B-cell Acute Lymphoblastic Leukemia Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 2026 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 0 Years to 70 Years |
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 |
Country | Name | City | State |
---|---|---|---|
Singapore | KK Women's and Children's Hospital | Singapore | |
Singapore | Singapore General Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
KK Women's and Children's Hospital | Singapore General Hospital |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Protocol Feasibility | To describe feasibility of delivering point-of-care manufactured CD19-directed CAR T-cell therapy to patients with relapsed / refractory B-lineage leukaemia / lymphoma by assessing number and percentage of enrolled patients who have successful manufacturing of CAR T-cell product, and number and percentage of enrolled patients who go on to receive the CAR T-cell product. | 3 years | |
Secondary | Overall Response Rate | To evaluate percentage of patients with complete response or partial response at 28 days, 3 months and 6 months post-infusion of the CD19-directed CAR T-cells. | 6 months | |
Secondary | Toxicity Evaluations | To evaluate overall incidence (percentage of infused patients) of toxicities post-infusion of CAR T-cells, in particular cytokine release syndrome (CRS) and neurotoxicity, and percentage with Grade 3 and above CRS and neurotoxicity following ASTCT definition and severity grading, and other toxicities as assessed by CTCAE v5.0. | 6 months |
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