Phase 1B/2A Study of CTO1681 for the Prevention and Treatment of Cytokine Release Syndrome in Patients With Diffuse Large B-Cell Lymphoma Receiving Chimeric Antigen Receptor T-Cell Therapy

Official Summary

This is an interventional study to evaluate the use of CTO1681 in preventing or reducing CAR T-cell-induced toxicities like cytokine release syndrome (CRS). This study will enroll adult patients with DLBCL who are scheduled to receive CD19-directed CAR T-cell therapy. The first phase of the study will be open label with dose escalation. Participants will start taking CTO1681 just prior to receiving their CAR T-cell therapy and continue to take the study drug three times daily for a total of 15 days.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NON_RANDOMIZED
• Model: SEQUENTIAL
• Masking: NONE
• Enrollment: 54 participants

Interventions

• DRUG: CTO1681 10 μg — Administered 3 times daily for 15 days (initial cohort).
• DRUG: CTO1681 20 μg — Administered 3 times daily for 15 days (successive cohort).
• DRUG: CTO1681 30 μg — Administered 3 times daily for 15 days (successive cohort).

Primary Outcomes

• Incidence of adverse events (AEs) (6 months following start of treatment)

Secondary Outcomes

• Incidence of CRS (any grade) (6 months following the start of treatment)
• Incidence of ICANS (any grade) (6 months following the start of treatment)
• Incidence of hospitalizations (6 months following the start of treatment)
• Use of other anticytokine therapies (6 months following the start of treatment)
• Proinflammatory cytokine levels (6 months following the start of treatment)

Trial Locations

• University of California, Irvine - Chao Family Comprehensive Cancer Center, Orange, California, United States
• Georgia Cancer Center at Augusta University, Augusta, Georgia, United States
• Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
• Duke Cancer Institute, Durham, North Carolina, United States
• University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
• Fred Hutchinson Cancer Center, Seattle, Washington, United States

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