A Phase I Dose Finding Study of MB-CART2219.1
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age12-75
SponsorUniversity Hospital Tuebingen
About this trial
A Phase I dose finding study of MB-CART2219.1 targeting CD19/CD22 in adult and pediatric patients with relapsed/refractory B-cell malignancies
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
For Cohort I Lymphoma, adults: Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).
For Cohort II ALL, pediatrics: Subject is ≥ 12 years of age at the time of signing ICF.
Patient or legal guardian understand and voluntarily sign an informed consent document prior to any study related assessments/procedures.
Able to adhere to the study visit schedule and other protocol requirements as well as agrees to continued follow up for up to 15 years as mandated by the regulatory guidelines for gene therapy trials.
Disqualifiers
Any investigational agent
Immunsupressive medication
Plasmapheresis
Major surgery (as defined by the investigator)
Trial design
Design model
Single group
Treatments tested in this trial
CAR-T cells targeting CD19 and CD22
Biological/VaccineUsing the 3+3 design, the following dose levels will be assessed: Dose level 1: 0.5x10e6 CAR-transduced T cells/kg; Dose level 2: 1x10e6 CAR-transduced T cells/kg; Dose level 3: 2x10e6 CAR-transduced T cells/kg; Dose level 0: 0.25x10e6 CAR-transduced T cells/kg
Treatment groups
36 Participants
are divided into 1 treatment groupGroup A: Dose findingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety and feasibility Phase I (CTCAE)
Objective: to assess feasibility, safety of ex vivo generated MB-CART2219.1 in patients with relapsed or refractory CD19 and/or CD22 positive B cell malignancies. Determination of the recommended dose of MB-CART-CD19CD22, determined on the basis of the maximum tolerated dose, defined as the highest dose level of the 2-3 dose levels tested at which \<33% of patients experience DLT until d+28 after infusion of MBCART2219.1 and on the basis of the safety and efficacy data. Safety and toxicity assessment of MB-CART2219.1 per adverse events reporting classified according to CTCAE version 5.0 defined by \<33% of patients experiencing DLT, or maximal administered dose. The Trial uses two separate disease and age specific cohorts for dose escalation: cohort I (Lymphoma incl. CLL, adults) and cohort II (ALL, children). For each cohort in using the standard 3+3 design, three dose levels will be assessed. Feasibility will be defined as successful treatment without major deviation from the protocol
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov