Relapse Multiple MyelomaNCT07359014
Novel CD19/BCMA Dual-Targeted CAR-T Cell Therapy for the Treatment of Relapsed/Refractory Multiple Myeloma
A study testing Dual CD19/BCMA CAR-T in people with Relapse Multiple Myeloma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This study aims to investigate the efficacy and safety of CD19/BCMA CAR-T cells in treating relapsed/refractory multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapse Multiple Myeloma
- What is being tested?
- Dual CD19/BCMA CAR-T
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2025to 31 Oct 2030
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Relapsed/refractory multiple myeloma.
- Confirmed by immunohistochemistry (IHC) or flow cytometry of bone marrow samples: plasma cell membrane expression of BCMA is positive (≥30%); no requirement for CD19 positivity rate. All sites must centrally submit bone marrow or plasmacytoma biopsy specimens to the lead site's pathology department or bone marrow/liquid specimens to KingMed Diagnostics (third-party laboratory) for BCMA expression verification.
- Relapsed/refractory patients must meet the following criteria:
- No response or disease progression after 3 cycles of bortezomib (proteasome inhibitor) or lenalidomide therapy No response or disease progression after 3 cycles of prior treatment regimen Interval between last treatment and disease progression >30 days No current indication for hematopoietic stem cell transplantation (HSCT), or patient refusal of HSCT
- Definition of disease progression follows the 2021 International Myeloma Working Group (IMWG) criteria, meeting at least one of the following:
- Serum M protein ≥ 5 g/L Urine M protein ≥ 200 mg/24 h If serum free light chain (FLC) ratio is abnormal, patient FLC level ≥ 100 mg/L Biopsy-confirmed evaluable plasmacytoma Increased myeloplasmacytic percentage ≥25% (absolute increase ≥10%) Myeloplasm cells constitute ≥30% of total bone marrow cells
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- Expected survival >12 weeks;
- Disease status is evaluable and meets at least one of the following:
- Serum M-protein ≥10 g/L, 24-hour urine M-protein ≥ 200 mg, Serum FLC ≥ 50 mg/L, Plasmacytoma evaluable by imaging or laboratory testing, Bone marrow plasma cell percentage ≥ 30%
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
- Sufficient venous access for apheresis or venipuncture, with no other contraindications to blood cell separation;
- white blood cell (WBC) ≥ 1.5 × 10⁹/L; platelet (PLT) ≥ 45 × 10⁹/L.
- Serum creatinine ≤ 1.5 times the upper limit of normal (ULN).
- Alanine Aminotransferase (ALT) ≤ 2.5 ULN, Aspartate Aminotransferase (AST) ≤ 2.5 ULN.
- All laboratory values within the above ranges must be achieved without ongoing supportive therapy.
Who cannot join
- Received systemic therapy such as cyclophosphamide and fludarabine for lymphoma clearance within 2 weeks prior to enrollment or single-cell collection; prior CD19/BCMA CAR-T therapy; or cell or bispecific antibody therapy within 8 weeks prior to treatment.
- Received bendamustine-containing regimens within 6 months prior to treatment.
- Hepatitis C virus (HCV) or Human Immunodeficiency Virus (HIV) positive status; any uncontrolled active infection, including active tuberculosis or Hepatitis B virus (HBV) DNA levels ≥1×10³ copies/mL.
- Active infection within 72 hours prior to treatment initiation; subjects on ongoing prophylactic antibiotics, antifungals, or antivirals are not excluded provided there is no evidence of active infection and the antibiotics are not on the prohibited drug list.
- Current systemic use of cyclosporine or steroids such as dexamethasone; recent or current use of inhaled steroids is not exclusionary.
- Renal impairment with serum creatinine >1.5 times the upper limit of normal (ULN).
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- Hepatic impairment with AST and/or ALT >2.5 times ULN and direct bilirubin >1.5 times ULN.
- Hyponatremia, serum sodium < 125 mmol/L.
- Baseline serum potassium < 3.5 mmol/L (exclusion not applied if potassium supplementation prior to study enrollment restores levels above this threshold).
- Pregnant or lactating women.
- Other serious conditions that may preclude participation in this trial (e.g., central nervous system disorders, severe heart failure, myocardial infarction within the past 6 months, unstable arrhythmia or unstable angina, gastric ulcer, active autoimmune disease, etc.).
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
Xuzhao Zhang
Hangzhou, 310003
Xuzhao Zhang, Dr., +086-571-89713679, zxzzju@zju.edu.cn
Wenbin Qian, Dr., +086-571-89713674, qianwb@zju.edu.cn
About this study
Official title: A Multicenter Clinical Study of Novel CD19/BCMA Dual-Targeted CAR-T Cell Therapy for the Treatment of Relapsed/Refractory Multiple Myeloma
This study aims to investigate the efficacy and safety of CD19/BCMA CAR-T cells in treating relapsed/refractory multiple myeloma.
Read the detailed description
B Cell Maturation Antigen (BCMA) Chimeric Antigen Receptor T-cell (CAR-T) therapy is currently a crucial treatment for relapsed/refractory multiple myeloma, yet approximately half of patients still experience relapse with limited subsequent treatment options. Recent studies suggest that dual-target CAR-T may offer new hope for relapsed/refractory multiple myeloma. Preliminary studies in this project demonstrate that the independently designed CD19/BCMA CAR-T exhibits potent anti-myeloma activity both in vitro and in tumor-bearing animal models, positioning it as a potential therapeutic strategy for relapsed/refractory multiple myeloma. Therefore, this study aims to investigate the efficacy and safety of CD19/BCMA CAR-T cells in treating relapsed/refractory multiple myeloma in humans, with the goal of providing novel therapeutic approaches for this disease.
- Conditions
- Relapse Multiple Myeloma
- Being tested
- Dual CD19/BCMA CAR-T
- Keywords
- CAR-T therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual CD19/BCMA CAR-TOther
Novel CD19/BCMA Dual-Targeted CAR-T Cell Therapy
| Study group | Role | What they receive |
|---|---|---|
| Dual CD19/BCMA CAR-T treatment | Experimental | R/R multiple myeloma patients will be treated with novel dual CD19/BCMA CAR-T Receives: Other: Dual CD19/BCMA CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of adverse events
The incidence of adverse events and abnormal laboratory findings that are "possibly" or "definitely" related to the study treatment, occurring at any time from the start of monitoring until Week 24, including dose-limiting toxicity (DLT).
Measured: up to 24 weeks
Primary implant endpoint
The survival time of CAR-T cells in vivo is defined as the "engraftment endpoint." PCR detection of CAR-T cell DNA sequences begins 24 hours post-infusion at scheduled follow-up time points and continues until any two consecutive tests yield negative results, at which point the "engraftment endpoint" is recorded.
Measured: up to 2 years
Secondary outcomes (7)
complete response (CR), very good partial response (VGPR), and partial response (PR)
According to the International Myeloma Working Group (IMWG) unified response criteria for multiple myeloma
Measured: up to 2 years
Overall survival
Overall survival
Measured: up to 2 years
Progression-free survival
Progression-free survival
Measured: up to 2 years
Detection and quantification of CD19/BCMA CAR-T cells
Detection and quantification of CD19/BCMA CAR-T cells in blood, bone marrow, and/or tumor tissue
Measured: up to 2 years
Detection and quantification of circulating soluble BCMA
Detection and quantification of circulating soluble BCMA
Measured: up to 2 years
BCMA expression
Evaluate BCMA expression in plasma cells and tumor cells
Measured: Throughout the entire follow-up period，up to 2 years
minimal residual disease (MRD)
Evaluate the minimal residual disease (MRD) required for subjects to achieve a complete response.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start1 Nov 2025
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapse Multiple MyelomaStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- relapsed/refractory multiple myeloma
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Tongji Hospital, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Jinhua Municipal Central Hospital
- Responsible party
- Sponsor
- Investigators
- Wenbin Qian, Dr., Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07359014
- Sponsor's protocol ID
- 2025-0650
- Status last verified
- Oct 2025
- First submitted
- 31 Dec 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- 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 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Clinical Study of Novel CD19/BCMA Dual-Targeted CAR-T Cell Therapy for the Treatment of Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07359014
- Acronym / sponsor ID
- 2025-0650
- Conditions
- Relapse Multiple Myeloma
- Keywords
- CAR-T therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Tongji Hospital, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Jinhua Municipal Central Hospital
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2030 (estimated)
- First posted
- 22 Jan 2026 (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 study aims to investigate the efficacy and safety of CD19/BCMA CAR-T cells in treating relapsed/refractory multiple myeloma.
Detailed description
B Cell Maturation Antigen (BCMA) Chimeric Antigen Receptor T-cell (CAR-T) therapy is currently a crucial treatment for relapsed/refractory multiple myeloma, yet approximately half of patients still experience relapse with limited subsequent treatment options. Recent studies suggest that dual-target CAR-T may offer new hope for relapsed/refractory multiple myeloma. Preliminary studies in this project demonstrate that the independently designed CD19/BCMA CAR-T exhibits potent anti-myeloma activity both in vitro and in tumor-bearing animal models, positioning it as a potential therapeutic strategy for relapsed/refractory multiple myeloma. Therefore, this study aims to investigate the efficacy and safety of CD19/BCMA CAR-T cells in treating relapsed/refractory multiple myeloma in humans, with the goal of providing novel therapeutic approaches for this disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- relapsed/refractory multiple myeloma
| Arm | Type | Receives |
|---|---|---|
| Dual CD19/BCMA CAR-T treatment | Experimental | Other: Dual CD19/BCMA CAR-TR/R multiple myeloma patients will be treated with novel dual CD19/BCMA CAR-T |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Relapsed/refractory multiple myeloma.
- Confirmed by immunohistochemistry (IHC) or flow cytometry of bone marrow samples: plasma cell membrane expression of BCMA is positive (≥30%); no requirement for CD19 positivity rate. All sites must centrally submit bone marrow or plasmacytoma biopsy specimens to the lead site's pathology department or bone marrow/liquid specimens to KingMed Diagnostics (third-party laboratory) for BCMA expression verification.
- Relapsed/refractory patients must meet the following criteria:
- No response or disease progression after 3 cycles of bortezomib (proteasome inhibitor) or lenalidomide therapy No response or disease progression after 3 cycles of prior treatment regimen Interval between last treatment and disease progression >30 days No current indication for hematopoietic stem cell transplantation (HSCT), or patient refusal of HSCT
- Definition of disease progression follows the 2021 International Myeloma Working Group (IMWG) criteria, meeting at least one of the following:
Key exclusion criteria (11 listed)
- Received systemic therapy such as cyclophosphamide and fludarabine for lymphoma clearance within 2 weeks prior to enrollment or single-cell collection; prior CD19/BCMA CAR-T therapy; or cell or bispecific antibody therapy within 8 weeks prior to treatment.
- Received bendamustine-containing regimens within 6 months prior to treatment.
- Hepatitis C virus (HCV) or Human Immunodeficiency Virus (HIV) positive status; any uncontrolled active infection, including active tuberculosis or Hepatitis B virus (HBV) DNA levels ≥1×10³ copies/mL.
- Active infection within 72 hours prior to treatment initiation; subjects on ongoing prophylactic antibiotics, antifungals, or antivirals are not excluded provided there is no evidence of active infection and the antibiotics are not on the prohibited drug list.
- Current systemic use of cyclosporine or steroids such as dexamethasone; recent or current use of inhaled steroids is not exclusionary.
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 |
|---|---|---|
| Dual CD19/BCMA CAR-TNovel CD19/BCMA Dual-Targeted CAR-T Cell Therapy | Other | Dual CD19/BCMA CAR-T treatment |
Primary outcome
The incidence of adverse events
Time frame: up to 24 weeks
The incidence of adverse events and abnormal laboratory findings that are "possibly" or "definitely" related to the study treatment, occurring at any time from the start of monitoring until Week 24, including dose-limiting toxicity (DLT).
Primary implant endpoint
Time frame: up to 2 years
The survival time of CAR-T cells in vivo is defined as the "engraftment endpoint." PCR detection of CAR-T cell DNA sequences begins 24 hours post-infusion at scheduled follow-up time points and continues until any two consecutive tests yield negative results, at which point the "engraftment endpoint" is recorded.
7 secondary outcomes
complete response (CR), very good partial response (VGPR), and partial response (PR)
Time frame: up to 2 years
Overall survival
Time frame: up to 2 years
Progression-free survival
Time frame: up to 2 years
Detection and quantification of CD19/BCMA CAR-T cells
Time frame: up to 2 years
Detection and quantification of circulating soluble BCMA
Time frame: up to 2 years
BCMA expression
Time frame: Throughout the entire follow-up period，up to 2 years
minimal residual disease (MRD)
Time frame: up to 2 years
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 22 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Wenbin Qian, Dr. principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual CD19/BCMA CAR-T in people with Relapse Multiple Myeloma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 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 22 Jan 2026. 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.
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 Xuzhao Zhang (+86-571-89713679, zxzzju@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of adverse events (time frame: up to 24 weeks). 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 22 Jan 2026.