R/R CD19-Positive B-Cell Malignancies, Indolent Non-Hodgkin Lymphoma, Aggressive Non-Hodgkin Lymphoma
Conditions
Keywords
Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone, Cellular therapy, Cell therapy, CNTY-101, Century Therapeutics, Induced pluripotent stem cells, CAR-NK, NK cell
Brief 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.
Interventions
BIOLOGICALCNTY-101
CNTY-101 cells for intravenous (IV) infusion
BIOLOGICALIL-2
IL-2 subcutaneous (SQ) injection
LDC as prespecified in the protocol.
Sponsors
Century Therapeutics, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Tolerated Dose (MTD) as Determined by the Percentage of Participants With Dose Limiting Toxicities (DLTs) and DLTs Based on Severity | Up to 28 days |
| Recommended Phase 2 Regimen (RP2R) as Recommended by the Safety Review Committee (SRC) | Up to 28 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response (DOR) | Up to 2 years | DOR is defined as time from first response (CR or PR) to the first documentation of progressive disease (PD) or death. |
| Time to Treatment Response (TTR) | Day 1 up to 2 years | TTR is defined as time from first CNTY-101 infusion to the first documentation of response (CR or PR). |
| Progression-Free Survival (PFS) | Day 1 up to 2 years | PFS is defined as time from first CNTY-101 infusion to the first documentation of PD, or death from any cause, whichever occurs first |
| Overall Survival (OS) | Day 1 up to 2 years | OS is defined as time from CNTY-101 infusion to death. |
| Cmax: Maximum Observed Plasma Concentration for CNTY-101 | Day 1 up to 2 years | — |
| Complete Response Rate (CRR) Based on Percentage of Participants Achieving Complete Response (CR) | Up to 2 years | CRR will be determined using Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification. |
| t1/2: Terminal Disposition Phase Half-life for CNTY-101 | Day 1 up to 2 years | — |
| AUC: Area under the Concentration-time Curve for CNTY-101 | Day 1 up to 2 years | — |
| Percentage of Participants With at Least one Treatment Emergent Adverse Event (TEAE) | Day 1 up to 2 years | — |
| Percentage of Participants With Clinically Significant Laboratory Abnormalities | Day 1 up to 2 years | — |
| Time to Treatment Initiation | Enrollment to first CNTY-101 infusion (up to approximately 2 weeks) | Time to treatment initiation is defined as the time from enrollment in the study to first CNTY-101 infusion. |
| Tmax: Time to Reach the Maximum Plasma Concentration for CNTY-101 | Day 1 up to 2 years | — |
| Objective Response Rate (ORR) Based on Percentage of Participants Achieving CR or Partial Response (PR) | Up to 2 years | ORR will be determined using Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification. |
Countries
United States
Outcome results
None listed