A Study of CNTY-101 in Participants With CD19-Positive B-Cell Malignancies
NCT ID: NCT05336409
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
28 participants
INTERVENTIONAL
2023-01-24
2025-07-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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).
CNTY-101
CNTY-101 cells for intravenous (IV) infusion
IL-2
IL-2 subcutaneous (SQ) injection
Lymphodepleting Chemotherapy
LDC as prespecified in the protocol.
Dose Escalation: Schedule B
LDC will be followed by administration of CNTY-101, 3 times over 3 weeks, alone or with supplemental IL-2.
CNTY-101
CNTY-101 cells for intravenous (IV) infusion
IL-2
IL-2 subcutaneous (SQ) injection
Lymphodepleting Chemotherapy
LDC as prespecified in the protocol.
Interventions
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CNTY-101
CNTY-101 cells for intravenous (IV) infusion
IL-2
IL-2 subcutaneous (SQ) injection
Lymphodepleting Chemotherapy
LDC as prespecified in the protocol.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Century Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
University of Southern California - Norris Comprehensive Cancer Center
Los Angeles, California, United States
University of California San Diego, Moores Cancer Center
San Diego, California, United States
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States
University of Kentucky - Markey Cancer Center
Lexington, Kentucky, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Henry Ford Hospital
Detroit, Michigan, United States
Corewell Health
Grand Rapids, Michigan, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Oncology Hematology Care, Inc-Kenwood
Cincinnati, Ohio, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
UT Southwestern
Dallas, Texas, United States
Houston Methodist Research Institute
Houston, Texas, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Swedish Cancer Institute
Seattle, Washington, United States
Countries
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Other Identifiers
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CNTY-101-111-01 (ELiPSE-1)
Identifier Type: -
Identifier Source: org_study_id