DRKS00011887
Completed
Phase 1
First in man study to evaluate the safety, tolerability and preliminary efficacy of the Fc-optimized FLT3 antibody FLYSYN for the treatment of acute myeloid leukemia patients with minimal residual disease - FLYSYN-101
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- C92.0
- Sponsor
- Synimmune GmbH
- Enrollment
- 31
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age \=18 years at the time of voluntarily signing an IEC\-approved informed consent, there is no upper age limit
- •Diagnosis of AML according to WHO criteria
- •Confirmed FLT3 expression on leukemic cells
- •Known mutational status of FLT3 (FLT3\-ITD, FLT3\-TKD, FLT3 wild type)
- •Hematological CR (ANC count \>1\.000/µL, Thrombocytes \> 100\.000/µL), but MRD positivity after any therapy except allogeneic stem cell transplantation
- •Life expectancy of \> 3 months
- •ECOG performance status \= 2
- •Subject must be willing to receive transfusion of blood products
- •Be willing and able to comply with the study protocol for the duration of the study
- •Females of childbearing potential (FCBP) must undergo repetitive pregnancy testing (serum or urine) and results must be negative
Exclusion Criteria
- •The presence of ANY of the following criteria will exclude a patient from study enrollment:
- •Patients proceeding to hematopoietic stem cell transplantation (suitable candidate and donor available, informed consent of patient)
- •Pregnant or breast feeding females
- •\>5% blasts in bone marrow or extramedullary disease
- •Treatment with monoclonal antibody within 3 months before treatment with FLYSYN or known immunoglobulin intolerance
- •Known positivity for HIV, active HBV, HCV, or Hepatitis A infection
- •No consent for registration, storage and processing of the individual disease\-characteristics and course as well as information of the family physician and/or other physicians involved in the treatment about study participation
- •No consent for biobanking
- •Presence of any medical/psychiatric condition or laboratory abnormalities which may limit full compliance with the study, increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study
- •Prior history of malignancies, other than AML/myelodysplastic syndrome (MDS), unless the subject has (i) been free of the disease for \= 2 years. (ii) Exceptions include the following: Basal cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, histological finding of prostate cancer of TNM stage 1\.
Outcomes
Primary Outcomes
Not specified
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