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Also known as Autologous PBL
IOV-2001 · 1 trial · 2 indications
to determine the recommended Phase 2 dose of IOV-2001 followed by interleukin-2 (IL-2)
To evaluate efficacy of the RP2D of IOV-2001 followed by IL-2 as measured by objective response rate (ORR) per investigator assessment
| Arm | Type | Description |
|---|---|---|
| Cohort 1a | EXPERIMENTAL | CLL/SLL patients whose disease has relapsed or is relapsing post ibrutinib or acalabrutinib therapy. Patients will receive IOV-2001 + low dose IL-2. |
| Cohort 1b | EXPERIMENTAL | CLL/SLL patients whose disease has relapsed or is relapsing post ibrutinib or acalabrutinib therapy. Patients will receive IOV-2001 + high dose IL-2. |
| Cohort 2 | EXPERIMENTAL | CLL/SLL patients with del 17p who progressed or are progressing on ibrutinib or acalabrutinib therapy. Patients will receive IOV-2001 + IL-2. |
| Cohort 3 | EXPERIMENTAL | CLL/SLL patients without del 17p who progressed or progressing on ibrutinib or acalabrutinib therapy. Patients will receive IOV-2001 + IL-2. |
| Name | Type | Description |
|---|---|---|
| IOV-2001 | BIOLOGICAL | Adoptive cell therapy (ACT) manufactured from peripheral blood lymphocytes (PBL). The final investigational product is a cryopreserved cell suspension. |
| Low dose IL-2 | DRUG | 6 doses of subcutaneous (SC) LD-IL-2 (9 MIU every 8-12 hours) will follow the infusion of IOV-2001 |
| High dose IL-2 | DRUG | 6 doses of IV HD-IL-2 (600,000 IU/kg Q8-12H will follow the infusion of IOV-2001 |
| IL-2 | DRUG | 6 doses of IL-2 will follow the infusion of IOV-2001 |
Inclusion Criteria: 1. Patients with CLL or SLL with radiographically measurable disease * Cohort 2 only: patients with progressed or progressing CLL/SLL on ibrutinib or acalabrutinib with del 17p and/or TP53 mutated * Cohort 3 only: patients with progressed or progressing CLL/SLL on ibrutin...
IOV-2001 is an investigational monoclonal antibody being developed by Iovance Biotherapeutics, Inc. for the treatment of chronic lymphocytic leukemia, a type of blood cancer. It is in Phase 1 clinical development and has been studied in a single completed trial. IOV-2001 is a biomarker-selected therapy, meaning it is directed at patients with a specific biological characteristic.
IOV-2001 is being developed for chronic lymphocytic leukemia, a cancer of the blood and bone marrow. The one completed Phase 1 trial also enrolled patients with small lymphocytic lymphoma alongside CLL. It remains investigational and is not an approved treatment for CLL or any other indication.
IOV-2001 is developed by Iovance Biotherapeutics, Inc., a biotechnology company whose common stock trades on the Nasdaq under the ticker IOVA. Iovance is the sponsor of the clinical program evaluating IOV-2001 in chronic lymphocytic leukemia and small lymphocytic lymphoma.
IOV-2001 is in Phase 1 clinical development. Its only recorded trial, NCT04155710, has been completed, and no active trials are currently listed. Because the program remains at the Phase 1 stage, IOV-2001 is investigational and has not been approved by the FDA for any indication.
IOV-2001 has been evaluated in one Phase 1 trial, NCT04155710, titled Study of Autologous Peripheral Blood Lymphocytes in the Treatment of Patients With CLL or SLL. The trial enrolled 7 patients, was controlled but not randomized or double blinded, and has completed. It was conducted in the United States in adults aged 18 years and older.
Yes. IOV-2001 is a biomarker-selected monoclonal antibody, meaning its development targets patients whose disease carries a specific biological marker rather than an unselected patient population. This biomarker-based approach was applied in its completed Phase 1 trial in chronic lymphocytic leukemia and small lymphocytic lymphoma.