NCT03192202

AFM13 in Relapsed/Refractory Cutaneous Lymphomas

Completed Phase 1, PHASE2 Results posted Last updated 20 July 2023

What this trial tests

Phase 1, PHASE2 trial testing AFM13 in Lymphoma, T-Cell, Cutaneous in 18 participants. Completed in 1 April 2020.

Timeline

17 July 2017

Primary endpoint
1 April 2020

1 April 2020

Quick facts

Lead sponsor	Ahmed Sawas
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	17 July 2017
Primary completion	1 April 2020
Estimated completion	1 April 2020
Sites	1 location across United States

Drugs / interventions tested

• AFM13 — full drug profile →

Conditions studied

• Lymphoma, T-Cell, Cutaneous — all drugs for Lymphoma, T-Cell, Cutaneous →

Sponsor

Ahmed Sawas

Who can join

18 and older, any sex, with Lymphoma, T-Cell, Cutaneous. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 Primary · Up to 2 years

Incidence of Treatment-Emergent Adverse Events \[Safety and Toxicity\] broken down by adverse event and CTCAE v4.0 grade of each event.

Group	Value	95% CI
Cohort 1	1
Cohort 2	0
Cohort 3	0
Cohort 4	0
Cohort 1	0
Cohort 2	2
Cohort 3	0
Cohort 4	0
Cohort 1	0
Cohort 2	1
Cohort 3	0
Cohort 4	0
Cohort 1	2
Cohort 2	0
Cohort 3	3
Cohort 4	6

Overall Response Rate (ORR) Secondary · Up to 2 years

The sum of patients with partial responses and complete responses.

Group	Value	95% CI
Cohort 1	2
Cohort 2	0
Cohort 3	2
Cohort 4	2

Adverse events — posted to ClinicalTrials.gov

Time frame: 2 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohort 1

Serious: 1/3 (33%)

Deaths: 0/3

Cohort 2

Serious: 1/3 (33%)

Deaths: 1/3

Cohort 3

Serious: 0/3 (0%)

Deaths: 0/3

Cohort 4

Serious: 0/6 (0%)

Deaths: 0/6

Serious adverse events (3 terms)

Reaction	System	Cohort 1	Cohort 2	Cohort 3	Cohort 4
G3/4 Infection and skin rash	Skin and subcutaneous tissue disorders	—	—	—	—
G1 IRR	General disorders	—	—	—	—
Death, G3 infection, IRR	General disorders	—	—	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Cohort 1	Cohort 2	Cohort 3	Cohort 4
Infusion related reaction (IRR)	General disorders	—	—	—	—

Most-reported serious reactions: G3/4 Infection and skin rash, G1 IRR, Death, G3 infection, IRR.

Data from ClinicalTrials.gov NCT03192202 adverse events section.

Sponsor's own description

The investigators plan to investigate AFM13 and evaluate its ability to facilitate and redirect the Natural Killer (NK) cells in eliminating CD30-positive lymphoma targets in the skin and, by inference, other organs involved by the lymphoma.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Exploring the NK cell platform for cancer immunotherapy.
   Myers JA, Miller JS. · · 2021 · cited 977× · PMID 32934330 · DOI 10.1038/s41571-020-0426-7
2. Emerging new therapeutic antibody derivatives for cancer treatment.
   Jin S, Sun Y, Liang X, Gu X, et al · · 2022 · cited 304× · PMID 35132063 · DOI 10.1038/s41392-021-00868-x
3. Clinical cancer immunotherapy: Current progress and prospects.
   Liu C, Yang M, Zhang D, Chen M, et al · · 2022 · cited 147× · PMID 36304470 · DOI 10.3389/fimmu.2022.961805
4. A phase 1b study of AFM13 in combination with pembrolizumab in patients with relapsed or refractory Hodgkin lymphoma.
   Bartlett NL, Herrera AF, Domingo-Domenech E, Mehta A, et al · · 2020 · cited 110× · PMID 32730586 · DOI 10.1182/blood.2019004701
5. Targeting Natural Killer Cells for Tumor Immunotherapy.
   Zhang C, Hu Y, Shi C. · · 2020 · cited 91× · PMID 32140153 · DOI 10.3389/fimmu.2020.00060
6. Expanding the Boundaries of Biotherapeutics with Bispecific Antibodies.
   Husain B, Ellerman D. · · 2018 · cited 83× · PMID 30132211 · DOI 10.1007/s40259-018-0299-9
7. Biology drives the discovery of bispecific antibodies as innovative therapeutics.
   Nie S, Wang Z, Moscoso-Castro M, D'Souza P, et al · · 2020 · cited 79× · PMID 33928225 · DOI 10.1093/abt/tbaa003
8. Bispecific, T-Cell-Recruiting Antibodies in B-Cell Malignancies.
   Lejeune M, Köse MC, Duray E, Einsele H, et al · · 2020 · cited 70× · PMID 32457743 · DOI 10.3389/fimmu.2020.00762