This is a Prospective Single Center, open label, Non-randomized, Single Arm, Single Dose, Phase II Clinical Trial. Adult patients \>18-year-old with CD19+ Non-Hodgkin lymphoma are eligible for the study if they meet eligibility criteria. Patients will receive a fresh single dose of MB-CART-19.1 and will be followed for 12 months and evaluated for efficacy and safety.
This is a prospective single center, open label, non-randomized, single arm, single dose, optimal 2-stage Simon design, and Phase II clinical trial. The trial includes Adult patients \> 18-year-old and up to 75 years old, with CD19+ non-Hodgkin lymphoma including diffuse Large B-cell Lymphoma, primary mediastinal B-cell lymphoma and relapsed refractory follicular lymphoma. Single infusion of freshly prepared MB-CART19.1 cells manufactured according to Miltinyi Biotec product manufacturing guidelines and good manufacturing product (GMP) of KHCC manufacturing standard operating procedures (SOPs). The patients will receive one infusion of the MB-CART19.1 product in infusion solution at a final volume adapted to the patients' weight, over a time of approx. 5-20 minutes (intravenous infusion via a large peripheral vein or central line). The objective of this trial is to assess the efficacy and safety of ex vivo generated MB-CART19.1 in adult patients with relapsed or refractory CD19 positive Non-Hodgkin lymphoma including diffuse Large B-cell Lymphoma, primary mediastinal B-cell lymphoma and relapsed refractory follicular lymphoma
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
The leukapheresed product will be used for the individual manufacturing of MB-CART19.1 by using the automated closed CliniMACS Prodigy System. CD4+ and CD8+ T-cells will be selected, enriched and activated, followed by lentivirus-based transduction with the CD19 CAR construct. Then the MB-CART19.1 transduced T cells will be expanded and finally formulated.
King Hussein Cancer Center
Amman, Jordan
RECRUITINGoverall response rate
ORR in NHL patients defined as the rate of overall response (CR or PR)
Time frame: on week 4 and at month 3 in patients not achieving CR on week 4
Safety and toxicity
Safety and toxicity of MB-CART19.1, Overall incidence and severity of adverse events
Time frame: From enrolment to the end of follow up at one year
CRS
The incidence rate of CRS
Time frame: From enrolment to the end of follow up at one year
Disease-free survival
Disease-free at 1 year after MB-CART 19.1 in patients not receiving alloHCT
Time frame: at 1 year after receiving study treatment
Duration of response
Duration of response
Time frame: From enrolment to end of follow up at one year
ICANS
The incidence rate of ICANS
Time frame: From enrolment to the end of follow up at one year
relapse rate
relapse rate
Time frame: From enrolment to the end of follow up at one year
time to relapse
time to relapse
Time frame: From enrolment to the end of follow up at one year
overall survival
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overall survival at 1 year after MB-CART 19.1 in patients not receiving alloHCT
Time frame: at 1 year after receiving study treatment