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CAR-T for R/R B-NHL

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03196830
Recruitment Status : Recruiting
First Posted : June 23, 2017
Last Update Posted : April 16, 2019
Sponsor:
Collaborator:
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Information provided by (Responsible Party):
The First Affiliated Hospital of Soochow University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Relapsed Non Hodgkin Lymphoma Refractory Non-Hodgkin Lymphoma CAR - T CD19/CD20/CD22/CD30 Biological: CAR-T Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Chimeric Antigen Receptor T Cell (CAR-T) Treating Relaspe/Refractory CD19/CD20/CD22/CD30 Postive Non-Hodgkin Lymphoma
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

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




Primary Outcome Measures :
  1. Overall Response Rate [ Time Frame: One months after CAR-T cells were infused ]
    Rate of complete remission and patial remission


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03196830


Contacts
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Contact: Cai-Xia Li 86 512 67781856 licaixia@suda.edu.cn

Locations
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China, Jiangsu
the First Affiliated Hospital of Soochow University Recruiting
Suzhou, Jiangsu, China, 215006
Contact: Jia Chen, M.D.    +86 512 67781856    chenjiasuzhou@gmail.com   
Sponsors and Collaborators
The First Affiliated Hospital of Soochow University
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: The First Affiliated Hospital of Soochow University
ClinicalTrials.gov Identifier: NCT03196830    
Other Study ID Numbers: SZ5601
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The First Affiliated Hospital of Soochow University:
Relapse/refractory non-Hodgkin lymphoma
CAR - T CD19/CD20/CD22/CD30
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases