NCT05995015

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
8mo left

Started Oct 2023

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress79%
Oct 2023Dec 2026

First Submitted

Initial submission to the registry

August 8, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 16, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

October 31, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

October 12, 2023

Status Verified

October 1, 2023

Enrollment Period

2.9 years

First QC Date

August 8, 2023

Last Update Submit

October 10, 2023

Conditions

B Cell Malignancies

Keywords

Universal CAR-TCD19 B-ALLPMBCLCNS-BCLBCL

Outcome Measures

Primary Outcomes (1)

  • Safety of 4SCAR19U CAR-T cells infusion

    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

    24 weeks

Secondary Outcomes (1)

  • Anti-tumor activity of 4SCAR19U cells after infusion

    1 year

Study Arms (1)

Universal 4SCAR19U cells to treat CD19-positive hematological malignancies

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

Interventions

Universal CD19-specific CAR gene-engineered T cellsBIOLOGICAL

Infusion of 4SCAR19U cells

Universal 4SCAR19U cells to treat CD19-positive hematological malignancies

Eligibility Criteria

Age6 Months - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

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 or HCV infection.
  • Pregnant and nursing mothers.
  • 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 (1)

Shenzhen Geno-Immune Medical Institute

Shenzhen, Guangdong, 518000, China

RECRUITING

Central Study Contacts

Lung-Ji Chang, Ph.D

CONTACT

+86-0755 8672-5195c@szgimi.org

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

August 8, 2023

First Posted

August 16, 2023

Study Start

October 31, 2023

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

October 12, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)