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

Century Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: Aggressive Non-Hodgkin Lymphoma; Indolent Non-Hodgkin Lymphoma; R/R CD19-Positive B-Cell Malignancies

Treatments: Drug: Lymphodepleting Chemotherapy; Biological: IL-2; Biological: CNTY-101

Study type: Interventional

Funder types: Industry

Identifiers

NCT05336409

CNTY-101-111-01 (ELiPSE-1)

Details and patient eligibility

About

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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75 participants in 2 patient groups

Dose Escalation: Schedule A

Experimental group

Description:

Lymphodepleting chemotherapy (LDC) will be followed by single dose administration of CNTY-101, alone or with supplemental human recombinant interleukin 2 (IL-2).

Treatment:

Biological: IL-2

Biological: CNTY-101

Drug: Lymphodepleting Chemotherapy

Dose Escalation: Schedule B

Experimental group

Description:

LDC will be followed by administration of CNTY-101, 3 times over 3 weeks, alone or with supplemental IL-2.

Treatment:

Biological: IL-2

Biological: CNTY-101

Drug: Lymphodepleting Chemotherapy