NCT05883449

Phase 2 Study of AFM13 in Combination With AB-101 in Subjects With R/R HL and CD30+ PTCL

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 CD-30 Positive Peripheral T-Cell Lymphoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Affimed GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Relapsed or Refractory Hodgkin Lymphoma
• Peripheral T Cell Lymphoma

Interventions

Type	Name	Description
DRUG	AFM13	anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
DRUG	AB-101	NK cell therapy, intravenous infusion
DRUG	Cyclophosphamide	Lymphodepleting chemotherapy, intravenous infusion
DRUG	Fludarabine	Lymphodepleting chemotherapy, intravenous infusion
DRUG	Interleukin-2	Immune cytokine, subcutaneously

Timeline

• Start date: 2023-10-10
• Primary completion: 2024-11-07
• Completion: 2025-06-13
• First posted: 2023-06-01
• Last updated: 2025-08-20
• Results posted: 2025-08-20

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study