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A PhaseⅠb Study Evaluating Safety and Efficacy of C-CAR011 Treatment in B- NHL Subjects

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: NCT03483688
Recruitment Status : Completed
First Posted : March 30, 2018
Last Update Posted : March 5, 2020
Sponsor:
Collaborator:
Cellular Biomedicine Group Ltd.
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Brief Summary:
This is a single arm, single-center, non-randomized study to evaluate the safety and efficacy of C-CAR011 therapy in relapsed or refractory B cell Non-Hodgkin Lymphoma (NHL).

Condition or disease Intervention/treatment Phase
B-cell Non-Hodgkin Lymphoma Biological: CD19-directed CAR-T cells Phase 1

Detailed Description:
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)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ⅰb Study Evaluating Safety and Efficacy of Anti-CD19 Chimeric Antigen Receptor T-cell (C-CAR011) Treatment in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
Actual Study Start Date : March 6, 2018
Actual Primary Completion Date : December 10, 2019
Actual Study Completion Date : January 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: CD19-directed CAR-T cells
Lymphocytes will be transduced with lentiviral vector containing CAR-CD19 gene
Biological: CD19-directed CAR-T cells
CD19-directed CAR-T cells single infusion intravenously at a target dose of 0.5-5.0 x 10^6 anti-CD19 CAR+ T cells/kg
Other Name: Anti-CD19 chimeric antigen receptor T cells (C- CAR011)




Primary Outcome Measures :
  1. AE [ Time Frame: 12 weeks ]
    Incidence of adverse events (AEs) and serious adverse events (SAEs)


Secondary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: 12 months ]
    The ORR will be assessed at weeks 4 ,weeks 12 ,months 6 and months 12

  2. Duration of remission (DOR) [ Time Frame: 12 months ]
    The DOR will be assessed at months 12

  3. Progression free survival (PFS) [ Time Frame: 12 months ]
    The PFS will be assessed at months 12

  4. Overall survival rate(OSR) [ Time Frame: 12 months ]
    The OSR will be assessed at weeks 12 ,months 6 and months 12



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

Inclusion Criteria:

  • Volunteered to participate in this study and signed informed consent.
  • Age 18-70 years old, male or female.
  • Relapse or refractory B cell non-Hodgkin's lymphoma ,Histologically diagnosed as DLBCL,follicular lymphoma and Mantle cell lymphoma according to the NCCN. nonHodgkin's lymphoma Clinical Practice Guidelines (2017 Version 1)

    1. DLBCL and Follicular Lymphoma (stage Ⅲ-Ⅳ, grade Ⅲb).

      1. Progressive disease after the last standard chemotherapy regimens.
      2. Stable disease after the last standard chemotherapy regimens(at least 4 cycles of first-line therapy or 2 cycles of later-line therapy).
      3. Relapse or progressive disease within 12 months after autologous stem cell transplantation (SCT).
    2. Follicular lymphoma (stage Ⅲ-Ⅳ) (gradeⅠ-Ⅲa)

      1. Relapse or progressive disease within 1 year after the last standard chemotherapy regimens(At least 2 combination chemotherapy regimens).
      2. Stable disease after the last standard chemotherapy regimens(at least 2 cycles of combination chemotherapy regimens).
    3. Mantle cell lymphoma

      1. Relapse after 1st CR or persistent disease, and not eligible or appropriate for SCT.
      2. Relapse or progressive disease within 1 year after the last chemotherapy regimens(at least 4 cycles of first-line therapy or 2 cycles of later- line therapy).
      3. Relapse or progressive disease within 12 months after autologous SCT.
  • All subjects must have received anti-CD20 monoclonal antibody (unless tumor is CD20-negative) and anthracycline-containing chemotherapy regimens according to NCCN non-Hodgkin lymphoma Clinical Practice Guidelines (2017 Version 1).
  • At least one measurable lesion per revised IWG Response Criteria (the longest diameter of the tumor ≥ 1.5cm).
  • Expected survival ≥ 12 weeks.
  • ECOG score 0-1.
  • Left ventricular ejection fraction (LVEF) ≥ 50% (detected by echocardiography).
  • No active pulmonary infections, normal pulmonary function and oxygen saturation ≥ 92% on room air.
  • At least 2 weeks from receiving previous treatment (radiotherapy or chemotherapy) prior to leukapheresis.
  • No contraindications of leukapheresis.
  • 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.

Exclusion Criteria:

  • History of allergy to cellular products.
  • Laboratory tests: absolute neutrophil count < 1.0 × 10^9 /L, platelet count < 50×10^9 /L, serum albumin < 30 g/L,serum bilirubin > 1.5 ULN, serum creatinine > ULN, ALT/AST > 3 ULN.
  • History of CAR T cell therapy or any other genetically modified T cell therapy.
  • Relapse after allogeneic hematopoietic stem cell transplantation.
  • Active infections that require treatment (uncomplicated urinary tract infections and bacterial pharyngitis are allowed), prophylactic antibiotic, antiviral and antifungal treatment are permitted.
  • Hepatitis B or hepatitis C virus infection (including carriers), syphilis, as well as acquired or congenital immune deficiency diseases, including but not limited to HIV infection.
  • Class III or IV heart failure according to the NYHA Heart Failure Classifications.
  • QT interval prolongation ≥ 450 ms.
  • History of epilepsy or other central nervous system disorders.
  • Evidence of CNS lymphoma by head enhancement scan or magnetic resonance imaging.
  • History of other primary cancers, with the following exceptions.

    1. Excisional non-melanoma (e.g. cutaneous basal cell carcinoma).
    2. Cured in situ carcinoma (e.g. cervical cancer, bladder cancer, breast cancer).
  • Autoimmune diseases that require treatment, immune deficiency diseases or other diseases that require immunosuppressive therapy.
  • Used of systemic steroids within two weeks (using inhaled steroids is an exception).
  • Women who are pregnant or lactating, or who have breeding intent in 6 months.
  • Participated in any other clinical trial within three months.
  • Any situation that investigators believe the risk of the subjects is increased or results of the trial are disturbed.

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): NCT03483688


Locations
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China, Beijing
Peking Union Medical College Hospital
Beijing, Beijing, China, 100010
Sponsors and Collaborators
Peking Union Medical College Hospital
Cellular Biomedicine Group Ltd.
Investigators
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Principal Investigator: Daobin Zhou Peking Union Medical College Hospital

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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03483688    
Other Study ID Numbers: CBMG-C2017007
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: March 5, 2020
Last Verified: March 2018

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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 Peking Union Medical College Hospital:
B-cell Non-Hodgkin Lymphoma
Refractory
Relapsed
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases