A Study of ELA026 in Participants With Relapsed/Refractory (R/R) T/NK Cell Malignancies (TCMs)
ConditionT Cell Malignancies
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorElectra Therapeutics Inc.
About this trial
This is a Phase 1, two-part, multicenter study to evaluate ELA026 in participants ≥18 years old with relapsed/refractory TCM following any line of prior therapy who are eligible for investigational treatments.
Eligibility criteria
Qualifiers
Age ≥18 years Participants with a confirmed histologic diagnosis of a TCM who are R/R following any line of prior therapy (participants with CTCLs should have received at least 2 prior lines of systemic therapy for R/R CTCL) and eligible for investigational therapies
Presence of measurable disease by clinical examination, radiologic imaging (computed tomography, magnetic resonance imaging, or whole body FDG-PET scans), and/or in bone marrow aspirate/biopsy
Eastern Cooperative Oncology Group performance score of ≤2
Anticipated life expectancy >6 months per investigator judgment
Disqualifiers
Participants who are eligible for standard of care or approved therapeutic options for R/R TCMs with established clinical benefit
Organ dysfunction as defined in the protocol
Participants with hemophagocytic lymphohistiocytosis (HLH) based on HLH2004 diagnostic criteria
Participants receiving or planning to start immunotherapy or immune effector cell therapy (such as chimeric antigen receptor [CAR] T-cell therapy, T-cell engagers, or programmed cell death protein 1 [PD1]/programmed cell death ligand 1 [PD-L1] inhibitors)
Trial design
Treatments tested in this trial
- ELA026
Treatment groups
84 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov