Safety and Efficacy of Sequential CD19 and CD22 Targeted CAR-T Therapy for Relapsed/Refractory B Cell Lymphoma

Kecellitics Biotech Company

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Lymphoma, B-Cell

Treatments: Biological: CD19 and CD22 targeted CAR-T cells

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05651100

Kece-4

Details and patient eligibility

About

This is a single arm study to evaluate the efficacy and safety of Sequential CD19 and CD22 targeted CAR-T cells therapy for patients with relapsed/refractory B Cell Lymphoma.

Full description

Although the CD19 targeted CAR-T cell therapies have gained significant results in patients with relapsed and refractory B-cell Leukemia and Lymphoma. There are some patients who resisted anti-CD19 CAR-T cells or get CD19 negative relapse. To make further improvement, We launch such a clinical trial using sequential CD19 and CD22 targeted CAR-T cells for patients with relapsed and refractory B Cell Lymphoma to evaluate the efficacy and safety of sequential CD19 and CD22 targeted CAR-T cell therapy.

Enrollment: 50 estimated patients

Sex: All

Ages: 3 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Relapsed or refractory B cell non-hodgkin lymphoma.
2. KPS>60.
3. Life expectancy>12 weeks.
4. Gender unlimited, age from 3 years to 70 years.
5. Evidence for cell membrane CD19 and/or CD22 expression;
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 trial

Exclusion criteria

1. Pregnancy and nursing females.
2. Patients are allergic to cytokines.
3. Uncontrolled active infection.
4. Acute or chronic GVHD.
5. Treated with T cell inhibitor.
6. Patients who had used steroid hormones within one week.
7. Patients who had used Rituximab within two weeks.
8. HIV/HBV/HCV Infection.
9. Other situations we think improper for the research.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

arm 1

Experimental group

Description:

sequential CD19 and CD22 targeted CAR-T cells treat

Treatment:

Biological: CD19 and CD22 targeted CAR-T cells