Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05817058
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2023-03-22
Brief Title:
First-in-Human Dose Escalation Study of AFM28 in Patients With RelapsedRefractory Acute Myeloid Leukemia
Sponsor:
Affimed GmbH
Organization:
Affimed GmbH
Study Overview
Official Title:
A Phase 1 Multicenter Open Label First-in-Human Dose Escalation Study of AFM28 a Bispecific ICE That Targets CD123 and CD16A in Patients With CD123-Positive RelapsedRefractory Acute Myeloid Leukemia
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a First In Human phase 1 open-label non-randomized multi-center multiple ascending dose escalation study evaluating AFM28 as a monotherapy in subjects with RelapsedRefractory CD123-positive Acute Myeloid Leukemia AML AFM28 is a tetravalent monoclonal antibody targeting the interleukin-3 receptor subunit alpha IL3RA CD123 and the low affinity immunoglobulin gamma Fc region receptor III-A FCGR3A CD16A It is developed as an antineoplastic agent for hematologic malignancies known to express CD123 The primary pharmacological Mode of Action of AFM28 is induction of cell death of CD123-expressing cells by stimulating Antibody-Dependent Cell-mediated Cytotoxicity mediated by CD16A-expressing immune cells primarily Natural Killer cells The aim of the dose escalation is to determine the Maximum Tolerated Dose MTD andor establish one or more Recommended Phase 2 Doses based on safety preliminary anti-leukemic activity and Pharmacokinetics Pharmacodynamics data
Detailed Description:
The study drug will be given by intravenous infusion once weekly as long as the subject is deriving clinical benefit until disease progression or other treatment discontinuation criteria met unacceptable toxicity or subjects refusal whichever occurs first The dose-limiting toxicity observation period will be 28 days reflecting adequate exposure for safety assessment The dose-escalation scheme will follow a Bayesian logistic regression model A safety review committee will monitor safety and recommend all cohort dosing decisions The starting First In Human dose for AFM28 will be 25 mg iv and treatment in each cohort will utilize a staggered approach with at least 7 days between the first dose of the first subject and the first dose of subsequent subjects In order to gather additional Pharmacokinetics Pharmacodynamics and safety data to inform potential final dose escalation decisions and selection of one or more recommended phase 2 doses at selected dose levels additional subjects may be enrolled in at least two cohorts consistent with backfilling a cohort up to 12 subjects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None