A Novel CAR-T Combined Expression of IL-15 in the Treatment of Malignant Hematological Tumors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorShanxi Bethune Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
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;
Disqualifiers
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;
Trial design
Design model
Sequential
Treatments tested in this trial
chimeric antigen receptor gene modified T cells
DrugThe 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.
Treatment groups
45 Participants
are divided into 1 treatment groupGroup A: Group1Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
monitor the survival time of CAR-T in vivo
The survival of CAR-T in vivo will be monitored periodically by flow cytometry after CAR T reinfusion.
Time frame
6 months2
Record antitumor effects after reinfusion of CAR-T
Determine partial response (PR) or complete response (CR) for subjects with active disease. In view of the small number of subjects, remission should be recorded in detail; For subjects treated with minimal residual lesion (MRD), MRD clearance results were recorded.
Time frame
28 daysSecondary outcomes
1
Disease-free survival
DFS was calculated from the first CAR-T cell infusion to death, progression of the disease, relapse or gene recurrence, whichever came first, or last visit.
Time frame
3 years2
Overall Survival
OS was calculated from the first CAR-T cell infusion to death or last follow-up
Time frame
3 yearsOther outcomes
1
The copy number of CAR-T cells
The copy number of CAR-T cells amplified in peripheral blood after administration
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov