Description:
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.
Title
- Brief Title: CD19/CD20 Dual-CAR-T in B-cell Leukemia Patients
- Official Title: CD19/CD20 Dual-CAR-T for Patients With B-cell Leukemia
Clinical Trial IDs
- ORG STUDY ID:
HXYT-007
- NCT ID:
NCT04260945
Conditions
Interventions
Drug | Synonyms | Arms |
---|
CD19/CD20 Dual-CAR-T cells | | CD19/CD20 Dual-CAR-T cells |
Purpose
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.
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.
Trial Arms
Name | Type | Description | Interventions |
---|
CD19/CD20 Dual-CAR-T cells | Experimental | 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
|
Eligibility 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.
Maximum Eligible Age: | 70 Years |
Minimum Eligible Age: | 1 Year |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Percentage of participants with adverse events. |
Time Frame: | 6 months |
Safety Issue: | |
Description: | The percentage of participants who achieved complete remission (CR) and partial remission over all participants. |
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 CAR-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