Relapsed or Refractory B-cell LymphomaEarly Phase 1NCT06045585
JY231 Injection in the Treatment of Relapsed or Refractory B-cell Lymphoma
A Early Phase 1 study testing infusion of JY231 injection in people with Relapsed or Refractory B-cell Lymphoma, run by Guangdong Second Provincial General Hospital at 1 site in China.
Trial summary
Early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of relapsed or refractory B-cell lymphoma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed or Refractory B-cell Lymphoma
- What is being tested?
- infusion of JY231 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 18 Aug 2023to 31 Dec 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- understand and sign the informed consent and are willing and able to comply with all test requirements;
- Age 18-75 years old, gender is not limited;
- Flow cytometry or malignant tumor cells were CD19 positive;
- Meet the clinical criteria for r/r B-cell lymphoma, including: indolent lymphoma (iNHL), follicular lymphoma (FL) and marginal zone lymphoma (MZL); Invasive B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), transformed follicular lymphoma (TFL), and T-lymphocyt-rich large B-cell lymphoma (TCRBCL);
- There is at least one measurable lesion on imaging (Lugano 2014 criteria), that is, a lymph node lesion with a diameter greater than 15 mm on CT cross-sectional images or an extranodal lesion with a diameter greater than 10 mm, with a positive FDG-PET test.
- Expected survival ≥12 weeks;
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- The ECOG (Eastern Tumor Collaboration Group) score at baseline was 0 ~ 1;
- Adequate organ function (indicators involving liver and kidney function can be appropriately relaxed) :
- ALT ≤3 xULN;
- AST)≤3x ULN;
- Total bilirubin ≤1.5 x ULN;
- Serum creatinine ≤ 1.5x ULN, or creatinine clearance ≥60 mL/min;
- Indoor oxygen saturation ≥92%;
- Left ventricular ejection fraction (LVEF) ≥55%, echocardiography confirmed no pericardial effusion, no clinically significant ECG findings;
- No clinically significant pleural effusion;
- Sufficient who with adequate bone marrow reserve, defined as:
- Absolute neutrophil count (ANC) > 1.000 /mm3; Absolute lymphocyte count (ALC) ≥300 /mm3; Platelet ≥50.000 /mm3; Hemoglobin > 8.0g/dl;
- Using the following drugs must meet the following conditions:
- Steroids: Therapeutic doses of steroids must be discontinued 72 hours before JY231 infusion. Physiological replacement doses of steroids are permitted;
- Immunosuppression: Any immunosuppressive drug must be stopped ≥4 weeks prior to enrollment;
- Anti-proliferative therapy other than lympho-depleting chemotherapy within two weeks of infusion; CD20 antibody therapy must be discontinued within 4 weeks prior to infusion or 5 half-lives (whichever is older);
- CNS disease prevention must be stopped 1 week before JY231 infusion (e.g., intrathecal methotrexate).
- Fertile men, to ensure that sexual partners can effectively prevent contraception; Women who are fertile, use effective birth control and consent to use birth control throughout the study period.
Who cannot join
- Subjects with active cerebrospinal fluid malignant cells or brain metastases, or subjects with active central nervous system (CNS) lymphoma;
- Subjects with a history of active CNS disease, such as seizures, cerebrovascular ischemia/bleeding, dementia, cerebellar disease, or any autoimmune disease involving the central nervous system;
- Subjects who have received other study drugs within 30 days prior to screening;
- Subjects who have previously received any anti-CD19 / anti-CD3 therapy or any other anti-CD19 therapy (except those with adequate bone marrow reserve and whose tumor is CD19-positive);
- Patients who have previously been treated with any gene therapy product, including CAR-T therapy (except those with no CAR T in the body, normal T cell count and function, and CD19-positive tumors);
- Subjects undergoing radiation therapy within 2 weeks prior to infusion;
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- Subjects with active hepatitis B (defined as hepatitis B virus DNA test value > 500 IU/mL) or hepatitis C (HCV RNA positive); Hiv-positive or treponem-positive subjects;
- Subjects with an acute life-threatening bacterial, viral, or fungal infection that has not yet been controlled (e.g., positive blood culture ≤72 hours prior to infusion);
- Participants with unstable angina pectoris and/or myocardial infarction in the 6 months prior to screening;
- Subjects with prior or concurrent development of other malignancies, except in the following cases:
- Adequately treated basal cell, thyroid papillary, squamous cell carcinomas (requiring adequate wound healing prior to enrollment);
- Carcinoma in situ of cervical or breast cancer with curative treatment and no signs of recurrence for at least 3 years prior to the study;
- The primary malignancy has been completely removed and in complete remission for ≥5 years.
- Clinically significant ventricular arrhythmia;
- Subjects received anticoagulant therapy within a week;
- Active neuroautoimmune or inflammatory conditions (e.g. Guillian-Barre syndrome, amyotrophic lateral sclerosis);
- Pregnant or lactating women, and female subjects who are planning to become pregnant within 2 years after JY231 injection infusion or male subjects whose partners plan to become pregnant within 2 years after JY231 injection infusion;
- Subjects who, in accordance with the investigator's judgment and/or clinical standards, are contraindicated with any study procedure or have other medical conditions that may place them at unacceptable risk.
- Other conditions that the investigator believes should not be included in this clinical trial, such as poor compliance.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong Second Provincial General Hospital
Guangzhou, Guangdong, 510317
About this study
Official title: Early Exploratory Clinical Study of the Safety, Tolerability and Initial Efficacy of JY231 Injection in the Treatment of Relapsed or Refractory B-cell Lymphoma
Early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of relapsed or refractory B-cell lymphoma
Read the detailed description
This is a single-center, single-arm, open-treatment clinical study. In this study, approximately 10-20 adult and elderly patients with CD19-positive relapsed or refractory B-cell lymphoma will be enrolled for JY231 infusion therapy. The safety of JY231 was evaluated by observing adverse events after cell therapy. Evaluate the effectiveness of JY231 treatment compared to the results of the subjects' own previous standard treatment regimens or base data. Blood, bone marrow, and cerebrospinal fluid were collected before and 12 months after the JY231 infusion to detection.
- Conditions
- Relapsed or Refractory B-cell Lymphoma
- Being tested
- infusion of JY231 injection
- Keywords
- JY231injection, Lymphoma
- Medical subject headings
- Recurrence, Lymphoma, B-Cell, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infusion of JY231 injectionBiological
Infusion of JY231 Injection by dose of 1-10 x10^6 TU/kg、 1-5 x10^7 TU/kg、 5-10 x10^7 TU/kg Administration method: intravenous infusion、intraperitoneally infusion、Lymph node infusion； Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion（PI evaluation is required）.
| Study group | Role | What they receive |
|---|---|---|
| infusion of JY231 injection | Experimental | Infusion of JY231 Injection by dose of 1-10 x10^6 TU/kg、 1-5 x10^7 TU/kg、 5-10 x10^7 TU/kg Administration method: intravenous infusion、intraperitoneally infusion、Lymph node infusion； Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion（PI evaluation is required）. Receives: Biological: infusion of JY231 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Metric/method of measurement:IWG-2（2007）《Revised response criteria for malignant lymphoma》
Measured: Month1、Month2、Month3、Month6、Month9、Month12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start18 Aug 2023
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Relapsed or Refractory B-cell 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Second Provincial General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qing Zhang, Guangdong Second Provincial General Hospital
- Investigators
- Qing Zhang, Doctoral, Principal investigator, Guangdong Second Provincial General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06045585
- Sponsor's protocol ID
- JY-CT-23-002
- Status last verified
- Sep 2023
- First submitted
- 11 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pule MA, Straathof KC, Dotti G, Heslop HE, Rooney CM, Brenner MK. A chimeric T cell antigen receptor that augments cytokine release and supports clonal expansion of primary human T cells. Mol Ther. 2005 Nov;12(5):933-41. doi: 10.1016/j.ymthe.2005.04.016. Epub 2005 Jun 23.
PubMed 15979412Frank AM, Weidner T, Brynza J, Uckert W, Buchholz CJ, Hartmann J. CD8-Specific Designed Ankyrin Repeat Proteins Improve Selective Gene Delivery into Human and Primate T Lymphocytes. Hum Gene Ther. 2020 Jun;31(11-12):679-691. doi: 10.1089/hum.2019.248. Epub 2020 Apr 23.
PubMed 32160795Vormittag P, Gunn R, Ghorashian S, Veraitch FS. A guide to manufacturing CAR T cell therapies. Curr Opin Biotechnol. 2018 Oct;53:164-181. doi: 10.1016/j.copbio.2018.01.025. Epub 2018 Feb 18.
PubMed 29462761Zhou Q, Schneider IC, Edes I, Honegger A, Bach P, Schonfeld K, Schambach A, Wels WS, Kneissl S, Uckert W, Buchholz CJ. T-cell receptor gene transfer exclusively to human CD8(+) cells enhances tumor cell killing. Blood. 2012 Nov 22;120(22):4334-42. doi: 10.1182/blood-2012-02-412973. Epub 2012 Aug 16.
PubMed 22898597Smith TT, Stephan SB, Moffett HF, McKnight LE, Ji W, Reiman D, Bonagofski E, Wohlfahrt ME, Pillai SPS, Stephan MT. In situ programming of leukaemia-specific T cells using synthetic DNA nanocarriers. Nat Nanotechnol. 2017 Aug;12(8):813-820. doi: 10.1038/nnano.2017.57. Epub 2017 Apr 17.
PubMed 28416815Koneru M, Purdon TJ, Spriggs D, Koneru S, Brentjens RJ. IL-12 secreting tumor-targeted chimeric antigen receptor T cells eradicate ovarian tumors in vivo. Oncoimmunology. 2015 Jan 23;4(3):e994446. doi: 10.4161/2162402X.2014.994446. eCollection 2015 Mar.
PubMed 25949921Locke FL, Neelapu SS, Bartlett NL, Siddiqi T, Chavez JC, Hosing CM, Ghobadi A, Budde LE, Bot A, Rossi JM, Jiang Y, Xue AX, Elias M, Aycock J, Wiezorek J, Go WY. Phase 1 Results of ZUMA-1: A Multicenter Study of KTE-C19 Anti-CD19 CAR T Cell Therapy in Refractory Aggressive Lymphoma. Mol Ther. 2017 Jan 4;25(1):285-295. doi: 10.1016/j.ymthe.2016.10.020. Epub 2017 Jan 4.
PubMed 28129122Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, Coiffier B, Fisher RI, Hagenbeek A, Zucca E, Rosen ST, Stroobants S, Lister TA, Hoppe RT, Dreyling M, Tobinai K, Vose JM, Connors JM, Federico M, Diehl V; International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007 Feb 10;25(5):579-86. doi: 10.1200/JCO.2006.09.2403. Epub 2007 Jan 22.
PubMed 17242396Neelapu SS, Tummala S, Kebriaei P, Wierda W, Gutierrez C, Locke FL, Komanduri KV, Lin Y, Jain N, Daver N, Westin J, Gulbis AM, Loghin ME, de Groot JF, Adkins S, Davis SE, Rezvani K, Hwu P, Shpall EJ. Chimeric antigen receptor T-cell therapy - assessment and management of toxicities. Nat Rev Clin Oncol. 2018 Jan;15(1):47-62. doi: 10.1038/nrclinonc.2017.148. Epub 2017 Sep 19.
PubMed 28925994
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Exploratory Clinical Study of the Safety, Tolerability and Initial Efficacy of JY231 Injection in the Treatment of Relapsed or Refractory B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT06045585
- Acronym / sponsor ID
- JY-CT-23-002
- Conditions
- Relapsed or Refractory B-cell Lymphoma
- Keywords
- JY231injection, Lymphoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Guangdong Second Provincial General HospitalUniversity, hospital or other
- Study start
- 18 Aug 2023 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Sep 2023 (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.
Early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of relapsed or refractory B-cell lymphoma
Detailed description
This is a single-center, single-arm, open-treatment clinical study. In this study, approximately 10-20 adult and elderly patients with CD19-positive relapsed or refractory B-cell lymphoma will be enrolled for JY231 infusion therapy. The safety of JY231 was evaluated by observing adverse events after cell therapy. Evaluate the effectiveness of JY231 treatment compared to the results of the subjects' own previous standard treatment regimens or base data. Blood, bone marrow, and cerebrospinal fluid were collected before and 12 months after the JY231 infusion to detection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| infusion of JY231 injection | Experimental | Biological: infusion of JY231 injectionInfusion of JY231 Injection by dose of 1-10 x10^6 TU/kg、 1-5 x10^7 TU/kg、 5-10 x10^7 TU/kg Administration method: intravenous infusion、intraperitoneally infusion、Lymph node infusion； Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion（PI evaluation is required）. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- understand and sign the informed consent and are willing and able to comply with all test requirements;
- Age 18-75 years old, gender is not limited;
- Flow cytometry or malignant tumor cells were CD19 positive;
- Meet the clinical criteria for r/r B-cell lymphoma, including: indolent lymphoma (iNHL), follicular lymphoma (FL) and marginal zone lymphoma (MZL); Invasive B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), transformed follicular lymphoma (TFL), and T-lymphocyt-rich large B-cell lymphoma (TCRBCL);
- There is at least one measurable lesion on imaging (Lugano 2014 criteria), that is, a lymph node lesion with a diameter greater than 15 mm on CT cross-sectional images or an extranodal lesion with a diameter greater than 10 mm, with a positive FDG-PET test.
Key exclusion criteria (19 listed)
- Subjects with active cerebrospinal fluid malignant cells or brain metastases, or subjects with active central nervous system (CNS) lymphoma;
- Subjects with a history of active CNS disease, such as seizures, cerebrovascular ischemia/bleeding, dementia, cerebellar disease, or any autoimmune disease involving the central nervous system;
- Subjects who have received other study drugs within 30 days prior to screening;
- Subjects who have previously received any anti-CD19 / anti-CD3 therapy or any other anti-CD19 therapy (except those with adequate bone marrow reserve and whose tumor is CD19-positive);
- Patients who have previously been treated with any gene therapy product, including CAR-T therapy (except those with no CAR T in the body, normal T cell count and function, and CD19-positive tumors);
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 |
|---|---|---|
| infusion of JY231 injectionInfusion of JY231 Injection by dose of 1-10 x10^6 TU/kg、 1-5 x10^7 TU/kg、 5-10 x10^7 TU/kg Administration method: intravenous infusion、intraperitoneally infusion、Lymph node infusion； Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion（PI evaluation is required）. | Biological | infusion of JY231 injection |
Primary outcome
Objective Response Rate
Time frame: Month1、Month2、Month3、Month6、Month9、Month12
Metric/method of measurement:IWG-2（2007）《Revised response criteria for malignant lymphoma》
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Background: PubMed 15979412Pule MA, Straathof KC, Dotti G, Heslop HE, Rooney CM, Brenner MK. A chimeric T cell antigen receptor that augments cytokine release and supports clonal expansion of primary human T cells. Mol Ther. 2005 Nov;12(5):933-41. doi: 10.1016/j.ymthe.2005.04.016. Epub 2005 Jun 23.
- Background: PubMed 32160795Frank AM, Weidner T, Brynza J, Uckert W, Buchholz CJ, Hartmann J. CD8-Specific Designed Ankyrin Repeat Proteins Improve Selective Gene Delivery into Human and Primate T Lymphocytes. Hum Gene Ther. 2020 Jun;31(11-12):679-691. doi: 10.1089/hum.2019.248. Epub 2020 Apr 23.
- Background: PubMed 29462761Vormittag P, Gunn R, Ghorashian S, Veraitch FS. A guide to manufacturing CAR T cell therapies. Curr Opin Biotechnol. 2018 Oct;53:164-181. doi: 10.1016/j.copbio.2018.01.025. Epub 2018 Feb 18.
- Background: PubMed 22898597Zhou Q, Schneider IC, Edes I, Honegger A, Bach P, Schonfeld K, Schambach A, Wels WS, Kneissl S, Uckert W, Buchholz CJ. T-cell receptor gene transfer exclusively to human CD8(+) cells enhances tumor cell killing. Blood. 2012 Nov 22;120(22):4334-42. doi: 10.1182/blood-2012-02-412973. Epub 2012 Aug 16.
- Background: PubMed 28416815Smith TT, Stephan SB, Moffett HF, McKnight LE, Ji W, Reiman D, Bonagofski E, Wohlfahrt ME, Pillai SPS, Stephan MT. In situ programming of leukaemia-specific T cells using synthetic DNA nanocarriers. Nat Nanotechnol. 2017 Aug;12(8):813-820. doi: 10.1038/nnano.2017.57. Epub 2017 Apr 17.
- Background: PubMed 25949921Koneru M, Purdon TJ, Spriggs D, Koneru S, Brentjens RJ. IL-12 secreting tumor-targeted chimeric antigen receptor T cells eradicate ovarian tumors in vivo. Oncoimmunology. 2015 Jan 23;4(3):e994446. doi: 10.4161/2162402X.2014.994446. eCollection 2015 Mar.
- Background: PubMed 28129122Locke FL, Neelapu SS, Bartlett NL, Siddiqi T, Chavez JC, Hosing CM, Ghobadi A, Budde LE, Bot A, Rossi JM, Jiang Y, Xue AX, Elias M, Aycock J, Wiezorek J, Go WY. Phase 1 Results of ZUMA-1: A Multicenter Study of KTE-C19 Anti-CD19 CAR T Cell Therapy in Refractory Aggressive Lymphoma. Mol Ther. 2017 Jan 4;25(1):285-295. doi: 10.1016/j.ymthe.2016.10.020. Epub 2017 Jan 4.
- Background: PubMed 17242396Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, Coiffier B, Fisher RI, Hagenbeek A, Zucca E, Rosen ST, Stroobants S, Lister TA, Hoppe RT, Dreyling M, Tobinai K, Vose JM, Connors JM, Federico M, Diehl V; International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007 Feb 10;25(5):579-86. doi: 10.1200/JCO.2006.09.2403. Epub 2007 Jan 22.
- Background: PubMed 28925994Neelapu SS, Tummala S, Kebriaei P, Wierda W, Gutierrez C, Locke FL, Komanduri KV, Lin Y, Jain N, Daver N, Westin J, Gulbis AM, Loghin ME, de Groot JF, Adkins S, Davis SE, Rezvani K, Hwu P, Shpall EJ. Chimeric antigen receptor T-cell therapy - assessment and management of toxicities. Nat Rev Clin Oncol. 2018 Jan;15(1):47-62. doi: 10.1038/nrclinonc.2017.148. Epub 2017 Sep 19.
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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. This study is not recruiting at the moment.
Qing Zhang, Doctoral principal investigator
Guangdong Second Provincial General Hospital
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 infusion of JY231 injection in people with Relapsed or Refractory B-cell Lymphoma, run by Guangdong Second Provincial General Hospital 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 23 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 21 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qing Zhang, Doctoral (+86 20 8916 8162, zhqing@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: Month1、Month2、Month3、Month6、Month9、Month12). 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 NCT06045585, which also lists 9 linked publications.
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 21 Sep 2023.