM13

    6) To assess Quality of Life (QOL) of subjects while on treatment with AFM13
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) At Screening and every 8 weeks for the first 3 assessments, then every 12 weeks thereafter.

    2) Every 8 weeks for the first 3 assessments, then every 12 weeks thereafter.

    3) Predose and at the end of each infusion (EOI), and laboratory safety evaluations. Cytokine levels in blood samples will be tested predose and EOI on Cycle 1 Day 1.

    4) Evaluation of the levels of AFM13 in serum will be performed at the time points described in Schedule of Assessments (Appendix A) of the protocol.

    5) Predose at Cycle 1, onwards at each Cycle on Day 1 and 29.

    6) Questionnaires will be performed at Screening and at same time point as every Disease Assessment until disease progression and at Final Study Visit.

    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Korea, Republic of
    Russian Federation
    Turkey
    United States
    France
    Germany
    Italy
    Poland
    Spain
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    End of study is defined as the point when all subjects have completed their Efficacy and Safety Follow-up Period (Final Study Visit) assessments following permanent discontinuation of study treatment.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 83
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 67
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 150
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    All subjects will undergo Efficacy and Safety Follow-up Period (Final Study Visit) assessments 30 - 37 days following permanent discontinuation of study treatment.
    Subjects who permanently discontinue study treatment for any reason other than clinical or radiological disease progression, withdrawal of consent, lost to follow-up or death, will be followed up to check for progression of disease and survival every 3 months or until initiation of subsequent anti-cancer therapy.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-01-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-01-11
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