๐ฌIn 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.
๐ 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. โฅ 18 years (adult group)
3. Adequate organ functions:
4. Life expectancy more than 12 weeks.
5. Karnofsky (age โฅ 16 years) or Lansky (age \< 16 years) performance status โฅ 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