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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06500273 | Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL | PHASE2 | RECRUITING | 250 | — | — | Jun 18, 2024 | Dec 1, 2032 | Jun 2, 2026 | 73 | United States, Australia +2 |
| Arm | Type | Description |
|---|---|---|
| cemacabtagene ansegedleucel | EXPERIMENTAL | Participants receive cemacabtagene ansegedleucel following lymphodepletion regimen comprised of fludarabine and cyclophosphamide. |
| Observation | OTHER | Participants do not receive any study treatments. They are observed as per the current standard of care. |
| Name | Type | Description |
|---|---|---|
| cemacabtagene ansegedleucel | GENETIC | An allogeneic CAR T cell therapy targeting CD19 |
| Fludarabine | DRUG | Chemotherapy for lymphodepletion |
| Cyclophosphamide | DRUG | Chemotherapy for lymphodepletion |
| Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™ | DEVICE | A diagnostic test intended to identify patients with minimal residual disease at the end of first line treatment for LBCL. |
Key Inclusion Criteria: 1. LBCL per WHO 2017 including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, and primary mediastinal B-cell lymphoma histologically confirmed by pathology report. 2. Participant has completed a full course of standard first line therapy (e.g., R-CHOP, dose-adjus...