Description:
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 ).
Title
- Brief Title: CD19-Synthetic T Cell Antigen Receptor(STAR)-T in B-cell Malignancies Patients
- Official Title: CD19-STAR-T for Patients With B Cell Malignancies
Clinical Trial IDs
- ORG STUDY ID:
HXYT-003
- NCT ID:
NCT03953599
Conditions
Interventions
Drug | Synonyms | Arms |
---|
CD19-STAR-T cells | | CD19-STAR-T cells |
Purpose
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 ).
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.
Trial Arms
Name | Type | Description | Interventions |
---|
CD19-STAR-T cells | Experimental | 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. | |
Eligibility Criteria
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.
Maximum Eligible Age: | 70 Years |
Minimum Eligible Age: | 1 Year |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Percentage of adverse events |
Time Frame: | 6 months |
Safety Issue: | |
Description: | Percentage of participants with adverse events. |
Secondary Outcome Measures
Measure: | Relapse-Free Survival(RFS ) |
Time Frame: | 6 months |
Safety Issue: | |
Description: | |
Measure: | Overall-Survival(OS) |
Time Frame: | 6 months |
Safety Issue: | |
Description: | |
Measure: | Persistence of STAR-T cells in vivo |
Time Frame: | 6 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Hebei Yanda Ludaopei Hospital |
Last Updated
August 11, 2020