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MB-CART20.1 Melanoma

AcronymISRCTNEudraCTClinicaltrials.govDRKS
M-2015-3072017-000120-10

Multicenter phase I trial of MB-CART20.1 for the treatment of patients with metastatic melanoma

Status: Active

Purpose / Objectives

Primary Outcome

  • To assess the feasibility, safety, and toxicity of adoptive cell therapy using MB-CART20.1 as per adverse events (AE) reporting classified according to CTCAEv.4.03 and Lee et.al. 20141

Secondary Outcomes

  • Preliminary evidence of response to treatment
  • To assess B cell aplasia
  • Immunophenotyping /Persistence of infused MB-CART20.1

Diagnosis

Patient attributes

Stage

III or IV

Age

18-99

Inclusion criteria

  • Male or female patients with
  • Histologically confirmed unresectable stage III melanoma with N3 macroscopic lymph nodes or in-transit/satellite metastases or stage IV melanoma
  • Tumor biopsy performed at screening
  • 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 modified WHO criteria
  • ECOG performance status of 0-2
  • [...]

Exclusion criteria

  • Evidence of brain metastases stable and asymptomatic for less than 3 months
  • CNS disorders and previous strokes, if clinically relevant
  • Clinically relevant autoimmune disorders
  • Patients with T-cell lymphoma
  • Previous treatment with mouse recombinant monoclonal antibody or other checkpoint blockade inhibitors
  • History of primary immunodeficiency
  • Use of anti-CD20 antibodies within 4 weeks before MB-CART20.1 infusion
  • Creatinine clearance <50ml/min calculated according to the modified formula of Cockcroft and Gault
  • Concurrent systemic radiotherapy
  • Use of systemic corticosteroids and immunosuppressive medication except hydrocortisone (prednisone ≤ 10 mg QD or equivalent)
  • [...]

Trial design

  • Phase I
  • Multicenter
  • Prospective
  • Open Label

Intervention

This is a 3+3 trial design with 1 log dose increments (1x105 /1x106 /1x107 MB-CART20.1 per kg BW in a single infusion) and maximum 3 dose levels. If none of the three patients in a cohort experiences a dose limiting toxicity, another three patients will be treated with the next highest dose level. If one DLT is observed in a dose group the group size for that dose will be doubled.

Documents (password protected)

Responsibilities in overall trial

Miltenyi Biotec GmbH

National Coordinating Investigator

Prof. Dr. med. Peter Borchmann

Study Sites

Klinik I für Innere Medizin

Study office

  • Klinisches Studienzentrum der Klinik I für Innere Medizin Köln

Status

Active

Principal Investigator

Prof. Dr. med. Peter Borchmann

Deputy of Principal Investigator

  • PD Dr. Dr. med. Udo Holtick

Subinvestigator

  • Carina Gärtner
  • Dr. Philipp Gödel
  • PD Dr. med. Matthias Kochanek
  • Dr. Nicole Kreuzberg
  • Dr. med. Armin Tuchscherer
  • PD Dr. med. Thomas Zander
  • Univ.-Prof. Dr. med. Dr. Cornelia Mauch
  • Johanna Prinz
  • Prof. Dr. med. Dr. h. c. Christoph Scheid
  • PD Dr. med. Boris Böll
  • Dr. med. Nadine Kutsch
  • Bodo Bühler
  • Dr. med. Carmen Diana Herling

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