Donor Derived CD19 CAR-T Cells in the Treatment of R/R B-cell Acute Lymphoblastic Leukemia

NCT ID: NCT06793241

Last Updated: 2025-01-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-31
• Study Completion Date: 2028-01-31

Brief Summary

A Clinical Study on the Safety and Effectiveness of donor derived CD19 CAR-T Cells in the treatment of R/R B-cell acute lymphoblastic leukemia

Detailed Description

In this study, 15 patients with relapsed refractory B-cell acute lymphoblastic leukemia were proposed to undergo CD19 CAR-T Cells therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of CD19 CAR-T Cells therapy for relapsed refractory B-cell acute lymphoblastic leukemia; At the same time, on the basis of expanding the sample size, more safety data on CD19 CAR-T Cells treatment for relapsed refractory B-cell acute lymphoblastic leukemia were accumulated.

Conditions

B-cell Acute Lymphoblastic Leukemia

Study Design

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

Study Groups

Administration of CD19 B-cell Acute Lymphoblastic Leukemia Targeted CAR T-cells

Dose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects.

Group Type: EXPERIMENTAL

CD19 B-cell Acute Lymphoblastic Leukemia Targeted CAR T-cells injection

Intervention Type: BIOLOGICAL

Each subject receive CD19 B-cell Acute Lymphoblastic Leukemia Targeted CAR T-cells by intravenous infusion

Interventions

CD19 B-cell Acute Lymphoblastic Leukemia Targeted CAR T-cells injection

Each subject receive CD19 B-cell Acute Lymphoblastic Leukemia Targeted CAR T-cells by intravenous infusion

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 1. Age ≥18 years old, gender unlimited;
• 2. Abnormal B cell immunotyping was CD19 positive;
• 3. Patients diagnosed with B-cell acute lymphoblastic leukemia by histological or immunotyping;
• 4. Meets the diagnosis of relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) and includes any of the following conditions:

1. No CR was obtained after standard chemotherapy;

2. CR was induced for the first time, but the duration of CR was less than 12 months;

3. R/R B-ALL that does not work after the first or more remedial treatments;

4. Two or more relapses;

• 5. The researchers believed that the patient had been adequately treated, such as auto-HSCT, auto-CART could not be prepared or preparation failed. Autologous CAR-T preparation failure was defined as including too few autologous lymphocytes (<1×109) or insufficient expansion during preparation or failure to meet the release criteria;
• 6. Total bilirubin ≤51 ( μmol/L), alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal, creatinine ≤176.8 (μmol/L);
• 7. Absolute neutrophil count: ≥ 0.5×109/L; Platelet: ≥ 30×109/L; Hemoglobin ≧60g/L;
• 8. Echocardiography showed left ventricular ejection fraction (LVEF) ≥40%;
• 9. The estimated survival is more than 3 months;
• 10. ECOG score 0-2;
• 11. Women and men who are fertile must consent to the use of appropriate contraception before entering the study, during study participation, and for 6 months after transfusion (the safety of this therapy for the unborn child is not known, with unknown risks);
• 12. Subjects who are willing to participate in the study are able to understand and have the ability to sign informed consent.

Exclusion Criteria

• 1. Known allergies to research preconditioning measures, etc;
• 2. People with a history of epilepsy or other central nervous system disorders;
• 3. People with a history of prolonged QT or severe heart disease;
• 4. Less than 100 days after receiving allogeneic hematopoietic stem cell transplantation;
• 5. Hiv-infected person;
• 6. Persons with active hepatitis B or C virus; Those who are not cured have active infections;
• 7. Insufficient amplification ability (< 5x) in response to CD3 / CD28 costimulatory signals;
• 8. Combined use of systemic steroids (e.g., prednisone ≥20mg) within 3 days prior to screening, except for ongoing or intermittent use of topical, inhaled or intranasal steroids within 2 weeks or at present; Or have systemic diseases that require long-term use of immunological agents;
• 9. Patients who received anti-cancer chemotherapy or other drugs within 2 weeks prior to screening;
• 10. Any situation that the investigator believes may increase the risk of the subjects or interfere with the study results.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yake Biotechnology Ltd.

INDUSTRY

Sponsor Role: collaborator

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

He Huang

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

He Huang, MD

Role: PRINCIPAL_INVESTIGATOR

Zhejiang University

Locations

The first affiliated hospital of medical college of zhejiang university

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

He Huang, MD

Role: CONTACT

hehuangyu@126.com

0571-87233772

Yongxian Hu, MD

Role: CONTACT

huyongxian2000@aliyun.com

0571-87233772

Facility Contacts

He Huang, MD

Role: primary

hehuangyu@126.com

0571-87233772

Yongxian Hu, MD

Role: backup

huyongxian2000@aliyun.com

0571-87233772

Other Identifiers

TXB2024011

Identifier Type: -

Identifier Source: org_study_id