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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04155710 | Study of Autologous Peripheral Blood Lymphocytes in the Treatment of Patients With CLL or SLL | PHASE1 | COMPLETED | 7 | — | — | Feb 19, 2020 | Dec 2, 2024 | Dec 24, 2025 | 7 | United States |
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...