Clinical Trials Logo

Clinical Trial Summary

To evaluate the safety and tolerability of CD19-CAR-DNT cells infusion in subjects with relapsed/refractory B-cell non-Hodgkin's Lymphoma


Clinical Trial Description

This is an open, single-arm, single-dose, dose-escalation and dose-expansion clinical trial designed to evaluate the maximum tolerated dose of CD19-CAR-DNT cells, the safety, the preliminary efficacy and the pharmacokinetic profile of CD19-CAR-DNT cells in vivo after infusion in clinical studies. 9 patients are planned to be enrolled in the dose-escalation trial (1×10^6 CD19-CAR-DNT cells/kg, 3×10^6 CD19-CAR-DNT cells/kg, 9×10^6 CD19-CAR-DNT cells/kg) and 3 patients in the dose-expansion trial. The primary endpoints are DLT, MTD, and the incidence of abnormalities in AE/SAE/AESI/laboratory tests/electrocardiograms/vital signs. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05453669
Study type Interventional
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Wenbin Qian, MD, PhD
Phone +8613605801032
Email qianwb@zju.edu.cn
Status Recruiting
Phase Phase 1
Start date June 15, 2022
Completion date June 2025

See also
  Status Clinical Trial Phase
Completed NCT00588094 - Dose Augmented Rituximab and ICE for Pts With Primary Refractory and Poor Risk Relapsed Aggressive B-Cell NHL Phase 2
Not yet recruiting NCT05091541 - A Phase 1/2 Study of CT120 in Patient With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma Phase 1/Phase 2
Recruiting NCT03639181 - Clinical Trial in Chinese Patients of B-cell Non-Hodgkin's Lymphoma(GB226) Phase 2
Recruiting NCT06104553 - A Trial of SHR-A1912 Combined With Other Therapies in B-cell Non-Hodgkin 's Lymphoma Phase 1/Phase 2
Terminated NCT01352312 - Combination of Pentostatin, Bendamustine and Ofatumumab for Treatment of Chronic Lymphocytic Leukemia and Lymphoma Phase 1
Not yet recruiting NCT05771883 - A Clinical Study of Injectable IMM0306 in Combination With Lenalidomide Phase 1/Phase 2
Not yet recruiting NCT06314828 - A Tolerability, Safety and Efficacy Study of RJMty19 in Subjects With Relapsed or Refractory B-NHL Phase 1
Enrolling by invitation NCT05332054 - Long-Term Follow-up Study
Suspended NCT04697290 - CD19/CD20 Dual-CAR-T in B-cell Non-Hodgkin's Lymphoma Patients. Early Phase 1
Completed NCT02564744 - Study to Evaluate the Efficacy and Tolerability of Debio 1562 in Combination With Rituximab in Participants With Relapsed and/or Refractory DLBCL and Other Forms of NHL Phase 2
Recruiting NCT05190068 - HMPL-760 in Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma Phase 1
Suspended NCT04746131 - Safety and Pharmacokinetic Study of IMM0306 in Patients With Refractory or Relapsed CD20-positive B-cell Non-Hodgkin's Lymphoma (B-NHL) Phase 1
Active, not recruiting NCT00927797 - Interventional Study on Pentostatin, Cyclophosphamide and Rituximab in Indolent B-Cell Non-Hodgkin-Lymphoma (B-NHL) Phase 2
Recruiting NCT05436223 - Human CD19 Targeted T Cells Injection(CD19 CAR-T) Therapy for Relapsed and Refractory B-cell Non-Hodgkin's Lymphoma Phase 2
Completed NCT00457782 - A Phase I Safety, PK and PD Study of KW-2478 in Patients With Multiple Myeloma, Chronic Lymphocytic Leukaemia or B-cell Non-Hodgkin's Lymphoma Phase 1
Not yet recruiting NCT03105596 - Chidamide Plus DICE Regimen for Patients With Relapse or Refractory B-cell Non-Hodgkin's Lymphoma (NHL) Phase 2