A Study of CD19/22 CART Cells Combined With PD-1 Inhibitor in Relapsed/Refractory B-cell Lymphoma

• Status: Recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a single center, non-randomized, open-label, phase 2 study to evaluate the efficacy and safety of CD19/22 CART cells combined with PD-1 Inhibitor in relapsed/refractory B Cell Lymphoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Soochow University
• Collaborator: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
• Treatments: Immune Checkpoint Inhibitors

Criteria

Inclusion Criteria:

1. R/R B-NHL with measurable (≧1.5cm) lesions confirmed by pathological immunohistochemistry or flow cytometry ( meeting any of the following conditions):

A.The lesion shrinkage <50% or disease progression after 4 courses of standard first-line treatment or 2 courses of two-line treatment (primary refractory disease) B. Progress disease as the best response after hematopoietic stem cell transplantation C.Progress disease or stable disease as the best response to most recent therapy regimen

2. Age ≥ 18 years

3. The Eastern Cooperative Oncoloy Group (ECOG) physical condition score ≤ 2 points

4. The main organ functions need to meet the following conditions:

A.Left ventricular ejection fraction ≥50% B.Creatinine ≤132umol/l or creatinine clearance ≥60 ml/min C.ALT and AST≤2 upper limitation of normal D.SpO2 > 90%

5. Results of pregnant test should be negative, and agree to conception control during treatment and 1 year after CAR-T infusion

6. Expected survival exceeds 3 months

7. Written informed consent could be acquired

Exclusion Criteria:

1. Immunosuppressant medications or steroids was used within 2 weeks before cell collection, or need to use steroids or immunosuppressant medications more than two years

2. Uncontrolled bacteria, fungi, viruses, mycoplasma or other types of infection

3. Active hepatitis B or hepatitis C infection

4. HIV infection

5. Severe acute or chronic graft-versus-host disease (GVHD)

6. Participated in any other drug research clinical trials within 30 days before enrollment

7. Prior CART cells therapy within 3 months before enrollment

8. Prior allogeneic hematopoietic stem cell transplantation within 6 months before enrollment

9. Have contraindications to the PD-1 inhibitors

10. Uncontrolled other tumor

11. Women in pregnancy,lactation or planning to become pregnant

12. The researcher considers inappropriate to participate in this research