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Starting soon Phase 1

A Study of Topical Duvelisib in Participants With Early-stage Mycosis Fungoides

NCT07714187 · tracked via the Priya Life Science USA tracker
Sponsor
SecuraBio
Phase
Phase 1
Started
2027-01
Last updated
2026-07-20

Condition(s) studied

Mycosis FungoidesCutaneous T-cell Lymphoma

Investigational drug(s) / intervention(s)

Duvelisib →

Duvelisib: Topical gel

Study summary

This study will evaluate the safety and preliminary efficacy of duvelisib topical gel in participants with early-stage mycosis fungoides.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria: * Have a clinical diagnosis of Stage IA, Stage IB, or Stage IIA mycosis fungoides (cutaneous T-cell lymphoma), without clinically significant lymphadenopathy (≥1.5 centimeters). * Have 3 to 5 active, treatment-accessible mycosis fungoides lesions; ulcerated lesions and lesions to the face, neck, inguinal folds and intergluteal cleft are not considered suitable for administration of study drug. * Have baseline organ function (without transfusion support within 30 days of Cycle 1 Day 1) as defined by the protocol. Key Exclusion Criteria: * Have Stage IIB to IVB mycosis fungoides or Sezary syndrome. * Have histopathologically confirmed lymph node involvement. * Received systemic treatment with a phosphoinositide 3-kinases inhibitor in the 60 days prior to starting study drug. * Received topical steroids or other topical treatment (for example, nitrogen mustard) on mycosis fungoides lesions in the 2 weeks prior to starting study drug. Participants who receive such agents may become eligible for the study after a 14-day washout period. * Received systemic steroids, immunosuppressants (for example, cyclosporine, prednisone), psoralen ultraviolet A radiation therapy, narrow-band ultraviolet B light therapy, carmustine or other systemic therapies for mycosis fungoides in the 3 weeks prior to starting study drug. * Received electron beam irradiation within the 3 months prior to starting study drug. Note: other protocol-defined criteria apply.

Primary outcome measure(s)

  • Number of Participants with Treatment-emergent Adverse Events (TEAEs) — Baseline through Day 114
  • Local Skin Reactions to Duvelisib Topical Gel — After each treatment administration up to Day 114
    Local skin reactions will be measured as a local skin reaction score using a four-point post-treatment assessment severity scale.
  • Maximum Tolerated Dose (MTD) of Duvelisib Topical Gel — Up to 28 days
  • Recommended Phase 2 Dose (RP2D) of Duvelisib Topical Gel — Up to 28 days

Trial sites (1)

FacilityCityRegionStatus
Johns Hopkins University Baltimore Maryland

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07714187 on ClinicalTrials.gov ↗ ← All trials in the USA