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

NCT ID: NCT06633354

Last Updated: 2024-10-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-20
• Study Completion Date: 2027-10-20

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

Detailed Description

In this study, 30 patients with relapsed refractory T-ALL were proposed to undergo CD5 CAR-T Cells therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of CD5 CAR-T Cells therapy for relapsed refractory T-ALL; At the same time, on the basis of expanding the sample size, more safety data on CD5 CAR-T Cells treatment for relapsed refractory T-ALL were accumulated.

Conditions

T-Acute Lymphoblastic Leukemia

Study Design

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

Study Groups

Administration of CD5+ T-ALL 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

CD5 CAR T-cells

Intervention Type: BIOLOGICAL

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

Interventions

CD5 CAR T-cells

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

Intervention Type: BIOLOGICAL

Other Intervention Names

CD5+ T-ALL Targeted CAR T-cells injection

Eligibility Criteria

Inclusion Criteria

• 1. According to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphocytic Leukemia (2020. v1), patients diagnosed as CD5+T-ALL;
• 2. Consistent with r/r CD5+T-ALL diagnosis, including any of the following conditions:

1. No CR after standard chemotherapy;

2. The first induction reaches CR, but CR ≤ 12 months;

3. Patients with r/r CD5+T-ALL have not responded to the first or multiple remedial treatments;

c.Multiple recurrences.

• 3. CD5 expression rate was >90%;
• 4. Number of blasts in the bone marrow (protolychic + larvae) >5% (morphology) and/or >1% (flow cytometry);
• 5. 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);
• 6. Echocardiography showed left ventricular ejection fraction (LVEF) ≥50%;
• 7.Refers to the pulse oxygen saturation 92% or higher oxygen (state);
• 8.Estimated life expectancy of minimum of 12 weeks;
• 9.ECOG 0-2;
• 10.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;
• 11. Those who voluntarily participated in this trial and provided informed consent;

Exclusion Criteria

• 1.Patients with the history of epilepsy or other CNS disease;
• 2. Patients with prolonged QT interval time or severe heart disease;
• 3. Active infection of hepatitis B virus, C virus or hepatitis E virus;
• 4. Active infection with no cure;
• 5. Before using any gene therapy products;
• 6. Received anti-tumor therapy before infusion, should meet the following any one should be ruled out:

1. 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);

2. received within 72 hours of small molecule targeted therapy;

3. 2 weeks received systemic chemotherapy except (pretreatment);

4. four weeks received radiotherapy;

• 7. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
• 8. Any unsuitable to participate in this trial judged by the investigator;
• 9. Any situation that researchers believe may increase the risk to the subjects or interfere with the trial results.

• 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

First Affiliated Hospital of 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

057187233772

Yongxian Hu, MD

Role: CONTACT

huyongxian2000@aliyun.com

057187233772

Facility Contacts

He Huang, MD

Role: primary

hehuangyu@126.com

057187233772

Yongxian Hu, MD

Role: backup

huyongxian2000@aliyun.com

057187233772

Other Identifiers

TXB2024014

Identifier Type: -

Identifier Source: org_study_id