AFM13 in Relapsed/Refractory Cutaneous Lymphomas

NCT03192202 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: AAAP4461
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lymphoma, T-Cell, Cutaneous

Keywords

Lymphoma; Cutaneous Lymphoma; cutaneous T-cell lymphoma (CTCL); CD30-Positive Cutaneous Lymphoma; T-cell lymphoma; PTCL; CTCL; CD30; immunotherapy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0

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

  Up to 2 years

Secondary Outcomes (1)

• Overall Response Rate (ORR)

  Up to 2 years

Study Arms (4)

Cohort 1

EXPERIMENTAL

1.5 mg/kg of AFM13 once weekly for weeks 1-8.

Drug: AFM13

Cohort 2

EXPERIMENTAL

7 mg/kg of AFM13 once weekly for weeks 1-8.

Drug: AFM13

Cohort 3

EXPERIMENTAL

7mg/kg CIVI for weeks 1-8.

Drug: AFM13

Cohort 4

EXPERIMENTAL

200mg flat dose once weekly for 8 weeks.

Drug: AFM13

Interventions

AFM13 DRUG

AFM13 is a recombinant antibody construct against human CD30 and CD16A. It will be given to patients intravenously at the dose and schedule applicable to the cohort the patient was enrolled in specified in the various arms listed.

Also known as: AFM13 recombinant antibody

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Histologically confirmed CD30-positive lymphoma with cutaneous involvement
• Failure or intolerance to at least one prior therapy for the current disease
• Presence of one or more cutaneous lesions (measuring at least 1 cm x 1 cm in size; if only one lesion is present it should be up to the investigator discretion to determine eligibility)
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2
• Adequate organ and marrow function
• Platelets ≥50,000/μL
• Absolute neutrophil count ≥ 1,000/μL
• Bilirubin \< 1.5 x institutional upper limit of normal (ULN) or \< 3 x ULN in patients with Gilbert's disease or liver involvement
• Serum albumin ≥ 2.0 g/dL
• Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) ≤2.5 × institutional ULN or, in the case of liver involvement by the primary disease AST/ALT ≤ 5 x ULN
• Creatinine≤1.5 x institutional ULN or estimated creatinine clearance of ≥45 mL/min by the Cockcroft-Gault equation or measured creatinine clearance \>45 mL/min
• Females of child bearing potential must have a negative serum pregnancy test with 7 days prior to first dose of treatment. Female patients of childbearing potential and all male partners must agree to use double barrier methods of contraception throughout the study period and for at least 30 days following investigational product discontinuation.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Any cancer-related therapy for the current disease within 2 weeks of screening (all supportive care measures are allowed)
• Major surgery within 2 weeks prior to first dose of study drug
• Evidence of active central nervous system (CNS) involvement
• Requirement for systemic immunosuppressive therapy (e.g. Graft-versus-Host Disease (GVHD) therapy within 12 weeks before the first dose of study drug)
• Uncontrolled concurrent serious illness.
• Concurrent malignancy or history of a previous malignancy within 3 years prior to first dose of the current study, unless curatively resected basal, squamous cell carcinoma of the skin, or cervical carcinoma in situ.
• Active infections including hepatitis B carrier status, hepatitis C virus (HCV) infection (patients must have a negative Hepatitis B and Hepatitis C viral load at screening)
• Known HIV-positive status
• Any significant medical conditions, laboratory abnormality, or psychiatric illness that would exclude the subject from participation or interfere with study treatment, monitoring and compliance such as:
• unstable angina pectoris, symptomatic congestive heart failure (New York Heart Association (NYHA) III or IV), myocardial infarction ≤ 6 months prior to first study drug, clinically significant and uncontrolled cardiac arrhythmia (e.g. atrial fibrillation/flutter ventricular cardiovascular physiology is allowed), cerebrovascular accidents ≤ 6 months before study drug start
• severely impaired lung function
• Serious, systemic infection requiring treatment ≤7 days before the first dose of study drug
• Any severe, uncontrolled disease or condition which in the investigator's opinion, may put the subject at significant risk, may confound the study results, or impact the subject's participation in the study.

Sponsors & Collaborators

• Ahmed Sawas: lead

Study Sites (1)

Center for Lymphoid Malignancies

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous; Lymphoma; Lymphoma, T-Cell

Interventions

AFM13

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Ahmed Sawas, MD
• Organization: Columbia University Irving Medical Center (CUIMC)

as4386@cumc.columbia.edu

212-305-0591

Study Officials

• Ahmed Sawas, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: June 16, 2017
• First Posted: June 20, 2017
• Study Start: July 17, 2017
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: July 20, 2023
• Results First Posted: July 20, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)