CD19/79b Bi-specific CAR-T Cell Therapy
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|ClinicalTrials.gov Identifier: NCT05436509
Recruitment Status : Recruiting
First Posted : June 29, 2022
Last Update Posted : June 29, 2022
|Condition or disease
|B Cell Malignancies
|Biological: bi-4SCAR CD19/79b T cells
|Phase 1 Phase 2
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-CD19/79b bi-specific CAR (bi-4SCAR-CD19/79b). The CAR molecules enable the T cells to recognize and kill tumor cells through the recognition of a surface antigen, CD19 or CD79b, which is expressed at high levels on tumor cells but not at significant levels on normal tissues.
CD79b is a B cell surface antigen, which is a component of B cell receptor. CD79b is up-regulated in more than 90% of B-cell lymphomas. Recent studies have shown that CD79b CAR-T cells have potential in targeting B-cell lymphomas. In addition, several immunotherapy drugs based on targeting CD79b have been reported worldwide. The CD79b specific CAR-T cells with binding moiety of CD79b specific scFv exhibited a high affinity and antitumor effect against CD79b+ tumor cells.
A potential strategy to prevent relapse due to antigen escape is to infuse T-cells capable of recognizing multiple antigens. To overcome tumor escape of single target antigen and enhance in vivo CAR-T efficacy, a novel bi-specific CD19/79b 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 CD79b positive cancer patients.
|Study Type :
|Interventional (Clinical Trial)
|Estimated Enrollment :
|Single Group Assignment
|None (Open Label)
|CD19/79b Bi-specific CAR-T Cells Targeting B Cell Malignancies
|Estimated Study Start Date :
|June 30, 2022
|Estimated Primary Completion Date :
|December 31, 2025
|Estimated Study Completion Date :
|June 30, 2026
|Experimental: bi-4SCAR-CD19/79b T Cell Therapy for CD19 and/or CD79b positive B cell malignancies
Biological: bi-4SCAR CD19/79b T cells
Infusion of bi-4SCAR-CD19/79b T cells at 10^6 cells/kg body weight via IV
- Safety of fourth generation bi-4SCAR-CD19/79b T cells in patients with B cell malignancies [ Time Frame: 12 weeks ]Safety of fourth generation bi-4SCAR-CD19/79b T cells in patients with B cell malignancies using CTCAE 4 standard to evaluate the level of adverse events standard to evaluate the level of adverse events
- Anti tumor activity of fourth generation bi-4SCAR-CD19/79b T cells in patients with relapsed or refractory B cell malignancies [ Time Frame: 1 year ]Scale of CAR copies (for efficacy)
- Anti tumor activity of fourth generation bi-4SCAR-CD19/79b T cells in patients with relapsed or refractory B cell malignancies [ Time Frame: 1 year ]Scale of leukemic cell burden (for efficacy)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05436509
|Contact: Lung-Ji Chang, PhD
|Shenzhen Geno-immune Medical Institute
|Shenzhen, Guangdong, China, 518000
|Contact: Lung-Ji Chang, PhD 86-075586725195 firstname.lastname@example.org