NCT06375161

Anti-CD19-CAR-T Cells in Relapsed/Refractory B-cell Tumor Patients.

An Exploratory Clinical Study Evaluating the Safety and Efficacy of Infusion of Anti-CD19-CAR-T Cells in Relapsed/Refractory B-cell Tumor Patients.

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Shanghai Tongji Hospital, Tongji University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Weeks – 70 Weeks
• Healthy volunteers: Not accepted

Summary

This study is a single-center, open-label, single-dose clinical trial of anti-CD19-CAR-T cell therapy in relapsed/refractory B-cell tumor patients after Qinglin pre-treatment. In this study phase, a traditional "3+3" trial design is employed for dose escalation.

Detailed description

The study plans to include CD19-positive relapsed/refractory B-cell tumor patients. After the screening period, peripheral blood mononuclear cell (PBMC) collection, and lymphocyte depletion pre-treatment period, subjects will receive a single infusion of anti-CD19-CAR-T cells. In addition to the baseline period, efficacy assessments will be conducted monthly for ALL subjects and at weeks 4, 12, 24, 36, and 48 post-treatment for NHL subjects, until disease progression (PD), relapse, change of treatment regimen, death, intolerable toxicity, at the discretion of the investigator, or voluntary withdrawal by the patient (whichever occurs first). Toxicity will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0). Safety of anti-CD19-CAR-T cell therapy will be evaluated through laboratory tests, 12-lead electrocardiograms, vital signs, physical examinations, etc. Blood samples will be collected from subjects to assess cellular pharmacokinetics and explore the effects of cellular drugs on ferritin, C-reactive protein, and related cytokines.

Conditions

• B Cell Malignancies

Interventions

Type	Name	Description
BIOLOGICAL	anti-CD19-CAR-T cells	Before cell infusion, Investigator may decide, based on necessity, whether to administer prophylactic medication, which may include options such as acetaminophen and diphenhydramine, or H1 antihistamines, among others. Subjects are allowed to receive adequate supportive care after anti-CD19-CAR-T cell infusion, including blood transfusions and blood products, antibiotic therapy, antiemetics, antidiarrheals, analgesics, etc.

Timeline

• Start date: 2023-12-11
• Primary completion: 2025-12-10
• Completion: 2039-12-10
• First posted: 2024-04-19
• Last updated: 2024-04-19

Locations

1 site across 1 country: China