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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07564401 | A Study to Evaluate DJI136, a DLL3-targeted CAR-T Therapy | PHASE1 | RECRUITING | 80 | — | — | May 14, 2026 | Mar 3, 2031 | May 27, 2026 | 2 | United States, Singapore |
Number of participants with AEs and SAEs, including changes in vital signs, electrocardiograms (ECGs) and laboratory values qualifying and reported as AEs.
Number of participants with DLTs. A DLT is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs within the first 28 days after DJI136 infusion and meets the criteria defined in the protocol. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.
Tumor response assessed by the investigator based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). ORR per RECIST v1.1 is defined as the proportion of patients with a confirmed best overall response of Complete response (CR) or Partial response (PR).
| Arm | Type | Description |
|---|---|---|
| Phase I | EXPERIMENTAL | Dose escalation with DJI136 |
| Phase II | EXPERIMENTAL | Treatment at the recommended dose(s) of DJI136 as identified in Phase I. |
| Name | Type | Description |
|---|---|---|
| DJI136 | DRUG | DLL3 targeted CAR-T therapy administered by intravenous (i.v.) infusion. |
Inclusion Criteria: * Phase I: Patients with ES-SCLC and disease progression after one or more chemotherapy regimens (that included a platinum-based doublet chemotherapy in combination with a PD-L1 inhibitor) according to the local SOC (2L+), unless the patient was ineligible to receive such therap...