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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
MB-CART20.1 consists of autologous CD20 Chimeric Antigen Receptor (CAR) transduced CD4/CD8 enriched T cells targeting CD20.positive tumor cells
University Hospital of Cologne - Clinic for Internal Medicine I
Cologne, North Rhine-Westphalia, Germany
Determination of MTD
MTD is defined as the highest dose level at which \< 33% of patients experience dose limiting toxicity (DLT)
Time frame: Week 4 after infusion of MB-CART20.1
Safety and Toxicity Assessment per Adverse Event reporting classified according to CTCAE V5.0
per Adverse Event reporting classified according to CTCAE V5.0
Time frame: until day 28 after infusion of MB-CART20.1
Clinical Response
Number of patients with either Complete Response, Partial Response, Stable Disease or Progressive Disease using RECIST 1.1
Time frame: 1 year after infusion of MB-CART20.1
Frequency of B-cell aplasia
Circulating B cell numbers in the peripheral blood will be assessed by Flow cytometry
Time frame: 1 year after infusion of MB-CART20.1
Phenotype and Persistence of infused MB-CART20.1
Blood samples for determination of persistence/phenotyping of infused MB-CART20.1 will be analysed.
Time frame: 1 year after infusion of MB-CART20.1
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
Time frame: Screening, 8 weeks after infusion of MB-CART20.1
Number of CD20+ tumor cells
Tumor biopsies for determination of number of CD20+ tumor cells
Time frame: Screening, 8 weeks after infusion of MB-CART20.1
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Persistence of T-cell expansion for each dose group
Blood samples for determination MB-CART20.1 levels (transgene copies / genomic DNA)
Time frame: Day 0 and week 12