Clinical Trials Logo

Clinical Trial Summary

CD19-directed CAR-T cell therapy has shown promising results for the treatment of relapsed or refractory B-cell malignancies; however, a subset of patients relapse due to the loss of CD19 in tumor cells. Dual Specificity CD19 and CD20 or CD22 CAR-T cells can recognize and kill the CD19 negative malignant cells through recognition of CD20 or CD22. This is a phase 1/2 study designed to determine the safety of the allogenic gene-edited dual specificity CD19 and CD20 or CD22 CAR-T cells and the feasibility of making enough to treat patients with relapsed or refractory hematological malignancies.


Clinical Trial Description

1. PRIMARY OBJECTIVES:

1. To evaluate the feasibility and safety of universal dual specificity CD19 and CD20 or CD22 CAR-T cells in patients with relapsed or refractory leukemia and lymphoma.

2. To evaluate the duration of in vivo persistence of adoptively transferred T cells, and the phenotype of persisting T cells. Real Time polymerase chain receptor (RT-PCR) and Flow cytometry(FCM) analysis of PB,BM and lymph node will be used to detect and quantify survival of universal dual specificity CD19 and CD20 or CD22 CAR-T cells over time.

2. SECONDARY OBJECTIVES:

1. For patients with detectable disease, measure anti-tumor response due to universal dual specificity CD19 and CD20 or CD22 CAR-T cell infusions.

2. Determine if cellular or humoral host immunity develops against the murine anti-CD19, and assess correlation with loss of detectable universal dual specificity CD19 and CD20 or CD22 CAR-T cells (loss of engraftment).

The CAR-T cells will be administered by i.v. injection over 20-30 minutes as a using a "split dose" approach to dosing: 10% on day 0, 30% on day 1 and 60% on day 2. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03398967
Study type Interventional
Source Chinese PLA General Hospital
Contact Wenying Zhang
Phone 86-10-55499341
Email zhangwenying.1984@163.com
Status Recruiting
Phase Phase 1/Phase 2
Start date January 2, 2018
Completion date May 20, 2022

See also
  Status Clinical Trial Phase
Completed NCT00001512 - Active Specific Immunotherapy for Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype Antigen Vaccines Phase 1
Recruiting NCT05415098 - Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas Phase 1
Withdrawn NCT02547948 - CD19-targeting CAR T Cells for B Cell Lymphoma Phase 1/Phase 2
Active, not recruiting NCT03258047 - Novel Autologou CAR-T Therapy for Relapsed/Refractory B Cell Lymphoma Phase 2
Active, not recruiting NCT03478514 - Phase II Palbociclib +Ibrutinib in Mantle Cell Lymphoma Phase 2
Not yet recruiting NCT06058858 - Incidence and Risks Factors of CMV Reactivation in Patients Receiving of CAR-T Cells for Acute Leukemia and Lymphoma Relapse, a Cohort Study Analysis
Recruiting NCT06415708 - Obinutuzumab Combined With Bendamustine in the Treatment of Mature B-cell Lymphoma Phase 2
Active, not recruiting NCT03307746 - A Combination of Rituximab and Varlilumab Immunotherapy in Patients With B-cell Lymphoma Phase 1/Phase 2
Terminated NCT03670888 - A Study to Compare the Bioequivalence and Safety of JHL1101 and Rituximab in CD20 Positive B Cell Lymphoma Patients Phase 1
Recruiting NCT06131801 - Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution
Recruiting NCT06213311 - A Study of Axicabtagene Ciloleucel and Glofitamab as Second-Line Therapy for Relapsed or Refractory Patients With Large B Cell Lymphoma Phase 2
Recruiting NCT04008251 - Humanized CD19 Chimeric Antigen Receptor (CAR)-Modified T Cell Therapy in Treating Patients With B-cell Malignancies Phase 1
Recruiting NCT04637763 - CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy for Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER) Phase 1
Recruiting NCT04782193 - a Clinical Research of CD19 and CD22 Targeted Prime CAR-T Cell in Relapsed/Refractory B Cell Lymphoma Phase 1/Phase 2
Recruiting NCT03146533 - CD19 CART Cells for Patients With Relapse and Refractory CD19+ B-cell Lymphoma. Phase 1/Phase 2
Recruiting NCT05385263 - Addition of Nivolumab to Anti-CD-19 CAR-T Cells in Patients With Stable/Progressive DLBCL at Lymphodepletion Phase 2
Recruiting NCT03366324 - Anti-CD19 CAR-T Therapy Combine With HSCT to Treat MRD+ B-cell Malignancies Phase 1/Phase 2
Recruiting NCT03929107 - Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T for Refractory/Relapsed B Cell Lymphoma. Phase 2
Enrolling by invitation NCT05332054 - Long-Term Follow-up Study
Recruiting NCT04289220 - Anti-CD19 CAR in PiggyBac Transposon-Engineered T Cells for Relapsed/Refractory B-cell Lymphoma or B-cell Acute Lymphoblastic Leukemia Phase 1