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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06313957 | A Study of LUCAR-20SP in Subjects With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma | PHASE1 | RECRUITING | 42 | — | — | Mar 14, 2024 | Sep 1, 2028 | Mar 25, 2025 | 3 | China |
DLT refers to a drug-related toxicity during treatment with the drug, the severity of which is clinically unacceptable, limiting the further escalation of drug dose.
An adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which does not necessarily have a causal relationship with the treatment.
RP2D established through accelerated titration design (ATD) and Bayesian Optimal Interval (BOIN) design.
CAR transgene levels in peripheral blood after LUCAR-20SP infusion. CAR positive T cells levels in bone marrow after LUCAR-20SP infusion.
CAR positive T cells levels in bone marrow after LUCAR-20SP infusion. CAR transgene levels in bone marrow after LUCAR-20SP infusion.
| Arm | Type | Description |
|---|---|---|
| Each subject will receive LUCAR-20SP cells | EXPERIMENTAL | Chimeric antigen receptor T cells LUCAR-20SP cells |
| Name | Type | Description |
|---|---|---|
| LUCAR-20SP cells | BIOLOGICAL | Prior to infusion of the LUCAR-20SP, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine. |
Inclusion Criteria: * Subjects voluntarily participate in clinical research; * Age ≥18 years old; * Eastern Cooperative Oncology Group (ECOG) score 0-1; * Histologically confirmed large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, histologically indolent lymphoma to diffuse large B-c...