Study of CART Cell (MB-CART19.1) in Patients With Relapsed or Refractory CD19 Positive NHL
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorKing Hussein Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients after progression on at least one standard chemotherapy and one salvage regimen or
Patients considered for alloSCT but are found ineligible or
Patients who have relapsed post alloSCT at least 100 days post-transplant, with no evidence of active GVHD, and no longer taking immunosuppressive agents for at least 30 days prior to enrollment.
Patients with CNS disease (excluding isolated CNS lymphoma) are eligible only if disease has been successfully cleared at the time of inclusion.
Disqualifiers
Residual CNS disease
Current autoimmune disease, or history of autoimmune disease with potential CNS involvement;
Active clinically significant CNS dysfunction (including but not limited to uncontrolled seizure disorders, cerebrovascular ischemia or hemorrhage, dementia, paralysis)
History of an additional malignancy other than non-melanoma skin cancer or carcinoma in situ unless disease free for ≥3 years;
Trial design
Design model
Single group
Treatments tested in this trial
MB-CART-19.1
Other interventionThe 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.
Treatment groups
26 Participants
are divided into 1 treatment groupGroup A: MB-CART-19.1Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
overall 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 4Secondary outcomes
1
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 year2
CRS
The incidence rate of CRS
Time frame
From enrolment to the end of follow up at one year3
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 treatment4
Duration of response
Duration of response
Time frame
From enrolment to end of follow up at one yearSponsors and contacts
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Source ClinicalTrials.gov