Safety of Autologous Humanized Anti-CD19 and Anti-CD20 Dual Specific CAR-T Cells in Adult Patient… (NCT04215016) | Clinical Trial Compass
UnknownPhase 1
Safety of Autologous Humanized Anti-CD19 and Anti-CD20 Dual Specific CAR-T Cells in Adult Patients With Diffuse Large B-cell Lymphoma
China18 participantsStarted 2019-12
Plain-language summary
This is a single-arm, open-label, dose escalation, phase I study, aiming to evaluate the safety and efficacy of Autologous Humanized Anti-CD19 and Anti-CD20 Dual Specific Chimeric Antigen Receptor (CAR) T-cells in patient with relapsed or refractory diffuse B cell lymphoma.
Who can participate
Age range18 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
✓. The subject or her/his legally guardian(s) must sign the informed consent form approved by the Institutional Ethics Committee (IEC) prior to any screening procedures;
✓. Subjects aged 18 years or older with relapsed or refractory DLBCL (primary mediastinal large B-cell lymphoma and transformed follicular lymphoma included), of which refractory is defined as:
✓. Subjects who have previously received ≥2 lines treatment, and at least including:
✓. Confirmation for either CD19 or CD20 positivity using immunohistochemistry or flow cytometry;
✓. According to the initial evaluation, staging and response assessment of Hodgkin's and non-Hodgkin's lymphoma -the Lugano Classification (2014), there is at least one measurable lesion at baseline;
✓. Life expectancy ≥12 weeks;
✓. Eastern Cooperative Oncology Group (ECOG) performance status that is either 0 or 1 at screening;
✓. Adequate organ function:
Exclusion criteria
✕. Prior treatment with any cell therapy before signing the informed consent form, including CAR-T therapy;
✕. Subjects with detectable cerebrospinal fluid malignant cells or brain metastases, or with a history of central nervous system (CNS) lymphoma or primary CNS lymphoma;
✕. Subjects with testicular invasion, including those who have had testicular resection;
✕. Subjects with current or previous history of central nervous system disease, such as seizures, cerebral ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving the central nervous system;
✕. Subjects who have previously received allogeneic hematopoietic stem cell transplantation (HSCT); or suitable and consenting to Autologous hematopoietic stem cell transplantation (ASCT);
✕. Chemotherapy other than lymphodepleting chemotherapy within 2 weeks of A-02 infusion;
✕. Patients on oral anticoagulation therapy within 1 week of A-02 infusion;
✕. Prior radiation therapy within 2 weeks of A-02 infusion;