Study of Anti-CD19 iCAR NK Cells in Relapsed and Refractory B Cell Lymphoma

NCT ID: NCT03824951

Last Updated: 2019-01-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2021-01-01

Brief Summary

This is a single-centre, single-arm and open-label study to investigate the safety and efficacy of anti CD19 iCAR NK cells in patients with relapsed refractory B cell lymphoma.

Conditions

Refractory B-Cell Lymphoma

Study Design

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

Study Groups

Anti-CD19 iCAR NK Cells

Group Type: EXPERIMENTAL

Anti-CD19 iCAR NK Cells

Intervention Type: BIOLOGICAL

Anti-CD19 iCAR NK Cells injection

Interventions

Anti-CD19 iCAR NK Cells

Anti-CD19 iCAR NK Cells injection

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. CD19 (+) B cell lymphoma confirmed by pathological immunohistochemistry or flow cytometry

2. Previously accepted ≥ first-line regimen chemotherapy

3. Unconditional acceptance of hematopoietic stem cell transplantation or recurrence after hematopoietic stem cell transplantation

4. Over 18 years old and under 70 years old

5. The expected survival period is more than 3 months.

6. ECOG≤2

7. Important organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥50%, no abnormal electrocardiogram; blood oxygen saturation ≥90%; creatinine clearance ≥40 mL/min; ALT and AST≤3 times normal range, Total bilirubin ≤ 2.0 mg / dL;

8. Blood routine: Hgb≥80 g/L, ANC≥1×109/L, PLT≥50×109/L;

9. The pregnancy test for women of childbearing age must be negative; both men and women must agree to use effective contraception during the treatment period and for the following 1 year.

10. Measurable target lesion

Exclusion Criteria

1. Patients with extramedullary relapse

2. Burkitt's lymphoma/leukemia

3. Previously received gene product treatment, anti-CD19/anti-CD3 treatment, or any anti-CD19 treatment;

4. Liver and kidney function:

• Total bilirubin > 2 x ULN (Gilbert Syndrome > 3 x ULN)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 3 × ULN
• Serum creatinine clearance >60 mL/min

5. Serological examination:

• Absolute neutrophil count (ANC) <0.75x109/L
• Platelet count (PLT) <50x109/L

6. Active hepatitis B (HBV-DNA > 1000 copies / mL), hepatitis C, or uncontrolled infection

7. GVHD ≥ 2 or anti-GVHD treatment

8. IM19 CAR NK cells received allogeneic cell therapy within 6 weeks before infusion, such as donor lymphocyte infusion;

9. Subject received the most recent treatment (release, chemotherapy, or other) less than 4 weeks

10. Active CNS disease (tumor cells in CSF, but < 5 WBCs/mL can be included);

11. Intracranial hypertension or unconsciousness; respiratory failure; diffuse vascular internal coagulation

12. Creatinine > 1.5 times normal upper limit or ALT / AST > 3 times normal upper limit or bilirubin > 2 times normal upper limit

13. New York Heart Association (NYHA) graded above or above

14. Uncontrollable diabetes

15. Suffering from other uncontrolled diseases, the researchers believe that it is not suitable for joining

16. Any situation that the investigator believes may increase the risk of the subject or interfere with the test results

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: collaborator

Allife Medical Science and Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CD19 iCAR NK-BJZL-01

Identifier Type: -

Identifier Source: org_study_id