CD19/79b Bi-specific CAR-T Cell Therapy
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2022
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2022
CompletedFirst Posted
Study publicly available on registry
June 29, 2022
CompletedStudy Start
First participant enrolled
June 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
ExpectedJune 29, 2022
June 1, 2022
3.5 years
June 22, 2022
June 28, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Anti tumor activity of fourth generation bi-4SCAR-CD19/79b T cells in patients with relapsed or refractory B cell malignancies
1 year
Anti tumor activity of fourth generation bi-4SCAR-CD19/79b T cells in patients with relapsed or refractory B cell malignancies
1 year
Study Arms (1)
bi-4SCAR-CD19/79b T Cell Therapy for CD19 and/or CD79b positive B cell malignancies
EXPERIMENTALInterventions
Infusion of bi-4SCAR-CD19/79b T cells at 10\^6 cells/kg body weight via IV
Eligibility Criteria
You may qualify if:
- age older than 6 months.
- malignant B cell surface expression of CD19 or CD79b molecules.
- the KPS score over 80 points, and survival time is more than 1 month.
- greater than Hgb 80 g/L.
- no contraindications to blood cell collection.
You may not qualify if:
- accompanied with other active diseases and difficult to assess patient response.
- bacterial, fungal, or viral infection, unable to control.
- living with HIV.
- active HBV or HCV infection.
- pregnant and nursing mothers.
- under systemic steroid treatment within a week of the treatment.
- prior failed CD19 and CD79b CAR-T treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, 518000, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2022
First Posted
June 29, 2022
Study Start
June 30, 2022
Primary Completion
December 31, 2025
Study Completion (Estimated)
June 30, 2026
Last Updated
June 29, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share