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

NCT06596057 | Active Not Recruiting Early Phase 1

• 1 other identifier: 2024CAR-T/NK B-nhl/ALL
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Safety and Efficacy

Outcome Measures

Primary Outcomes (2)

• ORR

  With reference to iRecist1.1, the proportion of patients whose tumor volume shrank to the pre-specified value and maintained the minimum time limit.The time from randomization to tumor progression or death from any cause.

  At least half a year

• PFS

  In tumor therapy, the proportion of patients whose tumor volume has shrunk to a predetermined value and can be maintained for a certain time. It includes the number of patients with complete response (CR) and partial response (PR) as a proportion of the total number of evaluable cases

  one year

Study Arms (1)

experimental group

EXPERIMENTAL

Biological: CAR-T/CAR-NK cells

Interventions

CAR-T/CAR-NK cells 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

experimental group

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients with expected survival of less than 3 months.
• Clinical findings (symptoms, signs, imaging, cerebrospinal fluid) of central nervous system leukemia.
• 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.
• 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).
• Patients with infections including fungal, bacterial, viral or other uncontrolled infections or those requiring level 4 isolation.
• Patients who test positive for HIV, HBV, HCV.
• Patients with central nervous system diseases including stroke, epilepsy, dementia or autoimmune central nervous system diseases.
• 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.
• Those who are receiving anticoagulation therapy or have severe coagulation dysfunction.
• According to the investigator's judgment, the drug treatment the patient is receiving will affect the safety and efficacy study of this project.
• Patients with allergy or history of allergy to the biologics used in this project.
• Pregnant or lactating women.
• Systematic use of systemic or systemic steroid drugs within 2 weeks prior to treatment (except those who have recently or currently used inhaled steroids).
• 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).
• Those who have other uncontrolled diseases that the researchers consider unsuitable for enrollment.

Sponsors & Collaborators

• The Second Hospital of Shandong University: lead

Study Sites (1)

Shandong Province

Shandong, Shandong, 250000, China

Location

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of medicine

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: September 19, 2024
• Study Start: February 10, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CN (1)