To hear about similar clinical trials, please enter your email below
Trial Title:
4SCAR19U T Cells Targeting B Cell Malignancies
NCT ID:
NCT05995015
Condition:
B Cell Malignancies
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Universal CAR-T
CD19 B-ALL
PMBCL
CNS-BCL
BCL
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Universal CD19-specific CAR gene-engineered T cells
Description:
Infusion of 4SCAR19U cells
Arm group label:
Universal 4SCAR19U cells to treat CD19-positive hematological malignancies
Summary:
The purpose of this study is to assess the feasibility, safety and efficacy of universal
CAR T cell therapy against CD19-positive hematological malignancies using a novel
CD19-specific CAR T cell product, 4SCAR19U T cells. The study also aims to learn more
about the function of the 4SCAR19U T cells and their persistence in patients. This is a
phase I trial enrolling patients from multiple clinical centers.
Detailed description:
Chimeric antigen receptor (CAR) T cell therapy has proven effective in treating B cell
malignancies. However, the application itself is still limited by the high cost and long
preparation time which often do not meet the urgent need of patients. In addition, some
patients may suffer from long-term immunosuppression caused by tumor microenvironment or
after radiotherapy and chemotherapy, resulting in exhaustion, aging and functional
defects of the autologous T cells, which will eventually affect the quality of the CAR-T
cells and affect the clinical efficacy.
The 4SCAR19U T cells are genetically engineered and manufactured in bulk amount that can
be supplied off-the-shelf without being custom made from individual patients. The
immediate availability of the CAR-T cells makes clinical treatment convenient and timely
for rapid progressing disease or for the highly immune suppressed patients. This
application can be time- and cost-effective. This novel approach may also overcome
problems of functionally defective autologous T cells. The purpose of this clinical trial
is to assess the feasibility, safety and efficacy of the 4SCAR19U T cell product in
hematological malignancies. Another goal of the study is to learn more about the function
of this novel product and its persistence in the patients
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age older than 6 months.
2. Primary B cell surface expression of CD19.
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 response after
treatment.
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 CAR-T treatment.
Gender:
All
Minimum age:
6 Months
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shenzhen Geno-Immune Medical Institute
Address:
City:
Shenzhen
Zip:
518000
Country:
China
Status:
Recruiting
Contact:
Last name:
Lung-Ji Chang, Ph.D
Phone:
+86-0755 8672-5195
Email:
c@szgimi.org
Start date:
October 31, 2023
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Shenzhen Geno-Immune Medical Institute
Agency class:
Other
Source:
Shenzhen Geno-Immune Medical Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05995015
