Dual Target CAR-T Cells in B-cell Lymphoma

Last updated: January 23, 2021
Sponsor: YuLi
Overall Status: Active - Recruiting

Phase

1/2

Condition

Lymphoma, B-cell

Lymphoma

Treatment

N/A

Clinical Study ID

NCT04723914
HEM-ONCO-006
  • Ages 14-75
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 WorldHealth 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 CD19expression;
  8. No serious heart, lung, liver or kidney disease;
  9. Ability to understand and willing to sign the informed consent form for thistrial.

Exclusion

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-pyruvictransaminase>2.5×ULN), abnormal renal function (serum creatinine>1.5×ULN);
  4. People with unstable angina or New York Heart Association class 3/4 congestiveheart 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 experimentaltreatment 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 subjectshave a pregnancy plan during the study period to 6 months after the end of thetest, and are unwilling to use a medically approved effective contraceptivemeasure during the test period (Such as intrauterine device or condom);
  12. The investigator judged that it is not suitable to participate in this trial.

Study Design

Total Participants: 20
Study Start date:
October 20, 2020
Estimated Completion Date:
December 31, 2022

Study 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.

Connect with a study center

  • Shenzhen University General hospital

    Shenzhen, Guangdong 518055
    China

    Active - Recruiting

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