Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Interleukin-2, Proleukin, IL-2
Aldesleukin · 5 trials · 33 indications
Objective tumor response as measured by RECIST
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.
Proportion of subjects who complete treatment without an event that meets criteria for feasibility failure
The highest dose level achieved according to the protocol-defined criteria for DLTs and determination of MTD.
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 |
|---|---|---|
| E7 TCR-T cells | EXPERIMENTAL | Subjects will receive a conditioning regimen, E7 TCR-T cells, and aldesleukin. |
| 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). |
| KK-LC-1 TCR-T cells | EXPERIMENTAL | Subjects will receive a conditioning regimen, KK-LC-1 TCR-T cells, and aldesleukin. |
| 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 |
|---|---|---|
| E7 TCR-T cells | BIOLOGICAL | Participants will receive a conditioning regimen consisting of cyclophosphamide and fludarabine. E7 TCR-T cells will be administered as a single intravenous infusion. |
| Aldesleukin | DRUG | Within 24 hours after E7 TCR-T cell infusion, aldesleukin 720,000 IU/kg IV every eight hours will be administered for up to six doses. Aldesleukin dosing will be stopped for aldesleukin-related grade 3 or greater toxicity other than flushing, fever, chills, or hemodynamic changes (tachycardia or hypotension) that respond to crystalloid infusion. Aldesleukin may also be stopped at any time at investigator discretion. |
| 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). |
| KK-LC-1 TCR-T cells | BIOLOGICAL | Participants will receive a conditioning regimen consisting of cyclophosphamide and fludarabine. KK-LC-1 TCR-T cells will be administered as a single intravenous infusion. |
| 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: Subjects must meet all the following criteria to participate in this study. 1. Histologically or cytologically confirmed metastatic or refractory/recurrent HPV-16+ cancer. 2. Tumor and/or blood with HPV16 genotype as determined by testing performed in a Clinical Laboratory Impro...
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Aldesleukin is an investigational small molecule developed by Iovance Biotherapeutics, Inc. (IOVA). It is being studied in oncology across several cancer types, including cervical cancer, gastric cancer, and malignant pleural effusion, as well as in chronic graft versus host disease. It is currently in Phase 2 clinical development.
Aldesleukin targets the interleukin-2 receptor subunits IL2RA, IL2RG, and IL2RB. It acts as an agonist at these receptors, meaning it activates signaling through the IL-2 receptor complex. This receptor-targeting mechanism underlies its investigation in oncology and immune-related conditions.
Aldesleukin is being developed by Iovance Biotherapeutics, Inc., which trades on the Nasdaq under the ticker IOVA. The company is sponsoring the clinical trials evaluating the drug in cancer and chronic graft versus host disease.
Aldesleukin is in Phase 2 clinical development. It is an investigational agent and has not been approved by the FDA for the indications being studied. The program includes one active trial, with no completed trials reported.
Aldesleukin is being evaluated in clinical trials including NCT07192900, a Phase 1 study in malignant pleural effusion and pleural disease, NCT05686226, a Phase 2 study in HPV-associated cancers including cervical cancer, NCT05639972, a Phase 1 study in HPV-associated cancers, and NCT05483491, a Phase 1 study in gastric, breast, cervical, and lung cancer.
Yes, Aldesleukin is also known as Interleukin-2. Both names refer to the same agent, so searches for either term point to the same drug candidate being developed by Iovance Biotherapeutics, Inc. for oncology and related indications.