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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MB-CART-19.1 | Experimental | One dose of fresh MB-CART-19.1 at dose level 1- 3x10^6/kg ABW for patients. The leukapheresed product will be used for the individual manufacturing of MB-CART19.1 by using the automated closed CliniMACS Prodigy System |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MB-CART-19.1 | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| overall response rate | ORR in NHL patients defined as the rate of overall response (CR or PR) | on week 4 and at month 3 in patients not achieving CR on week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and toxicity | Safety and toxicity of MB-CART19.1, Overall incidence and severity of adverse events | From enrolment to the end of follow up at one year |
| CRS | The incidence rate of CRS |
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Inclusion Criteria:
Eligible patients with a diagnosis of aggressive NHL:
Patients with CNS disease (excluding isolated CNS lymphoma) are eligible only if disease has been successfully cleared at the time of inclusion.
CD19 expression must be detected on the malignant cells by flow cytometry or immunohistochemistry
Age > 18 year up to 75 years old (if deemed fit by treating investigator);
Baseline absolute CD3+ T cell count by FACS ≥100/µl;
ECOG performance score of 0-2 at screening;
No active Hepatitis B, Hepatitis C, HIV I/II
No childbearing potential or negative pregnancy test at screening within 7 days from starting lymphodepletion chemotherapy and before bridging chemotherapy in women with childbearing potential;
Signed and dated informed consent, before conduct of any trial-specific procedure.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Hussein Cancer Center | Recruiting | Amman | 11941 | Jordan |
to maintain privacy and confidentiality of personal data
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This is a prospective single center, open label, non-randomized, single arm, single dose, optimal 2-stage Simon design, and Phase II clinical trial
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| 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 | at 1 year after receiving study treatment |
| Duration of response | Duration of response | From enrolment to end of follow up at one year |
| ICANS | The incidence rate of ICANS | From enrolment to the end of follow up at one year |
| relapse rate | relapse rate | From enrolment to the end of follow up at one year |
| time to relapse | time to relapse | From enrolment to the end of follow up at one year |
| overall survival | overall survival at 1 year after MB-CART 19.1 in patients not receiving alloHCT | at 1 year after receiving study treatment |