Non Hodgkin LymphomaEarly Phase 1NCT07003178
A Study to Evaluate the Safety and Clinical Efficacy of STR-P004
A Early Phase 1 study testing STR-P004 in people with Non Hodgkin Lymphoma, run by Starna Therapeutics at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Hodgkin Lymphoma
- What is being tested?
- STR-P004
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jun 2025to May 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with relapsed/refractory CD19-positive B-cell non-Hodgkin's lymphoma:
- 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);
- Pathologically confirmed B-cell non-Hodgkin's lymphoma meeting one of the following conditions:
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- Relapsed/refractory B-cell non-Hodgkin's lymphoma with the best response of SD or PD after receiving at least two lines of adequate therapy, the best response of PD during or after the last line of treatment, or the best response of SD after receiving at least two cycles of the last line of treatment;
- For relapse or PD within 12 months after autologous stem cell transplantation (ASCT) for B-cell non-Hodgkin's lymphoma, if salvage therapy is administered, no response (SD/PD) to the last treatment is required; for relapse or PD more than 12 months after ASCT, salvage therapy is needed, and no response (SD/PD) to the last treatment is required;
- Hemoglobin ≥80 g/L, neutrophils ≥1.0 × 109/L, platelets ≥75 × 109/L;
- At least one measurable tumor lesion according to the 2014 Lugano response criteria;
- Hepatic and renal function, as well as cardiopulmonary function, meet the following requirements:
- Serum creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL/min (calculated by the Cockcroft-Gault formula);
- Ejection fraction >50%, with no clinically significant pericardial effusion or pleural effusion detected;
- Baseline oxygen saturation >92%;
- Total bilirubin ≤1.5 × ULN (≤5 × ULN for Gilbert syndrome);
- ALT and AST ≤3 × ULN (≤5 × ULN for patients with liver metastases).
- Capable of understanding the study and having signed the informed consent form.
Who cannot join
- Subjects meeting any of the following conditions will not be eligible for participation:
- 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;
- Any unstable systemic disease, including but not limited to active infection (except for local infections), unstable angina, cerebrovascular accident or transient ischemic attack (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association [NYHA] class ≥III), severe arrhythmia requiring medication, or hepatic, renal, or metabolic disorders;
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- Any uncontrolled active condition that may interfere with study participation;
- Any condition deemed by the investigator to compromise subject safety or interfere with the study objective;
- Pregnant or breastfeeding women, or subjects who plan to become pregnant during the treatment period or within 1 year after treatment completion, or male subjects whose partners plan to become pregnant within 1 year after cell infusion;
- Subjects receiving systemic corticosteroid therapy within 14 days prior to enrollment and judged by the investigator to require long-term use of systemic corticosteroid during treatment (excluding inhaled or topical use);
- Presence of central nervous system or brain metastasis symptoms or receiving treatment for central nervous system or brain metastasis (radiotherapy, surgery, or other therapy) within 3 months prior to enrollment;
- Subjects with conditions that impair their ability to provide written informed consent or comply with study procedures, or those unwilling or unable to adhere to study requirements.
- Subjects deemed unsuitable for participation in this study by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Starna
Suzhou, Jiangsu, 215123
Li Shi, +8618896505123, shijingli@starnatx.com
About this study
Official title: An Early Clinical Study to Evaluate the Safety and Clinical Efficacy of STR-P004 in Subjects With Relapsed/Refractory CD19-Positive B-Lymphocytic Non-Hodgkin's Lymphoma
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.
Read the detailed description
This study employs a dose-escalation approach combining "accelerated titration" and "traditional 3+3". Within the dose range of xxmg/kg to xxxmg/kg, five dose-escalation cohorts are planned. The escalation follows a modified Fibonacci sequence (i.e., 2, 1.67, 1.5, 1.4, 1.33, 1.33 …… 1.33-fold increments). A faster escalation rate is used in the early phase to minimize patient exposure to ineffective doses and rapidly reach the predicted effective dose range, after which the escalation rate is reduced to ensure safety and explore efficacy.
This study plans to enroll adult patients with B-cell non-Hodgkin's lymphoma (NHL). Enrolled patients will receive STR-P004 at the corresponding dose via intravenous infusion. Patients will receive weekly treatment doses starting from D1 for 4 consecutive weeks (D1, D8, D15, D22), with each 4-week period constituting a treatment cycle. Based on preliminary treatment results from Cycle 1, the investigator will decide whether to proceed with subsequent cycles, which will follow the same regimen as Cycle 1. The DLT observation period is 28 days (i.e., D1 to D28). If no DLT occurs or if no Grade ≥2 AE judged by the investigator to be related to the study drug and medically significant is observed, patients will be enrolled into the next dose group after the 28-day DLT observation period for the previous dose group is ended. During the accelerated titration phase, if a DLT or any Grade ≥2 AE judged by the investigator to be related to the study drug and medically significant occurs within 28 days, enrollment will switch to the "3+3" pattern.
- Conditions
- Non Hodgkin Lymphoma
- Being tested
- STR-P004
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STR-P004Drug
An in vivo CART drug administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Dose1 | Experimental | STR-P004 Dose1 IV Receives: Drug: STR-P004 |
| Dose2 | Experimental | STR-P004 Dose2 IV Receives: Drug: STR-P004 |
| Dose 3 | Experimental | STR-P004 Dose3 IV Receives: Drug: STR-P004 |
| Dose4 | Experimental | STR-P004 Dose4 IV Receives: Drug: STR-P004 |
| Dose5 | Experimental | STR-P004 Dose5 IV Receives: Drug: STR-P004 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study startJun 2025 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Starna Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07003178
- Sponsor's protocol ID
- Starna Therapeutics P004
- Status last verified
- May 2025
- First submitted
- 19 May 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Early Clinical Study to Evaluate the Safety and Clinical Efficacy of STR-P004 in Subjects With Relapsed/Refractory CD19-Positive B-Lymphocytic Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT07003178
- Acronym / sponsor ID
- Starna Therapeutics P004
- Conditions
- Non Hodgkin Lymphoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Starna TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jun 2025 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 4 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study employs a dose-escalation approach combining "accelerated titration" and "traditional 3+3". Within the dose range of xxmg/kg to xxxmg/kg, five dose-escalation cohorts are planned. The escalation follows a modified Fibonacci sequence (i.e., 2, 1.67, 1.5, 1.4, 1.33, 1.33 …… 1.33-fold increments). A faster escalation rate is used in the early phase to minimize patient exposure to ineffective doses and rapidly reach the predicted effective dose range, after which the escalation rate is reduced to ensure safety and explore efficacy.
This study plans to enroll adult patients with B-cell non-Hodgkin's lymphoma (NHL). Enrolled patients will receive STR-P004 at the corresponding dose via intravenous infusion. Patients will receive weekly treatment doses starting from D1 for 4 consecutive weeks (D1, D8, D15, D22), with each 4-week period constituting a treatment cycle. Based on preliminary treatment results from Cycle 1, the investigator will decide whether to proceed with subsequent cycles, which will follow the same regimen as Cycle 1. The DLT observation period is 28 days (i.e., D1 to D28). If no DLT occurs or if no Grade ≥2 AE judged by the investigator to be related to the study drug and medically significant is observed, patients will be enrolled into the next dose group after the 28-day DLT observation period for the previous dose group is ended. During the accelerated titration phase, if a DLT or any Grade ≥2 AE judged by the investigator to be related to the study drug and medically significant occurs within 28 days, enrollment will switch to the "3+3" pattern.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dose1 | Experimental | Drug: STR-P004STR-P004 Dose1 IV |
| Dose2 | Experimental | Drug: STR-P004STR-P004 Dose2 IV |
| Dose 3 | Experimental | Drug: STR-P004STR-P004 Dose3 IV |
| Dose4 | Experimental | Drug: STR-P004STR-P004 Dose4 IV |
| Dose5 | Experimental | Drug: STR-P004STR-P004 Dose5 IV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Subjects with relapsed/refractory CD19-positive B-cell non-Hodgkin's lymphoma:
Key exclusion criteria (13 listed)
- Subjects meeting any of the following conditions will not be eligible for participation:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STR-P004An in vivo CART drug administered intravenously | Drug | Dose 3, Dose1, Dose2, Dose4, Dose5 |
Primary outcome
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.
Time frame: 24 months
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing STR-P004 in people with Non Hodgkin Lymphoma, run by Starna Therapeutics at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li Jing Shi (+8618896505123, shijingli@starnatx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.