Targeting CD5 CAR-T Cells in the Treatment of r/r CD5+ T-ALL

NCT06633354 | Recruiting Early Phase 1

• 1 other identifier: TXB2024014
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

A Clinical Study on the Safety and Effectiveness of targeting CD5 CAR-T Cells in the treatment of r/r CD5+ T-ALL

Conditions

T-Acute Lymphoblastic Leukemia

Keywords

CD5 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 (4)

• Overall response rate ,ORR

  Up to 12 weeks after CAR-T infusion

• Duration of remission ,DOR

  Up to 1 years after CAR-T infusion

• Progression Free Survival, PFS

  Up to 2 years after Treatment

• Overall survival, OS

  Up to 1 years after CAR-T infusion

Study Arms (1)

Administration of CD5+ T-ALL 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: CD5 CAR T-cells

Interventions

CD5 CAR T-cells BIOLOGICAL

Each subject receive CD5+ T-ALL Targeted CAR T-cells by intravenous infusion

Also known as: CD5+ T-ALL Targeted CAR T-cells injection

Administration of CD5+ T-ALL Targeted CAR T-cells

Eligibility Criteria

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

You may qualify if:

• \. According to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphocytic Leukemia (2020. v1), patients diagnosed as CD5+T-ALL;
• \. Consistent with r/r CD5+T-ALL diagnosis, including any of the following conditions:
• No CR after standard chemotherapy;
• The first induction reaches CR, but CR ≤ 12 months;
• Patients with r/r CD5+T-ALL have not responded to the first or multiple remedial treatments;
• c.Multiple recurrences.
• \. CD5 expression rate was \>90%;
• \. Number of blasts in the bone marrow (protolychic + larvae) \>5% (morphology) and/or \>1% (flow cytometry);
• \. Total bilirubin ≤51 (mol/L), Alanine aminotransferase (ALT)/Aspartate aminotransferase (AST) ≤ 3 times the upper limit of the normal range, creatinine ≤176.8 (mol/L);
• \. Echocardiography showed left ventricular ejection fraction (LVEF) ≥50%;
• Refers to the pulse oxygen saturation 92% or higher oxygen (state);
• Estimated life expectancy of minimum of 12 weeks;
• ECOG 0-2;
• Pregnant/lactating women, or male or female patients who have fertility and are willing to take effective contraceptive measures at least 6 months after the last cell infusion during the study period;
• \. Those who voluntarily participated in this trial and provided informed consent;

You may not qualify if:

• Patients with the history of epilepsy or other CNS disease;
• \. Patients with prolonged QT interval time or severe heart disease;
• \. Active infection of hepatitis B virus, C virus or hepatitis E virus;
• \. Active infection with no cure;
• \. Before using any gene therapy products;
• \. Received anti-tumor therapy before infusion, should meet the following any one should be ruled out:
• treated with systemic corticosteroids therapy within 72 hours (except glucocorticoid physiological replacement therapy, such as prednisone \< 10 mg/d or an equivalent dose of the drug);
• received within 72 hours of small molecule targeted therapy;
• weeks received systemic chemotherapy except (pretreatment);
• four weeks received radiotherapy;
• \. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
• \. Any unsuitable to participate in this trial judged by the investigator;
• \. Any situation that researchers believe may increase the risk to the subjects or interfere with the trial 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

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• He Huang, MD

  First Affiliated Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

He Huang, MD

CONTACT

057187233772; hehuangyu@126.com

Yongxian Hu, MD

CONTACT

057187233772; 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: October 8, 2024
• First Posted: October 9, 2024
• Study Start: October 20, 2024
• Primary Completion (Estimated): October 20, 2027
• Study Completion (Estimated): October 20, 2027
• Last Updated: October 9, 2024

Record last verified: 2024-10

Locations

CN (1)