CD19+Targeted CAR-T Cell Therapy for Relapsed/Refractory CD19+ B Cell Leukemia and Lymphoma

Chongqing Precision Biotech

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Lymphoma, B-Cell; Leukemia, B-cell; Lymphoma, Large B-Cell, Diffuse; Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell

Treatments: Biological: CD19 CAR-T cells

Study type: Interventional

Funder types: Industry

Identifiers

NCT04271410

PBC004

Details and patient eligibility

About

This is a single arm study to evaluate the efficacy and safety of CD19-targeted CAR-T cells therapy for patients with relapsed/refractory CD19+ B Cell Leukemia and Lymphoma.

Full description

There are limited options for treatment of relapse/refractory B Cell Leukemia and Lymphoma.CD19 is expressed on most B Cell Leukemia and Lymphoma cells so it is an ideal target for CAR-T. In this study, investigators will evaluate the safety and efficacy of CAR-T targeting CD19 in patients with elapsed/refractory CD19+ B Cell Leukemia and Lymphoma. The primary goal is safety and efficiency assessment, including adverse events and disease status after treatment.

Enrollment: 80 estimated patients

Sex: All

Ages: 2 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed written informed consent；

2. Diagnose as relapsed/refractory B Cell Leukemia and Lymphoma, and meet one of the following conditions:

   1. Failed to standard chemotherapy regimens;
   2. Relapse after complete remission, high-risk and / or refractory patients ;
   3. Relapse after hematopoietic stem cell transplantation;

3. For patients with Ph + ALL, the following conditions must be met: those who have received a standard induction chemotherapy regimen and who have not achieved complete remission after TKI treatment or have relapsed after remission (cannot tolerate TKI treatment or have contraindications to TKI treatment or the presence of TKI class) Except for drug resistant patients)；

4. Evidence for cell membrane CD19 expression；

5. All genders ，ages: 2 to 75 years；

6. The expect time of survive is above 3 months;

7. KPS>60；

8. No serious mental disorders ;

9. Left ventricular ejection fraction ≥50%

10. Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;

11. Sufficient renal function defined by creatinine clearance≤2 x ULN;

12. Sufficient pulmonary function defined by indoor oxygen saturation≥92%;

13. With single or venous blood collection standards, and no other cell collection contraindications;

14. Ability and willingness to adhere to the study visit schedule and all protocol requirements.

Exclusion criteria

1. Previous history of other malignancy;
2. Presence of uncontrolled active infection;
3. Evidence of disorder that need the treatment by glucocorticoids;
4. Active or chronic GVHD；
5. The patients treatment by inhibitor of T cell；
6. Pregnant or breasting-feeding women;
7. Any situation that investigators regard not suitable for attending in this study (e.g. HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

CD19 CAR-T cells treat

Experimental group

Description:

Patients will be be treated with CD19 CAR-T cells

Treatment:

Biological: CD19 CAR-T cells