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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05398614
Other study ID # SENL101 for CD7+
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date May 1, 2022
Est. completion date June 30, 2024

Study information

Verified date April 2022
Source Hebei Senlang Biotechnology Inc., Ltd.
Contact Liang Huang
Phone 027-83691785
Email tongjilunli@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the tolerability and safety of SENL101 in patients with relapsed or refractory CD7+ hematolymphoid malignancies.


Description:

Main research purposes: To evaluate the tolerability and safety of SENL101 in patients with relapsed or refractory CD7+ hematolymphoid malignancies. Secondary research purposes: To preliminarily evaluate the efficacy, pharmacokinetics and pharmacodynamics of SENL101 in the treatment of patients with relapsed or refractory CD7+ hemolymphoid malignancies. Exploratory research purpose: 1. To explore the immunogenicity of SENL101; 2. T cell NK cell recovery time after treatment; 3. Other indicators of interest to researchers。


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Study Design


Related Conditions & MeSH terms


Intervention

Biological:
SENL101
Patients will be treated with CD7 CAR-T cells

Locations

Country Name City State
China Tongji Hospital Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
Hebei Senlang Biotechnology Inc., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Cytokine release Changes from baseline in IFN-?, TNF-a, IL-2, IL-6, IL-10 12 months post CAR-T cells infusion
Other CD7 positive cells in peripheral blood at each time point Absolute value and ratio of CD7 positive cells (T cells NK cells) at each time point in peripheral blood 12 months post CAR-T cells infusion
Other T cell subsets T cell subsets monitoring at each time point (CD4+ CD8+ CD4+/ CD8+ ratio) 12 months post CAR-T cells infusion
Other Immunogenicity endpoint Detectable antibody concentration in serum at each time point 12 months post CAR-T cells infusion
Other T cell NK cell recovery time after treatment Absolute value of T cells NK cells at each time point 12 months post CAR-T cells infusion
Primary Safety: Incidence and severity of adverse events The incidence and severity of adverse events and adverse reactions from infusion to withdrawal or before the safety follow-up period 24 months post CAR-T cells infusion
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