ELiPSE-1: A Study of CNTY-101 in Participants With CD19-Positive B-Cell Malignancies

Sponsor

Century Therapeutics, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05336409

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
R/R CD19-Positive B-Cell Malignancies Indolent Non-Hodgkin Lymphoma Aggressive Non-Hodgkin Lymphoma	Biological: CNTY-101 Biological: IL-2 Drug: Lymphodepleting Chemotherapy	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The ELiPSE Study: A Phase 1, Multicenter, Open-Label Study of CNTY-101 in Subjects With Relapsed or Refractory CD19-Positive B-Cell Malignancies

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Aug 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
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).	Biological: CNTY-101 CNTY-101 cells for intravenous (IV) infusion Biological: IL-2 IL-2 subcutaneous (SQ) injection Drug: Lymphodepleting Chemotherapy LDC as prespecified in the protocol.
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.	Biological: CNTY-101 CNTY-101 cells for intravenous (IV) infusion Biological: IL-2 IL-2 subcutaneous (SQ) injection Drug: Lymphodepleting Chemotherapy LDC as prespecified in the protocol.

Arm

Intervention/Treatment

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).

Biological: CNTY-101

CNTY-101 cells for intravenous (IV) infusion

Biological: IL-2

IL-2 subcutaneous (SQ) injection

Drug: Lymphodepleting Chemotherapy

LDC as prespecified in the protocol.

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.

Biological: CNTY-101

CNTY-101 cells for intravenous (IV) infusion

Biological: IL-2

IL-2 subcutaneous (SQ) injection

Drug: Lymphodepleting Chemotherapy

LDC as prespecified in the protocol.

Outcome Measures

Primary Outcome Measures

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 Determined by the Safety Review Committee (SRC) [Up to 28 days]

Secondary Outcome Measures

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.
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.
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]
Tmax: Time to Reach the Maximum Plasma Concentration for CNTY-101 [Day 1 up to 2 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.
Life expectancy of ≥12 weeks.

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.
Presence of clinically significant CNS pathology.
Other comorbid conditions defined in the protocol.
Use of prohibited medications within the washout period defined in the protocol.