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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06909474 | Clinical Trial of CD5-targeted CAR-NK Therapy for Relapse/Refractory T-Cell Hematologic Malignancies | PHASE1 | RECRUITING | 15 | — | — | Mar 27, 2025 | Mar 31, 2028 | Apr 3, 2025 | 1 | China |
The incidence of adverse events after CAR-NK cell infusion was assessed by CTCAE, version 5.0.
Objective Response Rate (ORR) within 3 Months: 1. For patients with T-cell lymphoma, ORR includes complete response (CR) and partial response (PR); 2. For patients with T-cell acute lymphoblastic leukemia (T-ALL), ORR includes CR, CR with partial hematologic recovery (CRh), CR with incomplete hematologic recovery (CRi), and morphologic leukemia-free state (MLFS).
OS is defined as the time from CAR-NK cell infusion to death from any cause, reflecting the long-term survival benefit of the therapy.
DOR measures the time from the first achievement of objective response to disease progression or death, evaluating the durability of treatment efficacy in responding patients.
PFS is the time from CAR-NK cell infusion to disease progression or death from any cause, capturing both tumor control and survival outcomes
| Arm | Type | Description |
|---|---|---|
| CD5 CAR-NK cells | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Anti-CD5 CAR NK cells | BIOLOGICAL | Each patient will initially receive a single infusion of CAR-NK cells on Day 0. If a suboptimal response is observed after the first infusion (assessed by Day 28) and the safety profile remains acceptable, a second infusion may be administered as a remedial dose after Day 28. CAR-NK cells need to be controlled within 70 minutes from thawing to infusion completion. |
Inclusion Criteria: \- 1.Gender and Age: No gender restriction; age 18-75 years (inclusive). 2.Diagnosis: Confirmed diagnosis of T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoma, including: 1. T-ALL Patients: Bone marrow morphology during screening shows ≥5% blasts/immature lymphocy...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Soligenix, Inc. | SNGX | 1 | PHASE3 | Hypericin |
| Incyte Corporation | INCY | 2 | PHASE2 | Ruxolitinib, Pembrolizumab |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 1 | — | Undisclosed |