Dual Target CAR-T Cells in B-cell Lymphoma

YuLi

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Lymphoma, B-Cell

Refractory Lymphoma

Dual-target CAR-T Cells

Relapse/Recurrence

Treatments

Biological: dual target CAR-T cell therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04723914

HEM-ONCO-006

Details and patient eligibility

About

Prospectively evaluate the safety and effectiveness of CD19/CD20 dual-target CAR-T cells in the treatment of relapsed/refractory B-cell lymphoma .

Full description

Prospectively evaluate the safety and effectiveness of CD19/CD20 dual-target CAR-T cells in the treatment of relapsed/refractory B-cell lymphoma . Strictly follow the inclusion criteria to screen eligible subjects for inclusion in clinical trials. The selected patients received CD19/CD20 dual-target CAR-T cell therapy. After the treatment is over, follow-up regularly to determine the survival status and follow-up treatment.

Enrollment

20 estimated patients

Sex

All

Ages

14 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects must meet the following criteria to participate in this study:
1. 14-75 years old, no gender limit;
2. Diagnosed as relapsed/refractory B-cell lymphoma according to the 2020 World Health Organization (WHO) diagnostic criteria;
3. ECOG behavior status score is 0-2 points;
4. Expected survival time ≥ 3 months;
5. No contraindications to peripheral apheresis;
6. Flow cytometry/immunohistochemistry confirms that tumor cells express CD20;
7. Those who are tolerant to CD19 CAR-T cell therapy or those with low CD19 expression;
8. No serious heart, lung, liver or kidney disease;
9. Ability to understand and willing to sign the informed consent form for this trial.

Exclusion criteria

Patients with any of the following cannot be included in this study:
1. Tumor cells do not express CD20;
2. There is active infection;
3. Abnormal liver function (total bilirubin>1.5×ULN, glutamic-pyruvic transaminase>2.5×ULN), abnormal renal function (serum creatinine>1.5×ULN);
4. People with unstable angina or New York Heart Association class 3/4 congestive heart failure, multiple organ dysfunction;
5. HIV/AIDS patients;
6. Those who need long-term anticoagulation (warfarin or heparin), antiplatelet (aspirin, dose>300mg/d; clopidogrel, dose>75mg/d) treatment;
7. Those who received radiotherapy within 4 weeks before the start of the study (blood sampling);
8. Known or suspected drug abuse or alcohol dependence;
9. People with mental illness or other conditions cannot obtain informed consent, and cannot cooperate with the requirements for completing the experimental treatment and inspection procedures;
10. Those who have participated in other clinical trials within 30 days;
11. Pregnant or lactating women, male subjects (or their partners) or female subjects have a pregnancy plan during the study period to 6 months after the end of the test, and are unwilling to use a medically approved effective contraceptive measure during the test period (Such as intrauterine device or condom);
12. The investigator judged that it is not suitable to participate in this trial.