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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03952923
Other study ID # HXYT-002
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date August 1, 2019
Est. completion date March 31, 2021

Study information

Verified date August 2020
Source Hebei Yanda Ludaopei Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a single center, single arm, open-lable phase I study to determine the safety and efficacy of CD19-CAR-T cells in patients with refractory and relapsed B-cell malignancies.


Description:

This Phase I study is designed as a pilot trial evaluating the safety and of CD19-CAR-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-CAR-T cells. Safety and efficacy of CD19-CAR-T cells therapy will be monitored. The purpose of current study is to determine the clinical efficacy and safety of CD19-CAR-T cells therapy in patients with refractory and relapsed B-cell malignancies.


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date March 31, 2021
Est. primary completion date January 1, 2021
Accepts healthy volunteers No
Gender All
Age group 1 Year to 70 Years
Eligibility 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 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
CD19-CAR-T cells
CD19-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.

Locations

Country Name City State
China Hebei Yanda Ludaopei Hospital Sanhe Hebei

Sponsors (3)

Lead Sponsor Collaborator
Hebei Yanda Ludaopei Hospital Avalon GloboCare Corp., China Immunotech (Beijing) Biotechnology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of adverse events Percentage of participants with adverse events. 6 months
Primary Objective remission rate(ORR) The percentage of participants who achieved complete remission (CR) and partial remission over all participants. 6 months
Secondary Relapse-Free Survival(RFS ) 6 months
Secondary Overall-Survival(OS) 6 months
Secondary Persistence of CAR-T cells in vivo 6 months
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