A Novel CAR-T Combined Expression of IL-15 in the Treatment of Malignant Hematological Tumors

Official title

A Multicenter, Single Arm, Open Label Clinical Study on the Novel CAR-T Combined Expression of IL-15 in the Treatment of Malignant Hematological Tumors

Overview

The is a multicenter, single arm, open label clinical study on the novel CAR-T combined expression of IL-15 in the treatment of malignant hematological tumors.Plan to recruit 45 subjects with malignant hematological tumors.

Detailed description

The main objective is to evaluate the safety and efficacy of a novel CAR-T therapy that co expresses IL-15 in malignant hematological tumors.

The secondary objective is to investigate the in vivo survival time of the novel CAR-T co expressing IL-15 and the activation and proliferation of a novel CAR-T co expressing IL-15 in vivo.

Interventions

• Drug chimeric antigen receptor gene modified T cells
  The rate of intravenous infusion of CAR T cells was 10 mL to 20 mL/min, and the infusion was performed using a blood transfusion apparatus with a filter screen. Use saline rinsing tube prior to infusion; Rinse the infusion bag with 10 mL\~30 mL normal saline.

Primary outcome measures

• monitor the survival time of CAR-T in vivo [Time frame: 6 months]
• Record antitumor effects after reinfusion of CAR-T [Time frame: 28 days]

Secondary outcome measures (2)

• Disease-free survival [Time frame: 3 years]
• Overall Survival [Time frame: 3 years]

Eligibility criteria

Inclusion criteria

• I (or the authorized representative/legal guardian) agree and have signed an informed consent form, and am willing and capable of following the planned visits, research treatments, laboratory tests, and other research procedures;
• Histopathological or flow cytometric diagnosis of CD19 and/or CD22, BCMA-positive hematological malignancies;

-≥15 years old, ≤80 years old;

• If you meet one of the following three conditions, you can be included in the group:-Patients with recurrent or refractory hematologic malignancies treated with one standard chemotherapy regimen and one salvage regimen;-Minimal residual lesions persist after treatment with one standard chemotherapy regimen and one salvage regimen;-Patients with recurrence after hematopoietic stem cell transplantation;
• Estimated survival ≥12 weeks;
• Good heart, liver and kidney function:
• Serum creatinine ≤ 1.5 mg/dL (1mg/dl=88.4umol/L); Serum ALT/AST ≤ 2.5 ULN; Total bilirubin ≤ 1.5 mg/dl (1mg/dl=17.1umol/L):
• Cardiac ejection fraction ≥50%, cardiac ultrasound showed centropericardial effusion:
• Eastern Oncology Collaborative Group Activity Status Score (ECOG)0-3;
• Able to understand and voluntarily sign informed consent; If the subject is a child, the guardian will sign the informed consent.

If the answer to any of the above is \"no\", the subject will not be allowed to participate in this study.

Exclusion criteria

• Have a New York Heart Association (NYHA) classification \> Class III heart failure or myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically prominent heart disease within one year prior to signing the consent form, or have a QTC interval \>480ms at the time of screening (QTC interval is calculated using the Fridericia formula);
• Have active GVHD, or need immunosuppressants;
• Other malignancies were present within 5 years prior to screening, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, and breast ductal carcinoma in situ after radical resection of local prostate cancer;
• The presence of an active or uncontrolled infection requiring systemic treatment (except for mild genitourinary and upper respiratory tract infections) in the 7 days prior to screening;
• If HBSAg or HbCAb positive peripheral blood hepatitis B virus (HBV)DNA is higher than the lower limit of detection, it should be excluded. If hepatitis C virus (HCV) antibody positive, peripheral blood HCVRNA positive should be excluded; (HIV) antibody-positive; -Cytomegalovirus (CMV)DNA test positive for human immunodeficiency virus; Those who test positive for Treponema pallidum specific antibody (TPPA) should be excluded;
• Participating in another clinical trial within 4 weeks prior to the signing of the informed consent, or the signing date of the informed consent is still within 5 half-lives of the drug (whichever is longer) since the last drug used in the last clinical trial;
• A history of severe allergy to biological products;
• Systemic diseases that are considered unstable by the investigator: including but not -limited to severe liver, kidney, or metabolic diseases requiring medical treatment;
• Pregnant or lactating women, and female subjects who plan pregnancy within 2 years after cell transfusion or male subjects whose partner plans pregnancy within 2 years after cell transfusion;
• Conditions that the investigator believes may increase the risk to the subject or interfere with the test results.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Sequential

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Shanxi Bethune Hospital — Taiyuan

Identifiers

NCT: NCT06783816 · VC-HM-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗