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

Recruiting now · Phase 2

Conditions studied: Lymphoblastic Leukemia, Lymphoblastic Leukemia in Children, Lymphoblastic Leukemia, Acute Adult, B-cell Acute Lymphoblastic Leukemia, Large B-cell Lymphoma, CAR

In brief

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.

Key facts

Study ID

NCT05648019

Run by

KK Women's and Children's Hospital

People needed

40

Starts

2022-03-15

Expected to finish

2026-12-01

Last updated by the study team

2023-03-09

Who can join

Age: any, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Singapore General Hospital — Singapore, Singapore (enrolling)
• KK Women's and Children's Hospital — Singapore, Singapore (enrolling)

Full record on ClinicalTrials.gov

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