Clinical Study of CLL1 CAR-T Cells in the Treatment of Hematological Malignancies

NCT05252572 | Unknown Early Phase 1 DMC

• 1 other identifier: CLL1-001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

Clinical Study on the Safety and Effectiveness of CLL1 CAR-T Cells in the Treatment of CLL1-positive Hematological Malignancies

Conditions

AML

Keywords

AML; CLL1 CAR T-cell therapy

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity (DLT)

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

  Baseline up to 28 days after CLL1 CAR T-cells infusion

• Incidence of treatment-emergent adverse events (TEAEs)

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

  Up to 90 days after CLL1 CAR T-cells infusion

Secondary Outcomes (5)

• Concentration of CAR-T cells

  From admission to the end of the follow-up, up to 2 years

• Disease control rate, DCR

  From Day 28 CLL1 CAR-T infusion up to 2 years

• Duration of remission, DOR

  24 months post CLL1 CAR-T cells infusion

• Progression-free survival, PFS

  24 months post CLL1 CAR-Tcells infusion

• Overall survival, OS

  From CLL1 CAR-T infusion to death,up to 2 years

Study Arms (1)

Treatment of CLL1-positive Hematological Malignancies

EXPERIMENTAL

Administration of CLL1 CAR T-cells A dose levels of 2-8\*10E6/kg are administrated for each subject.

Biological: CLL1 CAR T-cells

Interventions

CLL1 CAR T-cells BIOLOGICAL

Drug: CLL1 CAR T-cells Each subject receive CLL1 CAR T-cells by intravenous infusion Other Name: CLL1 CAR T-cells injection

Treatment of CLL1-positive Hematological Malignancies

Eligibility Criteria

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

You may qualify if:

• \. Patients is histologically diagnosed with CLL1-positive AML according to the NCCN Clinical Practice Guidelines in Oncology：Acute Myeloid Leukemia（Version 2.2021） 2. The diagnosis is consistent with r/r CLL1 + AML, and includes any of the following conditions:
• No CR was obtained after 2 courses of standard chemotherapy
• The first induction was CR, but the duration of CR was less than 12 months
• No CR was obtained after the first or multiple remedial treatment;
• Relapse twice or more; 3. The number of blast cells in bone marrow was more than 5% (morphology) and / or \> 1% (flow cytometry).
• \. No active lung infection, inhaled air oxygen saturation ≥92% 5. The estimated survival time is more than 3 months 6. ECOG score was 0-2 7. The patients or their legal guardians voluntarily participated in the trial and signed the informed consent.

You may not qualify if:

• \. Patients with history of epilepsy or other central nervous system diseases; 2. Patients with prolonged QT or severe heart disease; 3. Pregnant or lactating women (the safety of this therapy for unborn children is unknown); 4. The patients with uncontrolled active infection; 5. Active hepatitis B or hepatitis C virus infection; 6. Previous application of gene therapy; 7. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal; 8. Serum creatinine \> 2.5mg/dl or ALT / AST \> 3 times ULN or bilirubin \> 2.0mg/dl; 9. Those who suffer from other uncontrolled diseases are not suitable to join the study; 10. HIV infection; 11. Any situation that the researchers believe may increase the risk of patients or interfere with the test results.

Sponsors & Collaborators

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

Study Sites (2)

The first affiliated hospital of medical college of zhejiang university

Hangzhou, Zhejiang, 310003, China

RECRUITING

The First Hospital of Zhejiang Medical Colleage Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

Study Officials

• He Huang, PhD

  First Affiliated Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

He Huang, PhD

CONTACT

+8613605714822; hehuangyu@126.com

Yongxian Hu, PhD

CONTACT

+8615957162012; 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: The President of The First Affiliated Hospital, College of Medicine, Zhejiang University

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: February 23, 2022
• Study Start: February 28, 2022
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: February 23, 2022

Record last verified: 2022-02

Locations

CN (2)