Study of CTO1681 for the Prevention and Treatment of CRS in Patients Receiving CAR T-Cell Therapy

Part of paid clinical trials in Orange, California.

Sponsor
CytoAgents, Inc.
Study ID
NCT05905328
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Cytokine Release Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CTO1681 10 µg — DRUG
    Administered 3 times daily for 15 days (initial cohort).
  • CTO1681 20 μg — DRUG
    Administered 3 times daily for 15 days (successive cohort).
  • CTO1681 30 μg — DRUG
    Administered 3 times daily for 15 days (successive cohort).
  • CTO1681 10 µg Run-in / 20 µg Treatment — DRUG
    Administered 3 times daily for up to 21 days (successive cohort).
  • CTO1681 20 µg Run-in / 30 µg Treatment — DRUG
    Administered three times daily for up to 21 days (successive cohort).

Study Details

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 lymphoma or multiple myeloma who are scheduled to receive CAR T-cell therapy. The first phase of the study is open label with dose escalation. Participants will start taking CTO1681 either the day before starting lymphodepleting chemotherapy or just prior to receiving their CAR T-cell therapy, depending on their cohort assignment. In both cases participants will continue to take the study drug three times daily until 13 days after their CAR T-cell infusion.

Key Dates

First listed
Jun 15, 2023
Start date
Dec 28, 2023
Status verified
Aug 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
54 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: CTO1681 30 μg Total Daily Dose
    Participants receive 10 μg CTO1681 orally 3 times daily (total daily dose of 30 μg) for 15 days.
  • Experimental: CTO1681 60 μg Total Daily Dose
    Participants receive 20 μg CTO1681 orally 3 times daily (total daily dose of 60 μg) for 15 days.
  • Experimental: CTO1681 90 μg Total Daily Dose
    Participants receive 30 μg CTO1681 orally 3 times daily (total daily dose of 90 μg) for 15 days.
  • Experimental: CTO1681 30 µg Run-in Daily Dose / 60 µg Treatment Daily Dose
    Participants receive 10 µg CTO1681 orally 3 times daily (total daily dose of 30 µg) during the run-in period and then 20 µg CTO1681 orally 3 times daily (total daily dose of 60 µg) during the treatment period. The total dosing duration is up to 21 days.
  • Experimental: CTO1681 60 µg Run-in Daily Dose / 90 µg Treatment Daily Dose
    Participants receive 20 µg CTO1681 orally 3 times daily (total daily dose of 60 µg) during the run-in period and then 30 µg CTO1681 orally 3 times daily (total daily dose of 90 µg) during the treatment period. The total dosing duration is up to 21 days.

Primary Outcome Measure

Incidence of adverse events (AEs) [ Time Frame: 6 months following start of treatment ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of California, Irvine - Chao Family Comprehensive Cancer CenterOrangeCalifornia92868
Blake Johnson
[email protected]
714-456-3476
Stefan Ciurea, MD (PRINCIPAL_INVESTIGATOR)
Georgia Cancer Center at Augusta UniversityAugustaGeorgia30912
Rebecca Paynter, MSN, RN
[email protected]
7064465177
Yenny Moreno, MD (PRINCIPAL_INVESTIGATOR)
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Jon Arnason, MD
[email protected]
617-667-9920
Jon Arnason, MD (PRINCIPAL_INVESTIGATOR)
Duke Cancer InstituteDurhamNorth Carolina27705
Jennifer Tichon, BSN, RN
[email protected]
919-660-7262
Chenyu Lin, MD (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Medical CenterPittsburghPennsylvania15232
Linda Elias, BSN, RN
[email protected]
4126236037
Alison Sehgal, MD (PRINCIPAL_INVESTIGATOR)
Fred Hutchinson Cancer CenterSeattleWashington98109
Immunotherapy Intake
[email protected]
206-606-4668
Jordan Gauthier, MD, MSc (PRINCIPAL_INVESTIGATOR)

Find similar trials in Orange, CA

By research site
University of California, Irvine - Chao Family Comprehensive Cancer Center· Orange, CAGeorgia Cancer Center at Augusta University· Augusta, GABeth Israel Deaconess Medical Center· Boston, MADuke Cancer Institute· Durham, NCUniversity of Pittsburgh Medical Center· Pittsburgh, PAFred Hutchinson Cancer Center· Seattle, WA

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