4SCAR19U T Cells Targeting B Cell Malignancies

Sponsor

Shenzhen Geno-Immune Medical Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT05995015

Collaborator

The Second Affiliated Hospital of Hainan Medical University (Other), Beijing Jingdu Children's Hospital (Other)

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
B Cell Malignancies	Biological: Universal CD19-specific CAR gene-engineered T cells	Phase 1

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Universal 4SCAR19U T Cell Therapy for the Treatment of Relapsed and Refractory B Cell Malignancies

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Aug 31, 2026

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Universal 4SCAR19U cells to treat CD19-positive hematological malignancies	Biological: Universal CD19-specific CAR gene-engineered T cells Infusion of 4SCAR19U cells

Arm

Intervention/Treatment

Experimental: Universal 4SCAR19U cells to treat CD19-positive hematological malignancies

Biological: Universal CD19-specific CAR gene-engineered T cells

Infusion of 4SCAR19U cells

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age older than 6 months.
Primary B cell surface expression of CD19.
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.

Exclusion Criteria:

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 or HCV infection.
Pregnant and nursing mothers.
under systemic steroid treatment within a week of the treatment.
Prior failed CAR-T treatment.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Jingdu Children's Hospital	Beijing	Beijing	China
2	Shenzhen Geno-Immune Medical Institute	Shenzhen	Guangdong	China	518000
3	The Second Affiliated Hospital of Hainan Medical University	Haikou	Hainan	China	570100