NCT02842138

Brief Summary

This is a single arm, open-label, one center, dose escalation clinical study to determine the safety and efficacy of infusion of autologous T cells expressing CD19-redirected Chimeric Antigen Receptor (CD19 CAR T) in adult patients with relapsed or refractory CD19 positive 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
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2016

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

June 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 13, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 22, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

February 25, 2019

Status Verified

February 1, 2019

Enrollment Period

1.7 years

First QC Date

July 13, 2016

Last Update Submit

February 21, 2019

Conditions

B-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Number of patients with adverse events

    2 years

Secondary Outcomes (3)

  • Treatment response rate of anti-CD19 CAR T cell infusion

    4 weeks

  • overall survival rate of patients treated with anti-CD19 CAR T cells

    2 years

  • progression-free survival of patients treated with anti-CD19 CAR T cells

    2 years

Other Outcomes (1)

  • Persistence of CAR T cells in patients

    2 years

Study Arms (1)

CD19 CAR T cells

EXPERIMENTAL

A standard dose escalation approach aimed to assess the safety and efficacy of autologous anti-CD19 CAR T cells will be applied.

Biological: autologous anti-CD19 CAR T cells

Interventions

autologous anti-CD19 CAR T cellsBIOLOGICAL

Patients will receive a three-day regimen of chemotherapy consisting of fludarabine and cyclophosphamide aimed to deplete the lymphocytes. Four days after lymphodepletion, patients are intravenously infused autologous anti-CD19 CAR T cells. A prescribed CAR T cell dose will be intravenously infused to patient in a three-day split-dose regimen (day0,30%; day1, 30%; day2, 40%).

CD19 CAR T cells

Eligibility Criteria

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

You may qualify if:

  • CD19+ B cell lymphoma,verified by IHC or flow cytometry.
  • a prior history of at least two standard care of medication.
  • ineligible for allogeneic transplantation or relapsed after transplantation.
  • patients are 18 years older.
  • life expectancy \> 3months.
  • ECOG ≤ 2.
  • satisfactory major organ functions: adequate heart function with LVEF≥50%; pulse oximetry of ≥ 90%; cockcroft-gault creatinine clearance≥40 ml/min; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3ULN; Bilirubin ≤2.0 mg/dl .
  • Blood: Hgb ≥ 80 g/L, ANC ≥ 1×10\^9/L, PLT ≥ 50×10\^9/L.
  • women of reproductive potential must have a negative pregnancy test. Male and female of reproductive potential must agree to use birth control during the study and one year post study.
  • measurable tumors.

You may not qualify if:

  • using immunosuppressive drugs or systemic steroids within one week of enrollment.
  • active infection.
  • HIV positive.
  • active hepatitis B virus infection or hepatitis C virus infection.
  • breastfeeding or pregnant women.
  • patients refuse to practice birth control during study and one year post study.
  • patients with a prior history of other malignances will be excluded from this study, but patients who have been cured from skin basal cell carcinoma or cervical cancer, or who have had their tumors removed by surgical resection but without further therapies and have more than 5 years of progression-free survival, can be included into the study.
  • currently enrolled in other study.
  • patients, in the opinion of investigators, may not be eligible or are not able to comply with the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Cancer Hospital

Beijing, 100142, China

Location

Related Publications (1)

  • Ying Z, Huang XF, Xiang X, Liu Y, Kang X, Song Y, Guo X, Liu H, Ding N, Zhang T, Duan P, Lin Y, Zheng W, Wang X, Lin N, Tu M, Xie Y, Zhang C, Liu W, Deng L, Gao S, Ping L, Wang X, Zhou N, Zhang J, Wang Y, Lin S, Mamuti M, Yu X, Fang L, Wang S, Song H, Wang G, Jones L, Zhu J, Chen SY. A safe and potent anti-CD19 CAR T cell therapy. Nat Med. 2019 Jun;25(6):947-953. doi: 10.1038/s41591-019-0421-7. Epub 2019 Apr 22.

    PMID: 31011207DERIVED

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jun Zhu, MD

    Peking University Cancer Hospital & Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 13, 2016

First Posted

July 22, 2016

Study Start

June 1, 2016

Primary Completion

February 28, 2018

Study Completion

August 1, 2019

Last Updated

February 25, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will share

Locations

CN(1)