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CD19-Directed Chimeric Antigen Receptor (CAR) T-Cell Therapy for Relapsed/Refractory B-Lineage Leukaemia / Lymphoma - A Feasibility Protocol

RecruitingPhase 2Ages 0 Years - 70 YearsAllKK Women's and Children's Hospital
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to describe feasibility of delivering point-of-care manufactured CD19-directed CAR T-cell therapy to patients with relapsed/ refractory B-lineage leukaemia/ lymphoma.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Eligible disease conditions: 1. Relapsed or refractory B-cell ALL (all must be satisfied) * Presence of lymphoblasts in bone marrow aspirate by morphologic assessment or positive minimal residual disease at screening. * Relapsed or refractory or ineligible for HSCT * For relapsed B-ALL: Documentation of CD19 tumour expression (e.g. by flow cytometry) demonstrated in bone marrow or peripheral blood within 3 months of study entry 2. Relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. 2. Age at screening: 1. \< 18 years (paediatric group); or 2. โ‰ฅ 18 years (adult group) 3. Adequate organ functions: 4. Life expectancy more than 12 weeks. 5. Karnofsky (age โ‰ฅ 16 years) or Lansky (age \< 16 years) performance status โ‰ฅ 50 at screening. 6. Must meet the institutional criteria to undergo leukapheresis or have a leukapheresis product of non-mobilized cells received and accepted by the manufacturing site. Exclusion Criteria: Patients with any of the following will be excluded: * B-ALL with isolated extramedullary disease relapse * Patients with concomitant genetic syndrome: such as patients with Fanconi anaemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Patients with Down syndrome will not be excluded. * Patients with Burkitt's lymphoma/leukaemia (i.e. patients with mature B-cell ALL; leukaemia with B-cell \[sIg positive and kappa or lambda restricted positivity\] ALL, with FAB L3 morphology and /or a MYC translocation) * Active or latent hepatitis B or active hepatitis C (test within 8 weeks of screening), or any uncontrolled infection at screening * Human Immunodeficiency Virus (HIV) positive test within 8 weeks of screening * Presence of grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD) * Active CNS involvement by malignancy, defined by CNS-3 per NCCN guidelines. Subjects with CNS-2 involvement or with history of CNS disease that have been actively treated are eligible. * Patient has an investigational medicinal product within the last 30 days prior to screening. * Pregnant or nursing women. * Women of childbearing potential (defined as all women physiologically capable of becoming pregnant) and all male participants, unless they are using highly effective methods of contraception for a period of 1 year after the CAR T-cell infusion. All female patients of childbearing potential must have a negative pregnancy test performed within 48 hours before infusion of CAR T-cells. The following are not strictly exclusion criteria but must be discussed with PI/Site-PI: * Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease * Treatment with any prior gene therapy product * Has had treatment with any prior anti-CD19/anti-CD3 therapy, or any other anti-CD19 therapy
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What it tests

  • Anti-CD19 CAR T-cells
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Where

2 sites
Singapore General Hospital
Singapore, Singapore
KK Women's and Children's Hospital
Singapore, Singapore
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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