Immune ThrombocytopeniaEarly Phase 1NCT06519565
Safety and Efficacy of PRG-1801 in Recurrent/Refractory Primary Immune Thrombocytopenia (ITP)
A Early Phase 1 study testing PRG-1801 in people with Immune Thrombocytopenia, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 2 sites in China.
Trial summary
This is a single center, open-label, 3+3 dose escalation, early phase 1 study to evaluate the safety, tolerability, and preliminary efficacy of PRG-1801 for patients with relapsed/refractory immune thrombocytopenia (ITP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immune Thrombocytopenia
- What is being tested?
- PRG-1801
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesChina
- Study dates
- 20 Aug 2024to 15 Aug 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
- 1. Age ≥18 years, regardless of gender.
- 2. Clinically diagnosed with primary immune thrombocytopenia for at least 6 months, with a platelet count <30×10^9/L within 48 hours before participating in the study.
- 3. Positive for anti-platelet glycoprotein autoantibodies (such as GPIIb/IIIa).
- 4. Previously received first-line and/or second-line ITP treatment (first-line treatment includes: corticosteroids or immunoglobulins; second-line treatment includes thrombopoietin receptor agonists (such as eltrombopag, romiplostim) and/or rituximab, etc.), but the treatment was ineffective (platelet count <30×10^9/L after treatment, or platelet count did not increase to twice the baseline value, or there was bleeding), or relapsed after effective treatment (platelet count dropped below 30×10^9/L after effective treatment, or dropped to less than twice the baseline value, or bleeding symptoms occurred) or difficult to maintain after stopping TPO receptor agonists.
- 5. Basic normal function of important organs:
- Echocardiography indicates an ejection fraction ≥50%, and the electrocardiogram shows no significant abnormalities.
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- Creatinine clearance rate (CrCl) (Cockcroft-Gault formula) ≥30 mL/min.
- Alanine transaminase (ALT) and aspartate transaminase (AST) ≤3.0× the upper limit of normal (ULN).
- Total bilirubin (TBIL) and alkaline phosphatase (AKP or ALP) ≤2.0×ULN (Gilbert's syndrome ≤ 3.0×ULN).
- Absolute lymphocyte count (ALC) ≥0.5×10^9/L; absolute neutrophil count (ANC) ≥1×10^9/L; hemoglobin (Hb) ≥60 g/L; platelet count ≥10×10^9/L.
- Blood oxygen saturation >92%.
- 6. Meet the standards for apheresis or venous blood collection, and have no contraindications to cell collection.
- 7. Men of reproductive potential and women of childbearing age must agree to use effective contraception from the signing of the informed consent form until 1 year after the use of the study drug. Blood pregnancy tests for women of childbearing age must be negative at screening and before cell infusion, and they must not be breastfeeding.
- 8. The participant or their guardian agrees to participate in this clinical trial and signs the informed consent form (ICF), indicating their understanding of the purpose and procedures of this clinical trial and their willingness to participate in the study.
Who cannot join
- 1. Thrombocytopenia caused by myelodysplastic syndromes, early aplastic anemia, atypical aplastic anemia, thrombotic thrombocytopenic purpura, etc.
- 2. Bone marrow examination during the screening period suggests myelofibrosis MF≥2 (European consensus scoring standard Thieleja2005) or bone marrow examination indicates the presence of primary diseases other than ITP that can cause thrombocytopenia.
- 3. Allergic history to any component in the cell product.
- 4. Suffering from any of the following heart diseases:
- Congestive heart failure of NYHA class III or IV.
- Myocardial infarction or coronary artery bypass grafting (CABG) or coronary stent implantation within ≤6 months before signing the ICF.
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- Clinically significant ventricular arrhythmias, or history of unexplained syncope (excluding vasovagal syncope or dehydration).
- Severe non-ischemic cardiomyopathy history.
- 5. Malignant tumors within the past 3 years before screening, except for the following: malignant tumors that have been treated radically and have no known active disease for ≥3 years before enrollment; or well-treated non-melanoma skin cancer with no evidence of disease.
- 6. Symptomatic deep vein thrombosis or pulmonary embolism within the past 6 months or currently requiring anticoagulant therapy.
- 7. Participation in other interventional clinical studies within 1 month before screening.
- 8. Vaccination with attenuated live vaccines within 4 weeks before screening.
- 9. Stroke or epileptic seizure within 6 months before signing the ICF (excluding old lacunar cerebral infarction).
- 10. The following treatments before CAR-T reinfusion: immunosuppressive treatment within 3 days; use of prednisone (or equivalent drugs) at a dose >10mg/day within 3 days.
- 11. The following treatments before CAR-T reinfusion: treatment with B-cell depleting agents such as rituximab within 24 weeks (unless B cells have recovered); immunoglobulin reinfusion treatment within 4 weeks.
- 12. Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and peripheral blood hepatitis B virus (HBV) DNA titer detection exceeds the normal range; positive for hepatitis C virus (HCV) antibody and peripheral blood hepatitis C virus (HCV) RNA titer detection exceeds the normal range; positive for human immunodeficiency virus (HIV) antibody; positive syphilis test.
- 13. Other conditions deemed unsuitable for participation in the study by the researcher.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Heng Mei, Ph.D&M.D., hmei@hust.edu.cn
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Heng Mei, 07596503286, hmei@hust.edu.cn
Jinhui Shu, 18326016087, sjh18326016087@163.com
About this study
Official title: Clinical Study on the Safety and Efficacy of PRG-1801 for the Treatment of Recurrent/Refractory Primary Immune Thrombocytopenia (ITP)
This is a single center, open-label, 3+3 dose escalation, early phase 1 study to evaluate the safety, tolerability, and preliminary efficacy of PRG-1801 for patients with relapsed/refractory immune thrombocytopenia (ITP).
Read the detailed description
This investigator-initiated clinical study aims to evaluate PRG-1801, a BCMA-targeted CAR-T cell therapy, in patients with relapsed refractory immune thrombocytopenia (ITP). The study employs a dose-escalation design to assess safety, tolerability, and preliminary efficacy.
Approximately 1 sites are planned to be selected for the clinical trial. The subjects, who sign the informed consent forms and been screened by inclusion/exclusion criteria, will be assigned into 100×10^6, and 200×10^6 CAR-T cells groups in order of sequence. And the subjects will undergo leukapheresis, lymphodepletion pre-treatment, and a single infusion of PRG-1801. Dose escalation will follow 3 + 3 design and 3-6 subjects in each group will complete a single dose. Within the same dose group, the next subject will be administered after the previous subject has completed at least 14 days of safety observation. After the last subject in each dose group has completed the dose-limiting toxicity (DLT) assessment window of 28 days after single dose, the enrollment and treatment for the next dose group may be initiated after the Safety Review Committee (SRC) agrees to enter the next dose group based on clinical safety data assessment.
When DLT occurs in 1 of 3 subjects in a dose group, 3 additional subjects in the same dose group will be required (up to 6 subjects in the dose group have completed DLT assessment): if no DLT occurs in the additional 3 subjects, dose escalation will continue; if 1 of the 3 additional subjects experiences one DLT, dose escalation will be discontinued; if more than 1 of the 3 additional subjects experiences DLTs, dose escalation will be discontinued, and 3 additional subjects will be required to be enrolled at one lower dose level for DLT assessment. After the end of escalation for the maximum dose group, if no MTD is observed, the highest dose level is defined as the MTD
- Conditions
- Immune Thrombocytopenia
- Being tested
- PRG-1801
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRG-1801Drug
Also called BCMA-targeting CAR-T Cells
PRG-1801 is a chimeric antigen receptor T-cell (CAR-T) therapy targeting BCMA. Participants will undergo leukapheresis to collect mononuclear cells for PRG-1801 manufacturing. Prior to infusion, patients receive lymphodepletion with cyclophosphamide (250-300 mg/m2/day) and fludarabine (25-30 mg/m2/day) for 3 days. PRG-1801 is then administered as a single intravenous infusion at one of three dose levels: 100×10^6, or 200×10^6 CAR-T cells. Premedication with antipyretics and antihistamines is given 30-60 minutes before infusion. The infusion rate is 2-5 ml/min. Patients are monitored for safety and efficacy for up to 24 months post-infusion. Some patients may be eligible for a second infusion if they respond initially but later relapse.
| Study group | Role | What they receive |
|---|---|---|
| PRG-1801(BCMA-targeting CAR-T Cells) | Experimental | The study was structured into two distinct phases: the dose exploration phase and the dose expansion phase. During the dose exploration phase, three dosage levels were established-100x10^6 CAR-T and 200x10^6 CAR-T-with each dosage group comprising 3 to 6 subjects with Immune Thrombocytopenia (ITP). If dose-limiting toxicity (DLT) was observed in one out of three subjects within any dosage group, an additional three subjects were enrolled at the same dosage level. Should DLT be present in two or more out of six subjects, considerations for dose reduction or potential study discontinuation were made.
Upon determining the safe and effective fixed dose of PRG-1801 during the dose exploration phase, the study progressed to the dose expansion phase. This subsequent phase involved enrolling an additional 3 to 6 subjects at the established fixed dose. The aim was to further assess and confirm the safety and efficacy of this specific dose for treating ITP. Receives: Drug: PRG-1801 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-related Adverse Events
Therapy-related adverse events (AE), including severe adverse events (SAE) and laboratory outliers with clinical significance, will be recorded and assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
Measured: Up to 28 days post-infusion
The safe dosage for a single infusion of PRG-1801
The safe PRG-1801 infusion dosage for ITP patients will be evaluated by comprehensively assessing the complete response (CR) rate and the incidence of adverse events (AEs).
Measured: Up to 28 days post-infusion
Secondary outcomes (3)
Complete response (CR) rate or Response (R) rate of administering PRG-1801 in the treatment of relapsed/refractory ITP
CR is defined as platelet count ≥100×10^9/L. R is defined as platelet count ≥30×10^9/L and at least doubling from baseline, without active bleeding.
Measured: At Day 28, Month 2, Month 3, Month 6,Month 9, Month 12, Month 18, and Month 24 post-infusion
The proliferation rate and persistence time of CAR-T cells
Evaluation of CAR-T cell expansion and persistence through measurement of CAR copy number in peripheral blood
Measured: At baseline, Day 2, Day 6, Day 10, Day 14, Day 21, Day 28, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24 post-infusion
Concentration of serum sBCMA, immunoglobulins (IgG, IgM, IgA), and anti-platelet glycoprotein autoantibodies
Pharmacodynamics of PRG-1801 were assessed by evaluating changes from baseline in serum sBCMA, immunoglobulins (IgG, IgM, IgA), and anti-platelet glycoprotein autoantibodies
Measured: At baseline, Day 28, Month 2, Month 3, Month 6,Month 9, Month 12, Month 18, and Month 24 post-infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start20 Aug 2024
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immune ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- PRG-1801 Injection
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Pregene Biopharma Co., Ltd.
- Responsible party
- Principal investigator, MEI HENG, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Heng Mei, Ph.D&M.D, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06519565
- Sponsor's protocol ID
- PRG1801E13
- Status last verified
- Dec 2024
- First submitted
- 9 Jul 2024
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shu J, Xu M, Li P, Xie W, Liu L, Li H, Bussel JB, Hu Y, Mei H. BCMA-directed CAR T-cell therapy induces durable drug-free remission in refractory primary immune thrombocytopenia. Blood. 2026 Oct 29;148(18):2306-2312. doi: 10.1182/blood.2026035047.
PubMed 42498681
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Safety and Efficacy of PRG-1801 for the Treatment of Recurrent/Refractory Primary Immune Thrombocytopenia (ITP)
- ClinicalTrials.gov ID
- NCT06519565
- Acronym / sponsor ID
- PRG1801E13
- Conditions
- Immune Thrombocytopenia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Shenzhen Pregene Biopharma Co., Ltd.
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Aug 2027 (estimated)
- First posted
- 25 Jul 2024 (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 is a single center, open-label, 3+3 dose escalation, early phase 1 study to evaluate the safety, tolerability, and preliminary efficacy of PRG-1801 for patients with relapsed/refractory immune thrombocytopenia (ITP).
Detailed description
This investigator-initiated clinical study aims to evaluate PRG-1801, a BCMA-targeted CAR-T cell therapy, in patients with relapsed refractory immune thrombocytopenia (ITP). The study employs a dose-escalation design to assess safety, tolerability, and preliminary efficacy.
Approximately 1 sites are planned to be selected for the clinical trial. The subjects, who sign the informed consent forms and been screened by inclusion/exclusion criteria, will be assigned into 100×10^6, and 200×10^6 CAR-T cells groups in order of sequence. And the subjects will undergo leukapheresis, lymphodepletion pre-treatment, and a single infusion of PRG-1801. Dose escalation will follow 3 + 3 design and 3-6 subjects in each group will complete a single dose. Within the same dose group, the next subject will be administered after the previous subject has completed at least 14 days of safety observation. After the last subject in each dose group has completed the dose-limiting toxicity (DLT) assessment window of 28 days after single dose, the enrollment and treatment for the next dose group may be initiated after the Safety Review Committee (SRC) agrees to enter the next dose group based on clinical safety data assessment.
When DLT occurs in 1 of 3 subjects in a dose group, 3 additional subjects in the same dose group will be required (up to 6 subjects in the dose group have completed DLT assessment): if no DLT occurs in the additional 3 subjects, dose escalation will continue; if 1 of the 3 additional subjects experiences one DLT, dose escalation will be discontinued; if more than 1 of the 3 additional subjects experiences DLTs, dose escalation will be discontinued, and 3 additional subjects will be required to be enrolled at one lower dose level for DLT assessment. After the end of escalation for the maximum dose group, if no MTD is observed, the highest dose level is defined as the MTD
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- PRG-1801 Injection
| Arm | Type | Receives |
|---|---|---|
| PRG-1801(BCMA-targeting CAR-T Cells) | Experimental | Drug: PRG-1801The study was structured into two distinct phases: the dose exploration phase and the dose expansion phase. During the dose exploration phase, three dosage levels were established-100x10^6 CAR-T and 200x10^6 CAR-T-with each dosage group comprising 3 to 6 subjects with Immune Thrombocytopenia (ITP). If dose-limiting toxicity (DLT) was observed in one out of three subjects within any dosage group, an additional three subjects were enrolled at the same dosage level. Should DLT be present in two or more out of six subjects, considerations for dose reduction or potential study discontinuation were made. Upon determining the safe and effective fixed dose of PRG-1801 during the dose exploration phase, the study progressed to the dose expansion phase. This subsequent phase involved enrolling an additional 3 to 6 subjects at the established fixed dose. The aim was to further assess and confirm the safety and efficacy of this specific dose for treating ITP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 1. Age ≥18 years, regardless of gender.
- 2. Clinically diagnosed with primary immune thrombocytopenia for at least 6 months, with a platelet count <30×10^9/L within 48 hours before participating in the study.
- 3. Positive for anti-platelet glycoprotein autoantibodies (such as GPIIb/IIIa).
- 4. Previously received first-line and/or second-line ITP treatment (first-line treatment includes: corticosteroids or immunoglobulins; second-line treatment includes thrombopoietin receptor agonists (such as eltrombopag, romiplostim) and/or rituximab, etc.), but the treatment was ineffective (platelet count <30×10^9/L after treatment, or platelet count did not increase to twice the baseline value, or there was bleeding), or relapsed after effective treatment (platelet count dropped below 30×10^9/L after effective treatment, or dropped to less than twice the baseline value, or bleeding symptoms occurred) or difficult to maintain after stopping TPO receptor agonists.
- 5. Basic normal function of important organs:
Key exclusion criteria (17 listed)
- 1. Thrombocytopenia caused by myelodysplastic syndromes, early aplastic anemia, atypical aplastic anemia, thrombotic thrombocytopenic purpura, etc.
- 2. Bone marrow examination during the screening period suggests myelofibrosis MF≥2 (European consensus scoring standard Thieleja2005) or bone marrow examination indicates the presence of primary diseases other than ITP that can cause thrombocytopenia.
- 3. Allergic history to any component in the cell product.
- 4. Suffering from any of the following heart diseases:
- 5. Malignant tumors within the past 3 years before screening, except for the following: malignant tumors that have been treated radically and have no known active disease for ≥3 years before enrollment; or well-treated non-melanoma skin cancer with no evidence of disease.
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 |
|---|---|---|
| PRG-1801Also: BCMA-targeting CAR-T CellsPRG-1801 is a chimeric antigen receptor T-cell (CAR-T) therapy targeting BCMA. Participants will undergo leukapheresis to collect mononuclear cells for PRG-1801 manufacturing. Prior to infusion, patients receive lymphodepletion with cyclophosphamide (250-300 mg/m2/day) and fludarabine (25-30 mg/m2/day) for 3 days. PRG-1801 is then administered as a single intravenous infusion at one of three dose levels: 100×10^6, or 200×10^6 CAR-T cells. Premedication with antipyretics and antihistamines is given 30-60 minutes before infusion. The infusion rate is 2-5 ml/min. Patients are monitored for safety and efficacy for up to 24 months post-infusion. Some patients may be eligible for a second infusion if they respond initially but later relapse. | Drug | PRG-1801(BCMA-targeting CAR-T Cells) |
Primary outcome
Incidence of Treatment-related Adverse Events
Time frame: Up to 28 days post-infusion
Therapy-related adverse events (AE), including severe adverse events (SAE) and laboratory outliers with clinical significance, will be recorded and assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
The safe dosage for a single infusion of PRG-1801
Time frame: Up to 28 days post-infusion
The safe PRG-1801 infusion dosage for ITP patients will be evaluated by comprehensively assessing the complete response (CR) rate and the incidence of adverse events (AEs).
3 secondary outcomes
Complete response (CR) rate or Response (R) rate of administering PRG-1801 in the treatment of relapsed/refractory ITP
Time frame: At Day 28, Month 2, Month 3, Month 6,Month 9, Month 12, Month 18, and Month 24 post-infusion
The proliferation rate and persistence time of CAR-T cells
Time frame: At baseline, Day 2, Day 6, Day 10, Day 14, Day 21, Day 28, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24 post-infusion
Concentration of serum sBCMA, immunoglobulins (IgG, IgM, IgA), and anti-platelet glycoprotein autoantibodies
Time frame: At baseline, Day 28, Month 2, Month 3, Month 6,Month 9, Month 12, Month 18, and Month 24 post-infusion
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 28 Nov 2025.
- Derived from this study: PubMed 42498681Shu J, Xu M, Li P, Xie W, Liu L, Li H, Bussel JB, Hu Y, Mei H. BCMA-directed CAR T-cell therapy induces durable drug-free remission in refractory primary immune thrombocytopenia. Blood. 2026 Oct 29;148(18):2306-2312. doi: 10.1182/blood.2026035047.
- 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.
Heng Mei, Ph.D&M.D principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
2 sites 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 PRG-1801 in people with Immune Thrombocytopenia, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 2 sites 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 14 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Heng Mei, Ph.D&M.D (027-8572600, hmei@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-related Adverse Events (time frame: Up to 28 days post-infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06519565, which also lists 1 linked publication.
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 28 Nov 2025.