B Cell Malignancies
Conditions
Keywords
Universal CAR-T, CD19 B-ALL, PMBCL, CNS-BCL, BCL
Brief 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
Important Regulatory Notice: This trial record is only for global academic information registration on ClinicalTrials.gov. Neither the sponsor Beijing Meikang Jimian Biotechnology Co., Ltd. nor collaborator Shenzhen Geno-Immune Medical Institute has obtained NMPA clinical trial approval or clinical technology filing permission to carry out interventional cell therapy trials in mainland China. ClinicalTrials.gov registration alone does not represent legal approval by Chinese health and drug regulatory authorities. 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
Interventions
BIOLOGICALUniversal CD19-specific CAR gene-engineered T cells
Infusion of 4SCAR19U cells
Sponsors
Shenzhen Geno-Immune Medical Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of 4SCAR19U CAR-T cells infusion | 24 weeks | Safety of 4SCAR19U T cells in patients with relapsed and refractory B-ALL, BCL using CTCAE 4 standard to evaluate the level of adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-tumor activity of 4SCAR19U cells after infusion | 1 year | Objective responses (complete response (CR) + partial response (PR)) are assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. |
Countries
China
Contacts
CONTACTLung-Ji Chang, Ph.D
Outcome results
None listed