CD19 and CD22 Targeted CAR-T Cell Therapy for Relapsed/Refractory B Cell Leukemia and Lymphoma

Chongqing Precision Biotech

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Lymphoma, B-Cell; Leukemia, B-cell

Treatments: Biological: CD19 and CD22 targeted CAR-T cells

Study type: Interventional

Funder types: Industry

Identifiers

NCT04649983

PBC012

Details and patient eligibility

About

This is a single arm study to evaluate the efficacy and safety of CD19 and CD22 targeted CAR-T cells therapy for patients with relapsed/refractory B Cell Leukemia and Lymphoma.

Full description

Although the anti-CD19 CAR-T cell therapies have gained significant results in patients with relapsed and refractory B-cell hematologic malignancies. There are patients who resisted anti-CD19 CAR-T cells or with CD19 negative relapse. To make further improvement, We launch such a clinical trial using CD19 and CD22 targeted CAR-T cells for patients with relapsed and refractory B Cell Leukemia and Lymphoma to evaluate the efficacy and safety of CD19 and CD22 targeted CAR-T cell therapy.

Enrollment: 40 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 and 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 and CD22 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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40 participants in 1 patient group

Arm 1

Experimental group

Description:

Patients will be be treated with CD19 and CD22 CAR-T cells

Treatment:

Biological: CD19 and CD22 targeted CAR-T cells