HyBryte (Synthetic Hypericin) Versus Valchlor (Mechlorethamine) in the Treatment of CTCL

Sponsor

Soligenix (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06149247

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this clinical study is to compare the safety and effectiveness of Valchlor versus HyBryte following 12 weeks of treatment.

Condition or Disease	Intervention/Treatment	Phase
Cutaneous T-Cell Lymphoma/Mycosis Fungoides	Drug: Hypericin Drug: Mechlorethamine Topical Gel	Phase 2

Detailed Description

Participants will be randomized to receive HyBryte or Valchlor in a 1:1 randomization. Participants will be treated for 12 weeks and follow-up visits will be conducted 1, 2, and 4 weeks after completion of the treatment phase of the trial.

Prior to randomization, each participant will have at least 3 and up to 5 lesions identified (index lesions) that will be evaluated during the treatment phase and during the follow-up visits.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Pilot Study of HyBryte (Synthetic Hypericin) Versus Valchlor (Mechlorethamine) in the Treatment of CTCL

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HyBryte (0.25 % hypericin) HyBryte (0.25 % hypericin) ointment will be applied to CTCL lesions and treated with visible light 18-24 hours later starting at 6 J/cm^2. Drug application/light session will be done twice a week (at least 2 calendar days apart) for 12 weeks.	Drug: Hypericin HyBryte is synthetic hypericin formulated as a 0.25% hypericin ointment. Other Names: HyBryte SGX301
Active Comparator: Valchlor (mechlorethamine) Valchlor (0.016% mechlorethamine) gel will be applied to CTCL lesions once daily for 12 weeks.	Drug: Mechlorethamine Topical Gel Valchlor is an FDA-approved drug for the treatment of CTCL. Other Names: Valchlor

Arm

Intervention/Treatment

Experimental: HyBryte (0.25 % hypericin)

HyBryte (0.25 % hypericin) ointment will be applied to CTCL lesions and treated with visible light 18-24 hours later starting at 6 J/cm^2. Drug application/light session will be done twice a week (at least 2 calendar days apart) for 12 weeks.

Drug: Hypericin

HyBryte is synthetic hypericin formulated as a 0.25% hypericin ointment.

Other Names:

HyBryte

SGX301

Active Comparator: Valchlor (mechlorethamine)

Valchlor (0.016% mechlorethamine) gel will be applied to CTCL lesions once daily for 12 weeks.

Drug: Mechlorethamine Topical Gel

Valchlor is an FDA-approved drug for the treatment of CTCL.

Other Names:

Valchlor

Outcome Measures

Primary Outcome Measures

Number of Participants with a Treatment Response in the Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) score [12 weeks]
A treatment response is defined as a ≥50% improvement in mCAILS score at Week 12 when compared to the mCAILS score at baseline. The Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) score measures: Erythema (or redness) on a scale of 0 (no redness) to 8 (very red), Scaling on a scale of 0 (no scaling) to 8 (all of the lesion is covered by a very rough surface), Plaque Elevation on a scale of 0 (no evidence of plaque above normal skin level) to 3 (plaque shows marked elevation above normal skin level) and Surface Area on a scale of 0 (no lesion/surface area is 0 cm^2) to 18 (the lesion is larger than 300 cm^2). A lower score means a better outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Minimum of 3 active treatment-accessible CTCL lesions
Subjects must have a clinical diagnosis of cutaneous T-cell lymphoma (CTCL, mycosis fungoides), Stage IA, IB, or Stage IIA
Subjects willing to follow the clinical protocol and voluntarily give their written informed consent
Female subjects not pregnant nor nursing and willing to undergo a pregnancy test within 30 days prior to treatment initiation

Exclusion Criteria:

History of severe allergic reaction to any of the components of HyBryte or mechlorethamine (Valchlor)
Pregnancy or mothers who are breast-feeding
All women of childbearing potential (WOCBP) and males with female partners who are WOCBP not willing to use effective contraception
Subjects with history of sun hypersensitivity or photosensitive dermatoses (eg, porphyria, systemic lupus erythematosus (SLE), Sjogren's syndrome, etc.)
Subjects whose condition is spontaneously improving
Subjects receiving Valchlor (or any topical compound containing Mechlorethamine) in the preceding 2 months
Subjects receiving topical steroids or other topical treatments (eg, targretin gel) on treatment accessible lesions for CTCL within 2 weeks of enrollment
Subjects receiving systemic steroids, psoralen ultraviolet A (UVA) radiation therapy (PUVA), narrow band ultraviolet B (UVB) light therapy (NB-UVB) or carmustine (BCNU) or other systemic therapies for CTCL within 3 weeks of enrollment
Subjects who have received electron beam irradiation within 3 months of enrollment
Subjects with a history of significant systemic immunosuppression
Subjects taking other investigational drugs or drugs of abuse within 30 days of enrollment
Subject has any condition that, in the judgment of the Investigator, is likely to interfere with participation in the study
Subjects receiving drugs known to cause photosensitization within 2 weeks of starting HyBryte therapy unless they have not had evidence of photosensitization after receiving a stable dose of the medication for a minimum of 4 weeks