To Evaluate the Safety, Tolerability, and Preliminary Antitumor Activity of STR-P004 (NCT07245251) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
To Evaluate the Safety, Tolerability, and Preliminary Antitumor Activity of STR-P004
11 participantsStarted 2025-12-03
Plain-language summary
This is a single-arm, single-center, open-label, multiple-dose, dose-escalation early clinical study aimed at evaluating the safety, tolerability, pharmacokinetic characteristics, and preliminary antitumor activity of STR-P004 in subjects with relapsed/refractory CD19-positive acute lymphoblastic leukemia.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients voluntarily sign the informed consent form;
. Age between 18 and 65 years, regardless of gender;
. Diagnosed with B-cell acute lymphoblastic leukemia and meeting any of the following conditions:
. No remission after ≥6 weeks of induction therapy or two courses of induction therapy;
. Relapse after ≥2 complete remissions (CR) or CR with incomplete hematologic recovery (CRi);
. First relapse after chemotherapy, with no remission after at least one salvage therapy;
. Within 3 months before screening, bone marrow or peripheral blood tests show leukemia cells expressing CD19;
. For Ph+ ALL patients, treatment failure with at least two tyrosine kinase inhibitors (TKIs) (including at least one second-generation TKI) or intolerance to TKI therapy; if the patient has a T315I mutation, TKI salvage therapy is not required;
Exclusion criteria
. Active central nervous system (CNS) leukemia (patients with CNS disease symptoms must undergo lumbar puncture to exclude CNS leukemia);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.