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Mycosis FungoidesPhase 2Resimmune®NCT02943642

Safety and Effectiveness of A-dmDT390-bisFv(UCHT1) Fusion Protein in Subjects With Mycosis Fungoides

A Phase 2 study testing A-dmDT390-bisFv(UCHT1) and Vorinostat in people with Mycosis Fungoides, run by Virogen Biotechnology Inc..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study evaluates the effectiveness - as judged by complete response - of a single four-day treatment with the fusion protein A-dmDT390-bisFv(UCHT1) compared to oral Zolinza (Vorinostat), in a randomized 2-arm trial after a maximum of 12 months of treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mycosis Fungoides
What is being tested?
A-dmDT390-bisFv(UCHT1) and Vorinostat
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
May 2026to 13 May 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must have signed the current IRB approved informed consent prior to registration (see Informed Consent).
  • Mycosis fungoides, confirmed by biopsy or flow cytometry, without large cell transformation.
  • Relapse or progression after 2 or more systemic therapies. Note: Total electron beam therapy can be counted as a systemic therapy.
  • Disease stage as follows:
  • Stage IB with no lymph node involvement including lymphadenopathy with mSWAT <50;
  • Stage IIB with no lymph node involvement including lymphadenopathy with mSWAT <50.
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  • Age 18 years.
  • Subjects must have a performance status of < 2 on Eastern Cooperative Oncology Group scale (see Appendix A).
  • Subjects must have normal lung function evaluated by pulse oximetry with O2 saturation values between 95-100%.
  • Subjects must have fully recovered from toxicity of prior chemotherapy or radiation therapy.
  • Subjects must have:
  • bilirubin < 1.5 mg/dL,
  • transaminases < 2.5 X ULN,
  • albumin > 3 gm/dL,
  • creatinine < 2.0 mg/dL.
  • Subjects who have had albumin < 3 gm/dL boosted by an albumin infusion must be observed to maintain albumin at > 3gm dL for 14 days without an additional infusion.
  • Subjects must have a normal echocardiogram (EF > 50% normal) without any evidence of cardiac chamber hypertrophy, dilatation or hypokinesis.
  • Females and males must be willing to use an approved form of birth control while on this study and for 2 weeks after completion.
  • Subjects must have a pretreatment anti-DT titer of 20 μg/ml or less. Subjects with titers between 21 and 35 μg/ml will have an additional anti-DT neutralization test using subject's serum and A-dmDT390-bisFv(UCHT1). If neutralization is not found these titers will be considered acceptable.

Who cannot join

  • Failure to meet any of the criteria.
  • Inability to give informed consent because of psychiatric problems, or complicated medical problems.
  • Allergic to diphtheria toxin a component of the study drug A-dmDT390-bisFv(UCHT1).
  • Serious concurrent medical problems, uncontrolled infections, or disseminated intravascular coagulopathy (DIC), hepatic cirrhosis, or chronic kidney disease.
  • CNS leukemia.
  • Preexisting cardiovascular disease. The only exception being well controlled essential hypertension with a sitting blood pressure (B.P.) of <160 systolic and <90 diastolic without any evidence of structural heart disease or one episode of myocardial infarction > 8 months ago. Subjects receiving a beta-blocker for hypertension should be converted to another antihypertensive drug class 2-3 weeks before receiving the study drug to prevent a drug-drug interaction reactive tachycardia. Angiotensin inhibitors, angiotensin receptor blockers and calcium channel blockers are all acceptable. A past history of any of the following conditions is considered as exclusions to study participation:
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  • Congestive heart failure,
  • Atrial fibrillation,
  • Pulmonary hypertension,
  • Anticoagulant drug therapy,
  • Thromboembolic events,
  • Cardiomyopathy or a myocardial infarction within the past 8 months. The PI and the Clinical Coordinator will be asked to verify that their referred subjects do not have these exclusionary histories listed in 3.2 and a copy of this verification must be sent to the Sponsor before the Sponsor will approve of enrollment. Referring physicians will not need to sign.
  • Pregnant or nursing women will be excluded from study.
  • History of cirrhosis of the liver based on the Child-Pugh score of Class B or C are not eligible to participate.
  • Prior treatment with alemtuzumab (Campath) or similar agents or procedures that depress blood T cell counts to below 50% of the lower limit of normal.
  • Prior history of bone marrow transplant or HSCT is an exclusion.
  • Prior treatment with vorinostat (Prior treatment with vorinostat for lead-in dosing arm is acceptable).

About this study

Official title: Safety and Effectiveness of A-dmDT390-bisFv(UCHT1) Fusion Protein (Resimmune®) in Subjects With Mycosis Fungoides: A Phase II Multi-center Randomized Clinical Trial

This study evaluates the effectiveness - as judged by complete response - of a single four-day treatment with the fusion protein A-dmDT390-bisFv(UCHT1) compared to oral Zolinza (Vorinostat), in a randomized 2-arm trial after a maximum of 12 months of treatment. Patient eligibility is stage IB/IIB mycosis fungoides with mSWAT < 50 who have never had lymphoid disease or a prior bone marrow / HSCT transplant.

Read the detailed description

Primary Objective: This study objective is to document the incidence of complete responses compared to oral vorinostat, in a randomized 2-arm trial after a maximum of 12 months of treatment for subjects with stage IB/IIB mycosis fungoides with mSWAT < 50 who have never had lymphoid disease or a prior bone marrow / HSCT transplant.

Secondary Objective: To further explore the toxicity profile of A-dmDT390-bisFv(UCHT1) fusion protein for subjects with mycosis fungoides who have been selected to be free from preexisting cardiac disease and never treated with Campath.

Number of Subjects: Lead-in Dosing: 12 / Randomized: 162

Patients will receive full supportive care during the course of the study. Participation in the study will require IV infusions of the research agent 2 times a day for four days (protocol FDA outpatient approved), as well as frequent outpatient blood draws for the first 30 days. Patients with partial or complete remissions at their 1 month follow up visit will have another follow-up visit on day 60, then every three months for 1 year, followed by annual visits to assess duration of the response.

Being tested
A-dmDT390-bisFv(UCHT1), Vorinostat
Keywords
MF, CTCL, Cutaneous T Cell Lymphoma
Medical subject headings
Mycosis Fungoides, Lymphoma, T-Cell, Cutaneous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • A-dmDT390-bisFv(UCHT1)Biological

    Also called Resimmune® (proposed marketing designation)

    anti-T cell immunotoxin (antibody targeting CD3 on T-cells tagged with diphtheria toxin without binding domain)

  • VorinostatDrug

    Also called Zolinza

    ZOLINZA is a histone deacetylase (HDAC) inhibitor indicated for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent or recurrent disease on or following two systemic therapies.

Study groups in NCT02943642
Study groupRoleWhat they receive
A-dmDT390-bisFv(UCHT1)ExperimentalA-dmDT390-bisFv(UCHT1) will be administered as Total Dose µg/kg given as 1/8 Total Dose µg/kg/injection twice a day 4-6 hours apart for four consecutive days (days 1-4) into a free flowing IV over a period of approximately 15 minutes.
Receives: Biological: A-dmDT390-bisFv(UCHT1)
VorinostatActive comparatorSubjects in the control arm will receive oral vorinostat capsules at a dose of 400 mg daily up to 12 months in duration until disease progression or uncontrolled side effects take place. Subjects in the vorinostat arm who experience progressive disease may cross over into the experimental arm after 6 months of treatment after a 2-week vorinostat washout period.
Receives: Drug: Vorinostat
Lead-in Dosing single armExperimentalDose Group 1: A-dmDT390-bisFv(UCHT1) will be administered as 5 µg/kg given as 0.625 µg/kg/injection twice a day 4-6 hours apart for four consecutive days (days 1-4) into a free flowing IV over a period of approximately 15 minutes. Dose Group 2: A-dmDT390-bisFv(UCHT1) will be administered as 10 µg/kg given as 1.25 µg/kg/injection twice a day 4-6 hours apart for four consecutive days (days 1-4) into a free flowing IV over a period of approximately 15 minutes.
Receives: Biological: A-dmDT390-bisFv(UCHT1)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Complete Responses (CR)

    Evaluation of Target Lesions

    Complete Response (CR) in mycosis fungoides: (a) Cutaneous lesions consisting of erythematous patches and plaques and erythroderma must be absent giving an mSWAT of 0 that persists for at least 30 days, and (b) the spleen and liver should be normal sized by physical exam. Subjects in the experimental arm who have a CR at 12 months will be encouraged to enter the Part B followup that consists of a a yearly physical exam from year 2 to year to year 6 and skin assessment as long as the CR is maintained.

    Partial Response (PR) in mycosis fungoides: (a) There must be a reduction of 50% in cutaneous lesions as judged by mSWAT and (b) no new evidence of disease or disease progression of skin lesions.

    Progressive Disease (PD): At least a 25% increase in the mSWAT score from its nadir value.

    Treatment Failure: Failure to achieve a PR or CR: Relapse/Progression: Relapse is defined at reevaluation as no longer a CR or PR.

    Measured: Skin lesions will be judged for mSWAT scores for judging the duration of response at 12 months in the experimental arm and 6 months in the comparator arm.

Secondary outcomes (2)

  1. Progression Free Survival

    Determine the Progression Free Survival duration, PFS

    Measured: 12 months

  2. Median duration of Complete Response

    Determine the Median duration of CR for each arm.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2016 (estimated)
  2. Study startMay 2026 (estimated)
  3. Primary completion13 May 2026
  4. Study completion13 May 2026

Why it stopped: This record is an earlier version (crossover design). After FDA-approved IND sponsor transfer to Virogen, the study was redesigned. This protocol will never start. The new protocol is NCT07529405.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02943642
Sponsor's protocol ID
FDA IND 100712 Phase II
Acronym
Resimmune®
Status last verified
May 2026
First submitted
18 Oct 2016
Last updated
18 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Frankel AE, Woo JH, Ahn C, Foss FM, Duvic M, Neville PH, Neville DM. Resimmune, an anti-CD3epsilon recombinant immunotoxin, induces durable remissions in patients with cutaneous T-cell lymphoma. Haematologica. 2015 Jun;100(6):794-800. doi: 10.3324/haematol.2015.123711. Epub 2015 Mar 20.

    PubMed 25795722

  • Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.

    PubMed 32632956

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing A-dmDT390-bisFv(UCHT1) and Vorinostat in people with Mycosis Fungoides, run by Virogen Biotechnology Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Complete Responses (CR) (time frame: Skin lesions will be judged for mSWAT scores for judging the duration of response at 12 months in the experimental arm and 6 months in the comparator arm.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02943642, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.

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