Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to assess the feasibility, safety and efficacy of anti-CD19/22 bi-specific CAR-T cell therapy in patients with CD19 and/or CD22 positive B cell malignancies. Another goal of the study is to learn more about the safety and function of the anti-CD19/22 bi-specific CAR-T cells and their persistency in patients.


Clinical Trial Description

Patients with refractory and/or recurrent B cell malignancies have poor prognosis despite complex multimodal therapy. Despite impressive progress, more than 50% of patients treated with CD19-targeting chimeric antigen receptor T cells (CAR19) experience progressive disease. Further, more than 40% patients with progressive large B cell lymphoma (LBCL) experienced reduced or lost expression of CD19 on the tumor cells after CAR19 treatment; low surface CD19 density before treatment was associated with progressive disease. Therefore, novel curative approaches are needed. The investigation attempts to use genetically modified T cells to express a 4th generation lentiviral anti-CD19/22 bi-specific CAR (bi-4SCAR-CD19/22). The CAR molecules enable the T cells to recognize and kill tumor cells through the recognition of a surface antigen, CD19 or CD22, which is expressed at high levels on tumor cells but not at significant levels on normal tissues. To overcome tumor escape of single target antigen and enhance in vivo CAR-T efficacy, a novel bi-specific CD19/22 CAR-T therapy regimen is developed to include booster and consolidation CAR-T applications to target highly-refractory B cell cancer. The aim is to evaluate safety and long term efficacy of the bi-CAR-T therapy strategy in CD19 and/or CD22 positive cancer patients. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05432882
Study type Interventional
Source Shenzhen Geno-Immune Medical Institute
Contact Lung-Ji Chang, PhD
Phone 86-0755-86725195
Email c@szgimi.org
Status Recruiting
Phase Phase 1/Phase 2
Start date June 30, 2022
Completion date June 30, 2026

See also
  Status Clinical Trial Phase
Recruiting NCT05995015 - 4SCAR19U T Cells Targeting B Cell Malignancies Phase 1
Recruiting NCT05436496 - CD19/70 Bi-specific CAR-T Cell Therapy Phase 1/Phase 2
Recruiting NCT05436509 - CD19/79b Bi-specific CAR-T Cell Therapy Phase 1/Phase 2
Terminated NCT00672152 - A Phase I Study of WT1 Peptides to Induce Anti-Leukemia Immune Responses Following Transplantation Phase 1
Recruiting NCT06375161 - Anti-CD19-CAR-T Cells in Relapsed/Refractory B-cell Tumor Patients. Early Phase 1
Recruiting NCT05618028 - Study to Evaluate Adverse Events and Change in Disease Activity in Adult Participants With B-Cell Malignancies Receiving Oral ABBV-525 Tablets Phase 1