Trial Title:
Phase 2 Study of AFM13 in Combination With AB-101 in Subjects With R/R HL and CD30+ PTCL
NCT ID:
NCT05883449
Condition:
Relapsed or Refractory Hodgkin Lymphoma
Peripheral T Cell Lymphoma
Conditions: Official terms:
Lymphoma
Hodgkin Disease
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Cyclophosphamide
Fludarabine
Interleukin-2
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AFM13
Description:
anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
Arm group label:
Dose Level A in Hodgkin Lymphoma
Arm group label:
Dose Level B in Hodgkin Lymphoma
Arm group label:
Exploratory: AFM13 + AB-101 on CD30-positive PTCL
Arm group label:
Safety run-in in Hodgkin Lymphoma
Intervention type:
Drug
Intervention name:
AB-101
Description:
NK cell therapy, intravenous infusion
Arm group label:
Dose Level A in Hodgkin Lymphoma
Arm group label:
Dose Level B in Hodgkin Lymphoma
Arm group label:
Exploratory: AFM13 + AB-101 on CD30-positive PTCL
Arm group label:
Safety run-in in Hodgkin Lymphoma
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
Lymphodepleting chemotherapy, intravenous infusion
Arm group label:
Dose Level A in Hodgkin Lymphoma
Arm group label:
Dose Level B in Hodgkin Lymphoma
Arm group label:
Exploratory: AFM13 + AB-101 on CD30-positive PTCL
Arm group label:
Safety run-in in Hodgkin Lymphoma
Intervention type:
Drug
Intervention name:
Fludarabine
Description:
Lymphodepleting chemotherapy, intravenous infusion
Arm group label:
Dose Level A in Hodgkin Lymphoma
Arm group label:
Dose Level B in Hodgkin Lymphoma
Arm group label:
Exploratory: AFM13 + AB-101 on CD30-positive PTCL
Arm group label:
Safety run-in in Hodgkin Lymphoma
Intervention type:
Drug
Intervention name:
Interleukin-2
Description:
Immune cytokine, subcutaneously
Arm group label:
Dose Level A in Hodgkin Lymphoma
Arm group label:
Dose Level B in Hodgkin Lymphoma
Arm group label:
Exploratory: AFM13 + AB-101 on CD30-positive PTCL
Arm group label:
Safety run-in in Hodgkin Lymphoma
Summary:
AFM13-203 is a phase 2, open-label, multi-center, multi-cohort study with a safety run-in
followed by expansion cohorts. The study is evaluating the safety and efficacy of AFM13
in combination with AB-101 in subjects with R/R classical HL and CD30-positive PTCL.
Detailed description:
The study will start with a safety run-in exploring AFM13/AB-101 combination treatment in
subjects with classical HL. Two dose levels of AFM13 and AB-101, respectively, will be
tested in 4 cohorts. Cohort 1 and 2 will enroll in parallel. Enrolment into Cohort 3 and
4 will start only if the combination treatment has been well tolerated.
Following the safety run-in observation period, a thorough risk-benefit analysis will be
performed to determine 2 of the 4 cohorts/dose levels that will be further evaluated in
the main part of the study which will also include subjects with classical HL and will
follow a Simon two-stage design.
An additional exploratory cohort (Cohort 5) will enroll subjects with select
CD30-positive PTCL subtypes after completion of the safety run-in.
All subjects will be treated with AFM13/AB-101 for a maximum of 3 cycles (cycle length is
48-days).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Subjects with a diagnosis of FDG-avid relapsed or refractory classical HL OR select
subtypes of FDG-avid CD30-positive relapsed or refractory PTCL
- For subjects with R/R PTCL a pre-enrollment tumor biopsy positive for CD30 locally
assessed by Ber-H2 targeted immunohistochemistry at ≥1% is mandatory (PTCL subtypes:
PTCL-NOS, Angioimmunoblastic T-cell lymphoma, ALCL, anaplastic lymphoma kinase
(ALK)-positive, ALCL, ALK-negative)
- Subjects with R/R classical HL must have received at least two lines of therapy
including one prior line of combination chemotherapy. Prior therapy must also have
included brentuximab vedotin and a PD1 check point inhibitor.
- Subjects with R/R PTCL must have received at least one prior line of combination
chemotherapy. Subjects with ALCL subtype of PTCL must have received or been
intolerant to brentuximab vedotin.
- Subjects with R/R classical HL AND R/R PTCL: Prior ASCT is permitted if completed at
least 3 months prior to the first dose of study treatment. Prior allogeneic stem
cell transplantation will be permitted if completed at least 1 year from study
enrollment and there are no signs or symptoms of GVHD. Prior CAR-T therapy is
permitted if last CAR-T dose completed at least 6 months prior to the first dose of
study treatment.
- Ability to understand and sign the ICF
Exclusion Criteria:
- Active central nervous system (CNS) involvement (untreated or uncontrolled
parenchymal brain metastasis or positive cytology of cerebrospinal fluid)
- Previous treatment with AFM13 or CBNK cells
- History of a solid organ allograft, or an inflammatory or autoimmune disease likely
to be exacerbated by IL-2 (including subjects requiring systemic treatment within
the past 3 months or a documented history of clinically severe autoimmune disease
that may require systemic steroids or immunosuppressive agents
- Treatment with any therapeutic mAb or immunosuppressive medications
- Known active Hepatitis B or C defined per protocol
- Active HIV Infection
- History of any other systemic malignancy, unless previously treated with curative
intent and the subject has been disease free for 2 years or longer
- Active acute or chronic graft vs. host disease (GVHD) or GVHD requiring
immunosuppressive treatment, clinically significant central nervous system (CNS)
dysfunction
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
O'Neal Comprehensive Cancer Center at UAB
Address:
City:
Birmingham
Zip:
35294
Country:
United States
Status:
Recruiting
Contact:
Last name:
Christopher Crawford Jr.
Email:
chriscrawford@uabmc.edu
Facility:
Name:
City of Hope National Medical Center
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Matthew Mei, MD
Email:
mamei@coh.org
Facility:
Name:
UC Irvine Health
Address:
City:
Orange
Zip:
92868
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lauren Pinter-Brown, MD
Email:
lpinterb@hs.uci.edu
Facility:
Name:
Sarah Cannon Research Institute
Address:
City:
Denver
Zip:
80218
Country:
United States
Status:
Recruiting
Contact:
Phone:
844-482-4812
Facility:
Name:
Norton Cancer Institute
Address:
City:
Louisville
Zip:
40207
Country:
United States
Status:
Recruiting
Contact:
Last name:
Tabby Thomas
Phone:
502-899-3366
Email:
StudyStartup@NCIResearch.org
Facility:
Name:
Beth Israel Deaconess Medical
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
John Fisher
Email:
jfisher6@bidmc.harvard.edu
Contact backup:
Last name:
Matthew J Weinstock, MD
Email:
mweinsto@bidmc.harvard.edu
Facility:
Name:
Karmanos Cancer Institute
Address:
City:
Detroit
Zip:
48201
Country:
United States
Status:
Recruiting
Contact:
Last name:
Grace Bae, MPH, CCRP
Phone:
313-576-8030
Email:
baeg@karmanos.org
Facility:
Name:
Masonic Cancer Center, University of Minnesota
Address:
City:
Minneapolis
Zip:
55455
Country:
United States
Status:
Recruiting
Contact:
Last name:
Joseph Maakaron, MD
Email:
maaka001@umn.edu
Facility:
Name:
Washington University School of Medicine
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Contact:
Last name:
Katherine Stricker
Email:
kstricker@wustl.edu
Facility:
Name:
John Theurer Cancer Center
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Status:
Recruiting
Contact:
Last name:
Elizabeth McCarthy
Email:
elizabethl.mccarthy@hmhn.org
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Anthony Zisa
Email:
zisaa@mskcc.org
Facility:
Name:
Cleveland Clinic
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Contact:
Last name:
Asala Issa
Email:
issaa@ccf.org
Facility:
Name:
University of Pennsylvania, Abramson Cancer Center
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Stefan Barta, MD
Email:
Stefan.barta@pennmedicine.upenn.edu
Contact backup:
Last name:
Allison Nelson
Email:
Allison.Nelson@pennmedicine.upenn.edu
Facility:
Name:
Fox Chase Cancer Center
Address:
City:
Philadelphia
Zip:
19111
Country:
United States
Status:
Recruiting
Contact:
Last name:
Allandria Straker-Edwards
Email:
allandria.straker-edwards@fccc.edu
Start date:
October 10, 2023
Completion date:
November 30, 2027
Lead sponsor:
Agency:
Affimed GmbH
Agency class:
Industry
Collaborator:
Agency:
Artiva Biotherapeutics, Inc.
Agency class:
Industry
Source:
Affimed GmbH
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05883449
