Status:
RECRUITING
CD19/22 Bi-specific CAR-T Cell Therapy
Lead Sponsor:
Shenzhen Geno-Immune Medical Institute
Conditions:
B Cell Malignancies
Eligibility:
All Genders
6-75 years
Phase:
PHASE1
PHASE2
Brief 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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05432882
Start Date
June 30 2022
End Date
June 30 2026
Last Update
June 27 2022
Active Locations (1)
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1
Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, China, 518000