OM336 in Sensitized Transplant Candidates
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMedical University of Vienna
About this trial
This investigator-initiated, single-arm, open-label Phase IIa pilot study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of OM336 in highly HLA-sensitized adults with chronic kidney disease awaiting kidney transplantation. The study will enroll 12 participants who have either a very low likelihood of receiving a compatible deceased donor kidney because of broad HLA sensitization or unacceptable donor-specific antibodies against a potential living donor.
Participants will receive one 4-week course of subcutaneous OM336, with the option of a second 4-week course based on the change in virtual panel-reactive antibody (vPRA) levels after the initial treatment period. Participants will subsequently be followed for up to 24 months and, if transplantation occurs, for at least 12 months after transplantation.
The primary objectives are to evaluate the safety and tolerability of OM336 through Week 24 and (co-primary endpoint) its effect on HLA sensitization, assessed by changes in vPRA levels at Week 24. Secondary and exploratory objectives include assessment of the durability of changes in vPRA and donor-specific antibodies, the number of potential compatible donors, transplantation rates, OM336 pharmacokinetics and immunogenicity, and effects on B-cell and plasma-cell immunity and antibody characteristics. An optional substudy will assess B-cell immunity in bone marrow and lymph-node samples.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Biologic male or female, 18 to 70 years of age at the time of informed consent.
Capable of and willing to provide signed informed consent (ICF); subject must sign ICF indicating that he or she understands the purpose of procedures required for the study and is willing to participate in the study. Consent is to be obtained prior to the initiation of any study-related tests or procedures that are not part of standard-of-care for the subject's disease.
Willing and able to comply with the visits, treatments, procedures, laboratory tests, and other requirements according to the current protocol, with a high probability for adherence and completion of the study.
Presensitized patient
Disqualifiers
Prior treatment with any therapy that is targeted to BCMA or any other CD3-redirecting drug.
Treatment with prohibited medications during the timeframes detailed below.
History of severe allergic reaction (per investigator judgment) or anaphylactic reaction to monoclonal antibody-based therapies or any components of OM336.
Congenital immunodeficiency with recurrent severe infections over the last 12 months.
Trial design
Design model
Single group
Treatments tested in this trial
OM3436
Biological/VaccineOM336 will be administered in a fractionated fashion, as weekly SC injections, over the first 4 weeks of study treatment. OM336 administration will consist of two step-up doses ( 3 and 20 mg, respectively), followed by three doses at 40 mg in weekly intervals until Day 28. The (optional) second cycle will consist of 4 doses: week 26: 3 mg; week 27: 20 mg; week 28: 40 mg; week 30: 40 mg.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: OM336 treatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Treatment-Emergent Adverse Events (TEAE) [Safety and Tolerability]
Number and percentage of participants experiencing TEAE through Week 24, including serious adverse events (SAE) and adverse events of special interest (AESI). Adverse events will be summarized by relationship to study treatment, severity, System Organ Class (SOC), and Preferred Term (PT). The number of participants experiencing each event and the number of events will be reported. Adverse events will be coded using the Medical Dictionary for Regulatory Activities (MedDRA).
Time frame
24 weeks2
Level of vPRA
Co-primary EP: Assessment of vPRA levels at week 24.
Time frame
24 weeksSecondary outcomes
1
Incidence of Treatment-Emergent Adverse Events (TEAE) through the end of the study
Number and percentage of participants experiencing TEAE through through month 24 and in the event of transplantation, over at least 12 months post-transplantation, including serious adverse events (SAEs) and adverse events of special interest (AESIs). Adverse events will be summarized by relationship to study treatment, severity, System Organ Class (SOC), and Preferred Term (PT). The number of participants experiencing each event and the number of events will be reported. Adverse events will be coded using the Medical Dictionary for Regulatory Activities (MedDRA).
Time frame
24 months2
Level of vPRA through 24 months.
Level of vPRA at 3, 12, 15, 18, 21, and 24 months.
Time frame
24 months3
Donor frequency according to ET Donor calculator through 24 months.
Donor frequency according to ET Donor calculator at 3, 6, 12, 15, 18, 21, and 24 months.
Time frame
24 months4
Number of unacceptable antigens
Number of unacceptable antigens that can be delisted at 3, 6, 12, 15, 18, 21, and 24 months, according to the following rules: (i) Unacceptable "plausible" antigens: if \<1000 MFI; (ii) locally unacceptable antigens without recorded sensitizing event: if \<10.000, provided a peri-transplant desensitization program is available (Vienna 6) or if \<3000, if no such program is available (Berlin). According to the ET rules, eligibility for AM allocation will be re-evaluated by the ET central lab after delisting antigens.
Time frame
24 monthsSponsors and contacts
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Source ClinicalTrials.gov
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