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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 for the treatment of Chronic Lymphocytic Leukemia (CLL). It is currently in Phase 1 clinical development and has been studied in patients with CLL or Small Lymphocytic Lymphoma (SLL).
IOV-2001 is being developed by Iovance Biotherapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol IOVA. The company is conducting clinical research on this investigational therapy for Chronic Lymphocytic Leukemia.
IOV-2001 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 clinical trial has been completed, involving 7 participants with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.
IOV-2001 has been studied in one clinical trial with the identifier NCT04155710, titled "Study of Autologous Peripheral Blood Lymphocytes in the Treatment of Patients With CLL or SLL." This Phase 1 trial was completed in the United States and enrolled 7 participants.
IOV-2001 is described as a monoclonal antibody, but the clinical trial NCT04155710 involved autologous peripheral blood lymphocytes, which are a type of cell therapy. The drug is being investigated for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma.