CD19-Synthetic T Cell Antigen Receptor(STAR)-T in B-cell Malignancies Patients
Study Details
Study Description
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 |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Percentage of adverse events [6 months]
Percentage of participants with adverse events.
- Objective Remission Rate(ORR) [6 months]
The percentage of participants who achieved complete remission (CR) and partial remission over all participants.
Secondary Outcome Measures
- Relapse-Free Survival(RFS ) [6 months]
- Overall-Survival(OS) [6 months]
- Persistence of STAR-T cells in vivo [6 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
- Relapsed and refractory CD19 positive B-cell acute malignancies with:
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Relapsed after competed remission, could not get competed remission after at more than 1 course of chemotherapy (including MRD≥0.1%);
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MRD≥0.1% after allogeneic hematopoietic stem cell transplantation(HSCT), or recurrence after complete remission or MRD ≥ 0.1% after HSCT;
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Refractory: at least two courses of chemotherapy did not achieve complete remission or MRD ≥ 0.1%;
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Patients must have evaluable evidence of disease, including minimal residual disease (MRD);
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Ph + patients who meet the following criteria can register:Failure to tolerate TKI or TKI treatment failure, or failure to transplant;
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Ages 1 to 70 years, including boundary values;
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ECOG score 0-3 points;
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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:
- patients with organ failure:
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Heart: NYHA heart function grade III or IV ;
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Liver: Grade C that achieves Child-Turcotte liver function grading;
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Kidney: kidney failure and uremia;
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Lung: symptoms of respiratory failure;
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Brain: a person with a disability;
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Active infections that are difficult to control;
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Human immunodeficiency virus (HIV) positive;
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Liver and kidney function: total bilirubin > 5 × ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 5 × ULN, serum creatinine clearance rate 60mL / min;
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GVHD ≥ 2 or receiving anti-GVHD treatment;
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Received allogeneic cell therapy within 4 weeks, such as donor lymphocyte infusion(DLI);
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Subject received anti-tumor treatment (chemotherapy, mAb, or hormone) for less than 1 week;
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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);
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intracranial hypertension or unconsciousness; respiratory failure; diffuse vascular internal coagulation;
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pregnant or lactating women;
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The patient does not agree to use effective contraception during the treatment period and for the next 3 months;
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Patients who participate in other clinical studies at the same time;
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hebei Yanda Ludaopei Hospital | Sanhe | Hebei | China | 065200 |
Sponsors and Collaborators
- Hebei Yanda Ludaopei Hospital
- China Immunotech (Beijing) Biotechnology Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HXYT-003