NCT03232619

Brief Summary

This study aims to evaluate the safety and efficacy of a novel CD19-CART in the treatment of refractory or recurrent ALL.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2018

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 28, 2017

Completed
1 year until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2020

Completed
Last Updated

September 22, 2020

Status Verified

September 1, 2020

Enrollment Period

1.8 years

First QC Date

July 20, 2017

Last Update Submit

September 20, 2020

Conditions

Acute Leukemia

Outcome Measures

Primary Outcomes (1)

  • Radiological assessment

    Radiological assessment of the therapeutic effect by systemic or local computed Tomography(CT) or positron emission tomography scan.

    Month1 to Month12

Secondary Outcomes (1)

  • The safety of CART immunotherapy

    Day 1 to Week 4

Study Arms (2)

CD19-CART with a murine scFv

EXPERIMENTAL

All enrolled patients in this arm will receive CD19-CART with a murine scFv.

Biological: CD19 CART

humanized CD19-CART

EXPERIMENTAL

All enrolled patients in this arm will receive humanized CD19-CART.

Biological: CD19 CART

Interventions

CD19 CARTBIOLOGICAL

Patients will get one course of CART treatment with the dose of 0.5-5\*10\~6/KgBW.

CD19-CART with a murine scFvhumanized CD19-CART

Eligibility Criteria

Age6 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • previously identified as CD19+ ALL.
  • ALL patients not eligible for allogeneic SCT or relapse after allogeneic SCT.
  • Expected survival \>12W.
  • Creatinine \< 2.5 mg/dl.
  • Alanine transaminase (ALT)/Aspartate Aminotransferase (AST) \< 3x normal
  • Bilirubin \<2.0 mg/dl
  • Voluntary informed consent is given.

You may not qualify if:

  • Pregnant or lactating women.
  • Uncontrolled active infection.
  • Active hepatitis B or hepatitis C infection.
  • Previously treatment with any gene therapy products.
  • Any uncontrolled active medical disorder that would preclude participation as outlined.
  • HIV infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Bioray Inc.

Shanghai, Shanghai Municipality, 200240, China

Location

Study Officials

  • Yunxiao Xu, MD

    Second Xiangya Hospital of Central South University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Enrolled patients will receive CD19-CART cell immunotherapy.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2017

First Posted

July 28, 2017

Study Start

August 1, 2018

Primary Completion

May 6, 2020

Study Completion

September 15, 2020

Last Updated

September 22, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)