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CD19-CD22 Chimeric Antigen Receptor T (CAR-T) Cell for Treatment of B Cell Acute Lymphoblastic Leukemia (B-ALL)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04034446
Recruitment Status : Not yet recruiting
First Posted : July 26, 2019
Last Update Posted : July 26, 2019
Sponsor:
Collaborator:
Juventas Cell Therapy Ltd.
Information provided by (Responsible Party):
wang, jianxiang, Institute of Hematology & Blood Diseases Hospital

Brief Summary:
This is a single arm, open-label, single center study to determine the safety and efficacy of CD19-CD22 CAR-T cells in patients with CD19+CD22+ Leukemia.

Condition or disease Intervention/treatment Phase
Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia Biological: CD19-CD22 CAR-T cells Early Phase 1

Detailed Description:
This is a single arm, open-label, single center study to determine the safety and efficacy of CD19-CD22 CAR-T cells in patients with relapsed or refractory B-ALL. The study will have the following sequential phases: Screening, Pre-Treatment (Cell Product Preparation & Lymphodepleting Chemotherapy), Treatment and Follow-up, and Survival Follow-up. The total duration of the study is 2 years from CD19-CD22 CAR-T cell infusion.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: a Feasibility and Safety Study of Bispecific CD19-CD22 CAR-T Cell in the Treatment of Relapsed or Refractory B-ALL
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Arm Intervention/treatment
Experimental: A
Single dose of CD19-CD22 CAR-T cells
Biological: CD19-CD22 CAR-T cells
0.5 to 3.0 x 106 autologous CD19-CD22 CAR-T cells per kg body weight, with a maximum dose of 4 x 108 autologous CD19-CD22 CAR-T cells via intravenous infusion.




Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: 24 months ]
  2. Overall remission rate (ORR) [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Response at Day 28 days [ Time Frame: 1 month ]
  2. Percentage of patients who achieve complete remission (CR) or complete remission with incomplete blood count recovery (CRi) at month 6 without SCT between CD19-CD22 CAR-T cells infusion and Month 6 response assessment. [ Time Frame: 6 months ]
  3. Percentage of patients who achieve CR or CRi with minimal residual disease (MRD) negative bone marrow [ Time Frame: 6 months ]
  4. Relapse-free survival (RFS) [ Time Frame: 24 months ]
  5. Duration of remission (DOR) [ Time Frame: 24 months ]
  6. Overall survival (OS) [ Time Frame: 24 months ]


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:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Informed consent is signed by a subject or his lineal relation.
  2. Age 3 and older.
  3. Documentation of cluster of differentiation 19 (CD19) and or cluster of differentiation 19 (CD22) expression on leukemic blasts in the BM, peripheral blood within 3 months of screening.;
  4. Relapsed or refractory B-cell ALL

    • Relapse within 12 months of first remission
    • Without remission after 2 cycles of induction chemotherapy regimen.
    • Without remission or relapse after salvage treatments.
    • Any BM relapse after autologous stem cell transplantation (ASCT).
  5. Without remission or relapse after any prior CD19 targeted therapy;
  6. Patients with Philadelphia chromosome positive (Ph+) ALL are eligible if they are intolerant to or have failed 2 lines of tyrosine kinase inhibitor therapy (TKI); no TKI salvage treatments if the patient has a BCR-ABL1 kinase domain gatekeeper mutation Thr315Ile (T315I) mutation.
  7. Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening;
  8. Eastern cooperative oncology group (ECOG) performance status of 0 to 2.
  9. Adequate organ function defined as:

    • Aspartate aminotransferase (AST) ≤3 upper limit of normal (ULN);
    • Serum alanine aminotransferase (ALT) ≤3 ULN;
    • Total bilirubin ≤ 2 ULN, except in individuals with Gilbert's syndrome;
    • Note: Patients with Gilbert's syndrome that bilirubin ≤ 3 ULN and direct bilirubin ≤ 1.5 ULN will be eligible.
    • A serum creatinine≤ 1.5 ULN or Creatine removal rate ≥ 60mL/min(Cockcroft and Gault)
    • Must have a minimum level of pulmonary reserve as ≤ Grade 1 dyspnea and oxygen saturation > 91% on room air.
    • Absolute lymphocyte count ≥0.3 x 10⁹/L.
  10. Women of child-bearing potential and all male participants must use highly effective methods of contraception for a period of 1 year after the CD19-CD22 CAR-T cells infusion.

Exclusion Criteria:

  1. Active central nervous system leukemia
  2. Patients with evidence of currently uncontrollable serious active infections (e.g., sepsis, bacteremia, fungemia, viremia, etc.).
  3. Patients who are positive for any of HIV antibody, TP antibody, hepatitis B surface antigen (HBsAg) and hepatitis C virus (HCV) antibody.
  4. Major surgery within ≤ 4 weeks before enrollment.
  5. Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent.
  6. Impaired cardiac function:

    • Left Ventricular Ejection Fraction (LVEF) ≤45%;
    • III/IV congestive heart failure (NYHA);
    • Severe arrhythmia (except for Atrial fibrillation, Paroxysmal supraventricular tachycardia);
    • Corrected QT interval (QTc) ≥450ms (male) or QTc≥470ms (female)(QTc using Bazett's formula (QTcB)=QT/RR^0.5);
    • Myocardial infarction or Coronary Artery Bypass Graft Surgery, heart stent surgery.
    • Other heart diseases that have been judged by the investigator to be unsuitable for receiving cell therapy.
  7. Patients with a history of epilepsy or other active central nervous system diseases.
  8. Life expectancy < 12 weeks.
  9. Allergy to macromolecule biopharmaceuticals such as antibodies or cytokines.
  10. Subjects who are receiving systemic steroid treatment and who have been determined by the researchers to require long-term treatment with systemic steroids during treatment, and subjects treated with systemic steroids must be excluded < 72 hours prior to CNCT19 infusion (except inhalation or local use).
  11. Patients with other conditions making the patients unsuitable for receiving cell therapy as judged by the investigator.

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): NCT04034446


Contacts
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Contact: Ying Wang, Dr. +86-22-23909278 wangying1@ihcams.ac.cn

Locations
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China
Institute of Hematology & Blood Diseases Hospital
Tianjin, China, 300020
Sponsors and Collaborators
Institute of Hematology & Blood Diseases Hospital
Juventas Cell Therapy Ltd.

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Responsible Party: wang, jianxiang, Professor, Institute of Hematology & Blood Diseases Hospital
ClinicalTrials.gov Identifier: NCT04034446    
Other Study ID Numbers: HY004001
First Posted: July 26, 2019    Key Record Dates
Last Update Posted: July 26, 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 wang, jianxiang, Institute of Hematology & Blood Diseases Hospital:
Relapsed
Refractory
B-ALL
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