Multiple MyelomaEarly Phase 1NCT07249073
CAR19-BCMA Dual-target CAR-T in the Treatment of Relapsed / Refractory Multiple Myeloma
A Early Phase 1 study testing CAR19-BCMA dual-target CAR-T in people with Multiple Myeloma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
1. Objective to evaluate the safety and tolerability of CAR19-BCMA dual-target CAR-T in the treatment of relapsed / refractory multiple myeloma. 2. To determine the maximum tolerated dose (MTD) of car19-bcma dual target car-t in the treatment of relapsed / refractory multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- CAR19-BCMA dual-target CAR-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 28 Mar 2025to 27 Mar 2029
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must satisfy all the following criteria to be enrolled in the study:
- 1. With Subjects' consent and signed informed consent, Subjects are willing and able to follow the planned visit, study treatment, laboratory examination and other test procedures; 2. Patients with relapsed / refractory multiple myeloma according to clinical diagnosis:
- The expression of BCMA and / or CD19 in myeloma cells was positive confimed by flow cytometry or immunohistochemistry;
- Patients with relapsed / refractory multiple myeloma who have received at least 1 line treatment (including proteasome inhibitors (PI), immunomodulatory drugs (IMID), CD38 mAb) or are resistant to proteasome inhibitors and / or immunomodulatory agents and / or CD38 mAb in the past.
- 3. Age 18-70 years old, both male and female; 4. Subjects with physical fitness status of 0-2 in the Eastern Cooperative Oncology Group (ECOG) score; 5. The estimated survival time from the date of signing informed consent is more than 3 months; 6. Hgb ≥ 60g/L (transfusible); 7. Liver and kidney function and cardiopulmonary function meet the following requirements:
- Creatinine ≤ 2 × ULN;
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- Left ventricular ejection fraction ≥ 50%;
- Blood oxygen saturation >90%;
- Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN; 8. Subjects with pregnancy plans must agree to take contraception before enrollment in the study and after six months of study duration; The investigator should be informed immediately if the subject is pregnant or suspected of pregnancy.
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Who cannot join
- If any of the following criteria is met, you cannot be enrolled:
- 1. There were severe cardiac insufficiency and left ventricular ejection fraction <50%; 2. Have a history of severe lung function impairment disease; 3. Combined with other advanced malignant tumors; 4. It was complicated with serious infection and could not be effectively controlled; 5. Complicated with severe autoimmune disease or innate immune deficiency; 6. Active hepatitis (hepatitis B virus deoxyribonucleic acid [hbv-dna] or hepatitis C virus ribonucleic acid [hcv-rna] test results are higher than the lower limit of detection); 7. Human immunodeficiency virus (HIV) infection or known acquired immune deficiency syndrome (AIDS), or syphilis infection; 8. Have a history of severe allergy to biological products (including antibiotics); 9. One month after immunosuppressant withdrawal, patients with acute graft-versus-host response (GVHD) after allogeneic hematopoietic stem cell transplantation still exist; 10. There are other serious physical or mental diseases or abnormal laboratory tests that may increase the risk of participating in the study, or interfere with the results of the study, as well as patients who the investigator believes are not suitable for participating in this study; 11. Female patients (patients with fertility) are in pregnancy or lactation. Note: severe infection: refers to the infection with uncontrolled sepsis or infection focus, which can be enrolled after infection control.
- -
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: Exploratory Clinical Study on the Safety and Efficacy of CAR19-BCMA Dual-target CAR-T in the Treatment of Relapsed / Refractory Multiple Myeloma
- Objective to evaluate the safety and tolerability of CAR19-BCMA dual-target CAR-T in the treatment of relapsed / refractory multiple myeloma.
- To determine the maximum tolerated dose (MTD) of car19-bcma dual target car-t in the treatment of relapsed / refractory multiple myeloma.
Read the detailed description
This study is an open, single arm, prospective, phase I clinical study, using "3+3" dose escalation to explore the safety, maximum tolerated dose, in vivo pharmacokinetic characteristics and preliminary efficacy of CAR19-BCMA dual-target CAR-T cell injection in the treatment of relapsed / refractory multiple myeloma subjects.
- Conditions
- Multiple Myeloma
- Being tested
- CAR19-BCMA dual-target CAR-T
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR19-BCMA dual-target CAR-TDrug
This drug is CAR-T cell injection. CAR-T cells are based on the traditional CAR-T treatment, using cytokine combination amplification and improved transfection technology to change the activation mode of T cells.
| Study group | Role | What they receive |
|---|---|---|
| CAR19-BCMA CAR-T | Experimental | This part follows the "3+3" dose escalation mode, with three dose groups (1E+06, 2E+06 and 3E+06 CAR+ cells /kg) Receives: Drug: CAR19-BCMA dual-target CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Adverse Events
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Measured: in 3 months after CART infusion
Laboratoty tests
Abnormal results of laboratoty tests
Measured: in 3 months after CART infusion
Secondary outcomes (6)
Overall response rate (ORR)
Percentage of subjects who achieved minimal response (MR) or better according to IMWG Uniform Response Criteria for Multiple Myeloma as assessed by the investigators
Measured: Day28, Month2, Month3, Month6, Month12, Month18, Month24 after CAR-T infusion
Minimal Residual Disease (MRD) negative rate
Proportion of subjects who achieved MRD negative
Measured: Day28, Month2, Month3, Month6, Month12, Month18, Month24 after CAR-T infusion
Overall Survival (OS)
Time from CAR19-BCMA CAR-T infusion to time of death due to any cause
Measured: Minimum of 2 years post CAR-T infusion
Progression-free Survival (PFS)
Time from CAR19-BCMA CAR-T infusion to first documentation of progressive disease (PD), or death due to any cause, whichever occurs first
Measured: Minimum of 2 years post CAR-T infusion
Event-free Survival (EFS)
Time from CAR19-BCMA CAR-T infusion to time of disease progression, recurrence, death, etc
Measured: Minimum of 2 years post CAR-T infusion
Disease Control Rate (DCR)
disease control rate after CAR19-BCMA CAR-T infusion
Measured: at Day28, Month2, Month3 , Month6, Month12, Month18, Month24 after CAR-T infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start28 Mar 2025
- Primary completion27 Mar 2028 (estimated)
- Study completion27 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Hebei Taihe Chunyu Biotechnology Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Yan Xu, MD, Principal investigator, Institute of Hematology & Blood Diseases Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07249073
- Sponsor's protocol ID
- IIT2025040
- Status last verified
- Sep 2025
- First submitted
- 31 Jul 2025
- Last updated
- 25 Nov 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 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Clinical Study on the Safety and Efficacy of CAR19-BCMA Dual-target CAR-T in the Treatment of Relapsed / Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07249073
- Acronym / sponsor ID
- IIT2025040
- Conditions
- Multiple Myeloma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Collaborators
- Hebei Taihe Chunyu Biotechnology Co., Ltd
- Study start
- 28 Mar 2025 (actual)
- Primary completion
- 27 Mar 2028 (estimated)
- Study completion
- 27 Mar 2029 (estimated)
- First posted
- 25 Nov 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.
- Objective to evaluate the safety and tolerability of CAR19-BCMA dual-target CAR-T in the treatment of relapsed / refractory multiple myeloma.
- To determine the maximum tolerated dose (MTD) of car19-bcma dual target car-t in the treatment of relapsed / refractory multiple myeloma.
Detailed description
This study is an open, single arm, prospective, phase I clinical study, using "3+3" dose escalation to explore the safety, maximum tolerated dose, in vivo pharmacokinetic characteristics and preliminary efficacy of CAR19-BCMA dual-target CAR-T cell injection in the treatment of relapsed / refractory multiple myeloma subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR19-BCMA CAR-T | Experimental | Drug: CAR19-BCMA dual-target CAR-TThis part follows the "3+3" dose escalation mode, with three dose groups (1E+06, 2E+06 and 3E+06 CAR+ cells /kg) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1. With Subjects' consent and signed informed consent, Subjects are willing and able to follow the planned visit, study treatment, laboratory examination and other test procedures; 2. Patients with relapsed / refractory multiple myeloma according to clinical diagnosis:
- The expression of BCMA and / or CD19 in myeloma cells was positive confimed by flow cytometry or immunohistochemistry;
- Patients with relapsed / refractory multiple myeloma who have received at least 1 line treatment (including proteasome inhibitors (PI), immunomodulatory drugs (IMID), CD38 mAb) or are resistant to proteasome inhibitors and / or immunomodulatory agents and / or CD38 mAb in the past.
- 3. Age 18-70 years old, both male and female; 4. Subjects with physical fitness status of 0-2 in the Eastern Cooperative Oncology Group (ECOG) score; 5. The estimated survival time from the date of signing informed consent is more than 3 months; 6. Hgb ≥ 60g/L (transfusible); 7. Liver and kidney function and cardiopulmonary function meet the following requirements:
- Creatinine ≤ 2 × ULN;
Key exclusion criteria (3 listed)
- 1. There were severe cardiac insufficiency and left ventricular ejection fraction <50%; 2. Have a history of severe lung function impairment disease; 3. Combined with other advanced malignant tumors; 4. It was complicated with serious infection and could not be effectively controlled; 5. Complicated with severe autoimmune disease or innate immune deficiency; 6. Active hepatitis (hepatitis B virus deoxyribonucleic acid [hbv-dna] or hepatitis C virus ribonucleic acid [hcv-rna] test results are higher than the lower limit of detection); 7. Human immunodeficiency virus (HIV) infection or known acquired immune deficiency syndrome (AIDS), or syphilis infection; 8. Have a history of severe allergy to biological products (including antibiotics); 9. One month after immunosuppressant withdrawal, patients with acute graft-versus-host response (GVHD) after allogeneic hematopoietic stem cell transplantation still exist; 10. There are other serious physical or mental diseases or abnormal laboratory tests that may increase the risk of participating in the study, or interfere with the results of the study, as well as patients who the investigator believes are not suitable for participating in this study; 11. Female patients (patients with fertility) are in pregnancy or lactation. Note: severe infection: refers to the infection with uncontrolled sepsis or infection focus, which can be enrolled after infection control.
- -
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 |
|---|---|---|
| CAR19-BCMA dual-target CAR-TThis drug is CAR-T cell injection. CAR-T cells are based on the traditional CAR-T treatment, using cytokine combination amplification and improved transfection technology to change the activation mode of T cells. | Drug | CAR19-BCMA CAR-T |
Primary outcome
Incidence and Severity of Adverse Events
Time frame: in 3 months after CART infusion
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Laboratoty tests
Time frame: in 3 months after CART infusion
Abnormal results of laboratoty tests
6 secondary outcomes
Overall response rate (ORR)
Time frame: Day28, Month2, Month3, Month6, Month12, Month18, Month24 after CAR-T infusion
Minimal Residual Disease (MRD) negative rate
Time frame: Day28, Month2, Month3, Month6, Month12, Month18, Month24 after CAR-T infusion
Overall Survival (OS)
Time frame: Minimum of 2 years post CAR-T infusion
Progression-free Survival (PFS)
Time frame: Minimum of 2 years post CAR-T infusion
Event-free Survival (EFS)
Time frame: Minimum of 2 years post CAR-T infusion
Disease Control Rate (DCR)
Time frame: at Day28, Month2, Month3 , Month6, Month12, Month18, Month24 after CAR-T 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 25 Nov 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.
Yan Xu, MD 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 Early Phase 1 study testing CAR19-BCMA dual-target CAR-T in people with Multiple Myeloma, 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 10 inclusion and 3 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 25 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 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?
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 Yan Xu, MD (13920593907 ext. +86, ec@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Severity of Adverse Events (time frame: in 3 months after CART 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?
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 25 Nov 2025.