CD19-CAR-T in B-cell Malignancies Patients

NCT ID: NCT03952923

Last Updated: 2022-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2021-03-31

Brief 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.

Detailed 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.

Conditions

B-cell Malignancy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

CD19-CAR-T cells

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

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 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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Immunotech (Beijing) Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Avalon GloboCare Corp.

UNKNOWN

Sponsor Role: collaborator

Hebei Yanda Ludaopei Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hebei Yanda Ludaopei Hospital

Sanhe, Hebei, China

Countries

China

Other Identifiers

HXYT-002

Identifier Type: -

Identifier Source: org_study_id