Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call
1-800-KARMANOS (1-800-527-6266)
or request an appointment below
Back to Results
A Phase 2, Open-Label, Multi-Center Study of Innate Cell Engager AFM13 in Combination with Allogeneic Natural Killer Cells (AB-101) in Subjects with Recurrent or Refractory Hodgkin Lymphoma and CD30-Positive Peripheral T-Cell Lymphoma (LuminICE-203)
Cancer Categories
Hematologic (Blood Cancers)
Karmanos Trial ID
2023-062
NCT ID
NCT05883449
Age Group
Adult
Scope
National
Phase
Phase II
Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks.
Phase II
Principal Investigator
Dipenkumar
Modi, M.D.
Oncology - Hematology, Oncology - Medical
View Profile
Objective:
Primary Objective:
Assess the antitumor activity of AFM13 in combination with AB-101 in subjects with R/R classical HL and CD30-positive PTCLs by ORR.
Secondary Objectives:
To assess efficacy of AFM13 in combination with AB-101
To assess the incidence of post-treatment transplant
To assess the safety and tolerability of AFM13 in combination with AB-101
To assess the immunogenicity of AFM13 in combination with AB-101
Request an Appointment
Refer a Patient
NCI Dictionary of Cancer Terms
KCI Clinical Trials App
Eligibility
Locations
Applicable Disease Site
Therapies | Drugs | Devices
Eligibility
Eligibility
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
Locations
Locations
Karmanos Cancer Institute - Detroit Headquarters
4100 John R
Detroit, MI 48201
Get Directions
Phone:
800-527-6266
Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills
31995 Northwestern Hwy
Farmington Hills, MI 48334
Get Directions
Phone:
800-527-6266
Applicable Disease Site
Applicable Disease Site
Hodgkin Lymphoma; Non-Hodgkin Lymphoma
Therapies, Drugs, Devices
Therapies | Drugs | Devices
Therapies
Cellular Therapy, Chemotherapy, Immunotherapy
Drugs
AB-101; AFM13; Cyclophosphamide; Fludara; Interleukin-2
Loading...