NCT05381662

Brief Summary

This is a single center,randomized ,two-cohorts, open-label ,phase 1/2 study to evaluate the efficacy and safety of T cells expressing CD19 chimeric antigen receptors combined with CD19 positive feeder T cells treatment for CD19+ acute lymphoblastic leukemia patients in remission .

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2018

Longer than P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
unknown

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

Study Start

First participant enrolled

August 2, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2018

Completed
3.8 years until next milestone

First Posted

Study publicly available on registry

May 19, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2024

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

February 10, 2023

Status Verified

December 1, 2022

Enrollment Period

6 years

First QC Date

August 5, 2018

Last Update Submit

February 8, 2023

Conditions

Acute Lymphoblastic Leukemia in Remission

Outcome Measures

Primary Outcomes (1)

  • Incidence of severe CRS

    The safety of the CD19 CAR-T cells and CD19 positive feeder T cells treatment will be evaluated

    12 months

Study Arms (2)

Cohort 1

EXPERIMENTAL

This cohort will determine the safety and efficacy of CD19 CAR-T cells and CD19 positive feeder T cells for CD19+ acute lymphoblastic leukemia without Chemotherapy pretreatment

Biological: CD19 CAR-T cells and CD19 positive feeder T cells

Cohort 2

EXPERIMENTAL

This cohort will determine the safety and efficacy of CD19 CAR-T cells and CD19 positive feeder T cells for CD19+ acute lymphoblastic leukemia with Chemotherapy pretreatment

Biological: CD19 CAR-T cells and CD19 positive feeder T cells

Interventions

CD19 CAR-T cells and CD19 positive feeder T cellsBIOLOGICAL

Detailed Description: Patients were divided into two groups, group 1 and group 2, and each group was enrolled in 5 patients. Group 1 patients did not receive any pretreatment, and group 2 patients received pretreatment with cyclophosphamide and fludarabine prior to reinfusion. Then Patients were given Chimeric Antigen Receptor T-Cell ( CAR-T) and CD19-positive T cells.

Cohort 1Cohort 2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 to 65
  • Voluntary informed consent is given
  • Expected survival ≥12 weeks
  • Relieve CD19+ acute leukemia
  • Organ function: (1)Left ventricular ejection fractions≥ 0.6 by echocardiography (2)ALT ≤3 times of ULN, or bilirubin \<2.0 mg/dl (3)Creatinine \< 2 mg/dl and less than 2.5 × normal for age (4)Prothrombin time and activated partial thromboplastin time \< 2 times of ULN (5)Arterial oxygen saturation\> 92%
  • Karnofsky score ≥ 60 ;
  • No history of combined chemotherapy in the recent 1 month and no immunotherapy in the recent 3 months;

You may not qualify if:

  • Uncontrolled active infections
  • Active hepatitis B or hepatitis C infection
  • HIV infection
  • History of myocardio infarction in the past 6 months, or history of severe arrhythmia
  • Congenital immunodeficiency
  • Pregnant or lactating women
  • History or presence of clinically relevant CNS pathology such as epilepsy, generalized seizure disorder, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
  • Previous treatment with any gene therapy products

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The first affiliated hospital of soochow university

Suzhou, Jiangsu, 200000, China

RECRUITING

The first affiliated hospital of soochow university

Suzhou, Jiangsu, 215006, China

RECRUITING

The First Affiliated Hospital of Soochow University

Suzhou, China

RECRUITING

Study Officials

  • Depei Wu, Ph.D

    The First Affiliated Hospital of Soochow University

    STUDY CHAIR

Central Study Contacts

Depei Wu, Ph.D

CONTACT

86-13328008851slxue@suda.edu.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2018

First Posted

May 19, 2022

Study Start

August 2, 2018

Primary Completion

August 2, 2024

Study Completion

December 1, 2025

Last Updated

February 10, 2023

Record last verified: 2022-12

Locations

CN(3)