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CD19/CD20 Dual-CAR-T in B-cell Leukemia Patients

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: NCT04260945
Recruitment Status : Completed
First Posted : February 7, 2020
Last Update Posted : March 8, 2022
Sponsor:
Collaborator:
China Immunotech (Beijing) Biotechnology Co., Ltd.
Information provided by (Responsible Party):
Hebei Yanda Ludaopei Hospital

Brief Summary:
This is a single center, single arm, open-label, phase I study to evaluate the safety and efficacy of CD19/CD20 Dual-CAR-T cells in patients with refractory and relapsed B-cell leukemia.

Condition or disease Intervention/treatment Phase
B-cell Leukemia Biological: CD19/CD20 Dual-CAR-T cells Phase 1

Detailed Description:
This Phase I study is designed as a pilot trial evaluating the safety and efficacy of CD19/CD20 Dual-CAR-T cell therapy in subjects with refractory and relapsed B cell leukemia. Subjects will receive cytoreductive chemotherapy with cyclophosphamide and fludarabine on days -5, -4 and -3 followed by infusion of CD19/CD20 Dual-CAR-T cells. Safety and efficacy of CD19/CD20 Dual-CAR-T cells therapy will be monitored. The purpose of current study is to determine the clinical efficacy and safety of CD19/CD20 Dual-CAR-T cells therapy in patients with refractory and relapsed B-cell leukemia.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CD19/CD20 Dual-CAR-T for Patients With B-cell Leukemia
Actual Study Start Date : March 10, 2020
Actual Primary Completion Date : October 10, 2021
Actual Study Completion Date : February 10, 2022


Arm Intervention/treatment
Experimental: CD19/CD20 Dual-CAR-T cells
CD19/CD20 Dual-CAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of CAR-T cells, subjects receive fludarabine at dose 30mg/m2/day and cyclophosphamide treatment at dose 250mg/m2 for 3 days and take a rest for 2 days before infusion.
Biological: CD19/CD20 Dual-CAR-T cells
CD19/CD20 Dual-CAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of CAR-T cells, subjects receive fludarabine at dose 30mg/m2/day and cyclophosphamide treatment at dose 250mg/m2 for 3 days and take a rest for 2 days before infusion.CD19/CD20 Dual-CAR-T cells will be intravenously infused with a escalated dose of 0.6-3×106 cells/kg.




Primary Outcome Measures :
  1. Percentage of participants with adverse events. [ Time Frame: 6 months ]
  2. Objective remission rate(ORR) [ Time Frame: 6 months ]
    The percentage of participants who achieved complete remission (CR) and partial remission over all participants.


Secondary Outcome Measures :
  1. Relapse-Free Survival(RFS ) [ Time Frame: 6 months ]
  2. Overall-Survival(OS) [ Time Frame: 6 months ]
  3. Persistence of CAR-T cells in vivo [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Relapsed and refractory B-cell acute malignancies with:

    • Relapsed after competed remission, could not get competed remission after at more than 1 course of chemotherapy (including MRD≥0.1%);
    • MRD≥0.1% after allogeneic hematopoietic stem cell transplantation(HSCT), or recurrence after complete remission or MRD ≥ 0.1% after HSCT;
    • Refractory: at least two courses of chemotherapy did not achieve complete remission or MRD ≥ 0.1%;
  2. Patients must have evaluable evidence of disease, including minimal residual disease (MRD);
  3. Ph + patients who meet the following criteria can register:Failure to tolerate TKI or TKI treatment failure, or failure to transplant;
  4. Double positive expression of CD19 / CD20 in B cells;
  5. Ages 1 to 70 years, including boundary values;
  6. ECOG score 0-3 points;
  7. Women of childbearing age (15-49 years old) must receive a pregnancy test within 7 days prior to initiation of treatment and the results are negative; male and female patients with fertility must use an effective contraceptive to ensure 3 months after discontinuation of treatment during the study period not pregnant inside.
  8. Patients who voluntarily sign informed consent and are willing to comply with treatment plans.

Exclusion Criteria:

  1. patients with organ failure:

    • Heart: NYHA heart function grade IV;
    • Liver: Grade C that achieves Child-Turcotte liver function grading;
    • Kidney: kidney failure and uremia;
    • Lung: symptoms of respiratory failure;
    • Brain: a person with a disability;
  2. Active infections that are difficult to control;
  3. Human immunodeficiency virus (HIV) positive;
  4. Liver and kidney function: total bilirubin > 5 × ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 5 × ULN, serum creatinine clearance rate 60mL / min;
  5. GVHD ≥ 2 or anti-GVHD treatment;
  6. Received allogeneic cell therapy within 4 weeks, such as donor lymphocyte infusion;
  7. Subject received anti-tumor treatment (chemotherapy, mAb, or hormone) for less than 1 week;
  8. Central nervous system white blood that is symptomatic or uncontrolled by systemic chemotherapy and intrathecal chemotherapy (a large number of tumor cells in CSF, white blood cell count >15WBCs/mL);
  9. intracranial hypertension or unconsciousness; respiratory failure; diffuse vascular internal coagulation;
  10. pregnant or lactating women;
  11. The patient does not agree to use effective contraception during the treatment period and for the next 3 months;
  12. Patients who participate in other clinical studies at the same time;
  13. The investigator believes that there are other factors that are not suitable for inclusion or influence the subject's participation or completion of the study.

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): NCT04260945


Locations
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China, Hebei
Hebei Yanda Ludaopei Hospital
Sanhe, Hebei, China, 065200
Sponsors and Collaborators
Hebei Yanda Ludaopei Hospital
China Immunotech (Beijing) Biotechnology Co., Ltd.
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Responsible Party: Hebei Yanda Ludaopei Hospital
ClinicalTrials.gov Identifier: NCT04260945    
Other Study ID Numbers: HXYT-007
First Posted: February 7, 2020    Key Record Dates
Last Update Posted: March 8, 2022
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, B-Cell
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases