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

Rekrutierend

NCT-Nummer:
NCT04101331

Studienbeginn:
November 2019

Letztes Update:
21.04.2021

Wirkstoff:
AFM13

Indikation (Clinical Trials):
Mycoses, Lymphoma, Lymphoma, T-Cell, Mycosis Fungoides, Lymphoma, T-Cell, Peripheral

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Affimed GmbH

Collaborator:
-

Studienleiter

Cassandra Choe-Juliak, MD
Study Director
Affimed Inc.
Won Seog Kim, Dr
Principal Investigator
Samsung Medical Center
Steven Horwitz, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center

Kontakt

Studienlocations
(3 von 66)

University of Alabama at Birmingham (O'Neal Comprehensive Cancer Center)
35294 Birmingham
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Amit Mehta, Dr

Harper Basquill, RN, BSN
Phone: (205)996-7079
E-Mail: habasquill@uabmc.edu
» Ansprechpartner anzeigen
Abramson Cancer Center of the University of Pennsylvania
19104 Philadelphia
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Tanya Latorre, RN, BSN, OCN
E-Mail: Tanya.Latorre@pennmedicine.upenn.edu

Terese Waite, PhD, RN, MBE
E-Mail: Terese.Waite@pennmedicine.upenn.edu
» Ansprechpartner anzeigen
MD Anderson Cancer Center
77030 Houston
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Chizobam Obam
Phone: 713-794-3074
E-Mail: ciobi@mdanderson.org

Isabel Mok
Phone: 713-792-1871
E-Mail: idmok@mdanderson.org
» Ansprechpartner anzeigen
Szpitale Pomorskie Sp. z o.o.. Szpital Morski im. PCK, Oddzial Hematologii i Transplantologii Szpiku
Gdynia
PolandRekrutierend» Google-Maps
Ansprechpartner:
Wanda Knopinska-Posluszny, MD, PhD
» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

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:

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

Studien-Arme

  • Experimental: Cohort A
    PTCL (peripheral T cell lymphoma) patients with CD30 expression ≥10%
  • Experimental: Cohort B
    PTCL (peripheral T cell lymphoma) patients with CD30 expression ≥1% to <10%
  • Experimental: Cohort C
    TMF (transformed mycosis fungoides) patients with CD30 expression ≥1%

Geprüfte Regime

  • AFM13:
    weekly intravenous infusions of 200mg

Quelle: ClinicalTrials.gov


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