A Clinical Study to Explore the Safety and Efficacy of CD33 CAR-T Cell in Relapsed/Refractory Acute Myeloid Leukemia

NCT06762132 | Recruiting Early Phase 1

• 1 other identifier: TXB2024025
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

A Clinical Study on the Safety and Effectiveness of targeting CD33 CAR-T Cell in the treatment of Relapsed/Refractory Acute Myeloid Leukemia

Conditions

Acute Myeloid Leukemia

Keywords

CD33 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)

• Complete response (CR), and complete response with incomplete hematologic recovery (CRi)

  Up to 12 weeks after CAR-T infusion

• Duration of remission ,DOR

  Up to 1 years after CAR-T infusion

• Overall survival, OS

  Up to 1 years after CAR-T infusion

• Leukemia-Free Survival, LFS

  Up to 2 years after Treatment

Study Arms (1)

CAR-T cells（ chimeric antigen receptor T cells）

EXPERIMENTAL

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

Biological: CD33 CAR T-cells

Interventions

CD33 CAR T-cells BIOLOGICAL

Each subject receive CD33 CAR T-cells by intravenous infusion

Also known as: CD33 CAR T-cells injection

CAR-T cells（ chimeric antigen receptor T cells）

Eligibility Criteria

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

You may qualify if:

• \. Male or female, age ≥ 18 years old;
• \. CAR-T cells can be prepared normally, or who have failed to prepare autologous CAR-T cells (including the number of autologous lymphocytes \<1×10\^9 or the expansion during the preparation process is insufficient or cannot reinfusion);
• \. Patients diagnosed with CD33 positive acute myeloid leukemia (AML) through histological or immunological examination，and CD33 positive expression rate \>80%;
• \. Complies with the 2016 WHO classification for AML diagnosis and meets the diagnostic criteria for recurrence and refractory acute myeloid leukemia in the "Chinese Guidelines for the Diagnosis and Treatment of relapsed and refractory acute myeloid leukemia (2017 edition)", and currently there are no clinically relevant treatments or suitable clinical trials for registration:
• a) Diagnostic criteria for recurrent AML: After complete remission (CR), leukemia cells reappear in peripheral blood or primitive cells in bone marrow\>0.050 (excluding other reasons such as bone marrow regeneration after consolidation chemotherapy) or leukemia cell infiltration appears outside the bone marrow;
• b) Diagnostic criteria for refractory AML: initial treatment cases that have failed to respond to two courses of standard protocol treatment; Patients who relapse within 12 months after consolidation and intensive treatment after CR; Patients who relapse after 12 months but fail conventional chemotherapy; Patients with 2 or more relapses; Persistent extramedullary leukemia;
• \. The number of primitive cells (promyelocytes and/or promyelocytes) in the bone marrow \> 5% (morphology) and/or \> 1% (flow cytometry detection);
• \. Total bilirubin ≤ 51 μmol / L, ALT and AST ≤ 3 times of the upper limit of normal value, serum creatinine ≤ 176.8 μmol / L；
• \. Echocardiography shows left ventricular ejection fraction (LVEF) ≥ 50%;
• \. There is no active pulmonary infection, and the oxygen saturation during air inhalation is more than 92%;
• \. The estimated survival time is more than 3 months;
• \. ECOG score was 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 with no cure;
• \. Active infection of hepatitis B virus or C virus ;
• \. Before using any gene therapy products;
• \. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
• \. Suffering from other uncontrolled diseases that the researchers consider unsuitable for joining;
• \. Infected with AIDS virus;
• \. 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

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic 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: Principal Investigator

Study Record Dates

• First Submitted: January 1, 2025
• First Posted: January 7, 2025
• Study Start: January 10, 2025
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: January 7, 2025

Record last verified: 2024-12

Locations

CN (1)