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DRUG CLASS:

CD30 inhibitor

2ms
CD16A Shedding Regulates Innate Cell Engager-Induced Serial Killing by Natural Killer Cells. (PubMed, Eur J Immunol)
The bispecific innate cell engager acimtamig (AFM13) was superior to IgG1 monoclonal antibodies in ADCC and in increasing the fraction of cytotoxic NK cells and serial killers...These results demonstrate that CD16A shedding represents an intrinsic feature of NK cell biology that is critical to sustain the antitumoral cytotoxicity of NK cells. This has implications for CD16A engineering of NK cell products and their combination with CD16A-directed NK cell engagers.
Journal
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FCGR3A (Fc Fragment Of IgG Receptor IIIa)
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acimtamig (AFM13)
2ms
NCI-2019-03536: Modified Immune Cells (AFM13-NK) and A Monoclonal Antibody (AFM13) in Treating Patients With Recurrent or Refractory CD30 Positive Hodgkin or Non-Hodgkin Lymphomas (clinicaltrials.gov)
P1/2, N=45, Completed, M.D. Anderson Cancer Center | Active, not recruiting --> Completed | N=30 --> 45 | Trial completion date: Apr 2027 --> Sep 2025 | Trial primary completion date: Apr 2027 --> Sep 2025
Trial completion • Enrollment change • Trial completion date • Trial primary completion date
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TNFRSF8 (TNF Receptor Superfamily Member 8)
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TNFRSF8 positive
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cyclophosphamide • fludarabine IV • acimtamig (AFM13)
4ms
LuminICE-203: Phase 2 Study of AFM13 in Combination With AB-101 in Subjects With R/R HL and CD30+ PTCL (clinicaltrials.gov)
P2, N=25, Terminated, Affimed GmbH | N=154 --> 25 | Trial completion date: Nov 2027 --> Jun 2025 | Recruiting --> Terminated | Trial primary completion date: Apr 2026 --> Nov 2024; Due to sponsor decision
Enrollment change • Trial completion date • Trial termination • Trial primary completion date
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ALK (Anaplastic lymphoma kinase) • TNFRSF8 (TNF Receptor Superfamily Member 8)
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ALK positive • TNFRSF8 positive • ALK negative
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cyclophosphamide • fludarabine IV • acimtamig (AFM13) • AFM13/AB-101 • AlloNK (GCC4001)
6ms
CD30biAb-AATC for CD30+ Malignancies (clinicaltrials.gov)
P1, N=42, Not yet recruiting, Medical College of Wisconsin | Phase classification: P1/2 --> P1 | Trial completion date: Jan 2027 --> Jul 2028
Phase classification • Trial completion date
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TNFRSF8 (TNF Receptor Superfamily Member 8)
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TNFRSF8 expression
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CD30 biAb-AATC • Leukine (sargramostim)
8ms
NCI-2019-03536: Modified Immune Cells (AFM13-NK) and A Monoclonal Antibody (AFM13) in Treating Patients With Recurrent or Refractory CD30 Positive Hodgkin or Non-Hodgkin Lymphomas (clinicaltrials.gov)
P1/2, N=30, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Apr 2025 --> Apr 2027 | Trial primary completion date: Apr 2025 --> Apr 2027
Trial completion date • Trial primary completion date
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TNFRSF8 (TNF Receptor Superfamily Member 8)
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TNFRSF8 positive
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cyclophosphamide • fludarabine IV • acimtamig (AFM13)
8ms
Allogeneic NK cells with a bispecific innate cell engager in refractory relapsed lymphoma: a phase 1 trial. (PubMed, Nat Med)
Outcomes of patients with CD30-positive (CD30+) lymphomas have improved with the advent of brentuximab vedotin (BV) and, in Hodgkin lymphoma, anti-PD1 checkpoint inhibitors (CPI)...AFM13-a CD30/CD16A bispecific antibody-activates natural killer (NK) cells to kill CD30+ cells...This therapy showed encouraging preliminary safety and efficacy. ClinicalTrials.gov Identifier: NCT04074746 .
P1 data • Journal
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TNFRSF8 (TNF Receptor Superfamily Member 8) • FCGR3A (Fc Fragment Of IgG Receptor IIIa)
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TNFRSF8 positive
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Adcetris (brentuximab vedotin) • acimtamig (AFM13)
9ms
A First-in-human Trial of GEN3017 in Hodgkin Lymphoma and Non-Hodgkin Lymphoma (clinicaltrials.gov)
P1/2, N=9, Terminated, Genmab | N=240 --> 9 | Trial completion date: Dec 2032 --> Feb 2025 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2029 --> Feb 2025; Genmab discontinued GEN3017 program following a strategic re-evaluation of Genmab's portfolio.
Enrollment change • Trial completion date • Trial termination • Trial primary completion date
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TNFRSF8 (TNF Receptor Superfamily Member 8)
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TNFRSF8 positive
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GEN3017
1year
Study of PD-1 Inhibitors After CD30.CAR T Cell Therapy in Relapsed/Refractory Hodgkin Lymphoma (clinicaltrials.gov)
P1, N=10, Active, not recruiting, UNC Lineberger Comprehensive Cancer Center | Trial completion date: Aug 2039 --> Jul 2037 | Trial primary completion date: Nov 2024 --> Apr 2025
Trial completion date • Trial primary completion date • CAR T-Cell Therapy • Immunomodulating
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TNFRSF8 (TNF Receptor Superfamily Member 8) • CCR4 (C-C Motif Chemokine Receptor 4)
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Keytruda (pembrolizumab) • Opdivo (nivolumab)
1year
A First-in-human Trial of GEN3017 in Hodgkin Lymphoma and Non-Hodgkin Lymphoma (clinicaltrials.gov)
P1/2, N=240, Active, not recruiting, Genmab | Recruiting --> Active, not recruiting
Enrollment closed
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TNFRSF8 (TNF Receptor Superfamily Member 8)
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TNFRSF8 positive
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GEN3017
1year
A Phase 2 study of acimtamig (AFM13) in patients with CD30-positive, relapsed or refractory peripheral T-cell lymphomas. (PubMed, Clin Cancer Res)
The promising clinical efficacy observed warrants further investigation, and development of acimtamig for patients with R/R CD30+ lymphomas continues in combination with allogeneic natural killer cells.
P2 data • Journal
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TNFRSF8 (TNF Receptor Superfamily Member 8) • FCGR3A (Fc Fragment Of IgG Receptor IIIa)
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TNFRSF8 positive • TNFRSF8 expression
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Adcetris (brentuximab vedotin) • acimtamig (AFM13)
1year
Study of PD-1 Inhibitors After CD30.CAR T Cell Therapy in Relapsed/Refractory Hodgkin Lymphoma (clinicaltrials.gov)
P1, N=10, Active, not recruiting, UNC Lineberger Comprehensive Cancer Center | Recruiting --> Active, not recruiting | N=20 --> 10 | Trial completion date: Jul 2037 --> Aug 2039 | Trial primary completion date: Apr 2025 --> Nov 2024
Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • CAR T-Cell Therapy • Immunomodulating
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TNFRSF8 (TNF Receptor Superfamily Member 8) • CCR4 (C-C Motif Chemokine Receptor 4)
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Keytruda (pembrolizumab) • Opdivo (nivolumab)
almost2years
Study of PD-1 Inhibitors After CD30.CAR T Cell Therapy in Relapsed/Refractory Hodgkin Lymphoma (clinicaltrials.gov)
P1, N=20, Recruiting, UNC Lineberger Comprehensive Cancer Center | Trial primary completion date: Apr 2024 --> Apr 2025
Trial primary completion date • CAR T-Cell Therapy • Immunomodulating
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TNFRSF8 (TNF Receptor Superfamily Member 8) • CCR4 (C-C Motif Chemokine Receptor 4)
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Keytruda (pembrolizumab) • Opdivo (nivolumab)