Kece-2

About this trial

Last updated 6 years ago

Study ID

Kece-2

Status

Unknown status

Type

Interventional

Phase

Phase 1/Phase 2

Placebo

Accepting

2 to 70 Years

All

Not accepting

Healthy Volunteers

Trial Timing

Ended 3 years ago

This study aims to evaluate the safety, efficacy and duration of response of CD22 Chimeric Antigen Receptor (CAR) redirected autologous T-cells in patients with high risk, relapsed CD22+ haematological malignancies.

Inclusion Criteria

1. Relapsed or refractory B cell derived acute lymphoblastic leukemia(ALL), chronic lymphoblastic leukemia(CLL) and non-hodgkin lymphoma.

2. KPS>60.

3. Life expectancy>3 months.

4. Gender unlimited, age from 2 years to 70 years.

5. CD22 expression must be detected on greater than 15% of the malignant cells by immunohistochemistry or greater than 30% by flow cytometry.

6. Patients who have failed at least one line of a standard treatment.

7. No serious mental disorder.

8. Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of >94%, and adequate renal function(Cr≤133umol/L).

9. No other serious diseases(autoimmune disease, immunodeficiency etc.).

10. No other tumors.

11. Patients volunteer to participate in the research.

12. Patients with history of allogeneic stem cell transplantation are eligible if at least 100 days post-transplant, if there is no evidence of active GVHD and no longer taking immunosuppressive agents for at least 30 days prior to

Exclusion Criteria

1. KPS<50.

2. Patients are allergic to cytokines.

3. Central nervous system leukemia within 28 days.

4. Uncontrolled active infection.

5. Acute or chronic GVHD.

6. Treated with T cell inhibitor.

7. Pregnancy and nursing females.

8. HIV/HBV/HCV Infection.

9. Other situations we think improper for the research.

Immunotherapy With CD22 CAR T-cells for B-Cell Lymphoma, ALL and CLL