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MB-CART20.1 Lymphoma

AcronymISRCTNEudraCTClinicaltrials.govDRKS
MB-CART20.12017-000121-12NCT03664635

A phase I/II safety, dose finding and feasibility trial of MB-CART20.1 in patients with relapsed or resistant CD20 positive B-NHL

Status: Active

Purpose / Objectives

Primary Outcome

Part I (Phase I)

  • To assess the feasibility, safety, and toxicity of MB-CART20.1

Part II (Phase II)

  • To assess response to treatment of adoptive cell therapy using MB-CART20.1

Secondary Outcomes

Part I (Phase I)

  • Preliminary evidence of response to treatment
  • Phenotype and persistence of MB-CART20.1

Phase II

  • Preliminary evidence of response to treatment.
  • Safety and toxicity assessment of MB-CART20.1
  • Phenotype and persistence of MB-CART20.1

Diagnosis

Patient attributes

Age

18-99

Inclusion criteria

  • Refractory/relapsed CD20+ B-NHL (including malignant transformation like Richter’s transformation) with no curative treatment option. CD20 positivity must be reconfirmed by FACS or immunohistochemistry if a respective biopsy has not been performed after end of last therapy or longer than 6 months before trial inclusion. Including, but not restricted to:
  • Diffuse large B cell lymphoma: relapsed/refractory disease after ASCT or ineligible for ASCT; transformation from CLL, SLL or FL allowed

  • Follicular lymphoma: at least 2 prior regimens and progression < 2 years after most recent line of therapy

  • Mantle cell lymphoma: beyond 1st CR with relapsed disease, progressive disease during first-line rituximab chemotherapy, or persistant disease after first line rituximab-chemotherapy and not eligible or appropriate for conventional, or autologous SCT or relapsed after prior autologous SCT

  • ECOG performance status of 0-2

  • Negative serological hepatitis B test defined as negative tests for HBsAg and HBcAb, negative testing of hepatitis C, negative HIV1/2 test within 6 weeks prior to enrollment

  • [...]

Exclusion criteria

  • Participation in another interventional trial that could interact with this trial
  • Active inflammatory CNS dysfunction or meningeosis
  • Patients with Chronic Lymphocytic Leukemia unless suffering from malignant transformation
  • Active systemic fungal, viral or bacterial infection
  • Serious cardiac functional incapacity (class III or IV as defined by the New York Heart Association Classification)
  • Severe pulmonary disease (DLCO and/or FEV1 < 65%, dyspnea at rest)
  • Liver dysfunction as indicated by a total bilirubin, AST, and ALT >/= 2 the institutional ULN value, unless directly attributable to the patient’s tumor

  • Creatinine clearance <50ml/min calculated according to the modified formula of Cockcroft and Gault

  • Active secondary malignancy requiring treatment (except basal cell carcinoma or malignant tumor curatively treated by surgery) within the last 5 years before enrollment.

  • [...]

Trial design

  • Phase I/II
  • Multicenter
  • Prospective
  • Open Label

Intervention

  • The patients will receive one infusion of the IMP in infusion solution which final volume is adapted to the patients’ weight, over a time period of > 15 minutes.

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

  • Priv.-Doz. Dr. med. Bastian von Tresckow

Subinvestigator

  • PD Dr. med. Boris Böll
  • Dr. med. Janine Böll, geb. Schwamb
  • Dr. med. Birgit Cremer
  • Dr. Philipp Gödel
  • PD Dr. Dr. med. Udo Holtick
  • Dr. med. Anja Jühling
  • Dr. med. Armin Tuchscherer
  • PD Dr. med. Thomas Zander
  • Hyatt Balke-Want
  • Prof. Dr. med. Markus Dietlein
  • Prof. Dr. med. Alexander Drzezga
  • Prof. Dr.med. Carsten Kobe
  • Prof. Dr. med. Matthias Schmidt
  • Prof. Dr. med. Dr. h. c. Christoph Scheid
  • Johanna Prinz
  • Prof. Dr. med. Christian Pallasch
  • Dr. med. Laura Beckmann
  • Benedikt Pelzer

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