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Monoclonal Antibodies

CNTY-101 for Lupus (CALiPSO-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

Participants must have a diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus for at least 6 months.

Participants must have elevated anti- double stranded deoxyribonucleic acid (anti-dsDNA) and/or elevated anti-Smith antibody test at Screening (a single retest of previously positive participants who were negative at screening will be allowed).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called CNTY-101 in people with autoimmune diseases like lupus. The study will determine the safety and effectiveness of different doses of the drug in patients who have

Who is the study for?

This trial is for people with tough-to-treat B cell-mediated autoimmune diseases, like severe lupus. They should have a specific diagnosis of SLE for at least 6 months and active disease as shown by certain test scores. Those with stable diabetes or hypothyroidism can join if their condition has been under control for over a month.

What is being tested?

CALiPSO-1 is testing CNTY-101's safety and effectiveness in patients with refractory autoimmune conditions. It involves giving participants CNTY-101 along with IL-2 and lymphodepleting chemotherapy to see how well it works against severe symptoms of diseases like lupus.

What are the potential side effects?

Possible side effects may include reactions related to the immune system, such as inflammation in different body parts due to IL-2, complications from lowering the body's immune cells through chemotherapy, and any specific effects tied to CNTY-101.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with SLE for at least 6 months.

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I have high levels of anti-dsDNA or anti-Smith antibodies.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Arm D: CNTY-101 in DcSSC ParticipantsExperimental Treatment3 Interventions

During Part 1 (Dose Confirmation Phase), participants with DcSSC will undergo LDC followed by administration of CNTY-101, administered 3 times over 3 weeks, during Cycle 1 (cycle length = 28 days), alone or with supplemental IL-2. After completion of Cycle 1, CNTY-101 (without preceding LDC), will be administered 3 times over 3 weeks, during Cycle 2 (cycle length = 28 days), alone or with supplemental IL-2. During Part 2 (Dose Expansion Phase), participants will receive treatments using the RP2R confirmed during Part 1.

Group II: Arm C: CNTY-101 in IIM ParticipantsExperimental Treatment3 Interventions

During Part 1 (Dose Confirmation Phase), participants with IIM will undergo LDC followed by administration of CNTY-101, administered 3 times over 3 weeks, during Cycle 1 (cycle length = 28 days), alone or with supplemental IL-2. After completion of Cycle 1, CNTY-101 (without preceding LDC), will be administered 3 times over 3 weeks, during Cycle 2 (cycle length = 28 days), alone or with supplemental IL-2. During Part 2 (Dose Expansion Phase), participants will receive treatments using the RP2R confirmed during Part 1.

Group III: Arm B: CNTY-101 in LN ParticipantsExperimental Treatment3 Interventions

During Part 1 (Dose Confirmation Phase), participants with LN will undergo LDC followed by administration of CNTY-101, administered 3 times over 3 weeks, during Cycle 1 (cycle length = 28 days), alone or with supplemental IL-2. After completion of Cycle 1, CNTY-101 (without preceding LDC), will be administered 3 times over 3 weeks, during Cycle 2 (cycle length = 28 days), alone or with supplemental IL-2. During Part 2 (Dose Expansion Phase), participants will receive treatments using the RP2R confirmed during Part 1.

Group IV: Arm A: CNTY-101 in SLE ParticipantsExperimental Treatment3 Interventions

During Part 1 (Dose Confirmation Phase), participants with SLE will undergo lymphodepleting chemotherapy (LDC) followed by administration of CNTY-101, administered 3 times over 3 weeks, during Cycle 1 (cycle length = 28 days), alone or with supplemental human recombinant interleukin 2 (IL-2). After completion of Cycle 1, CNTY-101 (without preceding LDC), will be administered 3 times over 3 weeks, during Cycle 2 (cycle length = 28 days), alone or with supplemental IL-2. During Part 2 (Dose Expansion Phase), participants will receive treatments using the recommended phase 2 regimen (RP2R) confirmed during Part 1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

IL-2

2007

Completed Phase 4

~1100

0 / 2Eligibility criteria met