Multiple MyelomaPhase 1/2NCT06503107
Nanobody-based Biepitope CAR-T Cells Targeting BCMA in the Treatment of R/RMM
A Phase 1/2 study testing Nanobody-based biepitope BCMA-targeting CAR-T cells in people with Multiple Myeloma, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
To explore the safety and efficacy of nanobody-based BCMA-targeting biepitope CAR-T cells in the treatment of relapsed/refractory multiple myeloma，this study will be conducted in multiple study centers, with 60 patients openly enrolled to receive CAR-T cell therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Nanobody-based biepitope BCMA-targeting CAR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 23 Apr 2024to 18 Oct 2026
- Phase
- Phase 1/2
- 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
- Patient or his or her legal guardian voluntarily participates in and signs an informed consent form.
- Aged ≥ 18 years and ≤ 75 years.
- Diagnosed as Multiple Myeloma (MM) according to the international standard for multiple myeloma (IMWG 2014).
- Diagnosed as relapsed/refractory disease or primary refractory disease; relapse is defined as disease progression within 60 days of the most recent treatment with three or more lines of therapy with different mechanisms of action; refractory is defined as failure to achieve MR or above efficacy with prior treatment and disease progression with recent treatment, or disease progression within 60 days of treatment.
- Flow cytometry or immunohistochemistry showed positive BCMA expression in myeloma cells.
- Have not been treated with antibody-based drugs within 2 weeks prior to cell therapy.
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- ECOG score 0-2 points.
- HGB≥70g/L，PLT≥30×10^9/L.
- Liver, kidney and cardiopulmonary functions meet the following requirements:
- Serum creatinine ≤ 1.5× ULN or creatinine clearance (Cockcroft-Gault) >30 ml/min；
- Left ventricular ejection fraction (LVEF) ≥50%,
- Baseline peripheral oxygen saturation > 90%;
- Total bilirubin ≤ 1.5×ULN; ALT and AST ≤2.5×ULN.
Who cannot join
- Previous diagnosis and treatment of other malignancies within 3 years;
- Presence of one of the following cardiac criteria: atrial fibrillation; Myocardial infarction within the last 12 months; Prolonged QT syndrome or secondary QT prolongation, as judged by the investigator. Echocardiogram LVSF <30% or LVEF <50%; Clinically significant pericardial effusion; Cardiac insufficiency NYHA (New York Heart Association) III or IV (absence of this symptom confirmed by echocardiography within 12 months of treatment);
- Patients with active GVHD;
- Patients with a history of severe pulmonary impairment disease;
- Combined with other malignant tumors in the advanced stage;
- Co-infection with severe or persistent infection that cannot be effectively controlled;
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- Combined with severe autoimmune disease or congenital immunodeficiency;
- Active hepatitis (hepatitis B virus deoxyribonucleic acid [HBV-DNA ≥ 500 IU/ml and abnormal liver function] or hepatitis C antibody [HCV-Ab] positive, HCV-RNA above the lower limit of detection of the analytical method and abnormal liver function);
- Human immunodeficiency virus (HIV) infection or syphilis infection;
- Patients with a history of severe allergy to biological products (including antibiotics);
- Patients with central nervous system disorders such as uncontrolled epilepsy, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, etc;
- Pregnant or Lactating Women; Patients and his or her spouses have a fertility plan within 12 months after CAR-T cell infusion;
- Other conditions considered inappropriate by the researcher.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Heng Mei, M.D., Ph.D, 027-8572600, hmei@hust.edu.cn
Heng Mei, M.D., Ph.D
About this study
Official title: A Multicenter Clinical Study on the Safety and Efficacy of Nanobody-based Biepitope CAR-T Cells Targeting BCMA in the Treatment of Relapsed/Refractory Multiple Myeloma
To explore the safety and efficacy of nanobody-based BCMA-targeting biepitope CAR-T cells in the treatment of relapsed/refractory multiple myeloma，this study will be conducted in multiple study centers, with 60 patients openly enrolled to receive CAR-T cell therapy. Patients participating in clinical trials will be tested and evaluated for treatment safety, efficacy, duration of response, and long-term survival.
Read the detailed description
This study is a multicenter, open-label, prospective, single-arm clinical study with patients with relapsed/refractory multiple myeloma as the test subjects, in order to evaluate the safety and efficacy of nanobody-based biepitope CAR-T cells targeting BCMA in the treatment of R/RMM, and to collect CAR-T PK/PD indicators. The structure of BCMA target CAR-T is designed to identify two different epitopes of BCMA protein with two recognition domains, in order to killig MM cells without secreting more pro-inflammatory factors and avoiding escape caused by the limitations of single BCMA antigen recognition.
- Conditions
- Multiple Myeloma
- Being tested
- Nanobody-based biepitope BCMA-targeting CAR-T cells
- Keywords
- CAR-T, BCMA, Relapsed / Refractory multiple myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanobody-based biepitope BCMA-targeting CAR-T cellsDrug
Each patient will receive nanobody-based biepitope BCMA-targeting CAR-T cell by intravenous infusion on day 0.
| Study group | Role | What they receive |
|---|---|---|
| Effective of nanobody-based biepitope BCMA-targeting CAR-T cells | Experimental | The recommended reinfusion dose of biepitope BCMA-targeting CAR-T cells in this trial is: 1 × 10^6/kg, 2 × 10^6/kg CAR-T cells. Receives: Drug: Nanobody-based biepitope BCMA-targeting CAR-T cells |
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 National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).
Measured: within 3 years after infusion
Overall response rate (ORR) of nanobody-based biepitope CAR-T cells targeting BCMA in R/R MM
Disease overall response rate (ORR) will be assessed from CAR-T cell infusion to death or last follow-up (censored).
The rates of stringent complete response (sCRs), complete response (CR), very good partial response (VGPR), partial response (PR), minimal response (MR) will be assessed from CAR T cell infusion to death or last follow-up (censored). ORR will be assessed from CAR T cell infusion to death or last follow-up.
Measured: within 3 years after infusion
The rates of complete response (CR) of nanobody-based biepitope CAR-T cells targeting BCMA in R/R MM
CR will be assessed from CAR-T cell infusion to death or last follow-up (censored).
Measured: within 3 years after infusion
Very good partial response (VGPR) of nanobody-based biepitope CAR-T cells targeting BCMA in R/R MM
VGPR will be assessed from CAR-T cell infusion to death or last follow-up (censored).
Measured: within 3 years after infusion
Partial response rate (PR) of nanobody-based biepitope CAR-T cells targeting BCMA in R/R MM
PR will be assessed from CAR-T cell infusion to death or last follow-up (censored).
Measured: within 3 years after infusion
Stable diseases (SD) of nanobody-based biepitope CAR-T cells targeting BCMA in R/R MM
SD will be assessed from CAR-T cell infusion to death or last follow-up (censored).
Measured: within 3 years after infusion
Secondary outcomes (3)
Overall survival (OS) of nanobody-based biepitope CAR-T cells targeting BCMA in Relapsed/Refractory multiple myeloma
OS will be assessed from CAR-T cell infusion to death or last follow-up (censored).
Measured: within 3 years after infusion
Progression-free survival (PFS) of nanobody-based biepitope CAR-T cells targeting BCMA in Relapsed/Refractory multiple myeloma
PFS will be assessed from CAR-T cell infusion to death or last follow-up (censored).
Measured: within 3 years after infusion
Event-free survival (EFS) of nanobody-based biepitope CAR-T cells targeting BCMA in Relapsed/Refractory multiple myeloma
EFS will be assessed from CAR-T cell infusion to death or last follow-up (censored).
Measured: within 3 years after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start23 Apr 2024
- Primary completion18 Apr 2026 (estimated)
- Study completion18 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Hebei Taihe Chunyu Biotechnology Co., Ltd, Huazhong University of Science and Technology Union Shenzhen Hospital, The Seventh Affiliated Hospital of Sun Yat-sen University
- Responsible party
- Principal investigator, MEI HENG, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06503107
- Sponsor's protocol ID
- biepitope BCMA CAR-T
- Status last verified
- Jul 2024
- First submitted
- 17 Jun 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cohen AD, Garfall AL, Stadtmauer EA, Melenhorst JJ, Lacey SF, Lancaster E, Vogl DT, Weiss BM, Dengel K, Nelson A, Plesa G, Chen F, Davis MM, Hwang WT, Young RM, Brogdon JL, Isaacs R, Pruteanu-Malinici I, Siegel DL, Levine BL, June CH, Milone MC. B cell maturation antigen-specific CAR T cells are clinically active in multiple myeloma. J Clin Invest. 2019 Mar 21;129(6):2210-2221. doi: 10.1172/JCI126397.
PubMed 30896447Berdeja JG, Madduri D, Usmani SZ, Jakubowiak A, Agha M, Cohen AD, Stewart AK, Hari P, Htut M, Lesokhin A, Deol A, Munshi NC, O'Donnell E, Avigan D, Singh I, Zudaire E, Yeh TM, Allred AJ, Olyslager Y, Banerjee A, Jackson CC, Goldberg JD, Schecter JM, Deraedt W, Zhuang SH, Infante J, Geng D, Wu X, Carrasco-Alfonso MJ, Akram M, Hossain F, Rizvi S, Fan F, Lin Y, Martin T, Jagannath S. Ciltacabtagene autoleucel, a B-cell maturation antigen-directed chimeric antigen receptor T-cell therapy in patients with relapsed or refractory multiple myeloma (CARTITUDE-1): a phase 1b/2 open-label study. Lancet. 2021 Jul 24;398(10297):314-324. doi: 10.1016/S0140-6736(21)00933-8. Epub 2021 Jun 24.
PubMed 34175021Lee DW, Kochenderfer JN, Stetler-Stevenson M, Cui YK, Delbrook C, Feldman SA, Fry TJ, Orentas R, Sabatino M, Shah NN, Steinberg SM, Stroncek D, Tschernia N, Yuan C, Zhang H, Zhang L, Rosenberg SA, Wayne AS, Mackall CL. T cells expressing CD19 chimeric antigen receptors for acute lymphoblastic leukaemia in children and young adults: a phase 1 dose-escalation trial. Lancet. 2015 Feb 7;385(9967):517-528. doi: 10.1016/S0140-6736(14)61403-3. Epub 2014 Oct 13.
PubMed 25319501Ali SA, Shi V, Maric I, Wang M, Stroncek DF, Rose JJ, Brudno JN, Stetler-Stevenson M, Feldman SA, Hansen BG, Fellowes VS, Hakim FT, Gress RE, Kochenderfer JN. T cells expressing an anti-B-cell maturation antigen chimeric antigen receptor cause remissions of multiple myeloma. Blood. 2016 Sep 29;128(13):1688-700. doi: 10.1182/blood-2016-04-711903. Epub 2016 Jul 13.
PubMed 27412889
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Clinical Study on the Safety and Efficacy of Nanobody-based Biepitope CAR-T Cells Targeting BCMA in the Treatment of Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06503107
- Acronym / sponsor ID
- biepitope BCMA CAR-T
- Conditions
- Multiple Myeloma
- Keywords
- CAR-T, BCMA, Relapsed / Refractory multiple myeloma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Hebei Taihe Chunyu Biotechnology Co., Ltd, Huazhong University of Science and Technology Union Shenzhen Hospital, The Seventh Affiliated Hospital of Sun Yat-sen University
- Study start
- 23 Apr 2024 (actual)
- Primary completion
- 18 Apr 2026 (estimated)
- Study completion
- 18 Oct 2026 (estimated)
- First posted
- 16 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.
To explore the safety and efficacy of nanobody-based BCMA-targeting biepitope CAR-T cells in the treatment of relapsed/refractory multiple myeloma，this study will be conducted in multiple study centers, with 60 patients openly enrolled to receive CAR-T cell therapy. Patients participating in clinical trials will be tested and evaluated for treatment safety, efficacy, duration of response, and long-term survival.
Detailed description
This study is a multicenter, open-label, prospective, single-arm clinical study with patients with relapsed/refractory multiple myeloma as the test subjects, in order to evaluate the safety and efficacy of nanobody-based biepitope CAR-T cells targeting BCMA in the treatment of R/RMM, and to collect CAR-T PK/PD indicators. The structure of BCMA target CAR-T is designed to identify two different epitopes of BCMA protein with two recognition domains, in order to killig MM cells without secreting more pro-inflammatory factors and avoiding escape caused by the limitations of single BCMA antigen recognition.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Effective of nanobody-based biepitope BCMA-targeting CAR-T cells | Experimental | Drug: Nanobody-based biepitope BCMA-targeting CAR-T cellsThe recommended reinfusion dose of biepitope BCMA-targeting CAR-T cells in this trial is: 1 × 10^6/kg, 2 × 10^6/kg CAR-T cells. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patient or his or her legal guardian voluntarily participates in and signs an informed consent form.
- Aged ≥ 18 years and ≤ 75 years.
- Diagnosed as Multiple Myeloma (MM) according to the international standard for multiple myeloma (IMWG 2014).
- Diagnosed as relapsed/refractory disease or primary refractory disease; relapse is defined as disease progression within 60 days of the most recent treatment with three or more lines of therapy with different mechanisms of action; refractory is defined as failure to achieve MR or above efficacy with prior treatment and disease progression with recent treatment, or disease progression within 60 days of treatment.
- Flow cytometry or immunohistochemistry showed positive BCMA expression in myeloma cells.
Key exclusion criteria (13 listed)
- Previous diagnosis and treatment of other malignancies within 3 years;
- Presence of one of the following cardiac criteria: atrial fibrillation; Myocardial infarction within the last 12 months; Prolonged QT syndrome or secondary QT prolongation, as judged by the investigator. Echocardiogram LVSF <30% or LVEF <50%; Clinically significant pericardial effusion; Cardiac insufficiency NYHA (New York Heart Association) III or IV (absence of this symptom confirmed by echocardiography within 12 months of treatment);
- Patients with active GVHD;
- Patients with a history of severe pulmonary impairment disease;
- Combined with other malignant tumors in the advanced stage;
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 |
|---|---|---|
| Nanobody-based biepitope BCMA-targeting CAR-T cellsEach patient will receive nanobody-based biepitope BCMA-targeting CAR-T cell by intravenous infusion on day 0. | Drug | Effective of nanobody-based biepitope BCMA-targeting CAR-T cells |
Primary outcome
Incidence of Treatment-related Adverse Events
Time frame: within 3 years after 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 National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).
Overall response rate (ORR) of nanobody-based biepitope CAR-T cells targeting BCMA in R/R MM
Time frame: within 3 years after infusion
Disease overall response rate (ORR) will be assessed from CAR-T cell infusion to death or last follow-up (censored). The rates of stringent complete response (sCRs), complete response (CR), very good partial response (VGPR), partial response (PR), minimal response (MR) will be assessed from CAR T cell infusion to death or last follow-up (censored). ORR will be assessed from CAR T cell infusion to death or last follow-up.
The rates of complete response (CR) of nanobody-based biepitope CAR-T cells targeting BCMA in R/R MM
Time frame: within 3 years after infusion
CR will be assessed from CAR-T cell infusion to death or last follow-up (censored).
Very good partial response (VGPR) of nanobody-based biepitope CAR-T cells targeting BCMA in R/R MM
Time frame: within 3 years after infusion
VGPR will be assessed from CAR-T cell infusion to death or last follow-up (censored).
Partial response rate (PR) of nanobody-based biepitope CAR-T cells targeting BCMA in R/R MM
Time frame: within 3 years after infusion
PR will be assessed from CAR-T cell infusion to death or last follow-up (censored).
Stable diseases (SD) of nanobody-based biepitope CAR-T cells targeting BCMA in R/R MM
Time frame: within 3 years after infusion
SD will be assessed from CAR-T cell infusion to death or last follow-up (censored).
3 secondary outcomes
Overall survival (OS) of nanobody-based biepitope CAR-T cells targeting BCMA in Relapsed/Refractory multiple myeloma
Time frame: within 3 years after infusion
Progression-free survival (PFS) of nanobody-based biepitope CAR-T cells targeting BCMA in Relapsed/Refractory multiple myeloma
Time frame: within 3 years after infusion
Event-free survival (EFS) of nanobody-based biepitope CAR-T cells targeting BCMA in Relapsed/Refractory multiple myeloma
Time frame: within 3 years after infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Background: PubMed 30896447Cohen AD, Garfall AL, Stadtmauer EA, Melenhorst JJ, Lacey SF, Lancaster E, Vogl DT, Weiss BM, Dengel K, Nelson A, Plesa G, Chen F, Davis MM, Hwang WT, Young RM, Brogdon JL, Isaacs R, Pruteanu-Malinici I, Siegel DL, Levine BL, June CH, Milone MC. B cell maturation antigen-specific CAR T cells are clinically active in multiple myeloma. J Clin Invest. 2019 Mar 21;129(6):2210-2221. doi: 10.1172/JCI126397.
- Background: PubMed 34175021Berdeja JG, Madduri D, Usmani SZ, Jakubowiak A, Agha M, Cohen AD, Stewart AK, Hari P, Htut M, Lesokhin A, Deol A, Munshi NC, O'Donnell E, Avigan D, Singh I, Zudaire E, Yeh TM, Allred AJ, Olyslager Y, Banerjee A, Jackson CC, Goldberg JD, Schecter JM, Deraedt W, Zhuang SH, Infante J, Geng D, Wu X, Carrasco-Alfonso MJ, Akram M, Hossain F, Rizvi S, Fan F, Lin Y, Martin T, Jagannath S. Ciltacabtagene autoleucel, a B-cell maturation antigen-directed chimeric antigen receptor T-cell therapy in patients with relapsed or refractory multiple myeloma (CARTITUDE-1): a phase 1b/2 open-label study. Lancet. 2021 Jul 24;398(10297):314-324. doi: 10.1016/S0140-6736(21)00933-8. Epub 2021 Jun 24.
- Results publication: PubMed 25319501Lee DW, Kochenderfer JN, Stetler-Stevenson M, Cui YK, Delbrook C, Feldman SA, Fry TJ, Orentas R, Sabatino M, Shah NN, Steinberg SM, Stroncek D, Tschernia N, Yuan C, Zhang H, Zhang L, Rosenberg SA, Wayne AS, Mackall CL. T cells expressing CD19 chimeric antigen receptors for acute lymphoblastic leukaemia in children and young adults: a phase 1 dose-escalation trial. Lancet. 2015 Feb 7;385(9967):517-528. doi: 10.1016/S0140-6736(14)61403-3. Epub 2014 Oct 13.
- Results publication: PubMed 27412889Ali SA, Shi V, Maric I, Wang M, Stroncek DF, Rose JJ, Brudno JN, Stetler-Stevenson M, Feldman SA, Hansen BG, Fellowes VS, Hakim FT, Gress RE, Kochenderfer JN. T cells expressing an anti-B-cell maturation antigen chimeric antigen receptor cause remissions of multiple myeloma. Blood. 2016 Sep 29;128(13):1688-700. doi: 10.1182/blood-2016-04-711903. Epub 2016 Jul 13.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nanobody-based biepitope BCMA-targeting CAR-T cells in people with Multiple Myeloma, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 13 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: status not confirmed, as of the sponsor's last update on 16 Jul 2024. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Mei Heng, M.D., Ph.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: within 3 years after infusion). The study lists 6 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 NCT06503107, which also lists 4 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 16 Jul 2024.