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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 : 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

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.

Condition or disease Intervention/treatment Phase
B Cell Lymphoma Biological: CD20-directed CAR-T cells Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 13, 2019
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : July 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: C-CAR066
Autologous C-CAR066 administered by intravenous (IV) infusion
Biological: CD20-directed CAR-T cells
Autologous 2nd generation CD20-directed CAR-T cells, single infusion intravenously
Other Name: C-CAR066




Primary Outcome Measures :
  1. Occurrence of study related adverse events [ Time Frame: 12 weeks ]
    Incidence and severity of Treatment emergent adverse events


Secondary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: 12weeks, 6months, 12 months ]
    Lugano criteria(NHL,2014).

  2. DOR [ Time Frame: 12 months ]
    Duration of remission

  3. PFS [ Time Frame: 12 months ]
    Progression free survival

  4. OS [ Time Frame: 12weeks, 6months, 12months ]
    Overall survival



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:   14 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT04036019


Contacts
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Contact: Aibin Liang, MD,Ph.D. 0086-021-66111019 lab7182@tongji.edu.cn
Contact: Ping Li, MD,Ph.D. 0086-021-66111015 lilyforever76@126.com

Locations
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China
Shanghai Tongji Hospital, Tongji University School of Medicine Recruiting
Shanghai, China, 200065
Contact: Aibin Liang, MD,Ph.D.    0086-021-66111019    lab7182@tongji.edu.cn   
Sponsors and Collaborators
Shanghai Tongji Hospital, Tongji University School of Medicine
Cellular Biomedicine Group Ltd.
Investigators
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Principal Investigator: Aibin Liang, MD,Ph.D. Shanghai Tongji Hospital, Tongji University School of Medicine

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Responsible Party: Aibin Liang,MD,Ph.D., Director,Department of Hematology, Shanghai Tongji Hospital, Tongji University School of Medicine
ClinicalTrials.gov Identifier: NCT04036019     History of Changes
Other Study ID Numbers: 05/03-04-009
First Posted: July 29, 2019    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019

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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 Aibin Liang,MD,Ph.D., Shanghai Tongji Hospital, Tongji University School of Medicine:
B cell lymphoma received prior CD19 CAR-T therapy
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin