CD19/22 Bi-specific CAR-T Cell Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: bi-4SCAR CD19/22 T cells.
- Who it may be relevant to
- Registry conditions: B Cell Malignancies. Basic parameters: 6 months — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
CD19/22 Bi-specific CAR-T Cells Targeting B Cell Malignancies
Overview
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.
Detailed 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.
Interventions
- Biological bi-4SCAR CD19/22 T cells
Infusion of bi-4SCAR CD19/22 T cells at 10\^6 cells/kg body weight via IV
Primary outcome measures
- Safety of fourth generation bi-4SCARCD19/22 T cells in patients with B cell malignancies [Time frame: 24 weeks]
Secondary outcome measures (1)
- Anti tumor activity of fourth generation bi-4SCARCD19/22 T cells in patients with relapsed or refractory B cell malignancies [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- age older than 6 months.
- malignant B cell surface expression of CD19 or CD22 molecules.
- the KPS score over 80 points, and survival time is more than 1 month.
- greater than Hgb 80 g/L.5. no contraindications to blood cell collection.
Exclusion criteria
- accompanied with other active diseases and difficult to assess patient response.
- bacterial, fungal, or viral infection, unable to control.
- 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 CD22 CAR-T treatment.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shenzhen Geno-immune Medical Institute — Shenzhen
Identifiers
NCT: NCT05432882 · GIMI-IRB-22007