Extramedullary Multiple MyelomaNCT06793475
Aponermin-Based Bridging Therapy Prior to CAR-T Infusion in Relapsed/Refractory Multiple Myeloma Patients With Extramedullary Disease
A study testing anti-BCMA/GPRC5D bispecific CAR-T, Apornemin and Carfilzomib in people with Extramedullary Multiple Myeloma, run by Institute of Hematology & Blood Diseases Hospital, China at 2 sites in China.
Trial summary
This is a prospective, single-arm, multicenter, open-label study to evaluate the efficacy and safety of aponermin-based bridging therapy prior to CAR-T infusion in relapsed/refractory multiple myeloma patients with extramedullary disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extramedullary Multiple Myeloma
- What is being tested?
- anti-BCMA/GPRC5D bispecific CAR-T, Apornemin and Carfilzomib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesChina
- Study dates
- 9 Apr 2025to Dec 2026
- Phase
- Interventional
- 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
- Be informed and voluntarily sign the Informed Consent Form (ICF).
- Age ≥18 years.
- Confirmed diagnosis of Multiple Myeloma(MM) (IMWG consensus guidelines)
- Subjects with diagnosed relapsed or refractory extramedullary multiple myeloma according to IMWG criteria and have had at least 1 prior lines of therapy. Extramedullary disease (EMD) is defined as soft-tissue plasmacytomas NOT arising from skeletal lesions. The maximum diameter of extramedullary lesions should ≥2cm detected by physical exam and confirmed (when required) by Weight Bearing CT/MRI/PET-CT and/or biopsy.
- ECOG score is ≤ 2
- No active infections.
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- Negative for HBV-DNA, HCV-RNA, and HIV.
- Liver function meeting the following criteria: Total bilirubin <1.5 × ULN (patients with Gilbert's syndrome must have total bilirubin <3 × ULN), ALT and AST <3 × ULN.
- Renal function meeting the following criteria: Creatinine clearance ≥30mL/min (calculated using the Cockcroft-Gault formula).
- Blood tests conducted within 7 days before screening must meet the following standards: WBC count ≥1.0×10⁹/L, Hemoglobin ≥70g/L, Platelet count ≥75×10⁹/L or ≥50×10⁹/L (if ≥50% plasma cells are present in bone marrow); Or as determined appropriate by the investigator.
- Patients receiving hematopoietic growth factors (e.g., erythropoietin, granulocyte colony-stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor [GM-CSF], and platelet-stimulating factors such as thrombopoietin [TPO] or interleukin-11) must stop such treatments at least 2 weeks prior to screening.
- Non-pregnant female patients must confirm pregnancy negativity at screening (via β-hCG serum test or urine pregnancy test).
- Male patients, female patients of childbearing potential, and their partners must agree to use effective contraception during the treatment period and for at least 3 months after CAR-T cell infusion.
- Male patients must agree not to donate sperm, starting from the initial screening period until 90 days after the last dose.
- Patients must agree to comply with study procedures and follow-up visits.
Who cannot join
- Plasma cell leukemia or solitary plasmacytoma.
- Prior exposure to both BCMA- and GPRC5D-targeted therapies (patients who have received only one of these targeted therapies are eligible for enrollment).
- Evidence of primary or secondary resistance to elotuzumab, carfilzomib, or thalidomide.
- Pregnant or breastfeeding women, or women with pregnancy plans within the next six months.
- Infectious diseases (e.g., HIV, active tuberculosis, etc.).
- Active hepatitis B or hepatitis C infection.
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- Abnormal vital signs or inability to cooperate with examinations.
- Mental or psychological disorders preventing compliance with treatment or treatment evaluation.
- Severe allergic constitution or severe allergic history, particularly to aponermin, carfilzomib, thalidomide, dexamethasone or other effective components or excipients of related drugs.
- Significant dysfunction of major organs, such as the heart, lungs, or brain.
- 9) Patients with severe autoimmune diseases. 11) Any other reasons deemed unsuitable for participation in this study as determined by the investigator.
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
- Recruiting
Beijing Gobroad Boren Hospital
Beijing
Wei Chen, 008615801145177, chenwei@gobroadhealthcare.com
- Recruiting
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin
Gang An, PhD&MD, 008613502181109, angang@ihcams.ac.cn
About this study
Official title: Aponermin-Based Bridging Therapy Prior to CAR-T Infusion in Relapsed/Refractory Multiple Myeloma Patients With Extramedullary Disease: A Prospective, Single-Arm, Multicenter, Open-Label Study
This is a prospective, single-arm, multicenter, open-label study to evaluate the efficacy and safety of aponermin-based bridging therapy prior to CAR-T infusion in relapsed/refractory multiple myeloma patients with extramedullary disease.
- Conditions
- Extramedullary Multiple Myeloma
- Being tested
- anti-BCMA/GPRC5D bispecific CAR-T, Apornemin, Carfilzomib, Thalidomide, Dexamethasone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-BCMA/GPRC5D bispecific CAR-TBiological
Autologous BCMA/GPRC5D bispecific CAR-T cells, infusion intravenously at a target dose of 2-4 x 10^6 anti-BCMA/GPRC5D bispecific CAR-T cells/kg.
AporneminDrug
Apornemin 10mg/kg will be administered by i.v. infusion. Apornemin will be administered on Days 1-5, 15-19 during bridging therapy, and on Days 1-5 every 28-day cycle during maintanance treatment.
CarfilzomibDrug
Carfilzomib 27mg/m^2 will be administered by i.v. on Days 1,2,8,9 during bridging therapy.
ThalidomideDrug
Thalidomide (150mg/d) will be administered by p.o. on Days 1-14 during bridging therapy, and Days 1-28 every 28-day cycle during maintanance treatment.
DexamethasoneDrug
Dexamethasone (20mg/d) will be administered by i.v. or p.o. on Days 1-4,8,9 during bridging therapy.
| Study group | Role | What they receive |
|---|---|---|
| Aponermin-based regimen bridging CAR-T therapy | Experimental | Patients will receive aponermin-based bridging therapy followed by Fc-based conditioning and CAR-T cell infusion. One month after CAR-T cell therapy, patients will begin maintenance therapy for at most 6 months or until disease progression, death, intolerance, withdrawal for other reasons, or the study's termination/completion. Receives: Biological: anti-BCMA/GPRC5D bispecific CAR-T; Drug: Apornemin; Drug: Carfilzomib; Drug: Thalidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
The definition of ORR is the proportion of participants who achieve a PR or better as the best response according to the IMWG criteria.
Measured: within 1 months after BCMA/GPRC5D CAR-T infusion
Secondary outcomes (4)
ORR before CAR-T cell infusion
ORR before CAR-T cell infusion is defined as the proportion of participants who achieve a confirmed PR or better as the best response after conditioning treatment but prior to CAR-T cell infusion.
Measured: before CAR-T cell infusion
Progression free survival(PFS)
Progression free survival is defined as the time from the start of Aponermin treatment to disease progression, as defined in the IMWG criteria, or death due to any cause, whichever occurs first.
Measured: Up to 2 year
Overall Survival (OS)
Overall Survival (OS) is defined as the time from the start of Aponermin treatment to the date of the participant's death.
Measured: Up to 2 year
Adverse events and serious adverse events
Adverse events (AEs), serious adverse events (SAEs), and assessments of clinical laboratory values
Measured: Up to 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start9 Apr 2025
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extramedullary Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793475
- Sponsor's protocol ID
- IIT2024113
- Status last verified
- Dec 2024
- First submitted
- 21 Jan 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aponermin-Based Bridging Therapy Prior to CAR-T Infusion in Relapsed/Refractory Multiple Myeloma Patients With Extramedullary Disease: A Prospective, Single-Arm, Multicenter, Open-Label Study
- ClinicalTrials.gov ID
- NCT06793475
- Acronym / sponsor ID
- IIT2024113
- Conditions
- Extramedullary Multiple Myeloma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 9 Apr 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Jan 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 is a prospective, single-arm, multicenter, open-label study to evaluate the efficacy and safety of aponermin-based bridging therapy prior to CAR-T infusion in relapsed/refractory multiple myeloma patients with extramedullary disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aponermin-based regimen bridging CAR-T therapy | Experimental | Biological: anti-BCMA/GPRC5D bispecific CAR-T, Drug: Apornemin, Drug: Carfilzomib, Drug: Thalidomide, Drug: DexamethasonePatients will receive aponermin-based bridging therapy followed by Fc-based conditioning and CAR-T cell infusion. One month after CAR-T cell therapy, patients will begin maintenance therapy for at most 6 months or until disease progression, death, intolerance, withdrawal for other reasons, or the study's termination/completion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Be informed and voluntarily sign the Informed Consent Form (ICF).
- Age ≥18 years.
- Confirmed diagnosis of Multiple Myeloma(MM) (IMWG consensus guidelines)
- Subjects with diagnosed relapsed or refractory extramedullary multiple myeloma according to IMWG criteria and have had at least 1 prior lines of therapy. Extramedullary disease (EMD) is defined as soft-tissue plasmacytomas NOT arising from skeletal lesions. The maximum diameter of extramedullary lesions should ≥2cm detected by physical exam and confirmed (when required) by Weight Bearing CT/MRI/PET-CT and/or biopsy.
- ECOG score is ≤ 2
Key exclusion criteria (11 listed)
- Plasma cell leukemia or solitary plasmacytoma.
- Prior exposure to both BCMA- and GPRC5D-targeted therapies (patients who have received only one of these targeted therapies are eligible for enrollment).
- Evidence of primary or secondary resistance to elotuzumab, carfilzomib, or thalidomide.
- Pregnant or breastfeeding women, or women with pregnancy plans within the next six months.
- Infectious diseases (e.g., HIV, active tuberculosis, etc.).
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 |
|---|---|---|
| anti-BCMA/GPRC5D bispecific CAR-TAutologous BCMA/GPRC5D bispecific CAR-T cells, infusion intravenously at a target dose of 2-4 x 10^6 anti-BCMA/GPRC5D bispecific CAR-T cells/kg. | Biological | Aponermin-based regimen bridging CAR-T therapy |
| AporneminApornemin 10mg/kg will be administered by i.v. infusion. Apornemin will be administered on Days 1-5, 15-19 during bridging therapy, and on Days 1-5 every 28-day cycle during maintanance treatment. | Drug | Aponermin-based regimen bridging CAR-T therapy |
| CarfilzomibCarfilzomib 27mg/m^2 will be administered by i.v. on Days 1,2,8,9 during bridging therapy. | Drug | Aponermin-based regimen bridging CAR-T therapy |
| ThalidomideThalidomide (150mg/d) will be administered by p.o. on Days 1-14 during bridging therapy, and Days 1-28 every 28-day cycle during maintanance treatment. | Drug | Aponermin-based regimen bridging CAR-T therapy |
| DexamethasoneDexamethasone (20mg/d) will be administered by i.v. or p.o. on Days 1-4,8,9 during bridging therapy. | Drug | Aponermin-based regimen bridging CAR-T therapy |
Primary outcome
Overall response rate (ORR)
Time frame: within 1 months after BCMA/GPRC5D CAR-T infusion
The definition of ORR is the proportion of participants who achieve a PR or better as the best response according to the IMWG criteria.
4 secondary outcomes
ORR before CAR-T cell infusion
Time frame: before CAR-T cell infusion
Progression free survival(PFS)
Time frame: Up to 2 year
Overall Survival (OS)
Time frame: Up to 2 year
Adverse events and serious adverse events
Time frame: Up to 2 year
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 14 Aug 2025.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anti-BCMA/GPRC5D bispecific CAR-T, Apornemin and Carfilzomib in people with Extramedullary Multiple Myeloma, run by Institute of Hematology & Blood Diseases Hospital, China 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 15 inclusion and 11 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 14 Aug 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.
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 Gang An, PhD&MD (86-022-23909171, angang@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: within 1 months after BCMA/GPRC5D CAR-T infusion). 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 14 Aug 2025.