a Clinical Research of CD19 and CD22 Targeted Prime CAR-T Cell in Relapsed/Refractory B Cell Lymphoma

Chongqing Precision Biotech

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: B Cell Lymphoma

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04782193

PBC026

Details and patient eligibility

About

This is a single arm study to evaluate the efficacy and safety of CD19 and CD22 targeted prime CAR-T cells therapy for patients with relapsed/refractory B Cell 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, the investigators launch such a clinical trial using CD19 and CD22 targeted prime CAR-T cells for patients with relapsed and refractory B Cell Lymphomato evaluate the efficacy and safety of CD19 and CD22 targeted prime 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 -ALL, 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. Evidence for cell membrane CD19 or CD22 expression

4. All genders ages: 2 to 75 years

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

6. KPS>60

7. No serious mental disorders ;

8. Left ventricular ejection fraction ≥50%

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

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

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

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

13. 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)

---

40 participants in 1 patient group

prime CAR- T cells

Experimental group

Description:

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

Treatment:

Biological: CD19 and CD22 targeted prime CAR- T cells