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

NCT06793241 | Recruiting Early Phase 1

• 1 other identifier: TXB2024011
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

B-cell Acute Lymphoblastic Leukemia

Keywords

CD19 CAR-T

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity (DLT)

  Adverse events assessed according to NCI-CTCAE v5.0 criteria

  Up to 28 days after Treatment

• Incidence of treatment-emergent adverse events (TEAEs)

  Incidence of treatment-emergent adverse events \[Safety and Tolerability\]

  Up to 2 years after Treatment

Secondary Outcomes (3)

• Duration of remission ,DOR

  Up to 1 years after CAR-T infusion

• Overall survival, OS

  Up to 2 years after Treatment

• Event-free survival (EFS)

  Up to 1 years after CAR-T infusion

Study Arms (1)

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

EXPERIMENTAL

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

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

Interventions

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

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

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

Eligibility Criteria

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

You may qualify if:

• \. Age ≥18 years old, gender unlimited;
• \. Abnormal B cell immunotyping was CD19 positive;
• \. Patients diagnosed with B-cell acute lymphoblastic leukemia by histological or immunotyping;
• \. Meets the diagnosis of relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) and includes any of the following conditions:
• No CR was obtained after standard chemotherapy;
• CR was induced for the first time, but the duration of CR was less than 12 months;
• R/R B-ALL that does not work after the first or more remedial treatments;
• Two or more relapses;
• \. 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;
• \. Total bilirubin ≤51 ( μmol/L), alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal, creatinine ≤176.8 (μmol/L);
• \. Absolute neutrophil count: ≥ 0.5×109/L; Platelet: ≥ 30×109/L; Hemoglobin ≧60g/L;
• \. Echocardiography showed left ventricular ejection fraction (LVEF) ≥40%;
• \. The estimated survival is more than 3 months;
• \. ECOG score 0-2;
• \. 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);

You may not qualify if:

• \. Known allergies to research preconditioning measures, etc;
• \. People with a history of epilepsy or other central nervous system disorders;
• \. People with a history of prolonged QT or severe heart disease;
• \. Less than 100 days after receiving allogeneic hematopoietic stem cell transplantation;
• \. Hiv-infected person;
• \. Persons with active hepatitis B or C virus; Those who are not cured have active infections;
• \. Insufficient amplification ability (\< 5x) in response to CD3 / CD28 costimulatory signals;
• \. 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;
• \. Patients who received anti-cancer chemotherapy or other drugs within 2 weeks prior to screening;
• \. Any situation that the investigator believes may increase the risk of the subjects or interfere with the study results.

Sponsors & Collaborators

• Zhejiang University: lead
• Yake Biotechnology Ltd.: collaborator

Study Sites (1)

The first affiliated hospital of medical college of zhejiang university

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Burkitt Lymphoma

Condition Hierarchy (Ancestors)

Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• He Huang, MD

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

He Huang, MD

CONTACT

0571-87233772; hehuangyu@126.com

Yongxian Hu, MD

CONTACT

0571-87233772; huyongxian2000@aliyun.com

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: Clinical Professor

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 27, 2025
• Study Start: January 31, 2025
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028
• Last Updated: January 27, 2025

Record last verified: 2025-01

Locations

CN (1)