Ultra High Risk mm (uhr-mm), 18-70 Years Old, Suitable for ASCT. And Meet Any of the Following uhr-mm DefinitionsPhase 1/2NCT07109323
Autologous Transplantation Combined With BCMA CAR-T in the Treatment of UHR-MM
A Phase 1/2 study testing BCMA CART in people with Ultra High Risk mm (uhr-mm), 18-70 Years Old, Suitable for ASCT. And Meet Any of the Following uhr-mm Definitions and Cytogenetics Ultra High Risk, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
To evaluate the safety and efficacy of autologous hematopoietic stem cell transplantation (ASCT) combined with BCMA-CART in the treatment of UHR-MM. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ultra High Risk mm (uhr-mm), 18-70 Years Old, Suitable for ASCT. And Meet Any of the Following uhr-mm Definitions, Cytogenetics Ultra High Risk, Primary Refractory
- What is being tested?
- BCMA CART
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 3 Mar 2025to 2 Mar 2030
- Phase
- Phase 1/2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following criteria to be enrolled:
- Ultra high risk mm (UHR-MM), 18-70 years old, suitable for ASCT. And meet any of the following definitions of UHR-MM: 1) cytogenetic ultra-high risk, which meets any of the following conditions, including: del(17p)≥60%； Two or more cytogenetic features: TP53 mutation, del (17p) or p53 deletion, t (4; 14), t (14; 16), t (14; 20), 1q21 gain or amplification, 1p deletion, myc translocation (deletion or copy number abnormality: ≥ 20% is positive; translocation: ≥ 10% is positive); 2) Primary refractory (first-line induction therapy based on standard three drug combination: 2 courses < Mr, 4 courses < PR); 3) Early progression (the best first-line treatment response of the regimen based on the standard three drug combination is maintained for less than 6 months); 4) Plasma cell leukemia (meeting the diagnostic criteria of mm at the initial diagnosis, and the proportion of peripheral plasma cells ≥ 5%); 5) Non paraosseous extramedullary infiltration; 6) R2-iss-iv /mpss-iv.
- The subjects voluntarily participated in the study and signed the informed consent form (ICF) by themselves or their legal guardians;
- The subject must have proper organ function and meet all the following inspection results:
- Serum total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; Creatinine clearance (CrCl) (Cockcroft Gault formula) ≥ 40ml/min; Prothrombin time (PT) ≤ 1.5 × ULN, partial prothrombin time (APTT) < 1.5 × ULN, international normalized ratio (INR) < 1.5 × ULN; Hemoglobin (HB) ≥ 60g/L; Absolute neutrophil count (ANC) ≥ 1.0 × 10^9/L (no growth factors such as granulocyte colony-stimulating factor [G-CSF] received within 7 days before laboratory examination in screening period); Absolute lymphocyte count (ALC) ≥ 0.5 × 10^9/L; Platelet (PLT) ≥ 50 × 10^9/L (no platelet transfusion within 7 days before laboratory examination in screening period); Left ventricular ejection fraction (LVEF) ≥ 45%; Blood oxygen saturation (SpO2) ≥ 92%; (3) The ECoG score is 0-1. See Appendix V for ECOG score; (4) Estimated survival ≥ 3 months; (5) The pregnancy test of fertile female subjects should be negative and not within the lactation period; Both female and male subjects need to take effective contraceptive tools or drugs within 24 months after cell infusion.
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- Exclusion Criteria:Subjects who have one or more of the following cannot be selected for this study:
- Have a history of allergy to any component in cell products;
- Serious heart disease, including but not limited to:
- Myocardial infarction, cardiac angioplasty or stent implantation within 6 months before signing ICF Unstable angina Severe arrhythmia History of severe non ischemic cardiomyopathy Congestive heart failure (New York Heart Association [nyha] class III or IV), and the NYHA score is shown in Appendix II
- History of autologous / allogeneic hematopoietic stem cell transplantation;
- Stroke or seizure within 6 months before signing ICF;
- Have autoimmune disease, immune deficiency or other diseases requiring immunosuppressant treatment;
- Within 3 years before signing the ICF, patients with malignant tumors other than multiple myeloma, except for fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, breast ductal carcinoma in situ after radical surgery, and carcinoma in situ in other parts one year after radical surgery, and there has been no treatment and no recurrence in the screening period Signs;
- The presence of uncontrolled active infection;
- Unstable systemic diseases judged by the investigator: including but not limited to serious liver, kidney or metabolic diseases requiring drug treatment;
- Any of the following conditions exist within 1 week before lymphocyte collection:
- The detection value of hepatitis B virus (HBV) DNA in peripheral blood was higher than the lower limit of detection Hepatitis C virus (HCV) antibody positive and peripheral HCV-RNA positive Human immunodeficiency virus (HIV) antibody positive Syphilis antigen or antibody positive Cmv-dna positive
- More than 5mg/d prednisone (or equivalent amount of other corticosteroids) was applied within 1 week before lymphocyte collection Vegan);
- Have used any car-t cell products or other genetically modified T cell therapies;
- Received BCMA targeted therapy;
- Have a history of live vaccination within 4 weeks before signing ICF;
- Have a history of alcohol abuse, drug abuse or mental illness;
- Other researchers consider it inappropriate to participate in this study. -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality
Yan Xu, MD, 13920593907 ext. +86, xuyan1@ihcams.ac.cn
About this study
Official title: Clinical Study on the Safety and Efficacy of Autologous Hematopoietic Stem Cell Transplantation Combined With BCMA-CAR-T in the Treatment of Ultra-high Risk Multiple Myeloma
To evaluate the safety and efficacy of autologous hematopoietic stem cell transplantation (ASCT) combined with BCMA-CART in the treatment of UHR-MM.
Read the detailed description
This study is a single center, prospective clinical study initiated by researchers to evaluate the safety and efficacy of autologous hematopoietic stem cell transplantation combined with BCMA CAR-T in the treatment of ultra high risk multiple myeloma (UHR-MM).
- Conditions
- Ultra High Risk mm (uhr-mm), 18-70 Years Old, Suitable for ASCT. And Meet Any of the Following uhr-mm Definitions, Cytogenetics Ultra High Risk, Primary Refractory, Early Progression, Plasma Cell Leukemia, Non Paraosseous Extramedullary Infiltration
- Being tested
- BCMA CART
- Medical subject headings
- Disease Progression, Leukemia, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCMA CARTDrug
Bcma-cart was reinfused at a dose of 1.0-2.0 × 10 ^ 6 / kg on day +3 (± 1 day) after autologous hematopoietic stem cell reinfusion.
| Study group | Role | What they receive |
|---|---|---|
| BCMA CART | Experimental | BCMA-CART was reinfused at a dose of 1.0-2.0 × 10 ^ 6 CAR-T cells/ kg on day +3 (± 1 day) after autologous hematopoietic stem cell reinfusion. Receives: Drug: BCMA CART |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRD negative rate at 3 month after treatment of ASCT+CAR-T
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start3 Mar 2025
- Primary completion2 Mar 2028 (estimated)
- Study completion2 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultra High Risk mm (uhr-mm), 18-70 Years Old, Suitable for ASCT. And Meet Any of the Following uhr-mm DefinitionsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Hebei Taihe Chunyu Biotechnology Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Dehui Zou, Principal investigator, Institute of Hematology & Blood Diseases Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07109323
- Sponsor's protocol ID
- IIT2025026
- Status last verified
- Apr 2025
- First submitted
- 31 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Safety and Efficacy of Autologous Hematopoietic Stem Cell Transplantation Combined With BCMA-CAR-T in the Treatment of Ultra-high Risk Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07109323
- Acronym / sponsor ID
- IIT2025026
- Conditions
- Ultra High Risk mm (uhr-mm), 18-70 Years Old, Suitable for ASCT. And Meet Any of the Following uhr-mm Definitions, Cytogenetics Ultra High Risk, Primary Refractory, Early Progression, Plasma Cell Leukemia, Non Paraosseous Extramedullary Infiltration
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Collaborators
- Hebei Taihe Chunyu Biotechnology Co., Ltd
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 2 Mar 2028 (estimated)
- Study completion
- 2 Mar 2030 (estimated)
- First posted
- 7 Aug 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.
To evaluate the safety and efficacy of autologous hematopoietic stem cell transplantation (ASCT) combined with BCMA-CART in the treatment of UHR-MM.
Detailed description
This study is a single center, prospective clinical study initiated by researchers to evaluate the safety and efficacy of autologous hematopoietic stem cell transplantation combined with BCMA CAR-T in the treatment of ultra high risk multiple myeloma (UHR-MM).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BCMA CART | Experimental | Drug: BCMA CARTBCMA-CART was reinfused at a dose of 1.0-2.0 × 10 ^ 6 CAR-T cells/ kg on day +3 (± 1 day) after autologous hematopoietic stem cell reinfusion. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Ultra high risk mm (UHR-MM), 18-70 years old, suitable for ASCT. And meet any of the following definitions of UHR-MM: 1) cytogenetic ultra-high risk, which meets any of the following conditions, including: del(17p)≥60%； Two or more cytogenetic features: TP53 mutation, del (17p) or p53 deletion, t (4; 14), t (14; 16), t (14; 20), 1q21 gain or amplification, 1p deletion, myc translocation (deletion or copy number abnormality: ≥ 20% is positive; translocation: ≥ 10% is positive); 2) Primary refractory (first-line induction therapy based on standard three drug combination: 2 courses < Mr, 4 courses < PR); 3) Early progression (the best first-line treatment response of the regimen based on the standard three drug combination is maintained for less than 6 months); 4) Plasma cell leukemia (meeting the diagnostic criteria of mm at the initial diagnosis, and the proportion of peripheral plasma cells ≥ 5%); 5) Non paraosseous extramedullary infiltration; 6) R2-iss-iv /mpss-iv.
- The subjects voluntarily participated in the study and signed the informed consent form (ICF) by themselves or their legal guardians;
- The subject must have proper organ function and meet all the following inspection results:
- Serum total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; Creatinine clearance (CrCl) (Cockcroft Gault formula) ≥ 40ml/min; Prothrombin time (PT) ≤ 1.5 × ULN, partial prothrombin time (APTT) < 1.5 × ULN, international normalized ratio (INR) < 1.5 × ULN; Hemoglobin (HB) ≥ 60g/L; Absolute neutrophil count (ANC) ≥ 1.0 × 10^9/L (no growth factors such as granulocyte colony-stimulating factor [G-CSF] received within 7 days before laboratory examination in screening period); Absolute lymphocyte count (ALC) ≥ 0.5 × 10^9/L; Platelet (PLT) ≥ 50 × 10^9/L (no platelet transfusion within 7 days before laboratory examination in screening period); Left ventricular ejection fraction (LVEF) ≥ 45%; Blood oxygen saturation (SpO2) ≥ 92%; (3) The ECoG score is 0-1. See Appendix V for ECOG score; (4) Estimated survival ≥ 3 months; (5) The pregnancy test of fertile female subjects should be negative and not within the lactation period; Both female and male subjects need to take effective contraceptive tools or drugs within 24 months after cell infusion.
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| BCMA CARTBcma-cart was reinfused at a dose of 1.0-2.0 × 10 ^ 6 / kg on day +3 (± 1 day) after autologous hematopoietic stem cell reinfusion. | Drug | BCMA CART |
Primary outcome
MRD negative rate at 3 month after treatment of ASCT+CAR-T
Time frame: 3 month
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 7 Aug 2025.
- Individual participant dataSharing planned: No
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.
Dehui Zou principal investigator
Institute of Hematology & Blood Diseases Hospital, China
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 BCMA CART in people with Ultra High Risk mm (uhr-mm), 18-70 Years Old, Suitable for ASCT. And Meet Any of the Following uhr-mm Definitions and Cytogenetics Ultra High Risk, run by Institute of Hematology & Blood Diseases Hospital, China 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 24 inclusion and 0 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 7 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 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?
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 Dehui Zou (13920593907 ext. +86, zoudehui@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRD negative rate at 3 month after treatment of ASCT+CAR-T (time frame: 3 month). 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 7 Aug 2025.