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

• Register: ClinicalTrials.gov
• Last refreshed on: 6 January 2025
• Main ID: NCT05336409
• Date of registration: 08/04/2022
• Prospective Registration: Yes
• Primary sponsor: Century Therapeutics, Inc.
• Public title: A Study of CNTY-101 in Participants With CD19-Positive B-Cell Malignancies ELiPSE-1
• Scientific title: 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
• Date of first enrolment: January 24, 2023
• Target sample size: 75
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT05336409
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Nikolaus Trede

Key inclusion & exclusion criteria

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.


Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Aggressive Non-Hodgkin Lymphoma

R/R CD19-Positive B-Cell Malignancies

Indolent Non-Hodgkin Lymphoma

Intervention(s)

Drug: Lymphodepleting Chemotherapy

Biological: CNTY-101

Biological: IL-2

Primary Outcome(s)

Recommended Phase 2 Regimen (RP2R) as Recommended by the Safety Review Committee (SRC) [Time Frame: Up to 28 days]

Maximum Tolerated Dose (MTD) as Determined by the Percentage of Participants With Dose Limiting Toxicities (DLTs) and DLTs Based on Severity [Time Frame: Up to 28 days]

Secondary Outcome(s)

Objective Response Rate (ORR) Based on Percentage of Participants Achieving CR or Partial Response (PR) [Time Frame: Up to 2 years]

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

AUC: Area under the Concentration-time Curve for CNTY-101 [Time Frame: Day 1 up to 2 years]

Percentage of Participants With at Least one Treatment Emergent Adverse Event (TEAE) [Time Frame: Day 1 up to 2 years]

Complete Response Rate (CRR) Based on Percentage of Participants Achieving Complete Response (CR) [Time Frame: Up to 2 years]

Duration of Response (DOR) [Time Frame: Up to 2 years]

Time to Treatment Initiation [Time Frame: Enrollment to first CNTY-101 infusion (up to approximately 2 weeks)]

Time to Treatment Response (TTR) [Time Frame: Day 1 up to 2 years]

Cmax: Maximum Observed Plasma Concentration for CNTY-101 [Time Frame: Day 1 up to 2 years]

Overall Survival (OS) [Time Frame: Day 1 up to 2 years]

Percentage of Participants With Clinically Significant Laboratory Abnormalities [Time Frame: Day 1 up to 2 years]

Progression-Free Survival (PFS) [Time Frame: Day 1 up to 2 years]

t1/2: Terminal Disposition Phase Half-life for CNTY-101 [Time Frame: Day 1 up to 2 years]

Secondary ID(s)

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

Source(s) of Monetary Support

Please refer to primary and secondary sponsors