About this trial
This study is a single-arm, single-center, open-label, multiple-dose, dose-escalation early clinical study aimed at evaluating the safety, tolerability, and pharmacokinetic profile of STR-P004 in subjects with relapsed/refractory CD19-positive B-cell non-Hodgkin lymphoma, and preliminarily observing its antitumor activity.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years, regardless of gender;
Life expectancy >12 weeks;
ECOG score of 0-2;
Diagnosis of B-cell non-Hodgkin's lymphoma confirmed by cytology or histopathology according to WHO 2016 criteria, including: diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), transformed follicular lymphoma (TFL), and high-grade B-cell lymphoma (HGBCL);
Disqualifiers
History of malignancies other than diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), transformed follicular lymphoma (TFL), or high-grade B-cell lymphoma (HGBCL) within 5 years prior to screening, except for adequately treated cervix carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery, or thyroid cancer after radical surgery;
Presence of any of the following high-risk factors: sum of product of diameters (SPD) of lesions (all measurable lesions ≥1.5 cm in the longest diameter) ≥100 cm; bulky disease (single lesion ≥10 cm); lesions located in the pharynx or trachea with pressure symptom; lesions adjacent to critical hollow organs such as the gastrointestinal tract or bile ducts, where enlargement may press or invade surrounding organs and impair their functions;
Subjects who have not completed a washout period of at least 5 half-lives since their last anticancer therapy (including I/O therapy) prior to the first dose of study treatment; for anticancer therapies with a half-life >5 days, a washout period >14 days is acceptable; or participation in any other clinical study within 4 weeks prior to the first treatment;
Any of the following conditions: positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B e antigen (HBeAg); positive for hepatitis B e antibody (HBe-Ab) with HBV-DNA copy number above the lower limit of detection; positive for hepatitis C antibody (HCV-Ab); positive for anti-Treponema pallidum antibody (TP-Ab); positive for human immunodeficiency virus (HIV) antibody; EBV-DNA or CMV-DNA copy number above the lower limit of detection;
Trial design
Sequential
Treatments tested in this trial
STR-P004
DrugAn in vivo CART drug administered intravenously
Treatment groups
Trial outcomes
Primary outcomes
In accordance with the (US) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and the ASTCT consensus. The incidence of DLT events in this trial.
DLTs in this trial are defined as dose-escalation phase, toxic reactions related to the study drug (including definitely related, probably related, and possibly related) that occur from the time of first receipt of STR-P004 IV infusion to the end of the first treatment cycle (i.e., D1\~ D28), and primarily include hematologic and non-hematologic toxicities. \> Hematologic DLT: \- Grade 4 neutropenia does not return to ≤ grade 2 or baseline status within 28 days of G-CSF (granulocyte colony-stimulating factor) treatment and excludes involvement/infiltration due to the disease itself; \- Grade 4 thrombocytopenia that does not return to grade ≤2 or baseline status within 28 days of rhTPO/TPO-RA (recombinant human thrombopoietin and thro
Sponsors and contacts
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