IASO207 Injection in the Treatment of Relapsed/Refractory B-cell Malignancies
ConditionMalignancies
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPeking University People's Hospital
About this trial
This is a single-center, open-label, exploratory clinical study to evaluate the efficacy and safety of IASO207 Injection in patients with Relapsed/Refractory B-cell Malignancies。
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Age ≥ 18 years old and ≤ 75 years old.
Diffuse large B-cell lymphoma, not otherwise specified (DLBCL NOS); high-grade B-cell lymphoma (HGBL);
DLBCL transformed from indolent lymphoma, including transformation from follicular lymphoma (FL) or marginal zone lymphoma (MZL), and DLBCL transformed from CLL/SLL (Richter transformation);
Grade 3B follicular lymphoma (FL3B); primary mediastinal large B-cell lymphoma (PMBCL).
Disqualifiers
1. There is invasion of central nervous system tumors; and/or primary central nervous system DLBCL, primary testicular LBCL.
2. The tumor involves the small intestine, colon, and/or imaging examination indicates that the tumor involves the sub-mucosal layer of the gastrointestinal tract, and the patient has been evaluated to have a risk of organ perforation.
3. Within the past 5 years before screening, the subject has had other malignant tumors except for the disease under study, excluding cervical carcinoma in situ after radical treatment, basal cell or squamous cell skin cancer after radical treatment, local prostate cancer, breast duct carcinoma in situ or thyroid papillary carcinoma.
4. Infectious disease screening meets one of the following conditions: i. The subject has positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and abnormal peripheral blood HBV DNA test (abnormal HBV DNA test is defined as: HBV DNA quantitative test higher than the detection center's lower limit or higher than the normal reference range of the detection center or HBV DNA qualitative test positive); ii. The subject has positive hepatitis C virus (HCV) antibody and positive peripheral blood HCV RNA; iii. The subject has positive human immunodeficiency virus (HIV) antibody; iv. The subject has syphilis; v. The subject is an active CMV infection patient.
Trial design
Design model
Single group
Treatments tested in this trial
IASO207 Injection
DrugIASO207 is a third-generation replication-deficient self-inactivating lentiviral vector that carries the gene encoding a second-generation anti-human CD19 chimeric antigen receptor (CD19 CAR) containing the 4-1BB co-stimulatory factor. IASO207 has been engineered through surface modification of the lentiviral envelope to enable it to selectively bind and transduce T cells within the body, thereby directly generating CD19 CAR-T cells in vivo.
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: IASO207 InjectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety endpoint - Adverse Events (AEs)
Incidence and severity of adverse events as assessed by NCI-CTCAE v5.0 (except CRS and ICANS per 2019 ASTCT criteria).
Time frame
up to 2 years from IASO207 Injection infusion2
Safety endpoint - The incidence of dose-limiting toxicity (DLT)
Percentage of participants who experienced DLT within 28 days after IASO207 administration.
Time frame
up to 28 days from IASO207 Injection infusion3
Safety endpoint - The types,incidence and severity of abnormal laboratory tests
The types, incidence and severity of abnormal laboratory results assessed by CTCAEV5.0 will be analyzed and reported.
Time frame
up to 2 years from IASO207 Injection infusionSecondary outcomes
1
Efficacy endpoint - Objective response rate (ORR)
ORR was defined as the percentage of participants who achieved partial response (PR) or better as assessed by the investigator according to the Lugano 2014 Criteria.
Time frame
up to 2 years from IASO207 Injection infusion2
Efficacy endpoint - Objective response rate (ORR) at pre-specified timepoints
ORR at 3, 6, 12 months as assessed by the investigator according to the Lugano 2014 Criteria.
Time frame
up to 2 years from IASO207 Injection infusion3
Efficacy endpoint - Complete response rate (CRR)
CRR was defined as the percentage of participants who achieved complete response (CR) as assessed by the investigator according to the Lugano 2014 Criteria.
Time frame
up to 2 years from IASO207 Injection infusion4
Efficacy endpoint - Duration of Response (DOR)
DOR was defined as the time (in months) from the date of initial documented response (PR or better response) to the date of first documented evidence of progressive disease (PD) or death.
Time frame
up to 2 years from IASO207 Injection infusionOther outcomes
1
Immunogenicity
Prevalence and titer of confirmed human anti-CAR antibodies in peripheral blood.
Time frame
up to 2 years from IASO207 Injection infusion2
Replication competent lentivirus (RCL)
Prevalence of replication-competent lentivirus (RCL) in peripheral blood.
Time frame
up to 2 years from IASO207 Injection infusion3
Virus shedding
Presence of viral shedding in body fluid samples (urine, feces, and saliva).
Time frame
Up to 7 days from IASO207 Injection infusion4
percentage of CD19-positive target cells
Quantification of the percentage of CD19-positive target cells in baseline patient samples, measured by flow cytometry prior to IASO207 infusion.
Time frame
Baseline (within 7 days before IASO207 infusion)Sponsors and contacts
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Source ClinicalTrials.gov