Allogeneic CD19 CAR-T Cells for the Treatment of Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia

NCT05164042 | Unknown Phase 1

• 1 other identifier: HEM-ONCO-007
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

CD19 CAR-T has been widely developed in patients with R/R ALL and has also been generally recognized by the industry. In 2017, the U.S. FDA approved Novartis's CD 19 CAR-T product Kymriah for the treatment of R/R ALL. However, these CAR-T cells are constructed from patients' autologous T cells, and the production and preparation time is long; on the other hand, most patients have received multiple chemotherapy before CAR-T treatment, and the quantity and quality of T cells often cannot meet the needs of clinical treatment. It is also an important factor leading to the failure of CAR-T cell therapy, which limits the large-scale clinical application of CAR-T. T cells derived from healthy donors are not only sufficient in quantity and quality guaranteed, but also available at any time. In December 2020, lancet reported a clinical study of 19 patients receiving allogeneic CAR-T cell ALL. 14 patients were evaluated as CR/CRi (67%) 28 days after treatment, and the median sustained remission time was 4.1 moon. Allogeneic CAR-T cells are safe and effective for the treatment of ALL, and their clinical application range is expected to improve the remission rate and survival rate of patients with R/R ALL.

Conditions

Relapse Leukemia; Refractory Leukemia

Outcome Measures

Primary Outcomes (1)

• CRR

  Complete remission rate

  From data of enrollment until the first documented progression of disease, up to 2 years.

Secondary Outcomes (1)

• OS

  From admission to the end of follow up, up to 2 years.

Study Arms (1)

Treatment group

EXPERIMENTAL

Subjects who meet the enrollment conditions will receive intravenous infusion of allogeneic CD19 CAR-T cells after pretreatment.

Biological: Allogeneic CD19 CAR-T cells

Interventions

Allogeneic CD19 CAR-T cells BIOLOGICAL

infusion of allogeneic CD19 CAR-T cells

Treatment group

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years old (including 14, 70 years old), no gender limit;
• According to the 2020 World Health Organization (WHO) diagnostic criteria, it is diagnosed as relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL);
• The ECOG behavior status score is 0-2 points;
• Expected survival time ≥ 3 months;
• Flow cytometry confirms that the original cells express CD19;
• Those who have failed autologous CAR-T cell preparation or autologous CAR-T cell therapy under the existing technical conditions;
• No serious heart, lung, liver, or kidney disease;
• Ability to understand and willing to sign the informed consent form for this trial.

You may not qualify if:

• Primitive cells do not express CD19;
• Active infection;
• Abnormal liver function (total bilirubin\>1.5×ULN, ALT\>2.5×ULN), abnormal renal function (serum creatinine\>1.5×ULN);
• People with unstable angina or New York Heart Association class 3/4 congestive heart failure, multiple organ dysfunction;
• HIV/AIDS patients;
• Those who need long-term anticoagulation (warfarin or heparin), antiplatelet (aspirin, dose\>300mg/d; clopidogrel, dose\>75mg/d) treatment;
• Those who received radiotherapy within 4 weeks before the start of the study;
• Known or suspected drug abuse or alcohol dependence;
• People with mental illness or other conditions cannot obtain informed consent, and cannot cooperate with the requirements of completing the experimental treatment and inspection procedures;
• Participated in other clinical trials within 30 days;
• 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 contraceptive devices or condoms);
• Those who are judged by the investigator to be unsuitable to participate in this trial.

Sponsors & Collaborators

• Shenzhen University General Hospital: lead

Study Sites (1)

Li Yu

Shenzhen, Guangdong, 518000, China

RECRUITING

MeSH Terms

Conditions

Leukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Li Yu, Dr

  Shenzhen University General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Yu

CONTACT

+8675521839178; liyu@vip.163.com

Study Design

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

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 20, 2021
• Study Start: February 5, 2021
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: December 20, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)