CAR-T for R/R B-NHL

April 14, 2019 updated by: The First Affiliated Hospital of Soochow University

Safety and Efficacy of Chimeric Antigen Receptor T Cell (CAR-T) Treating Relaspe/Refractory CD19/CD20/CD22/CD30 Postive Non-Hodgkin Lymphoma

This study is a single arm study to investigate the efficacy and safety of CAR-T targeted CD19/CD20/CD22/CD30 in relapse and refractory non-Hodgkin lymphoma patients. Ten patients will recruieted, admitted in hospital for 1 month for the CAR-T treatment and follow-up for at least 2 years.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • Recruiting
        • The First Affiliated Hospital of Soochow University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 65 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histological detection confirmed CD19/CD20/CD22/CD30 postive non-Hodgkin lymphoma
  • Recieved more than 2 lines of chemotherapy
  • With contraindications of hematopoietic stem cell transplantation or relapse after hematopoietic stem cell transplantation
  • Expected survival more than 3 months
  • Karmofsky performance score ≤ 60, and ECOG ≥ 2.
  • Enough organ function: EF≥50%; normal ECG; CCR≥40ml/min; ALT and AST ≤ 3 × upper limitation of normal, T-BIL ≤ 2.0mg/dl; PT and APTT < 2 × upper limitation of normal; SpO2 > 92%
  • CBC results: Hb ≥ 80g/L, ANC > 1 × 10E9/L, Plt ≥ 50 × 10E9/L
  • Results of pregnant test should be negative, and agree to conception control during treatment and 1 year after CAR-T infusion
  • With measurable disease
  • Written informed consent could be acquired

Exclusion Criteria:

  • Received immunol suppression treatment or steroids in recent 1 week before recruitment
  • Uncontrolled infection
  • HIV positive patients
  • Active HBV or HCV infection
  • Women in pregnancy and lactation
  • Refuse to conception control during treatment and 1 year after CAR-T infusion
  • Uncured malignancies other than non-Hodgkin lymphoma
  • Have participated similar trial for treating relapse/refractory non-Hodgkin lymphoma
  • Inheritated immune deficiancy
  • Severe heart disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment group
the group of patients who received CAR-T treatment
Biological: CAR-T
For eligible patients, CAR-T cells targeted to patients' tumor cell antigen will be infused after 48 hours later of chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate
Time Frame: One months after CAR-T cells were infused
Rate of complete remission and patial remission
One months after CAR-T cells were infused

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse toxicity
Time Frame: Day 0, day 4, week 1, week 3, week 4, month 2, month 24 after CAR-T cells were infused
Accordingto CTCAE 4.0 criteria
Day 0, day 4, week 1, week 3, week 4, month 2, month 24 after CAR-T cells were infused
CAR-T cell survival
Time Frame: every week in first 4 weeks after CAR-T cells infusion, then every 3 months for 2 years, then every 6 months for next 2 years
the survival of CAR-T cells detected in patients' peripheral blood
every week in first 4 weeks after CAR-T cells infusion, then every 3 months for 2 years, then every 6 months for next 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Soochow University

Collaborators

Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2017

Primary Completion (ANTICIPATED)

May 31, 2021

Study Completion (ANTICIPATED)

May 31, 2021

Study Registration Dates

First Submitted

June 20, 2017

First Submitted That Met QC Criteria

June 21, 2017

First Posted (ACTUAL)

June 23, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 14, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SZ5601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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