NCT03263208

Brief Summary

The purpose of this study is to infusion CD19 CAR-T cells to the patients with relapsed and refractory CD19+ B cell leukemia, to assess the safety and feasibility of this strategy. The CAR enables the T cell to recognize and kill the leukemic cell through the recognition of CD19, a protein expressed of the surface of the leukemic cell in patients with CD19+ leukemia.

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
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

2 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 16, 2017

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 28, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

October 20, 2017

Status Verified

August 1, 2017

Enrollment Period

1.4 years

First QC Date

August 24, 2017

Last Update Submit

October 19, 2017

Conditions

B-cell Acute Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (2)

  • safety as assessed by the occurence of study related adverse events

    number of participants with adverse events

    30 days

  • anti-tumor responses of CD19 CAR-T cells

    1 year

Secondary Outcomes (2)

  • Persistence of the CD19 CAR+ T cells

    1 year

  • Number of participants who have T cells ablated with cetuximab

    1 year

Study Arms (1)

CD19 CAR-T

EXPERIMENTAL

A conditioning chemotherapy regiment of fludarabine and cyclophosphamide will be administered followed by a single infusion of CAR transduced autologous T cells administered intravenously.

Drug: CyclophosphamideDrug: FludarabineBiological: CD19 CAR-T

Interventions

CyclophosphamideDRUG

patients will receive a standard pre-conditioning regime with cyclophosphamide 0.6-0.8g/m2/day IV for 2 days(Day-5 to day-4).

CD19 CAR-T
FludarabineDRUG

Fludarabine 25-30mg/m2/day IV for 3 days(Day-5 to day-3).

CD19 CAR-T
CD19 CAR-TBIOLOGICAL

CD19 CAR-T cells will be administered after completion of the chemotherapy.

CD19 CAR-T

Eligibility Criteria

Age2 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \. 2 years to 70 years, expected survival \> 3 months;
  • \. CD19 positive B-cell acute lymphoblastic leukemia;
  • \. ECOG \< 2；
  • \. The tumor load in the bone marrow is less than 60%;
  • \. Cardiac function: 1-2 levels; Liver: TBIL≤3ULN，AST ≤2.5ULN，ALT ≤2.5ULN; kidney: Cr≤1.25ULN; Peripheral Blood: WBC ≥ 2.0×109/L, Hb ≥80 g/L, PLT ≥ 30×109/L）;
  • \. No leukemia cells in the central nervous system;
  • \. No serious allergic constitution;
  • \. No other serous diseases that conflicts with the clinical program;
  • \. No other cancer history;
  • \. No serious mental disorder;
  • \. female participants of reproductive potential must have a negative serum pregnancy test;
  • \. Informed consent is signed by a subject or his lineal relation.

You may not qualify if:

  • \. Pregnant or lactating women;
  • \. Uncontrolled active infection, HIV infection, syphilis serology reaction positive;
  • \. Active hepatitis B or hepatitis C infection;
  • \. Recent or current use of glucocorticoid or other immunosuppressor;
  • \. With severe cardiac, liver, renal insufficiency, diabetes and other diseases;
  • \. Participate in other clinical research in the past three months; previously treatment with any gene therapy products;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

NOT YET RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

RECRUITING

MeSH Terms

Conditions

Burkitt Lymphoma

Interventions

Cyclophosphamidefludarabine

Condition Hierarchy (Ancestors)

Epstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Central Study Contacts

Yongping Song

CONTACT

+86 13521186987ph200811@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2017

First Posted

August 28, 2017

Study Start

August 16, 2017

Primary Completion

January 1, 2019

Study Completion

July 1, 2019

Last Updated

October 20, 2017

Record last verified: 2017-08

Locations

CN(2)