A Study of CNTY-101 in Participants With CD19-Positive B-Cell Malignancies (NCT05336409) | Clinical Trial Compass
TerminatedPhase 1
A Study of CNTY-101 in Participants With CD19-Positive B-Cell Malignancies
Stopped: Strategic decision
United States28 participantsStarted 2023-01-24
Plain-language summary
ELiPSE-1 is a Phase 1, multi-center, dose-finding study to evaluate the safety, pharmacokinetics, and preliminary efficacy of CNTY-101 in participants with relapsed or refractory cluster of differentiation (CD)19-positive B-cell malignancies.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Diagnosis of CD19-positive relapsed or refractory (R/R) B-cell Non-Hodgkin's Lymphoma (NHL).
✓. Must have met the following criteria for prior treatment:
✓. Participants with aggressive NHL must have received at least 2 lines of systemic therapy (if not intended for transplant, have already undergone or be unwilling or unable to undergo chimeric antigen receptor \[CAR\] T-cell therapy to be eligible), or at least 3 lines of systemic therapy. Previous therapy must have included a CD20-targeted agent and an anthracycline or alkylator.
✓. Participants with follicular lymphoma (FL) must have received at least 2 lines of systemic therapy and have high-risk disease. Previous therapy must have included a CD20-targeted agent and an alkylator.
✓. Participants with marginal zone lymphoma (MZL) must have received at least 2 prior systemic therapies.
✓. Measurable disease on screening evaluations.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
✓. Adequate organ function.
Exclusion criteria
✕. Any condition that confounds the ability to interpret data from the study.
✕. Central nervous system (CNS)-only involvement by malignancy. (Note: participants with secondary CNS involvement are allowed.)
✕. Prior allogeneic stem cell transplant.
What they're measuring
1
Maximum Tolerated Dose (MTD) as Determined by the Percentage of Participants With Dose Limiting Toxicities (DLTs) and DLTs Based on Severity
Timeframe: Up to 28 days
2
Recommended Phase 2 Regimen (RP2R) as Recommended by the Safety Review Committee (SRC)