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 range18 Years – 65 Years

SexALL

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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);
✕. Isolated extramedullary relapse;
✕. Prior CAR-T therapy or other genetically modified cell therapy within 6 months before screening;
✕. Chemotherapy within 2 weeks before dosing, except for the following:

What they're measuring

Safety and tolerability endpoints

Timeframe: 12 months

Trial details

NCT IDNCT07245251

SponsorStarna Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-11-02

View on ClinicalTrials.gov More Acute Lymphobkastic Leukemia trials