Stopped: The risk-benefit assessment was not as expected.
Germany9 participantsStarted 2019-03-08
Plain-language summary
This is a phase l multi-centric, single arm, prospective, open, dose-escalation study in patients with unresectable stage III oder IV melanoma. The trial will include 15 adult patients. The trial is a classic 3+3 design with 1 Log dose increments and maximum 3 dose levels of the intravenously administered MB-CART20.1.
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:
Male or female patients with
* Histologically confirmed unresectable stage III or stage IV melanoma
* Willingness to provide a tumor biopsy between the screening visit and prior to administration of the IMP and eight weeks after treatment
* Progressive disease despite treatment with indicated standard therapies. Time window for decision about progressive disease is to be made depending on the treatment regimen chosen.
* Measurable lesions according to RECIST1.1
* ECOG (Eastern cooperative oncology group) performance status of 0-2
* Negative serological hepatitis B (HBV) test defined as negative tests for HBsAg and HBcAb, unless serology is positive due to recent IVIG therapy, HBcAb positivity will be allowed if HbsAb is present, negative testing of HCVAb, negative human immunodeficiency virus (HIV) 1/2 test within 6 weeks prior to enrollment.
* Estimated life expectancy of more than 6 months
* At least 18 years of age
* WBC ≥ 2500/µL
* ANC ≥ 1000/µL
* Platelets ≥ 75 x 103/µL
* Hemoglobin ≥ 9 g/dL
* AST ≤ 3 x upper limit of normal (ULN) for patients without liver metastasis
* AST \< 5 x ULN for patients with liver metastasis
* Total Bilirubin ≤ 2 x ULN
* patients with Gilbert's Syndrome increase of indirect bilirubin \< 6mg/dL
* No childbearing potential (i.e. postmenopausal, absence of menstrual bleeding for at least 1 year, hysterectomy, bilateral ovariectomy or tubal section/ligation) or negative pregnancy test at screening and before chemotherapy in w…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Determination of MTD
Timeframe: Week 4 after infusion of MB-CART20.1
2
Safety and Toxicity Assessment per Adverse Event reporting classified according to CTCAE V5.0
Timeframe: until day 28 after infusion of MB-CART20.1