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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05902520 | Adoptive Cell Therapy Using Cancer Specific CD8+ Tumor Infiltrating Lymphocytes in Adult Patients With Solid Tumors | PHASE1 | ACTIVE NOT_RECRUITING | 18 | — | — | Jun 19, 2023 | Dec 31, 2026 | Jan 8, 2026 | 1 | United States |
Frequency and severity of treatment-related adverse events as assessed by CTCAE v5.0 in participants treated with DP CD8 TIL adoptive cell therapy with and without ex vivo siRNA PD-1 modulation after lymphodepleting chemotherapy and followed by high-dose and low-dose IL-2.
| Arm | Type | Description |
|---|---|---|
| DP CD8 TIL | EXPERIMENTAL | Adoptive Cell Transfer of tumor infiltrating lymphocytes that were selected for tumor reactivity by the expression of cell surface proteins CD39 an CD103 and expanded in vitro. A suspension of 1-40 billion cells will be delivered one time by intravenous infusion. |
| DP CD8 TIL KD | EXPERIMENTAL | Adoptive Cell Transfer of tumor infiltrating lymphocytes that were selected for tumor reactivity by the expression of cell surface proteins CD39 and CD103 and expanded in vitro in the presence of PH-762, a silencing RNA that reduces the expression of the checkpoint inhibitor PD-1. A suspension of 1-40 billion cells will be delivered one time by intravenous infusion. |
| Name | Type | Description |
|---|---|---|
| DP CD8 TIL | BIOLOGICAL | intravenous infusion of T cell suspension |
| DP CD8 TIL KD | BIOLOGICAL | intravenous infusion of T cell suspension |
| Low dose IL-2 | BIOLOGICAL | Low dose IL-2 delivered subcutaneously for 1, 2 or 3 weeks |
Inclusion Criteria * Participants must have signed and dated a current IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. Patients must have the ability to understand a written informed consent document, and the willingness to sign it. * Conse...