DC Vaccination for Post-remission Therapy in AML

MediGene

Status and phase

Completed

Phase 2

Phase 1

Conditions

Acute Myeloid Leukemia

Treatments

Biological: WT1/PRAME vaccination

Study type

Interventional

Funder types

Industry

Identifiers

NCT02405338

CD-FDC-001

Details and patient eligibility

About

This is a multi-centre, open label, prospective, non-randomized phase I/II trial in 20 patients including a safety-run in phase I part comprising 6 patients.

Trial subjects will receive repeated immunotherapies with autologous Dendritic Cells (DCs), presenting two leukemia-associated antigens.

Full description

20 patients with AML who are in remission (ELN criteria by Döhner et al 2017) receive WT1/PRAME autologous DC vaccine by intradermal injection once per week during the first 4 weeks and 1 per month thereafter for 23 consecutive months.

Primary objective is to assess the safety and tolerability of the DC vaccine in the aforementioned population and the feasibility.

Secondary objectives include evaluation of clinical response and exploratory immune monitoring assessments.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of Acute Myeloid Leukemia (AML)
Age 18 - 75 years
Morphologic remission (CR) with or without hematological recovery (CRi) following induction chemotherapy
WT1 with or without PRAME positivity by qPCR
Negative pregnancy test in women of childbearing potential (within 7 days before the first vaccination). Women of childbearing potential and sexually active male participants must use reliable methods of contraception during the whole treatment period and 3 months after the last trial drug dose
Negative HIV 1 and 2 test, Hepatitis B and C test and negative Syphilis test at screening
Informed consent signed prior to any trial related activities

Exclusion criteria

Patients suitable for allogeneic stem cell transplantation
AML M3 (acute promyelocytic leukemia)
Patients not in complete remission (CR or CRi), bone marrow blast count ≥ 5 %
Active immunodeficiency syndromes
Concurrent active second malignancy other than non-melanoma skin cancers
Clinically relevant autoimmune disease
Prior immunotherapy
Severe organ dysfunction precluding the apheresis procedure:
Creatinine > 200 mmol/l
Bilirubin, ALAT and ASAT > 3 x upper normal limit
Respiratory insufficiency with pO2 < 60 mmHg
Clinically relevant coronary heart disease of ventricular arrhythmia, congestive heart failure > grade II NYHA
Recent cerebral hemorrhage
Known allergies to substances used in the generation of DCs
Other severe acute or chronic medical psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or the administration of the investigational product
Use of corticosteroids
Active CMV infection (Antibody-positivity due to previous, now inactive infection is accepted)
Inability to comply with the trial protocol
Participation in other clinical trials that, according to the investigator's discretion, may interfere with this trial