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Safety and Efficacy of Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy in R/R Acute B Lymphoblastic Leukemia

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: NCT04094766
Recruitment Status : Withdrawn (Production plan adjustment)
First Posted : September 19, 2019
Last Update Posted : November 5, 2020
Sponsor:
Collaborator:
Nanjing Legend Biotech Co.
Information provided by (Responsible Party):
Second Affiliated Hospital of Xi'an Jiaotong University

Brief Summary:
This is a single arm, open-label, dose escalation clinical study to evaluate the safety and efficacy of infusion of dual specificity CD19 and CD22 CAR-T cells in patients with relapsed and refractory acute B lymphoblastic leukemia.

Condition or disease Intervention/treatment Phase
Refractory B Acute Lymphoblastic Leukemia Relapse B Acute Lymphoblastic Leukemia Drug: Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy Phase 1

Detailed Description:
CD19-directed CAR-T cell therapy has shown promising results for the treatment of relapsed or refractory acute B lymphoblastic leukemia. CD19 and CD22 are proteins usually expressed on the surface of the B leukemia cells. The dual specificity CAR enables the T-cells to recognize and kill the tumor cell through recognition of CD19 and CD22.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Clinical Study of Dual Specificity CD19 and CD22 Chimeric Antigen Receptor T Cell Therapy in Relapsed or Refractory Acute B Lymphoblastic Leukemia
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : August 30, 2020


Arm Intervention/treatment
Experimental: BLLCAR-L10D treatment group
In BLLCAR-L10D treatment group, patients will be treated with dual specificity CD19 and CD22 CAR-T cells with a escalation approach, 3 CAR-T dosage will be tested in this study: 0.5×10^6, 1.5×10^6, 2.0×10^6 CAR-T cells/kg.
Drug: Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy
Patients will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of CAR-T cells. After a pre-treatment lymphodepletion therapy, patients will receive the Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy by intravenous injection.




Primary Outcome Measures :
  1. Occurrence of treatment related adverse events [ Time Frame: Day 1-100 days after injection ]
    Assessed by CTCAE v4.0


Secondary Outcome Measures :
  1. Objective response rate [ Time Frame: Day 1-5 years after injection ]
    Objective response include complete remission and partial remission

  2. Overall survival [ Time Frame: Day 1-5 years after injection ]
  3. Progression free survival [ Time Frame: Day 1-5 years after injection ]

Other Outcome Measures:
  1. Copy numbers of CAR-T cells in patients [ Time Frame: Day 1-5 years after injection ]


Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written informed consent could be acquired;
  2. Diagnosed with relapse/refractory acute lymphoblastic leukemia;
  3. Relapse was defined as recurrence of blast cell(more than 5%) in peripheral blood or in bone marrow or extramedullary involvement;
  4. Refractory was defined as failed to achieve complete remission after two courses of induction therapy;
  5. CD19/CD22 postive leukemia cell was confirmed by flow cytometry or immunohistochemistry within 90 days since enrollment in this trial;
  6. Karnofsky score ≥70;
  7. Results of pregnant test should be negative, and agree to conception control during treatment and 6 months after CAR-T infusion.
  8. Adequate organ function: EF≥50%; normal ECG; CCR ≥ 50ml/min or Cr < 2.0mg/dL or < 2 times upper limitation of normal; ALT and AST<5 times upper limitation of normal; Serum bilirubin ≤ 3.0mg/dL; DLCO or FEV1 > 45% of predict value;
  9. At least 2 weeks intervals since the last chemotherapy;
  10. At least 2 weeks intervals since the last anti-GVHD therapy if patients have ever ;

Exclusion Criteria:

  1. Patients diagnosed with acute promyelocytic leukemia:t(15;17)(q22;q12);
  2. Women in pregnancy and lactation;
  3. Uncontrolled infection, Active HBV or HCV infection, HIV positive or any other deadly bacterial/virual diseases;
  4. Long term use of systemic corticosteroids(5mg per day for 2 weeks);
  5. Any other uncontrolled life-threaten diseases;
  6. Patients with history of anaphylaxis to any drugs;
  7. With central nervous system (CNS) involvement;
  8. Patients with GVHD after allo-HSCT who needed immunosuppressive agents ;
  9. Patients with acute autoimmune diseases such as psoriasis or rheumatoid arthritis;
  10. Other conditions that principle investigator considered may increase the risk of the patients or interference the results.

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): NCT04094766


Locations
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China, Shaanxi
Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710000
Sponsors and Collaborators
Second Affiliated Hospital of Xi'an Jiaotong University
Nanjing Legend Biotech Co.
Investigators
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Principal Investigator: Aili He, MD, PhD Second Affiliated Hospital of Xi'an Jiaotong University
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Responsible Party: Second Affiliated Hospital of Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT04094766    
Other Study ID Numbers: XJTU-BLLCAR-L10D
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: November 5, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Second Affiliated Hospital of Xi'an Jiaotong University:
Chimeric Antigen Receptor T cells
CD19 and CD22
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases