Clinical trial · Interventional
A Study of CNTY-101 in Participants With CD19-Positive B-Cell Malignancies
The ELiPSE-1 Study: A Phase 1, Multicenter, Open-Label Study of CNTY-101 in Subjects With Relapsed or Refractory CD19-Positive B-Cell Malignancies
NCT05336409CI-TRIAL-00099257ELiPSE-1terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Strategic decision
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Aggressive Non-Hodgkin Lymphoma | Aggressive Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Indolent Non-Hodgkin Lymphoma | Indolent Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| R/R CD19-Positive B-Cell Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CNTY-101 | Biological | — | UNRESOLVED |
| IL-2 | Biological | — | UNRESOLVED |
| Lymphodepleting Chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose Escalation: Schedule A
- description
- Lymphodepleting chemotherapy (LDC) will be followed by single dose administration of CNTY-101, alone or with supplemental human recombinant interleukin 2 (IL-2).
- interventionNames
- Biological: CNTY-101
- Biological: IL-2
- Drug: Lymphodepleting Chemotherapy
- type
- EXPERIMENTAL
- label
- Dose Escalation: Schedule B
- description
- LDC will be followed by administration of CNTY-101, 3 times over 3 weeks, alone or with supplemental IL-2.
- interventionNames
- Biological: CNTY-101
- Biological: IL-2
- Drug: Lymphodepleting Chemotherapy
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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: 1. 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.
References
Publications (0)
Data not yet available
No reference posted for this study.