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CAR T-cell Therapy
CNTY-101 for B-Cell Malignancies (ELiPSE-1 Trial)
Phase 1
Recruiting
Research Sponsored by Century Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of CD19-positive relapsed or refractory (R/R) B-cell Non-Hodgkin's Lymphoma (NHL)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Must not have
Presence of clinically significant CNS pathology
Prior allogeneic stem cell transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new treatment called CNTY-101 to see if it is safe and effective for patients whose B-cell cancers have come back or did not respond to previous treatments. The treatment works by targeting a marker called CD19 on the cancer cells.
Who is the study for?
This trial is for people with CD19-positive B-cell Non-Hodgkin's Lymphoma that has come back or hasn't responded to treatment. They must have tried at least two or three prior therapies, including a CD20-targeted agent and an anthracycline or alkylator. Participants should be fairly active (ECOG 0-1), have measurable disease, good organ function, and a life expectancy of over 12 weeks.
What is being tested?
The ELiPSE-1 study is testing CNTY-101 in patients with certain types of blood cancer. It's the first phase where they're figuring out safe doses, how the body processes the drug, and if it works well against these cancers. Patients will also receive lymphodepleting chemotherapy and IL-2 as part of their treatment.
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as fever and fatigue, effects from chemotherapy like nausea and hair loss, plus risks associated with new drugs like CNTY-101 which are being studied but could affect organs or cause allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lymphoma is CD19-positive and has come back or didn't respond to treatment.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a significant brain or spinal cord condition.
Select...
I have had a stem cell transplant from a donor.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Complete Response Rate (CRR) Based on Percentage of Participants Achieving Complete Response (CR)
Duration of Response (DOR)
Objective Response Rate (ORR) Based on Percentage of Participants Achieving CR or Partial Response (PR)
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Dose Escalation: Schedule BExperimental Treatment3 Interventions
LDC will be followed by administration of CNTY-101, 3 times over 3 weeks, alone or with supplemental IL-2.
Group II: Dose Escalation: Schedule AExperimental Treatment3 Interventions
Lymphodepleting chemotherapy (LDC) will be followed by single dose administration of CNTY-101, alone or with supplemental human recombinant interleukin 2 (IL-2).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IL-2
2007
Completed Phase 4
~1100
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
CD19-targeted therapies, such as CAR-T cell therapy and monoclonal antibodies, are pivotal in treating B Cell Malignancies. CAR-T cell therapy involves modifying a patient's T cells to express a receptor specific to CD19, a protein found on the surface of B cells, enabling these engineered T cells to identify and destroy malignant B cells.
Monoclonal antibodies, like rituximab, also target CD19 or other B cell-specific antigens, marking the cancer cells for destruction by the immune system. These therapies are significant because they offer targeted treatment options that can lead to substantial remission rates in patients with relapsed or refractory B Cell Malignancies, providing hope where traditional therapies may have failed.
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Who is running the clinical trial?
Century Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
405 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a significant brain or spinal cord condition.My lymphoma is CD19-positive and has come back or didn't respond to treatment.I am fully active or restricted in physically strenuous activity but can do light work.My cancer has spread to my brain but not only there.I have followed specific treatment guidelines for my type of non-Hodgkin lymphoma.My organs are working well.I have had a stem cell transplant from a donor.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation: Schedule A
- Group 2: Dose Escalation: Schedule B
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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