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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04720313 | NXC-201 (formerly HBI0101) Multiple Myeloma | PHASE1 | ACTIVE NOT_RECRUITING | 160 | — | — | Jan 1, 2021 | Jan 1, 2027 | Mar 14, 2025 | 1 | Israel |
Part A: Determination of MTD Part B: Confirmation of selected dose tested (at or below MTD) ( safety )
| Arm | Type | Description |
|---|---|---|
| CART BCMA | EXPERIMENTAL | The dose escalation phase (Part A) will include the following doses of CAR-positive (CAR+) T cells: 150×10\^6, 450×10\^6, 800×10\^6 or 1200 ×10\^6 The expansion phase (Part B) will include a dose between 450×10\^6 to 800×10\^6 CAR-positive (CAR+) T cells |
| Name | Type | Description |
|---|---|---|
| NXC-201 (formerly HBI0101) | DRUG | NXC-201 (formerly HBI0101) CART is defined as autologous T cells transduced ex-vivo with anti-BCMA CAR retroviral vector encoding the chimeric antigen receptor (CAR) targeted to human BCMA. The NXC-201 (formerly HBI0101) CART is provided fresh without cryopreservation. |
Inclusion Criteria: * ≥18 years of age * Voluntarily signed informed consent form (ICF) * Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2 * Diagnosis of MM with relapsed or refractory disease and have had at least 3 different prior lines of therapy including proteasome inh...