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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

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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

Tracking Information
First Submitted Date  ICMJE March 15, 2020
First Posted Date  ICMJE March 20, 2020
Last Update Posted Date March 20, 2020
Actual Study Start Date  ICMJE September 18, 2019
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2020)
incidence of adverse events [ Time Frame: up to 12months after C-CAR066 infusion ]
the incidence of treatment-emergent adverse events (TEAEs)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2020)
objective response rate [ Time Frame: up to 12 months after C-CAR066 infusion ]
the percentage of subjects who achieved complete response and partial response
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 18, 2020)
  • complete response rate [ Time Frame: up to 12 months after C-CAR066 infusion ]
    the percentage of subjects who achieved complete response
  • Duration of response [ Time Frame: up to 12 months after C-CAR066 infusion ]
  • Progression free survival [ Time Frame: up to 12 months after C-CAR066 infusion ]
  • overall survival [ Time Frame: up to 12months after C-CAR066 infusion ]
    time to death from any cause
  • 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
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Study of C-CAR066 in Subjects With r/r Diffuse Large B Cell Lymphoma Who Received CD19 CAR-T Therapy
Official Title  ICMJE 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
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diffuse Large B Cell Lymphoma
Intervention  ICMJE 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).
Study Arms  ICMJE Experimental: C-CAR066
Autologous C-CAR066 (CD20-directed CAR T-cell) administered by intravenous (IV) infusion
Intervention: Drug: C-CAR066
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 18, 2020)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Wei Liu, MD +0086-022-23909282 liuwei@ihcams.ac.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04316624
Other Study ID Numbers  ICMJE 0502-014
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Zou Dehui, Institute of Hematology & Blood Diseases Hospital
Study Sponsor  ICMJE Institute of Hematology & Blood Diseases Hospital
Collaborators  ICMJE Shanghai Celluar Biopharmaceutical Group Ltd.
Investigators  ICMJE
Principal Investigator: Dehui Zou Institute of Hematology & Blood Diseases Hostipal
PRS Account Institute of Hematology & Blood Diseases Hospital
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP