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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04830137 | A Study of NX-2127 in Adults With Relapsed/Refractory B-cell Malignancies | PHASE1 | RECRUITING | 248 | — | — | May 5, 2021 | May 1, 2027 | Mar 20, 2026 | 16 | United States |
Phase 1a
Phase 1a
Phase 1b
Phase 1a/1b
| Arm | Type | Description |
|---|---|---|
| Phase 1a Dose Escalation | EXPERIMENTAL | Multiple dose levels of NX-2127 to be evaluated; determination of MTD/Phase 1b recommended dose |
| Phase 1b Dose Optimization Stage 1 in CLL or SLL (Dose A) | EXPERIMENTAL | CLL/SLL patients whose disease has failed treatment with a BTK inhibitor |
| Phase 1b Dose Optimization Stage 1 in MCL (Dose A) | EXPERIMENTAL | MCL patients whose disease has failed treatment with a BTK inhibitor and an anti-CD20 monoclonal antibody (mAb) based regimen |
| Phase 1b Dose Optimization Stage 1 in FL, MZL or WM (Dose A) | EXPERIMENTAL | FL or MZL patients whose disease has failed treatment with an anti-CD20 mAb-based regimen; or WM whose disease has failed treatment with a BTK inhibitor |
| Phase 1b Dose Optimization Stage 1 in DLBCL (Dose A) | EXPERIMENTAL | DLBCL patients whose disease has failed treatment with an anti-CD20 mAb-based regimen and either: an anthracycline-based regimen; or an anti-CD19-based regimen; or another/palliative regimen |
| Phase 1b Dose Optimization Stage 1 in PCNSL (Dose A) | EXPERIMENTAL | PCNSL patients whose disease has failed at least 1 prior line of treatment |
| Phase 1b Dose Optimization Stage 2 in CLL or SLL (Randomized to Dose A or Dose B) | EXPERIMENTAL | CLL/SLL patients whose disease has failed treatment with a BTK inhibitor |
| Phase 1b Dose Optimization Stage 2 in MCL (Randomized to Dose A or Dose B) | EXPERIMENTAL | MCL patients whose disease has failed treatment with a BTK inhibitor and an anti-CD20 monoclonal antibody (mAb) based regimen |
| Phase 1b Dose Optimization Stage 2 in FL, MZL or WM (Randomized to Dose A or Dose B) | EXPERIMENTAL | FL or MZL patients whose disease has failed treatment with an anti-CD20 mAb-based regimen; or WM whose disease has failed treatment with a BTK inhibitor |
| Phase 1b Dose Optimization Stage 2 in DLBCL (Randomized to Dose A or Dose B) | EXPERIMENTAL | DLBCL patients whose disease has failed treatment with an anti-CD20 mAb-based regimen and either: an anthracycline-based regimen; or an anti-CD19-based regimen; or another/palliative regimen |
| Phase 1b Dose Optimization Stage 2 in PCNSL (Randomized to Dose A or Dose B) | EXPERIMENTAL | PCNSL patients whose disease has failed at least 1 prior line of treatment |
| Name | Type | Description |
|---|---|---|
| NX-2127 | DRUG | Oral NX-2127 |
Inclusion Criteria: * Patients must be ≥ 18 years of age * Patients must have measurable disease per disease-specific response criteria * Patients with indolent forms of NHL must meet the criteria requiring systemic treatment (i.e., iwCLL, IWG, Lugano Classification of Lymphoma response criteria, o...