Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase 1 Study Evaluating Safety and Efficacy of C-CAR011 Treatment in DLBCL Subjects (C-CAR011)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02976857
Recruitment Status : Completed
First Posted : November 29, 2016
Last Update Posted : January 17, 2019
Sponsor:
Collaborator:
The First Affiliated Hospital with Nanjing Medical University
Information provided by (Responsible Party):
Cellular Biomedicine Group Ltd.

Brief Summary:
The trial is a single arm, single-center, non-randomized phase I clinical trial which is designed to evaluate the safety and efficacy of C-CAR011 in treatment of refractory DLBCL

Condition or disease Intervention/treatment Phase
Refractory Diffuse Large B-Cell Lymphoma Biological: C-CAR-011 Phase 1

Detailed Description:

The 3x3 dose escalation design will be adopted in order to determine the maximum tolerated dose (MTD). Subjects will be enrolled into low-dose group, medium-dose group and high-dose group as below:

Dose CAR+ cells/kg

Low 0.8×106

Medium 2.5×106

High 5.0×106

DLT is evaluated within 30 days post C-CAR011 infusion).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Single Center, Non-randomized Study Evaluating Safety and Efficacy of Anti-CD19 Chimeric Antigen Receptor T-cell (C-CAR011) Treatment in Subjects With Refractory Diffuse Large B-cell Lymphoma
Study Start Date : December 2016
Actual Primary Completion Date : September 11, 2018
Actual Study Completion Date : January 9, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: C-CAR011
C-CAR011 infusion In the first cell therapy 0, 1 and 2 days, respectively 10%, 30% and 60% ratio three times reinfusion.
Biological: C-CAR-011
lymphocytes will be transduced with lentiviral vector containing CAR-CD19 gene.
Other Name: CAR-CD19




Primary Outcome Measures :
  1. Dose-limiting toxicity (DLT) [ Time Frame: 28 days ]
    Non-haematological dose-limiting toxicities was any toxicity of grade 3 or higher occurring within 28 days of C-CAR011 infusion judged possibly related to the treatment regimen.The following toxicities were not considered dose limiting toxicities: tumor lysis syndrome, abnormal electrolytes responding to supplementation, hypoalbuminemia, liver dysfunction resolving to ≤grade 2 within 14 days, transient (<72 hours) grade 4 hepatic enzyme abnormality, and grade 3 or 4 fever or neutropenic fever.


Secondary Outcome Measures :
  1. Overall response rate [ Time Frame: 4 and 12 weeks ]
    Overall response rate (ORR) = complete response (CR) rate + partial response (PR) rate, ORR will be assessed at weeks 4 and weeks 12 according to International Working Group (IWG) revised criteria.

  2. Disease control rate [ Time Frame: 12 weeks ]
    Disease control rate (DCR) = complete response (CR) rate + partial response (PR) rate + stable disease (SD) rate, DCR will be assessed at weeks 12 according to International Working Group (IWG) revised criteria.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically diagnosed as DLBCL according to the NCCN non-Hodgkin's lymphoma Clinical Practice Guidelines (3rd edition 2016)
  • Refractory DLBCL
  • All subjects must have received adequate prior therapy including anti-CD20 monoclonal antibody (unless tumor is CD20-negative) and an anthracycline containing chemotherapy regimen. The standardized treatment regimens reference to NCCN non-Hodgkin lymphoma Clinical Practice Guidelines (2016 Version 3)
  • At least one measurable lesion per revised IWG Response Criteria (the longest diameter of the tumor ≥ 1.5 cm)
  • Age 18-70 years old, male or female
  • Expected survival ≥ 12 weeks
  • ECOG score 0-1
  • Subject's left ventricular ejection fraction (LVEF) is ≥ 50% and no evidence of pericardial effusion as determined by an ECHO
  • At least 4 weeks from receiving previous treatment (radiotherapy, chemotherapy, monoclonal antibody therapy or other treatments)
  • No contraindications of peripheral blood apheresis
  • Female subjects in childbearing age, their serum or urine pregnancy test must be negative, and must agree to take effective contraceptive measures during the trial measures
  • Volunteered to participate in this study and signed informed consent

Exclusion Criteria:

  • Have a history of allergy to cellular products
  • Used any genetically modified T cell therapy
  • History of allogeneic hematopoietic stem cell transplantation
  • Severe active infection (uncomplicated urinary tract infections, bacterial pharyngitis allowed) or currently receiving intravenous antibiotic therapy and received intravenous antibiotic therapy within one week. Prophylactic antibiotic, antiviral and antifungal treatment is permissible
  • Hepatitis B or hepatitis C virus infection (including carriers), as well as acquired, congenital immune deficiency diseases, including but not limited to HIV-infected persons
  • Patients with class III and IV heart failure according to the NYHA Heart Failure Classifications
  • A history of QT prolongation
  • A history of epilepsy or other central nervous system disorders
  • The patient had a history of other primary cancers, with the following exceptions: Excisional non-melanoma such as cutaneous basal cell carcinoma; Cured in situ carcinoma such as cervical cancer, bladder cancer or breast cancer
  • Subjects with any autoimmune disease or any immune deficiency disease or other disease in need of immunosuppressive therapy
  • Used of systemic steroids within two weeks (using inhaled steroids is an exception)
  • Women who are pregnant or lactating or have breeding intent in 6 months
  • Participated in any other clinical trial within three months
  • The investigators believe that any increase in the risk of the subject or interference with the results of the trial

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): NCT02976857


Locations
Layout table for location information
China, Jiangsu
Hematological Department, People's Hospital of Jiangsu Province
Nanjing City, Jiangsu, China, 210029
Sponsors and Collaborators
Cellular Biomedicine Group Ltd.
The First Affiliated Hospital with Nanjing Medical University
Investigators
Layout table for investigator information
Principal Investigator: Jianyong Li The First Affiliated Hospital with Nanjing Medical University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Cellular Biomedicine Group Ltd.
ClinicalTrials.gov Identifier: NCT02976857    
Other Study ID Numbers: CBMG2016002
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Cellular Biomedicine Group Ltd.:
refractory diffuse large B-cell lymphoma
anti-CD19 chimeric antigen receptor T-cell
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin