Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy for CD19+CD22+ Relapsed and Refractory Lymphoma

Shanghai Jiao Tong University

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Lymphoma

Treatments

Biological: Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03468153

Ruijin-CAR-01

Details and patient eligibility

About

Patients with relapsed or refractory lymphoma often develop resistance to chemotherapy. Chimeric antigen receptor-modified T cell (CART) therapy showed promising effect in B-cell malignancies these years. CD19 and CD22 are proteins expressed on the surface of the lymphoma cells in patients with CD19+CD22+ lymphoma. The CAR enables the T-cells to recognize and kill the tumor cell through recognition of CD19 and CD22. This is a phase 2 trial to study the safety and efficacy of dual specificity CD19 and CD22 CAR-T cell immunotherapy for CD19+CD22+ relapsed and refractory lymphoma.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histological detection confirmed CD19/CD22 postive lymphoma;
Recieved more than 2 lines of chemotherapy;
Not eligible for hematopoietic stem cell transplantation or relapsed after hematopoietic stem cell transplantation;
Life expectation for more than 3 months;
ECOG ≥ 2;
Adequate organ function: EF≥50%; normal ECG; CCR≥40ml/min; ALT and AST ≤ 3 × upper limitation of normal, T-BIL ≤ 2.0mg/dl; PT and APTT < 2 × upper limitation of normal; SpO2 > 92%;
CBC results: Hb ≥ 80g/L, ANC > 1 × 10E9/L, Plt ≥ 50 × 10E9/L;
Results of pregnant test should be negative, and agree to conception control during treatment and 1 year after CAR-T infusion;
With measurable disease;
Written informed consent could be acquired;

Exclusion criteria

Immunosuppressive agents or steroids in recent 1 week before recruitment;
Uncontrolled infection;
HIV positive ;
Active HBV or HCV infection;
Women in pregnancy and lactation;
Refuse to conception control during treatment and 1 year after CAR-T infusion;
Uncured malignancies other than non-Hodgkin lymphoma;
Have participated similar trial for treating relapse/refractory non-Hodgkin lymphoma;
Inheritated immune deficiancy;
Severe heart disease.