A Study of CNTY-101 in Participants With CD19-Positive B-Cell Malignancies
Purpose
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.
Conditions
- R/R CD19-Positive B-Cell Malignancies
- Indolent Non-Hodgkin Lymphoma
- Aggressive Non-Hodgkin Lymphoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Diagnosis of CD19-positive relapsed or refractory (R/R) B-cell Non-Hodgkin's Lymphoma (NHL). 2. Must have met the following criteria for prior treatment: 1. 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. 2. 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. 3. Participants with marginal zone lymphoma (MZL) must have received at least 2 prior systemic therapies. 3. Measurable disease on screening evaluations. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 5. Adequate organ function. 6. Life expectancy of ≥12 weeks.
Exclusion Criteria
- Any condition that confounds the ability to interpret data from the study. 2. Central nervous system (CNS)-only involvement by malignancy. (Note: participants with secondary CNS involvement are allowed.) 3. Prior allogeneic stem cell transplant. 4. Presence of clinically significant CNS pathology. 5. Other comorbid conditions defined in the protocol. 6. Use of prohibited medications within the washout period defined in the protocol.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Dose Escalation: Schedule A |
Lymphodepleting chemotherapy (LDC) will be followed by single dose administration of CNTY-101, alone or with supplemental human recombinant interleukin 2 (IL-2). |
|
|
Experimental Dose Escalation: Schedule B |
LDC will be followed by administration of CNTY-101, 3 times over 3 weeks, alone or with supplemental IL-2. |
|
Recruiting Locations
UK Center for Clinical and Translational Science and nearby locations
University of Kentucky - Markey Cancer Center
Lexington, Kentucky 40536
Lexington, Kentucky 40536
More Details
- NCT ID
- NCT05336409
- Status
- Recruiting
- Sponsor
- Century Therapeutics, Inc.