NCT04237428

Brief Summary

To evaluate the safety and efficacy of targeted CD19 chimeric antigen receptor T cell infusion in the treatment of relapsed or refractory CD19 positive non-Hodgkin's 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 below P25 for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

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 31, 2019

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 23, 2020

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

January 23, 2020

Status Verified

January 1, 2020

Enrollment Period

15 days

First QC Date

January 13, 2020

Last Update Submit

January 17, 2020

Conditions

Non Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

  • BORR

    Best objective response rate

    6 months

Secondary Outcomes (5)

  • Incidence of AE

    2 years

  • Pharmacokinetic parameters

    90 Days

  • Overall survival time

    through study completion, an average of 5 year

  • Duration of remission after administration

    through study completion, an average of 5 year

  • Disease progression free survival

    through study completion, an average of 5 year

Study Arms (1)

hCD19 CAR-T cells Infusion

EXPERIMENTAL
Biological: CD19 CAR-T cells infusion

Interventions

CD19 CAR-T cells infusionBIOLOGICAL

Biological: CD19 CAR-T cells infusion Biological: CD19 CAR-T cells infusion. Pretreatment: patients enrolled in this study will receive cyclophosphamide or fludarabine plus cyclophosphamide. CD19 CAR-T cells infusion are allowed within 2 weeks after treatment. CD19 CAR-T cells infusion: 30-60 minutes before infusion, H1 anti-histamine agents are applied (acetaminophen 30mg,po.; promethazine 25mg,i.v. ; diphenhydramine 0.5-1mg/kg, no more than 50mg.). Non-physiological doses of corticosteroids are not applied for patients during treatment or recovery unless a life-threatening emergency occurs. CD19 CAR-T cells are infused into patients for one time, the number of infused CD19 CAR-T cells are 0.5-4×10\^6/kg.

hCD19 CAR-T cells Infusion

Eligibility Criteria

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

You may not qualify if:

  • Non Hodgkin's lymphoma was confirmed by histological examination, and one of the following conditions was met:
  • Relapsed and refractory CD19 positive diffuse large B-cell lymphoma: at least after the standard second-line drug treatment, the efficacy evaluation did not reach partial remission or above, or reached partial remission or disease progression after partial remission, or relapsed after complete remission;
  • Relapsed and refractory CD19 positive follicular lymphoma: at least after the standard three-line drug treatment, the efficacy evaluation did not reach partial remission or above, or reached partial remission and disease progress after partial remission, or relapsed after complete remission;
  • Relapsed refractory CD19 positive diffuse large B-cell lymphoma and follicular lymphoma: primary drug resistance; relapse within 1 year after autologous stem cell transplantation only, not affected by other treatment methods previously used; CD20 positive patients should receive corresponding targeted treatment;
  • Age: 18-65 years (including boundary value), gender unlimited;
  • The expected survival time was more than 3 months;
  • ECOG score 0-1 (dose increasing stage), ECoG score 0-2 (expanding group stage);
  • The functions of liver and kidney, heart and lung meet the following requirements:
  • ① Creatinine ≤ 1.5 ULN
  • ②ALT/AST ≤2.5 ULN；
  • ③ Total bilirubin ≤ 1.5 × ULN;
  • ④ Baseline oxygen saturation ≥ 92%;
  • ⑤ No pericardial effusion was detected by echo;
  • According to Lugano's response standard, there should be at least one measurable tumor focus;
  • Be able to understand the test and have signed the informed consent.
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Mingzhi Zhang, Doctor

CONTACT

+8613838565629mingzhi_zhang@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2020

First Posted

January 23, 2020

Study Start

May 31, 2019

Primary Completion

June 15, 2019

Study Completion

May 31, 2021

Last Updated

January 23, 2020

Record last verified: 2020-01

Locations

CN(1)