Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Interleukin-2 · 2 trials · 7 indications
flow cytometry for cellular ACT identity
incidence of Treatment-Emergent Adverse Events (Safety) of intrapleural administration of the locally manufactured ACT product, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Adverse events are considered dose-limiting toxicities by the criteria defined in protocol Section 6.2. If 1 or 0 out of 5 participants in the same dose-level cohort experience a DLT, escalation to the next dose level will take place. If this is dose-level C, then dose C is the MTD. If 2 or more participants out of 5 in the same dose level experience a DLT, then the previous dose-level will be the MTD. If this is dose-level A, accrual will stop.
| Arm | Type | Description |
|---|---|---|
| locally manufactured adoptive cellular therapeutic (ACT) product | EXPERIMENTAL | Single dose, intrapleural delivery (via indwelling pleural catheter) of adoptive cellular therapy (ACT) product derived from autologous pleural infiltrating T-cells. Low dose Interleukin-2 (IL-2) will also be administered intrapleural at the dose of 20 milliliters (mL) at 1 x 10⁵ International Units (IU)/mL starting approximately 2 hours after ACT infusion and every 8 to 16 hours thereafter, as tolerated, for up to 4 doses (total 8 x 10⁶ IU). |
| Treg-enriched infusion plus 8-week low-dose Interleukin-2 | EXPERIMENTAL | Treg-enriched Cell Dose: Participants will be targeted to a defined dose of donor Treg-enriched total nucleated cells. Initial enrollment will be at target dose-level A. Subsequent cohorts will be dose escalated/de-escalated per the schema. Interleukin-2: Starting the day of Treg-enriched cell infusion, each participant will receive daily subcutaneous IL-2 for self-administration for 8 weeks, followed by a 4-week hiatus. IL-2 will be administered on an outpatient basis. Expected toxicities and potential risks as well as dose modifications are described in Section 6 (Expected Toxicities and Dosing Delays/Dose Modification). |
| Name | Type | Description |
|---|---|---|
| locally manufactured adoptive cellular therapy (ACT) product | BIOLOGICAL | Single dose, intrapleural delivery (via indwelling pleural catheter) of adoptive cellular therapy (ACT) product derived from autologous pleural infiltrating T-cells. |
| Interleukin-2 | DRUG | Low dose Interleukin-2 (IL-2) will also be administered intrapleural at the dose of 20 milliliters (mL) at 1 x 10⁵ International Units (IU)/mL starting approximately 2 hours after ACT infusion and every 8 to 16 hours thereafter, as tolerated, for up to 4 doses (total 8 x 10⁶ IU). |
| Treg-enriched infusion | OTHER | Treg-enriched Cell Dose: Participants will be targeted to a defined dose of donor Treg-enriched total nucleated cells. Initial enrollment will be at target dose-level A. Subsequent cohorts will be dose escalated/de-escalated per the schema |
Inclusion Criteria: 1. Patients with symptomatic, biopsy-proven malignant to the pleura, or mesothelioma with pleural effusions. Patients must have received and be refractory to available standard of care (SOC) therapy specific to their cancer type and must have exhausted or failed available standa...
Interleukin-2 is being studied for malignant pleural effusion and chronic graft versus host disease. It is an investigational small molecule in Phase 1 clinical development by Iovance Biotherapeutics, Inc. for these conditions.
Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) is developing Interleukin-2. The company is conducting clinical trials to evaluate the drug for malignant pleural effusion and chronic graft versus host disease.
Interleukin-2 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. There is one active Phase 1 trial and one additional Phase 1 trial that is active but not recruiting.
Interleukin-2 is being studied in two Phase 1 trials: NCT01937468 for steroid-refractory chronic graft versus host disease, and NCT07192900 for metastatic cancer patients with pleural disease. Both trials are enrolling adults in the United States.
Interleukin-2 is a small molecule that modulates the immune system. It is being investigated for its ability to regulate T-cells, including regulatory T-cells, which may help manage immune responses in chronic graft versus host disease and malignant pleural effusion.