Health TrialsbyHealthPanel

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

ConditionCytokine Release Syndrome
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCytoAgents, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older.

Undergone leukapheresis and is scheduled to receive protocol-specified CAR T-cell therapy (axicabtagene ciloleucel, lisocabtagene maraleucel, idecabtagene vicleucel, or ciltacabtagene autoleucel) for relapsed or refractory lymphoma or multiple myeloma. All patients must have relapsed or refractory disease to at least one prior line of systemic therapy. Prior CAR T-cell therapy is allowable with approval from the Sponsor and Medical Monitor.

Met all inclusion criteria for CAR T-cell therapy per institutional guidelines.

Estimated Creatinine Clearance per Cockroft Gault formula ≥ 60 mL/min.

Disqualifiers

Any cytotoxic chemotherapy within 14 days prior to leukapheresis.

Clinically significant malabsorption syndromes and swallowing difficulties which are inadequately controlled with medication (eg, odynophagia, dysphagia, gastroesophageal reflux disease) as per Investigator assessment.

Potassium < 3.0 or > 5.5 mmol/L

Sodium < 130 or > 150 mmol/L

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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).

Treatment groups

54 Participants
are divided into 5 treatment groups
Group A: CTO1681 30 μg Total Daily DoseExperimental treatment 1 intervention
Group B: CTO1681 60 μg Total Daily DoseExperimental treatment 1 intervention
Group C: CTO1681 90 μg Total Daily DoseExperimental treatment 1 intervention
Group D: CTO1681 30 µg Run-in Daily Dose / 60 µg Treatment Daily DoseExperimental treatment 1 intervention
Group E: CTO1681 60 µg Run-in Daily Dose / 90 µg Treatment Daily DoseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of adverse events (AEs)

AEs graded by CTCAE v5.0

Time frame
6 months following start of treatment

Secondary outcomes

1

Incidence of CRS (any grade)

CRS graded by ASTCT Consensus Grading

Time frame
6 months following the start of treatment
2

Incidence of ICANS (any grade)

ICANS graded by ASTCT Consensus Grading

Time frame
6 months following the start of treatment
3

Incidence of hospitalizations

Unplanned hospitalizations

Time frame
6 months following the start of treatment
4

Use of other anticytokine therapies

Use of cytokine mitigating therapies other than CTO1681

Time frame
6 months following the start of treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CytoAgents, Inc.

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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