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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2024-07-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Leukemia, B-cell Lymphoma, B-Cell

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

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

Group Type EXPERIMENTAL

CD19 and CD22 targeted CAR-T cells

Intervention Type BIOLOGICAL

A single infusion of CD19 and CD22 CAR-T cells will be administered intravenously

Interventions

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CD19 and CD22 targeted CAR-T cells

A single infusion of CD19 and CD22 CAR-T cells will be administered intravenously

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No