Dual Target CAR-T Cells in B-cell Lymphoma

NCT ID: NCT04723914

Last Updated: 2021-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-20

Study Completion Date

2022-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Lymphoma, B-Cell Relapse/Recurrence Refractory Lymphoma Dual-target CAR-T Cells

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment group

Dual target CAR-T cell therapy

Group Type EXPERIMENTAL

dual target CAR-T cell therapy

Intervention Type BIOLOGICAL

CD19/CD20 dual target CAR-T cell therapy

Interventions

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dual target CAR-T cell therapy

CD19/CD20 dual target CAR-T cell therapy

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

14 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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YuLi

OTHER

Sponsor Role lead

Responsible Party

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YuLi

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Li Yu, Dr

Role: PRINCIPAL_INVESTIGATOR

Shenzhen University General Hospital

Locations

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Shenzhen University General hospital

Shenzhen, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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shujiao he, Dr

Role: CONTACT

+86-0755-21839178

Facility Contacts

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Shujiao He, Dr

Role: primary

+86-0755-2183-9178

Other Identifiers

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HEM-ONCO-006

Identifier Type: -

Identifier Source: org_study_id

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