Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Anti-CD5 CAR NK cells · 1 trial · 1 indication
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 |
|---|---|---|---|---|
| Incyte Corporation | INCY | 2 | PHASE2 | Ruxolitinib, Pembrolizumab |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 1 | - | Undisclosed |
Anti-CD5 CAR NK cells is an investigational cell therapy being developed for the treatment of relapsed or refractory T-cell hematologic malignancies, specifically T-ALL and lymphoma. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
Anti-CD5 CAR NK cells targets the CD5 protein, which is expressed on malignant T cells. The therapy uses natural killer cells engineered with a chimeric antigen receptor (CAR) to recognize and attack CD5-positive tumor cells in patients with T-ALL or lymphoma.
Anti-CD5 CAR NK cells is being developed by Precision BioSciences, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol DTIL. The company is conducting a Phase 1 clinical trial of this investigational therapy for T-cell hematologic malignancies.
Anti-CD5 CAR NK cells is in Phase 1 clinical development. It is an investigational therapy, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 1 trial is currently recruiting patients with relapsed or refractory T-ALL or lymphoma.
Anti-CD5 CAR NK cells is being evaluated in a single Phase 1 clinical trial registered as NCT06909474. This open-label, uncontrolled study is recruiting 15 adult patients in China with relapsed or refractory T-cell hematologic malignancies, including T-ALL and lymphoma.
Yes, Anti-CD5 CAR NK cells is the same therapy as the CD5-targeted CAR-NK therapy described in clinical trial NCT06909474. The trial title refers to it as CD5-targeted CAR-NK therapy, and it is being studied for the treatment of relapse or refractory T-cell hematologic malignancies.