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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

ELiPSE-1 Trial Summary

This trialstudies a new drug's safety & effectiveness to treat patients with B-cell cancers that have returned or aren't responding to treatments.

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.Check my eligibility

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.See study design

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.

ELiPSE-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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.

ELiPSE-1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum Tolerated Dose (MTD) as Determined by the Percentage of Participants With Dose Limiting Toxicities (DLTs) and DLTs Based on Severity

Recommended Phase 2 Regimen (RP2R) as Recommended by the Safety Review Committee (SRC)

Secondary outcome measures

AUC: Area under the Concentration-time Curve for CNTY-101

Cmax: Maximum Observed Plasma Concentration for CNTY-101

Complete Response Rate (CRR) Based on Percentage of Participants Achieving Complete Response (CR)

+10 more

ELiPSE-1 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

~1180

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Century Therapeutics, Inc.Lead Sponsor

2 Previous Clinical Trials

401 Total Patients Enrolled

Media Library

CNTY-101 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05336409 — Phase 1

B Cell Malignancies Research Study Groups: Dose Escalation: Schedule A, Dose Escalation: Schedule B

B Cell Malignancies Clinical Trial 2023: CNTY-101 Highlights & Side Effects. Trial Name: NCT05336409 — Phase 1

CNTY-101 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05336409 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still open recruitment slots for this research experiment?

"Affirmative. The information provided on clinicaltrials.gov states that this medical experiment is currently recruiting patients, with the initial posting being made on December 1st 2022 and an update occurring November 29th of the same year. 75 participants are needed from one site for participation in this study."

Answered by AI

How reliable is Dose Escalation: Schedule B for individuals?

"In light of the fact that this is a Phase 1 trial, meaning there are only limited data points supporting its safety and efficacy, our team at Power gave Dose Escalation: Schedule B a score of one."

Answered by AI

How many participants are being monitored in this research project?

"Affirmative, details displayed on clinicaltrials.gov indicate that this medical trial is actively enrolling individuals. The study was originally posted on December 1st 2022 and recently revised as of November 29th 2022. 75 people are sought after at a single site for participation in the experiment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Study of CNTY-101 in Participants With CD19-Positive B-Cell Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05336409.