Status:
UNKNOWN
MB-CART19.1 in Patients With R/R ALL
Lead Sponsor:
Shanghai Children's Medical Center
Collaborating Sponsors:
Miltenyi Biomedicine GmbH
Conditions:
Precursor B-Lymphoblastic Lymphoma/Leukaemia Refractory
Eligibility:
All Genders
2-18 years
Phase:
PHASE2
Brief Summary
Precursor-B acute lymphoblastic leukemia (ALL) is the most common cancer in childhood. Despite major advances in ALL therapy, 20% of children and 40-50% of adults fail state-of-the art first-line trea...
Detailed Description
This is an open-label, non-randomized phase II paediatric study. In this study, eligible patients will receive autologous T cells transduced with the lentiviral vector pLTG1563 (MB-CART19.1) at a does...
Eligibility Criteria
Inclusion
- Age ≤18 years (if deemed fit by treating investigator)
- CD19 expression must be detected on the malignant cells by flow cytometry.
- Patients with relapsed disease with \>5% blasts in BM (M2 or M3) after at least one standard chemotherapy and one salvage regimen who are ineligible for allogeneic stem cell transplant (alloSCT)
- Patients have refractory disease activity precluding alloSCT at this time, 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 combined extramedullary ALL are eligible if extramedullary disease has been successfully cleared by conventional therapy at the time of inclusion (e.g. intrathecal chemotherapy, orchiectomy). This includes patients with combined CNS-2 (\<5 WBC/µl CSF, with blasts on cytospin) or CNS-3 (5WBC/µl CSF, with blasts on cytospin) disease and patients with combined testicular relapse.
- Patients and/or parents must give their written informed consent/assent.
Exclusion
- Rapidly progressive disease that in the estimation of live less than 12 weeks
- Isolated extramedullary relapse (CNS and/or testicular) in ALL
- 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.
- Pulmonary function: Patients with pre-existing severe lung disease (FEV1 or FVC \< 65%) or an oxygen requirement of \>28% O2 supplementation or active pulmonary infiltrates on chest X-ray at the time scheduled for T cell infusion
- Cardiac function: Fractional shortening \<28% or left ventricular ejection fraction \<50% by echocardiography
- Renal function: Creatinine clearance \<50 mL/min/1.73 m2
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2019
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03321123
Start Date
December 1 2017
End Date
December 31 2019
Last Update
October 25 2017
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