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Melanoma (Skin)Early Phase 1NCT03893019

MB-CART20.1 Melanoma

A Early Phase 1 study testing MB-CART20.1 in people with Melanoma (Skin), run by Miltenyi Biomedicine GmbH at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma (Skin)
What is being tested?
MB-CART20.1
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteGermany
Study dates
8 Mar 2019to 30 Jan 2023
Phase
Early Phase 1
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

  • 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
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  • 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 women with childbearing potential. Sexually active female patients of childbearing potential should use one of the following highly effective methods of contraception (Pearl index < 1%): hormonal contraceptives (oral, injected, implanted, transdermal), intrauterine devices or systems (e.g. hormonal and non-hormonal IUD), or vasectomized sexual partner for at least 1 month before the trial start, during the course of the trial and in the 6 months following dosing. Sexual abstinence is restricted to true abstinence ( in line with the preferred and usual lifestyle of the subject).
  • male patients, unless surgically sterile, must be using two acceptable methods for contraception (e.g. spermicide and condom) during the trial and refrain from fathering a child throughout the trial and for up to 12 months after dosing.
  • Signed and dated informed consent before conduct of any trial-specific procedure.

Who cannot join

  • Any evidence of brain metastases
  • CNS (central nervous system) disorders and previous strokes, if clinically relevant
  • Patients with epilepsy
  • Clinically relevant autoimmune disorders or history of clinically relevant autoimmune disorders
  • Patients with T-cell lymphoma
  • Treatment with anti-CD20 antibodies or checkpoint blockade inhibitors within 6 weeks before leukapheresis
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  • Chemotherapy within 6 weeks prior to leukapheresis
  • History of primary immunodeficiency
  • Creatinine clearance < 50 ml/min calculated according to the modified formula of Cockcroft and Gault
  • concurrent systemic radiotherapy
  • Use of systemic corticosteroids and immunosuppressive medication except prednisone ≤ 10 mg QD or equivalent
  • Patients with severe cardiac disease (e.g. NYHA Functional Class III or IV, myocardial infarction within 6 months before inclusion, ventricular tachyarrhythmia requiring ongoing treatment, unstable angina pectoris)
  • Other investigational treatment within 4 weeks before MB-CART20.1 infusion
  • Hypersensitivity against any drug or its ingredients/impurities that is scheduled or likely to be given during trial participation, e.g. as part of the mandatory lymphodepletion protocol, pre-medication for infusion, rescue medication/salvage therapies for treatment related toxicities
  • Patients in which such medication (likely to be given during trial participation) is contraindicated for other reasons than hypersensitivity, e.g. live vaccines and fludarabine.
  • Severe pulmonary disease (DLCO and/or FEV1 < 65%, dyspnoea at rest)
  • Active systemic fungal, viral or bacterial infection
  • Pregnant or lactating women
  • Patient's lack of accountability, inability to appreciate the nature, meaning and consequence of the trial and to formulate his/her own wishes correspondingly
  • Patients who have a relationship of dependence or employer employee relationship to the sponsor or the investigator
  • Committal to an institution on judicial or official order

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Hospital of Cologne - Clinic for Internal Medicine I

    Cologne, North Rhine-Westphalia, 50937

Other trials in Germany

About this study

Official title: Multicenter Phase I Trial of MB-CART20.1 for the Treatment of Patients With Metastatic Melanoma

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.

Read the detailed description

This Phase I trial will be the first trial with CD20 CAR transduced T cells in Europe targeting melanoma. The rationale for the trial is based on the finding that melanoma cancer sustaining cells express CD20 and that targeting CD20+ cells in preclinical model has a strong antitumor effect.

Conditions
Melanoma (Skin)
Being tested
MB-CART20.1
Medical subject headings
Melanoma

What participants receive

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

  • MB-CART20.1Biological

    Also called CD20-targeting CAR T cells, anti-CD20 CAR T cells

    MB-CART20.1 consists of autologous CD20 Chimeric Antigen Receptor (CAR) transduced CD4/CD8 enriched T cells targeting CD20.positive tumor cells

Study groups in NCT03893019
Study groupRoleWhat they receive
Dose Level 1: 1x10e5 MB-CART20.1 cellsExperimental3+3 patients will be treated with 1x10e5 MB-CART20.1 cells per kg body weight administered intravenously
Receives: Biological: MB-CART20.1
Dose Level 2: 1x10e6 MB-CART20.1 cellsExperimental3+3 patients will be treated with 1x10e6 MB-CART20.1 cells per kg body weight administered intravenously
Receives: Biological: MB-CART20.1
Dose Level 3: 1x10e7 MB-CART20.1 cellsExperimental3+3 patients will be treated with 1x10e7 MB-CART20.1 cells per kg body weight administered intravenously
Receives: Biological: MB-CART20.1

What is being measured

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

  1. Determination of MTD

    MTD is defined as the highest dose level at which < 33% of patients experience dose limiting toxicity (DLT)

    Measured: Week 4 after infusion of MB-CART20.1

  2. Safety and Toxicity Assessment per Adverse Event reporting classified according to CTCAE V5.0

    per Adverse Event reporting classified according to CTCAE V5.0

    Measured: until day 28 after infusion of MB-CART20.1

Secondary outcomes (6)

  1. Clinical Response

    Number of patients with either Complete Response, Partial Response, Stable Disease or Progressive Disease using RECIST 1.1

    Measured: 1 year after infusion of MB-CART20.1

  2. Frequency of B-cell aplasia

    Circulating B cell numbers in the peripheral blood will be assessed by Flow cytometry

    Measured: 1 year after infusion of MB-CART20.1

  3. Phenotype and Persistence of infused MB-CART20.1

    Blood samples for determination of persistence/phenotyping of infused MB-CART20.1 will be analysed.

    Measured: 1 year after infusion of MB-CART20.1

  4. Presence and phenotype of MB-CART20.1 and B cells in biopsies

    Tumor biopsies for determination of persistence/phenotyping of infused MB-CART20.1 will be analysed

    Measured: Screening, 8 weeks after infusion of MB-CART20.1

  5. Number of CD20+ tumor cells

    Tumor biopsies for determination of number of CD20+ tumor cells

    Measured: Screening, 8 weeks after infusion of MB-CART20.1

  6. Persistence of T-cell expansion for each dose group

    Blood samples for determination MB-CART20.1 levels (transgene copies / genomic DNA)

    Measured: Day 0 and week 12

Timeline

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

  1. First posted27 Mar 2019
  2. Study start8 Mar 2019
  3. Primary completion30 Jan 2023
  4. Study completion30 Jan 2023

Why it stopped: The risk-benefit assessment was not as expected.

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
Early Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03893019
Sponsor's protocol ID
M-2015-307
Status last verified
May 2024
First submitted
6 Mar 2019
Last updated
16 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Aleksandrova K, Leise J, Priesner C, Aktas M, Apel M, Assenmacher M, Burger I, Richter A, Altefrohne P, Schubert C, Holzinger A, Barden M, Bezler V, von Bergwelt-Baildon M, Borchmann P, Goudeva L, Glienke W, Arseniev L, Esser R, Abken H, Koehl U. Automated manufacturing and characterization of clinical grade autologous CD20 CAR T cells for the treatment of patients with stage III/IV melanoma. Front Immunol. 2024 Sep 25;15:1328368. doi: 10.3389/fimmu.2024.1328368. eCollection 2024.

    PubMed 39386211

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing MB-CART20.1 in people with Melanoma (Skin), run by Miltenyi Biomedicine GmbH at 1 site in Germany.

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 20 inclusion and 21 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: stopped early, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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 stopped early (reason given: The risk-benefit assessment was not as expected.). Results are not available in the source record.

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?

Determination of MTD (time frame: Week 4 after infusion of MB-CART20.1). The study lists 2 primary outcomes in all. 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 NCT03893019, which also lists 1 linked publication.

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 16 May 2024.

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