Clinical Research of CD19 Targeted CAR-T Cell in Relapsed/Refractory B Cell Lymphoma (NCT06180174) | Clinical Trial Compass
RecruitingPhase 1
Clinical Research of CD19 Targeted CAR-T Cell in Relapsed/Refractory B Cell Lymphoma
China24 participantsStarted 2023-12-31
Plain-language summary
This is a single-arm, open-label, dose-escalation phase I clinical study to explore the safety, tolerability, and cytokinetic characteristics of MC-1-50 cell formulation, and to preliminarily observe the efficacy of MC-1-50 cell formulation in subjects with relapsed/refractory CD19-positive B-cell non-Hodgkin lymphoma.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. The patient or his/her guardian agrees to participate in the clinical trial and signs the ICF, indicating that he/she understands the purpose and procedure of the clinical trial and is willing to participate in the study;
✓. Age ≥18 years old, gender unlimited;
✓. Confirmed cytological or histological diagnosis of B-cell non-Hodgkin lymphoma according to WHO 2017 criteria, including the following pathological types:
✓. Diffuse large B-cell lymphoma: including non-specific type (DLBCL, NOS), chronic inflammatory associated DLBCL, primary cutaneous DLBCL (leg type), EBV-positive DLBCL (NOS);
✓. High-grade B-cell lymphomas (including NOS and high-grade B-cell lymphomas with MYC and BCL2 and/or BCL6 rearrangements);
✓. Primary mediastinal large B-cell lymphoma;
✓. Rich T/ histiocytic large B-cell lymphoma;
✓. Transformed DLBCL (e.g., transformed DLBCL of follicular lymphoma, chronic lymphocytic leukemia/small B lymphocytic lymphoma, marginal zone lymphoma, etc.);
Exclusion criteria
✕. Secondary CNS lymphoma was allowed to be included, except those with active CNS invasion or symptoms of CNS involvement or primary CNS lymphoma at the time of screening;
✕. Patients who have received CAR-T therapy or other gene-modified cell therapy before screening;
✕
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Timeframe: 1 month
2
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
. Received allogeneic hematopoietic stem cell transplantation (allo-HSCT) before screening;
✕. Received the following anti-tumor therapy before cell infusion: received chemotherapy, targeted therapy and other drug treatment (preconditioning) within 14 days or at least 5 half-lives (whichever is longer)
✕. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA detection greater than the normal range; Hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA detection greater than the normal range; Positive for human immunodeficiency virus (HIV) antibodies; Syphilis positive; Cytomegalovirus (CMV) DNA test positive;
✕. Have any of the following heart conditions:
✕. New York Heart Association (NYHA) Stage III or IV congestive heart failure;
✕. Had myocardial infarction or coronary artery bypass grafting (CABG) within 6 months prior to enrollment;