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This Phase 2 study aims to describe the feasibility of delivering point-of-care manufactured CD19-directed CAR T-cell therapy to patients with relapsed or refractory B-lineage leukaemia and lymphoma. Eligible participants include people with relapsed or refractory B-cell ALL who have lymphoblasts in the bone marrow or positive minimal residual disease at screening, or who are ineligible for stem cell transplant. The trial is currently recruiting.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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. ≥ 18 years (adult group)
3. Adequate organ functions:
4. Life expectancy more than 12 weeks.
5. Karnofsky (age ≥ 16 years) or Lansky (age \< 16 years) performance status ≥ 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