NCT03574168

Brief Summary

This is a single center, single arm, open-lable phase 1 study to determine the safety and efficacy of autologous or donor-derived allogeneic T cells expressing CD19 chimeric antigen receptors (referred to as "CD19-CAR-T cells") in patients with relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL).

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
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2018

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

First Submitted

Initial submission to the registry

June 11, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 29, 2018

Completed
21 days until next milestone

Study Start

First participant enrolled

July 20, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

June 29, 2018

Status Verified

June 1, 2018

Enrollment Period

1.4 years

First QC Date

June 11, 2018

Last Update Submit

June 20, 2018

Conditions

B-cell Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate, ORR

    The percentage of participants who achieved complete remission (CR) over all participants (CRR). The percentage of participants who achieved partial remission (PR) over all participants (PRR).

    Up to Day90 after the CD19-CAR-T cell infusion

Secondary Outcomes (2)

  • The amount of CAR-T cells remaining in vivo

    2 years after cell infusion.

  • The lifetime of CAR-T cells remaining in vivo

    2 years after cell infusion.

Study Arms (1)

CD19-CAR-T Cells

EXPERIMENTAL

Subjects will receive CD19-CAR-T Cells on Day 0 : 100% of total dose.

Biological: CD19-CAR-T Cells

Interventions

CD19-CAR-T CellsBIOLOGICAL

T cells purified from the PBMC of subjects or subjects' relatives which depends on their conditions, transduced with 4-1BB/CD3-ζ lentiviral vector, expanded in vitro for future administration.

CD19-CAR-T Cells

Eligibility Criteria

Age3 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Obtain Informed Consent Form (ICF) voluntarily signed by the patient;
  • Age 3-70 years old;
  • Primary resistant or relapsed B-cell line acute lymphoblastic leukemia;
  • B cells are positive for CD19 expression;
  • Peripheral blood tumor cell load \<50%; 6. KPS score \>50 points;
  • \. Normal liver and kidney function; 8. Normal heart function; 9. Good follow-up compliance; 10. Women of childbearing age (15-49 years old) must have a pregnancy test within 7 days before treatment and have a negative result; Men and women with fertility should agree to use effective contraception to ensure that during the study period and following 3 months after treatment the women will not get pregnant.

You may not qualify if:

  • Patients with non-B cell acute leukemia;
  • Organ failure: Heart: Grade III and IV Liver: Class C with Child-Turcotte liver function classification Kidney: Renal failure and uremia Lung: severe respiratory failure Brain: Disabilities
  • Active infection;
  • Human immunodeficiency virus (HIV) positive;
  • Acute and chronic graft-versus-host disease (GVHD)\> Level 1；
  • Pregnant or lactating women;
  • Patients do not agree to use effective contraception during the treatment period and following 3 months;
  • Patients who participated in other clinical studies at the same time;
  • Long-term use greater doses of hormones than physiological doses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hebei Yanda Ludaopei Hospital

Langfang, Hebei, 065000, China

RECRUITING

MeSH Terms

Conditions

Burkitt Lymphoma

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

Study Officials

  • Peihua Lu, MD, PhD

    Hebei Yanda Ludaopei Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhongwei Xu, MD, Phd

CONTACT

+86 010-69739722willyxu001@bioceltech.com

Study Design

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

Study Record Dates

First Submitted

June 11, 2018

First Posted

June 29, 2018

Study Start

July 20, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

June 29, 2018

Record last verified: 2018-06

Locations

CN(1)