Multi-CAR-T Cells Targeting B Cell Lymphomas
Primary, Booster and Consolidation Multi-CAR-T Cell Therapy for the Treatment of Refractory B Cell Lymphomas
1 other identifier
interventional
11
1 country
3
Brief Summary
This study aims to evaluate safety and efficacy of a combination of 4th generation chimeric antigen receptor gene-modified T cells targeting B cell surface molecules including CD19 and alternative CARTs as booster and consolidation treatment for patients with highly resistant B cell lymphomas, including primary mediastinal B cell lymphoma (PMBCL) and BCL involving central nervous system (CNS-BCL). Clinical response and development of a simplified and standardized lentiviral vector and cell production protocol will be investigated. This is a phase I/II trial enrolling patients from multiple clinical centers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2020
Typical duration for phase_1
3 active sites
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
Study Start
First participant enrolled
June 1, 2020
CompletedFirst Submitted
Initial submission to the registry
June 9, 2020
CompletedFirst Posted
Study publicly available on registry
June 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedJune 12, 2020
June 1, 2020
3.2 years
June 9, 2020
June 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety of fourth generation anti-CD19 and anti-CD20/CD22/CD70/PSMA/CD13/CD79b/GD2 CAR-T cells infusion
Safety of fourth generation anti-CD19 and anti-CD20/CD22/CD70/PSMA/CD13/CD79b/GD2 CAR-T cells in patients with relapsed B cell lymphoma (BCL) using CTCAE 4 standard to evaluate the level of adverse events
24 weeks
Secondary Outcomes (1)
Anti tumor activity of fourth generation anti-CD19 and anti-CD20/CD22/CD70/PSMA/CD13/CD79b/GD2 CAR-T cells infusion
1 year
Study Arms (1)
4SCAR19 and 4SCAR20/22/70/PSMA/13/79b/GD2
EXPERIMENTALPatients who have relapsed and refractory B cell lymphoma (BCL) after chemotherapy will be treated with a combination of 4SCAR gene-engineered T cells.
Interventions
Patients who have relapsed and refractory B cell lymphoma (BCL) after conventional chemotherapy will be treated with multiple 4SCAR gene-engineered T cells
Eligibility Criteria
You may qualify if:
- Age older than 6 months.
- Primary B cell lymphoma surface expression of CD19 and/or CD22/CD70/PSMA/ CD13/CD79b/GD2 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 response after treatment.
- Bacterial, fungal, or viral infection, unable to control.
- Living with HIV.
- Active HBV and HCV infection.
- Pregnant and nursing mothers.6. under systemic steroid treatment within a week of the treatment.
- \. Prior failed CAR-T treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Shenzhen Children's Hospital
Shenzhen, Guangdong, 518000, China
Shenzhen Geno-Immune Medical Institute
Shenzhen, Guangdong, 518000, China
The Seventh Affilliated Hospital, Sun Yat-Sen University
Shenzhen, Guangdong, 518107, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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 9, 2020
First Posted
June 12, 2020
Study Start
June 1, 2020
Primary Completion
July 31, 2023
Study Completion
December 31, 2023
Last Updated
June 12, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share