Clinical Study of CD38 CAR-T Cells in the Treatment of Hematological Malignancies

NCT05239689 | Unknown Early Phase 1 DMC

• 1 other identifier: CD38-001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical Study on the Safety and Effectiveness of CD38 CAR-T Cells in the Treatment of CD38-positive Hematological Malignancies

Conditions

AML

Keywords

AML; CD38 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 CD38 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 CD38 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 CD38 CAR-T infusion up to 2 years

• Duration of remission, DOR

  24 months post CD38 CAR-T cells infusion

• Progression-free survival, PFS

  24 months post CD38 CAR-Tcells infusion

• Overall survival, OS

  From CD38 CAR-T infusion to death，up to 2 years

Study Arms (1)

Treatment of CD38-positive Hematological Malignancies

EXPERIMENTAL

Administration of CD38 CAR T-cells A dose levels of 2-8\*10E6/kg are administrated for each subject.

Biological: CD38 CAR T-cells

Interventions

CD38 CAR T-cells BIOLOGICAL

Drug: CD38 CAR T-cells Each subject receive CD38 CAR T-cells by intravenous infusion Other Name: CD38 CAR T-cells injection

Treatment of CD38-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 CD38-positive AML according to the NCCN Clinical Practice Guidelines in Oncology：Acute Myeloid Leukemia（Version 2.2021）;
• \. The diagnosis is consistent with r/r CD38 + 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
• \. 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%;
• \. The estimated survival time is more than 3 months;
• \. ECOG score was 0-2;
• \. 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;
• \. Patients with prolonged QT or severe heart disease;
• \. Pregnant or lactating women (the safety of this therapy for unborn children is unknown);
• \. The patients with uncontrolled active infection;
• \. Active hepatitis B or hepatitis C virus infection;
• \. Previous application of gene therapy;
• \. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
• \. Serum creatinine \> 2.5mg/dl or ALT / AST \> 3 times ULN or bilirubin \> 2.0mg/dl;
• \. Those who suffer from other uncontrolled diseases are not suitable to join the study;
• \. HIV infection;
• \. 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 (1)

The first affiliated hospital of medical college of 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

86-13605714822; hehuangyu@126.com

Yongxian Hu, PhD

CONTACT

86-15957162012; 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 15, 2022
• Study Start: February 28, 2022
• Primary Completion: December 5, 2024
• Study Completion: December 5, 2024
• Last Updated: February 15, 2022

Record last verified: 2022-02

Locations

CN (1)