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Safety and Efficacy of CD19 and CD22 Targeted CAR-T Therapy for Relapsed/Refractory B Cell Leukemia and Lymphoma

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ClinicalTrials.gov Identifier: NCT04648475
Recruitment Status : Recruiting
First Posted : December 1, 2020
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Chongqing Precision Biotech Co., Ltd

Study Description
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Brief Summary:
This is a single arm study to evaluate the efficacy and safety of CD19 and CD22 targeted CAR-T cells therapy for patients with relapsed/refractory B Cell Leukemia and Lymphoma.

Condition or disease Intervention/treatment Phase
Leukemia, B-cell Lymphoma, B-Cell Biological: CD19 and CD22 targeted CAR-T cells Phase 1 Phase 2

Detailed Description:
Although the CD19 targeted CAR-T cell therapies have gained significant results in patients with relapsed and refractory B-cell Leukemia and Lymphoma. There are patients who resisted anti-CD19 CAR-T cells or with CD19 negative relapse. To make further improvement, We launch such a clinical trial using CD19 and CD22 targeted CAR-T cells for patients with relapsed and refractory B Cell Leukemia and Lymphoma to evaluate the efficacy and safety of CD19 and CD22 targeted CAR-T cell therapy.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CD19 and CD22 Targeted CAR-T Cell Therapy for Relapsed/Refractory B Cell Leukemia and Lymphoma
Actual Study Start Date : August 25, 2020
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : July 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1
CD19 and CD22 targeted CAR-T cells treat
 Biological: CD19 and CD22 targeted CAR-T cells
A single infusion of CD19 and CD22 CAR-T cells will be administered intravenously


Outcome Measures
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Primary Outcome Measures :
  1. Adverse events that related to treatment [ Time Frame: 2 years ]
    Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).

  2. The response rate of CD19 and CD22 CAR-T treatment in patients with relapse/refractory B Cell Leukemia and Lymphoma [ Time Frame: 6 months ]
    The response rate of CD19 and CD22 CAR-T treatment will be recorded and assessed according to the National Comprehensive Cancer Network Guideline.


Secondary Outcome Measures :
  1. Rate of CD19 and CD22 CAR-T cells in bone marrow and peripheral blood [ Time Frame: 2 years ]
    In vivo (bone marrow and peripheral blood) rate of CD19 and CD22 CAR-T cells were determined by means of flow cytometry

  2. Quantity of CD19 and CD22 CAR copies in bone marrow and peripheral blood [ Time Frame: 2 years ]
    In vivo (bone marrow and peripheral blood) quantity of CD19 and CD22 CAR copies were determined by means of qPCR

  3. Cellular kinetics of CD19 and CD22 positive cells in Bone marrow [ Time Frame: 1 years ]
    In vivo (bone marrow) rate and quantity of CD19 and CD22 positive cells were determined by means of flow cytometry

  4. Levels of IL-6 in Serum [ Time Frame: 3 months ]
    In vivo (Serum) quantity of IL-6

  5. Levels of IL-10 in Serum [ Time Frame: 3 months ]
    In vivo (Serum) quantity of IL-10

  6. Levels of TNF-α in Serum [ Time Frame: 3 months ]
    In vivo (Serum) quantity of TNF-α

  7. Levels of CRP in Serum [ Time Frame: 3 months ]
    In vivo (Serum) quantity of CRP

  8. Duration of Response (DOR) of CD19 and CD22 CAR-T treatment in patients with refractory/relapsed B Cell Leukemia and Lymphoma [ Time Frame: 2 years ]
    DOR will be assessed from the first assessment of CR/CRi to the first assessment of recurrence or progression of the disease or death from any cause (censored)

  9. Progress-free survival(PFS) of CD19 and CD22 CAR-T treatment in patients with refractory/relapsed B Cell Leukemia and Lymphoma [ Time Frame: 2 years ]
    PFS will be assessed from the first CAR-T cell infusion to death from any cause or the first assessment of progression (censored).

  10. Overall survival(OS) of CD19 and CD22 CAR-T treatment in patients with refractory/relapsed B Cell Leukemia and Lymphoma [ Time Frame: 2 years ]
    OS will be assessed from the first CAR-T cell infusion to death from any cause (censored)


Eligibility Criteria
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Ages Eligible for Study:   3 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed written informed consent;

  2. Diagnose as relapsed /refractory B Cell Leukemia and Lymphoma, and meet one of the following conditions:

    1. Failed to standard chemotherapy regimens;
    2. Relapse after complete remission, high-risk and / or refractory patients ;
    3. Relapse after hematopoietic stem cell transplantation;
  3. For patients with Ph + ALL, the following conditions must be met: those who have received a standard induction chemotherapy regimen and who have not achieved complete remission after TKI treatment or have relapsed after remission (cannot tolerate TKI treatment or have contraindications to TKI treatment or the presence of TKI class) Except for drug resistant patients)；
  4. Evidence for cell membrane CD19 and CD22 expression;
  5. All genders, ages: 3 to 75 years；
  6. The expect time of survive is above 12 weeks;
  7. KPS>60；
  8. No serious mental disorders ;
  9. Left ventricular ejection fraction ≥50%
  10. Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;
  11. Sufficient renal function defined by creatinine clearance≤2 x ULN;
  12. Sufficient pulmonary function defined by indoor oxygen saturation≥92%;
  13. With single or venous blood collection standards, and no other cell collection contraindications;
  14. Ability and willingness to adhere to the study visit schedule and all protocol requirements.

Exclusion Criteria:

  1. Have received CAR-T therapy or other genetically modified cell therapy before screening；
  2. Participated in other clinical research within 1 month before screening；
  3. Have received the following anti-tumor treatment before screening: Have received chemotherapy, targeted therapy or other experimental drug treatment within 4 weeks, except those who have confirmed disease progression after treatment;
  4. Live attenuated vaccine within 4 weeks before screening;
  5. Convulsion or stoke within past 6 months;
  6. Previous history of other malignancy;
  7. Presence of uncontrolled active infection;
  8. Subjects with positive HBsAg or HBcAb positive and peripheral blood HBV DNA titer is higher than the lower limit of detection of the research institution; HCV antibody positive and peripheral blood HCV RNA titer is higher than the lower limit of detection of the research institution; HIV antibody positive; syphilis primary screening antibody positive;
  9. Pregnant or breasting-feeding women;
  10. Any situation that investigators regard not suitable for attending in this study or may affect the data analysis.
Contacts and Locations
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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): NCT04648475


Contacts
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Contact: Zhi Yang, PhD 86-13206140093 yangzhi@precision-biotech.com
Contact: Yingzi Zhang 86-18623351275 yingzi6526@163.com

Locations
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China, Chongqing
Chongqing University Cancer Hospital Recruiting
Chongqing, Chongqing, China
Contact: Cheng Qian, PhD       cqian3184@163.com   
Contact: Ying Xiang, MD       1324339678@qq.com   
Principal Investigator: Cheng Qian, PhD         
Principal Investigator: Ying Xiang, MD         
Sponsors and Collaborators
Chongqing Precision Biotech Co., Ltd
Investigators
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Principal Investigator: Cheng Qian, PhD Chongqing University Cancer Hospital
More Information
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Responsible Party: Chongqing Precision Biotech Co., Ltd
ClinicalTrials.gov Identifier: NCT04648475    
Other Study ID Numbers: PBC019
First Posted: December 1, 2020    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: August 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
Keywords provided by Chongqing Precision Biotech Co., Ltd:
CAR-T
CD19
CD22
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Lymphoma, B-Cell
Leukemia, B-Cell
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid