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

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ClinicalTrials.gov Identifier: NCT04036019
Recruitment Status : Unknown
Verified July 2019 by Aibin Liang,MD,Ph.D., Shanghai Tongji Hospital, Tongji University School of Medicine.
Recruitment status was:  Recruiting
First Posted : July 29, 2019
Last Update Posted : July 29, 2019
Sponsor:
Collaborator:
Cellular Biomedicine Group Ltd.
Information provided by (Responsible Party):
Aibin Liang,MD,Ph.D., Shanghai Tongji Hospital, Tongji University School of Medicine

Tracking Information
First Submitted Date  ICMJE July 8, 2019
First Posted Date  ICMJE July 29, 2019
Last Update Posted Date July 29, 2019
Actual Study Start Date  ICMJE May 13, 2019
Estimated Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2019)
Occurrence of study related adverse events [ Time Frame: 12 weeks ]
Incidence and severity of Treatment emergent adverse events
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2019)
  • Overall response rate (ORR) [ Time Frame: 12weeks, 6months, 12 months ]
    Lugano criteria(NHL,2014).
  • DOR [ Time Frame: 12 months ]
    Duration of remission
  • PFS [ Time Frame: 12 months ]
    Progression free survival
  • OS [ Time Frame: 12weeks, 6months, 12months ]
    Overall survival
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of C-CAR066 in Subjects With r/r B Cell Lymphoma Who Received CD19 CAR-T Therapy
Official Title  ICMJE A Study Evaluating Safety and Efficacy of CD20 CAR-T(C-CAR066) in Subjects With r/r B Cell Lymphoma Who Received CD19 CAR-T Therapy
Brief Summary The study is a single arm, single-center, non-randomized clinical study which is designed to evaluate the safety and efficacy of C-CAR066 in treatment of r/r B cell lymphoma who received CD19 CAR-T therapy.
Detailed Description

This study plans to enroll 12 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), Treatment and Follow-up.

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 B Cell Lymphoma
Intervention  ICMJE Biological: CD20-directed CAR-T cells
Autologous 2nd generation CD20-directed CAR-T cells, single infusion intravenously
Other Name: C-CAR066
Study Arms  ICMJE Experimental: C-CAR066
Autologous C-CAR066 administered by intravenous (IV) infusion
Intervention: Biological: CD20-directed CAR-T cells
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 25, 2019)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 30, 2021
Estimated Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Volunteered to participate in this study and signed informed consent
  2. Age 14-70 years old, male or female
  3. Patients with CD20+ DLBCL(including PMBL and according to the NCCN. non Hodgkin's lymphoma Guidelines(2019 version1.0) , at least one measurable lesion(LDi≥ 1.5 cm);
  4. r/r patients who received prior CD19 CAR-T therapy;
  5. At least one week from the end of treatment regimen (radiation, chemotherapy, mAb, etc) to apheresis;
  6. No immunosuppressive therapy was used within 1 week before infusion, including but not limited to systemic therapy;
  7. No mAb treatment within 2 weeks before infusion
  8. LVEF≥ 50% (UCG)
  9. No active pulmonary infections, normal pulmonary function and SpO2≥92%
  10. No contraindications of apheresis;
  11. Expected survival ≥ 3months
  12. ECOG score 0 or 1
  13. The apheresis was received by laboratory and met the requirements for manufacturing CAR-T cell

Exclusion Criteria:

  1. Have a history of allergy to cellular products
  2. Laboratory criteria: Serum total bilirubin ≥2mg/dl, albumin≤35g/L, AST and ALT ≥5 x ULN, Creatinine≥2.0mg/dl, ANC≤750/uL, Platelets≤ 50x10^9/L
  3. Have a hereditary syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome ,etc;
  4. According to the NYHA cardiac function grading standards, patients with grade III or IV cardiac dysfunction;
  5. A history of QT prolongation
  6. Patients with central nervous system involvement
  7. Severe active infections (except for simple urinary tract infections, bacterial pharyngitis), or currently undergoing intravenous infusion of antibiotics, or intravenous infusion of antibiotics within 1 week prior to cell infusion. However, prophylactic antibiotic, antiviral and antifungal infection treatments are permissible;
  8. People infected with HIV, HBV, HCV and TPPA/RPR, and carriers with HBV;
  9. Subjects who are not sterilized have any of the following conditions:

    1. are pregnant/lactating; or
    2. planned pregnancy during the trial; or
    3. being fertile and unable to use effective contraception;
  10. The investigators consider that the subject has other conditions that are not suitable for this trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04036019
Other Study ID Numbers  ICMJE 05/03-04-009
Has Data Monitoring Committee Not Provided
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 Not Provided
Responsible Party Aibin Liang,MD,Ph.D., Shanghai Tongji Hospital, Tongji University School of Medicine
Study Sponsor  ICMJE Shanghai Tongji Hospital, Tongji University School of Medicine
Collaborators  ICMJE Cellular Biomedicine Group Ltd.
Investigators  ICMJE
Principal Investigator: Aibin Liang, MD,Ph.D. Shanghai Tongji Hospital, Tongji University School of Medicine
PRS Account Shanghai Tongji Hospital, Tongji University School of Medicine
Verification Date July 2019

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