NCT03146533

Brief Summary

This is a clinical study to observe the maximum tolerated dose (MTD) and the safety and feasibility of chimeric antigen receptor 19 (CD19 CART) cells in relapsed and refractory patients with CD19+ B cell lymphoma.

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 May 2017

Typical duration for phase_1

Geographic Reach
1 country

1 active site

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

May 1, 2017

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 10, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

May 17, 2017

Status Verified

April 1, 2017

Enrollment Period

1.9 years

First QC Date

May 7, 2017

Last Update Submit

May 16, 2017

Conditions

B Cell Lymphoma

Outcome Measures

Primary Outcomes (6)

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

    monitor the occurence of study related adverse events

    6 months

  • observe the maximum tolerated dose (MTD)

    2 months

  • objective response rate

    CR+PR

    2 years

  • disease control rate

    CR+PR+SD

    2 years

  • overall survival

    OS

    2 years

  • Progression-Free Survival

    2 years

Secondary Outcomes (3)

  • Determine duration of in vivo survival of CD19 CART cells

    2 years

  • Peripheral blood cytokines

    2 months

  • subgroup of T cell

    2 years

Study Arms (1)

CD19 CART

EXPERIMENTAL

patients will receive a pre-conditioning with cyclophosphamide and fludarabine before infusion of CD19 CART cells. The CD19 CART cells are to be administered on day0,day1,day2.

Drug: FludarabineDrug: CyclophosphamideBiological: CD19 CART

Interventions

FludarabineDRUG

Fludarabine 30 mg/m2/day IV for 3 days.

CD19 CART
CyclophosphamideDRUG

patients will receive a standard pre-conditioning regime with cyclophosphamide 0.8g/m2/day IV for 2 days.

CD19 CART
CD19 CARTBIOLOGICAL

CD19 CART cells will be administered using a split dose on day0(10%), 1(30%), and 2(60%) after completion of the chemotherapy.

CD19 CART

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 18 years to 70 years, expected survival \> 3 months;
  • \. CD19 positive B-cell lymphoma;
  • \. KPS \>80;
  • \. Having at least one measurable lesions;
  • \. Cardiac function: 1-2 levels; Liver: TBIL≤3ULN，AST ≤2.5ULN，ALT ≤2.5ULN; kidney: Cr≤1.25ULN; bone marrow: WBC ≥ 3.0×109/L, Hb ≥90 g/L, PLT ≥ 80×109/L）;
  • \. No serious allergic constitution;
  • \. No other serous diseases that conflicts with the clinical program;
  • \. No other cancer history;
  • \. No serious mental disorder;
  • \. Informed consent is signed by a subject or his lineal relation.

You may not qualify if:

  • \. Pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test);
  • \. 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;
  • \. Transaminase \>2.5ULN, Bilirubin \>3ULN，Creatinine\>1.25ULN
  • \. Participate in other clinical research in the past three months; previously treatment with any gene therapy products;
  • \. Researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second People's Hospital of Shenzhen

Shenzhen, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell

Interventions

fludarabineCyclophosphamide

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Study Officials

  • geng tian

    Shenzhen Second People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

geng tian

CONTACT

13724395569tiangeng666@aliyun.com

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

May 7, 2017

First Posted

May 10, 2017

Study Start

May 1, 2017

Primary Completion

April 1, 2019

Study Completion

October 1, 2019

Last Updated

May 17, 2017

Record last verified: 2017-04

Locations

CN(1)