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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05436509
Other study ID # GIMI-IRB-22009
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date June 30, 2022
Est. completion date June 30, 2026

Study information

Verified date June 2022
Source Shenzhen Geno-Immune Medical Institute
Contact Lung-Ji Chang, PhD
Phone 86-0755-86725195
Email c@szgimi.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the feasibility, safety and efficacy of CD19/79b bi-specific CAR-T cell therapy in patients with CD19 and/or CD79b positive B cell malignancies. Another goal of the study is to learn more about the safety and function of the anti-CD19/79b bi-specific CAR-T cells and their persistency in patients.


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-CD19/79b 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date June 30, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 6 Months to 75 Years
Eligibility Inclusion Criteria: 1. age older than 6 months. 2. malignant B cell surface expression of CD19 or CD79b molecules. 3. the KPS score over 80 points, and survival time is more than 1 month. 4. greater than Hgb 80 g/L. 5. no contraindications to blood cell collection. Exclusion Criteria: 1. accompanied with other active diseases and difficult to assess patient response. 2. bacterial, fungal, or viral infection, unable to control. 3. living with HIV. 4. active HBV or HCV infection. 5. pregnant and nursing mothers. 6. under systemic steroid treatment within a week of the treatment. 7. prior failed CD19 and CD79b CAR-T treatment.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
bi-4SCAR CD19/79b T cells
Infusion of bi-4SCAR-CD19/79b T cells at 10^6 cells/kg body weight via IV

Locations

Country Name City State
China Shenzhen Geno-immune Medical Institute Shenzhen Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Shenzhen Geno-Immune Medical Institute

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety of fourth generation bi-4SCAR-CD19/79b T cells in patients with B cell malignancies 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 12 weeks
Secondary Anti tumor activity of fourth generation bi-4SCAR-CD19/79b T cells in patients with relapsed or refractory B cell malignancies Scale of CAR copies (for efficacy) 1 year
Secondary Anti tumor activity of fourth generation bi-4SCAR-CD19/79b T cells in patients with relapsed or refractory B cell malignancies Scale of leukemic cell burden (for efficacy) 1 year
See also
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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