Cytoplasmic Activated PD-1 CAR T Cells in Refractory/Relapsed B Cell Lymphoma

• Status: Unknown status
• Trial end date: 2020-04-30
• Target enrollment: 0
• Participant gender: All

Summary

Evaluation of the safety and efficacy of CAR19 T cells carrying cytoplasmic activated PD1 in patients with refractory relapsed B-cell lymphoma

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

Details

• Lead Sponsor: Henan Cancer Hospital
• Collaborator: The Pregene (ShenZhen) Biotechnology Company, Ltd.

Criteria

Inclusion Criteria:

• 18-70 years old and the expected lifetime >3 months

• Refractory/relapsed CD19 positive B cell lymphoma by pathology

• ECOG score <2

• Measureable lesions according to RECIST 1.1

• Sufficient heart, liver, kidney and bone marrow function (heart: no heart disease or coronary heart disease, patient heart function NYHA grade 1-2; liver: TBIL ≤ 3ULN, AST ≤ 2.5ULN, ALT ≤ 2.5ULN; kidney: Cr≤ 1.25ULN; bone marrow: WBC ≥ 2.0 × 109/L, Hb ≥ 80 g/L, PLT ≥ 30 × 109/L)

• no serious allergies

• No other serious diseases that conflict with this protocol (eg, autoimmune diseases, immunodeficiency, organ transplantation)

• No other history of malignancy

• No serious mental disorders

• Women of childbearing age must be negative for blood pregnancy test within 7 days and must take appropriated contraceptive measures during and 3 months after the study

• The patient himself agrees to participate in this clinical study and signed the "informed consent"

Exclusion Criteria:

• Lactating women

• Severe infectious or viral diseases (HIV positive, syphilis, etc.)

• Active hepatitis B or C viral hepatitis

• Patients who used high-dose glucocorticoids within 1 week

• Participation in other clinical studies in the past 3 months or having been treated with other gene products