To Evaluate the Safety, Tolerability, and Preliminary Antitumor Activity of STR-P004

NCT07245251 | Not Yet Recruiting

• 1 other identifier: STR-P004-004
• Study Type: interventional
• Target: 11
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Acute Lymphobkastic Leukemia

Keywords

STR-P004; ALL

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability endpoints

  Dose-limiting toxicity (DLT), all adverse events (AEs)/serious adverse events (SAEs), and other safety evaluation indicators

  12 months

Study Arms (1)

Dose

EXPERIMENTAL

Five dose-escalation cohorts are planned within the dose range of AA mg/kg to BB mg/kg. The escalation follows a modified Fibonacci sequence

Drug: STR-P004

Interventions

STR-P004 DRUG

This study enrolls adult patients with B-cell acute lymphoblastic leukemia (B-ALL). Enrolled patients receive STR-P004 at the corresponding dose via intravenous infusion, administered four times

Dose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with relapsed/refractory CD19-positive B-cell acute lymphoblastic leukemia who currently have poor prognosis treatment options:
• 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:
• (1) Relapse: Relapse within 12 months after first remission following standard treatment;
• (2) Refractory:
• 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;
• d) Relapse after autologous or allogeneic hematopoietic stem cell transplantation;
• 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;
• During screening, the proportion of bone marrow blasts and immature lymphocytes is ≥5%;
• Hemoglobin ≥60 g/L, platelets ≥30 × 10\^9/L;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;

You may not qualify if:

• Subjects meeting any of the following criteria cannot be enrolled:
• 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:
• Pre-treatment chemotherapy as specified in the protocol;
• TKI and hydroxyurea must be discontinued 72 hours before cell infusion;
• mercaptopurine, 6-thioguanine, methotrexate (standard dose), cytarabine (standard dose), vincristine, and asparaginase must be discontinued 1 week before cell infusion;
• Intrathecal chemotherapy for CNS leukemia prophylaxis must be discontinued 1 week before cell infusion; 2. Systemic corticosteroid therapy discontinued for less than 72 hours before dosing, except for physiological replacement doses (e.g., prednisone \<10 mg/day or equivalent); 3. Acute graft-versus-host disease (GVHD) within 4 weeks before screening or moderate to severe chronic GVHD; systemic medication for GVHD within 4 weeks before dosing; 4. Active systemic autoimmune disease under treatment; 5. Any of the following:
• Hepatitis B surface antigen (HBsAg) and/or hepatitis B e antigen (HBeAg) positive;
• Hepatitis B e antibody (HBe-Ab) positive with HBV-DNA copy number above the lower limit of quantification;
• Hepatitis C antibody (HCV-Ab) positive;
• Anti-Treponema pallidum antibody (TP-Ab) positive;
• Human immunodeficiency virus (HIV) antibody positive;
• EBV-DNA or CMV-DNA copy number above the lower limit of quantification; 6. History or presence of other malignancies within 5 years before screening, except for those with low risk of recurrence as judged by the investigator after curative treatment and follow-up for more than 5 years; 7. Any of the following cardiac conditions:

Sponsors & Collaborators

• Starna Therapeutics: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: December 3, 2025
• Primary Completion (Estimated): November 2, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share