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A Study of C-CAR066 in Subjects With r/r Diffuse Large B Cell Lymphoma Who Received CD19 CAR-T Therapy

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: NCT04316624
Recruitment Status : Recruiting
First Posted : March 20, 2020
Last Update Posted : March 20, 2020
Sponsor:
Collaborator:
Shanghai Celluar Biopharmaceutical Group Ltd.
Information provided by (Responsible Party):
Zou Dehui, Institute of Hematology & Blood Diseases Hospital

Brief Summary:
This is a single-center, non-randomized and dose-escalation study to evaluate the safety and efficacy of C-CAR066 in treatment of r/r DLBCL who received CD19 CAR-T therapy.

Condition or disease Intervention/treatment Phase
Diffuse Large B Cell Lymphoma Drug: C-CAR066 Phase 1

Detailed Description:

This study plans to enroll 10 patients to assess the safety and efficacy of C-CAR066. Subjects who meet the eligibility criteria will receive a single dose of C-CAR066 injection.

The study will include the following sequential phases: Screening, Pre-Treatment (Cell Product Preparation, Lymphodepleting Chemotherapy), C-CAR066 infusion and Follow-up Visit.

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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: A Study Evaluating Safety and Efficacy of CBM.CD20 CAR-T(C-CAR066) in Subjects With r/r Diffuse Large B Cell Lymphoma Who Received CD19 CAR-T Therapy
Actual Study Start Date : September 18, 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: C-CAR066
Autologous C-CAR066 (CD20-directed CAR T-cell) administered by intravenous (IV) infusion
Drug: C-CAR066
Single infusion of C-CAR066 at a target dose of 1.0-9.0x 10^6 CAR+T cells/kg. Divided into three dose levels: low (1.0-3.0×10^6 CAR+T cells/kg), medium (3.0-6.0×10^6 CAR+T cells/kg) and high (6.0-9.0×10^6 CAR+T cells/kg).




Primary Outcome Measures :
  1. incidence of adverse events [ Time Frame: up to 12months after C-CAR066 infusion ]
    the incidence of treatment-emergent adverse events (TEAEs)


Secondary Outcome Measures :
  1. objective response rate [ Time Frame: up to 12 months after C-CAR066 infusion ]
    the percentage of subjects who achieved complete response and partial response


Other Outcome Measures:
  1. complete response rate [ Time Frame: up to 12 months after C-CAR066 infusion ]
    the percentage of subjects who achieved complete response

  2. Duration of response [ Time Frame: up to 12 months after C-CAR066 infusion ]
  3. Progression free survival [ Time Frame: up to 12 months after C-CAR066 infusion ]
  4. overall survival [ Time Frame: up to 12months after C-CAR066 infusion ]
    time to death from any cause

  5. duration of C-CAR066 in vivo [ Time Frame: up to 12months after C-CAR066 infusion ]
    duration of detectable C-CAR066 in vivo evaluate by qPCR

  6. duration CD20+ B-cell aplasia [ Time Frame: up to 12 months after C-CAR066 infusion ]
    duration of CD20+ B-cell aplasia post C-CAR066 infusion



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.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient volunteered to participate in the study, and signed the Informed Consent;
  • Age 18-75 years old, male or female;
  • Subjects diagnosed with diffuse large B-cell lymphoma (DLBCL) histologically according to the 2016 edition of the WHO Lymphocytic Tumor Classification Standard;
  • At least one measurable lesion(LDi≥ 1.5 cm);
  • r/r patients who received prior CD19 CAR-T therapy, and the CD19 CAR-T cell therapy must be at least 3 months from the screening period and positive for CD20;
  • At least 2 weeks from the end of treatment regimen (radiation, chemotherapy, mAb, etc) to apheresis;
  • Echocardiography showed normal diastolic function, left ventricular ejection fraction (LVEF) ≥50%, no Pericardial effusion and no severe arrhythmia;
  • No active pulmonary infections, normal pulmonary function and oxygen saturation ≥ 92% on room air.
  • NEUT ≥ 1.0 × 10^9 / L, PLT ≥ 50 × 10^9 / L, TBIL ≤ 1.5 times the upper limit of the normal range, Cr ≤ the upper limit of the normal range, ALT, AST ≤ 3 times the upper limit of the normal range;
  • No contraindications of peripheral blood apheresis;
  • Expected survival time > 3 months;.
  • ECOG scores 0 - 1;
  • The apheresis was received by laboratory and met the requirements for manufacturing CAR-T cell.

Exclusion Criteria:

  • Have a history of allergy to cellular products;
  • Patients with cardiac insufficiency classified as Class III or IV according to the New York Heart Association (NYHA) Heart Function Classification Standard;
  • A history of craniocerebral trauma, consciousness disorder, epilepsy, cerebral ischemia or hemorrhagic cerebrovascular disease ;
  • Patients with active CNS involvement;;
  • Patients with autoimmune disease, immunodeficiency, or other treatment requiring inhibitors
  • After allogeneic hematopoietic stem cell transplantation;
  • Autologous stem cell transplantation within 6 weeks before cell therapy;
  • Severe active infection (except simple urinary tract, bacterial pharyngitis), or currently receiving intravenous antibiotics. However, prophylactic antibiotics, antiviral and antifungal treatments are allowed;
  • Live vaccination within 4 weeks before peripheral blood apheresis;
  • HIV, HBV, HCV and TPPA / RPR infections, and HBV carriers;
  • Have a history of alcoholism, drug addiction and mental illness;
  • Non-sterile subjects had any of the following: a) being pregnant / lactating; or b) having a pregnancy plan during the trial; or c) having fertility without taking effective contraception;
  • Patients with severe fludarabine or cyclophosphamide hypersensitivity;
  • The patient has a history of other primary cancers, except for the following:
  • Non-melanoma such as skin basal cell carcinoma cured by resection;
  • Cured carcinoma in situ such as cervical, bladder or breast cancer;
  • The investigators believe that there are other circumstances that are not suitable for 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): NCT04316624


Contacts
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Contact: Wei Liu, MD +0086-022-23909282 liuwei@ihcams.ac.cn

Locations
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China
Institute of Hematology & Blood Diseases Hospital Recruiting
Tianjin, China, 300020
Contact: Wei Liu, MD    +86-022-23909282    liuwei@ihcams.ac.cn   
Principal Investigator: Dehui Zou, MD         
Sub-Investigator: Wei Liu, MD         
Sponsors and Collaborators
Institute of Hematology & Blood Diseases Hospital
Shanghai Celluar Biopharmaceutical Group Ltd.
Investigators
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Principal Investigator: Dehui Zou Institute of Hematology & Blood Diseases Hostipal
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Responsible Party: Zou Dehui, Chief Physician, Institute of Hematology & Blood Diseases Hospital
ClinicalTrials.gov Identifier: NCT04316624    
Other Study ID Numbers: 0502-014
First Posted: March 20, 2020    Key Record Dates
Last Update Posted: March 20, 2020
Last Verified: March 2020
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
Additional relevant MeSH terms:
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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