Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06255028 | A Study of CNTY-101 in Participants With Refractory B Cell-mediated Autoimmune Diseases | PHASE1 | ACTIVE NOT_RECRUITING | 6 | — | — | Feb 6, 2025 | Aug 1, 2028 | Jan 8, 2026 | 6 | United States |
| Arm | Type | Description |
|---|---|---|
| Arm A: CNTY-101 in SLE Participants | EXPERIMENTAL | 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. |
| Arm B: CNTY-101 in LN Participants | EXPERIMENTAL | 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. |
| Arm C: CNTY-101 in IIM Participants | EXPERIMENTAL | 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. |
| Arm D: CNTY-101 in DcSSC Participants | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| CNTY-101 | BIOLOGICAL | CNTY-101 cells for intravenous (IV) infusion |
| IL-2 | BIOLOGICAL | IL-2 subcutaneous (SC) injection |
| Lymphodepleting Chemotherapy | DRUG | LDC as prespecified in the protocol. |
Inclusion Criteria: General Inclusion Criteria: 1. 17 years of age and older. 2. Participants must have adequate organ function as defined in the protocol. SLE/LN-specific Inclusion Criteria: 1. Participants must have a diagnosis of SLE according to the 2019 European League Against Rheumatism/Am...