ET019003-T Cells in Relapsed/Refractory CD19+ B-Cell Leukemia and Lymphoma

• Status: Active, not recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a single center, open-label, 3+3 dose escalation, phase 1 study to evaluate the efficacy and safety of ET019003-T cells therapy for patients with relapsed/refractory CD19+ acute lymphoblastic leukemia and lymphoma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wuhan Union Hospital, China
• Collaborator: Eureka(Beijing) Biotechnology Co., Ltd.

Criteria

Inclusion Criteria:

1. Patient or his or her legal guardian voluntarily participates in and signs an informed consent form.

2. Male or female, aged 18 to 75 years (including 18 and 75 years old).

3. Pathological and histological examination confirmed CD19+ B-cell malignancies, and patients met the following criteria for refractory or relapsed B-cell malignancies.

A. Refractory/relapsed B-cell lymphoblastic leukemia (Meeting one of the following) i. Recurrence within 6 months after first remission. ii. Primary refractory disease which cannot achieve complete remission (CR) after 2 cycles of standardized chemotherapy regimen.

iii. Failure to achieve CR or relapse after one line or multiple lines of salvage chemotherapy.

iv. Not suitable for hematopoietic stem cell transplantation (HSCT), or abandon HSCT due to various restrictions, or relapse after HSCT.

B. Refractory/relapsed B-cell lymphoma (Meeting 1 of the first 4 items plus item 5) i. Tumor shrinkage less than 50% or disease progression after 4 cycles of standard chemotherapy.

ii. Achieved CR after standard chemotherapy, but relapsed within 6 months. iii. Two or more relapses after CR. iv. Not suitable for HSCT, or abandon HSCT due to various restrictions, or relapse after HSCT.

v. Subjects must have received adequate treatment in the past, including anti-CD20 monoclonal antibody and combination chemotherapy with anthracyclines.

4. Having a measurable or evaluable lesion:

A. Patients with lymphoma require a single lesion≥15mm or 2 or more lesions≥10mm.

B. Patients with leukemia require persistent positive or positive relapse of bone marrow MRD.

5. Patient's main organs functioning well:

A. Liver function: ALT/AST < 3 times the upper limit of normal (ULN) and total bilirubin≤34.2μmol/L.

B. Renal function: Creatinine < 220μmol/L. C. Pulmonary function: Indoor oxygen saturation≥95%. D. Cardiac Function: Left ventricular ejection fraction (LVEF) ≥40%.

6. Patients did not receive any antitumor treatments such as chemotherapy, radiotherapy and immunotherapy within 4 weeks before enrollment, and the toxicity related to previous treatments had returned to < 1 level at enrollment (except for low grade toxicity such as alopecia).

7. Patients' peripheral superficial venous blood flow smoothly, which can meet the needs of intravenous drip.

8. ECOG score≤ 2, estimated survival time≥3 months.

Exclusion Criteria:

1. Women who are pregnant or breastfeeding.

2. Women of child-bearing potential and all male participants can't use effective methods of contraception for at least 12 months following infusion.

3. Patients fail to collect enough PBMC.

4. Patients with other uncontrolled diseases, such as active infections.

5. Active replication of hepatitis B or active hepatitis C.

6. Known HIV positive patients.

7. Patients with active autoimmune diseases requiring systemic immunosuppressive therapy.

8. Participants with other active malignancies (except non-melanoma skin cancer and cervical cancer) within three years. Patients with a history of successfully-treated tumors with no sign of recurrence in the last two years may be enrolled.

9. Patients with severe mental disorder or disorders of consciousness.

10. Organ failure:

A. Heart: Patients with NYHA class III or higher cardiac failure, or with malignant arrhythmia.

B. Liver: Patients with Wuhan Conference Classification (1983) class III or higher liver failure.

C. Kidney: patients with 3rd stage and above kidney failure.

11. Patients use glucocorticoid or another immune inhibitor in two weeks.

12. Patients with insufficient T cells or T cell transfection problem.

13. Patients who need immediate treatment to control tumor progression or relieve tumor burden.

14. Patients took other clinical treatments within 6 weeks.

15. Patients with drug addiction.

16. Patients with poor treatment compliance or difficult to communicate and other problems.