This Phase 1, single centre, open label dose escalation study aims to identify a safe dose of third-generation anti-CD19 CAR T-cells (WZTL-002) in the treatment of patients with relapsed or refractory (r/r) B-cell Non Hodgkin Lymphoma, for use in further efficacy trials. An expansion cohort will assess automated closed-system manufacture of WZTL-002 and outpatient management of participants.
Who can participate
Age range16 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 16 to 75 years (inclusive)
* Biopsy-proven relapsed or treatment refractory aggressive B-cell non-Hodgkin lymphoma of the following subtypes per World Health Organisation (WHO) classification: DLBCL and its variants, PMBCL, tFL, FL, MCL
* Requirement for treatment in the opinion of the investigator
* Presence of measurable disease as per Lugano 2014 Criteria
* No other curative treatments available, or not suitable due to patient or disease characteristics or lack of stem cell donor
* Malignancy documented to express CD19 based on flow cytometric or immunohistochemical staining
* Provision of written informed consent for this study
* Lymphoma-related life expectancy at least 12 weeks, and life-expectancy from non-lymphoma related causes of \> 12 months
* European Cooperative Oncology Group (ECOG) performance status of 0 to 2 inclusive
* Adequate haematologic function, defined by neutrophils ≥ 1.0 × 10\^9/L and platelets ≥ 50 × 10\^9/L
* No serious cardiac, pulmonary, hepatic or renal disease.
* Serum bilirubin \< 2.5 times Upper limit of normal (ULN)
* Estimated creatinine clearance (CrCl) ≥ 50 mL/min using the modified Cockroft Gault estimation or as assessed by direct measurement
* Cardiac Ejection Fraction ≥ 50% as determined by Echocardiogram or MUGA Scan
* Oxygen saturations \> 92% on room air
* Diffuse Capacity of the lungs for carbon monoxide (DLCO) or Carbon monoxide transfer coefficient (KCO), Forced expiratory volume in one seco…
What they're measuring
1
Number and severity of adverse events assessed by CTCAE v5.0, except for Cytokine Release Syndrome and Immune Effector Cell-Associated Neurotoxicity Syndrome, which will be assessed by ASTCT consensus grading criteria