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CD19-Synthetic T Cell Antigen Receptor(STAR)-T in B-cell Malignancies 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03953599
Recruitment Status : Recruiting
First Posted : May 16, 2019
Last Update Posted : August 11, 2020
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-lable phase I study to determine the safety and efficacy of CD19-STAR-T cells in patients with refractory and relapsed B-cell malignancies (such as NHL and ALL ).

Condition or disease Intervention/treatment Phase
B Cell Malignancy Biological: CD19-STAR-T cells Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CD19-STAR-T for Patients With B Cell Malignancies
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
Experimental: CD19-STAR-T cells
CD19-STAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of STAR-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-STAR-T cells
CD19-STAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of STAR-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.

Primary Outcome Measures :
  1. Percentage of adverse events [ Time Frame: 6 months ]
    Percentage of participants with adverse events.

  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 STAR-T cells in vivo [ Time Frame: 6 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:   1 Year to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Relapsed and refractory CD19 positive 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. Ages 1 to 70 years, including boundary values;
  5. ECOG score 0-3 points;
  6. 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.

Exclusion Criteria:

  1. patients with organ failure:

    • Heart: NYHA heart function grade III or 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 receiving anti-GVHD treatment;
  6. Received allogeneic cell therapy within 4 weeks, such as donor lymphocyte infusion(DLI);
  7. Subject received anti-tumor treatment (chemotherapy, mAb, or hormone) for less than 1 week;
  8. Central nervous system leukemias 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 identifier (NCT number): NCT03953599

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Contact: Xian Zhang, PhD +8613641041596

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China, Hebei
Hebei Yanda Ludaopei Hospital Recruiting
Sanhe, Hebei, China, 065200
Contact: Xian Zhang, PhD    +8613641041596   
Sponsors and Collaborators
Hebei Yanda Ludaopei Hospital
China Immunotech (Beijing) Biotechnology Co., Ltd.
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Responsible Party: Hebei Yanda Ludaopei Hospital Identifier: NCT03953599    
Other Study ID Numbers: HXYT-003
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: August 11, 2020
Last Verified: August 2020

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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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