Tests CD19 CAR T-cell therapy in people with returned blood cancers

Trial details

Who runs it

KK Women's and Children's Hospital

Trial code

NCT05648019

Record updated

9 March 2023

Original description

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.Read full original descriptionShow less

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

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.

Inclusion: Eligible disease conditions:; 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; 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; Age at screening:; < 18 years (paediatric group); or; ≥ 18 years (adult group); Adequate organ functions:; Life expectancy more than 12 weeks; Karnofsky (age ≥ 16 years) or Lansky (age < 16 years) performance status ≥ 50 at screening; 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: 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; Patient has an investigational medicinal product within the last 30 days prior to screening; Treatment with any prior gene therapy product; Has had treatment with any prior anti-CD19/anti-CD3 therapy, or any other anti-CD19 therapy; B-ALL with isolated extramedullary disease relapse; 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; Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease; Patients with any of the following will 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); 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:.

ClinicalTrials.gov NCT05648019