Safety and Effectiveness of A-dmDT390-bisFv(UCHT1) Fusion Protein in Subjects With Mycosis Fungoides (NCT02943642) | Clinical Trial Compass
WithdrawnPhase 2
Safety and Effectiveness of A-dmDT390-bisFv(UCHT1) Fusion Protein in Subjects With Mycosis Fungoides
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.
0Started 2026-05
Plain-language 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. Patient eligibility is stage IB/IIB mycosis fungoides with mSWAT \< 50 who have never had lymphoid disease or a prior bone marrow / HSCT transplant.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
* 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 mus…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial for mycosis fungoides was withdrawn before enrolling anyone — do you know why it was pulled, and does that affect whether A-dmDT390-bisFv(UCHT1) is still being studied anywhere else I could potentially access?
2Since this was a Phase 2 trial measuring complete responses, what does that tell us about how much safety and effectiveness data actually exists for this drug, and is there enough published information for you to assess whether it might be appropriate for my situation?
3Given that this trial is no longer recruiting, are there other active clinical trials studying similar fusion protein or immunotoxin approaches for mycosis fungoides that might be worth looking into together?
4How does A-dmDT390-bisFv(UCHT1) work differently from the standard treatments currently available for mycosis fungoides, and would you recommend trying established options first before pursuing experimental therapies like this?
5If we wanted to explore whether any trials targeting T-cells with this kind of fusion protein approach are still open, what resources or specialists would you suggest we contact to find out?'}
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Complete Responses (CR)
Timeframe: 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.