Safety and Efficacy of CD19 CAR-T/CAR-NK Cells

NCT ID: NCT06596057

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-10
• Study Completion Date: 2026-06-30

Brief Summary

To investigate the safety and efficacy of CD19 CAR-T/CAR-NK cells in patients with relapsed/refractory B-cell lymphoma and acute B-lymphoblastic leukemia.

Detailed Description

Patients who met the exclusion criteria were treated with advanced FC regimen, and subjects who met the infusion criteria assessed by the investigators were given CAR-T/CAR-NK cell infusion 1 to 2 days after completion of eluvial chemotherapy. The CAR-T/CAR-NK dose is calculated according to the patient's body weight, and the total number of cells transfused is about 1-2x106 /kg. Single intravenous infusion.

The study was divided into five stages: screening period, single harvest period, pretreatment chemotherapy period, treatment period, observation and follow-up period after treatment.

For lymphoma, refer to the 2014 version of Lugano efficacy evaluation criteria

Conditions

Safety and Efficacy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

experimental group

Group Type: EXPERIMENTAL

CAR-T/CAR-NK cells

Intervention Type: BIOLOGICAL

One to two days after completion of eluvial chemotherapy, CAR-T/CAR-NK cells were transfused in subjects assessed by the investigators as eligible for infusion. The CAR-T/CAR-NK dose is calculated according to the patient's body weight, and the total number of cells transfused is about 1-2x106 /kg. Single intravenous infusion

Interventions

CAR-T/CAR-NK cells

One to two days after completion of eluvial chemotherapy, CAR-T/CAR-NK cells were transfused in subjects assessed by the investigators as eligible for infusion. The CAR-T/CAR-NK dose is calculated according to the patient's body weight, and the total number of cells transfused is about 1-2x106 /kg. Single intravenous infusion

Intervention Type: BIOLOGICAL

Eligibility Criteria

Exclusion Criteria

1. Patients with expected survival of less than 3 months.

2. Clinical findings (symptoms, signs, imaging, cerebrospinal fluid) of central nervous system leukemia.

3. Patients with hyperleukocytoemia (white blood cell count ≥50 x109 /L) or patients whose disease is progressing rapidly at the time of enrollment, as determined by the investigator, to be unable to ensure the completion of a full treatment cycle.

4. Patients with skin cancer other than melanoma or other primary tumors (such as cervical cancer, bladder cancer, breast cancer) (unless cured for more than 3 years).

5. Patients with infections including fungal, bacterial, viral or other uncontrolled infections or those requiring level 4 isolation.

6. Patients who test positive for HIV, HBV, HCV.

7. Patients with central nervous system diseases including stroke, epilepsy, dementia or autoimmune central nervous system diseases.

8. Myocardial infection, cardiac angiography or stenting, active angina pectoris or other obvious clinical symptoms, or cardiac asthma or cardiovascular lymphocyte infiltration in the 12 months prior to enrollment.

9. Those who are receiving anticoagulation therapy or have severe coagulation dysfunction.

10. According to the investigator's judgment, the drug treatment the patient is receiving will affect the safety and efficacy study of this project.

11. Patients with allergy or history of allergy to the biologics used in this project.

12. Pregnant or lactating women.

13. Systematic use of systemic or systemic steroid drugs within 2 weeks prior to treatment (except those who have recently or currently used inhaled steroids).

14. The efficiency of T cell transduction by replication-deficient lentivirus is less than 30%, or the ability to expand in response to CD3 / CD28 costimulatory signals is insufficient (<5 times).

15. Those who have other uncontrolled diseases that the researchers consider unsuitable for enrollment.

16. Any situation that the investigator believes may increase the risk to the subject or interfere with the test results.

17. Patients who are also participating in other clinical studies.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Second Hospital of Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Linlin Cui

professor of medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shandong Province

Shandong, Shandong, China

Countries

China

Other Identifiers

2024CAR-T/NK B-nhl/ALL

Identifier Type: -

Identifier Source: org_study_id