Relapsed or Refractory Multiple MyelomaNCT06068400
Clinical Study to Evaluate the Safety and Efficacy of CAR-T in the Treatment of Relapsed or Refractory Multiple Myeloma
A study testing BCMA/GPRC5D dual CAR-T in people with Relapsed or Refractory Multiple Myeloma, run by Guangzhou Bio-gene Technology Co., Ltd at 1 site in China.
Trial summary
This is a single arm, single center clinical study evaluating the safety and efficacy of CAR-T treatment for relapsed or refractory multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed or Refractory Multiple Myeloma
- What is being tested?
- BCMA/GPRC5D dual CAR-T
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteChina
- Study dates
- 21 Sep 2023to 2 Feb 2024
- Phase
- Interventional
- 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
- 1. Patients or their guardians understand and voluntarily sign an informed consent form and are expected to complete the follow-up examinations and treatments related to the study.
- 2. Aged 18-75 years, any gender.
- 3. Diagnosed with multiple myeloma according to IMWG diagnostic criteria.
- 4. Documented evidence that the patient's multiple myeloma is refractory or relapsed, defined as:
- a) Refractory: No response to salvage therapy (no response defined as no achievement of minimal response [MR] or disease progression during treatment), or disease progression within 60 days of the last treatment, or patients who achieved MR or higher but experienced disease progression.
- b) Relapsed: No response to any treatment, including no achievement of MR or higher in any prior treatment, but with minimal changes in M-protein without clinical progression or relapse as per the progression definition.
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- 5. Measurable disease at screening based on any of the following criteria: serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours, or diagnosed with light-chain multiple myeloma in the absence of measurable disease in serum or urine: serum immunoglobulin free light chain ≥10 mg/dL and an abnormal κ/γ free light chain ratio, extramedullary measurable lesions, or presence of tumor cells in bone marrow biopsy.
- 6. Patients have recovered from toxicity of prior treatment, with CTCAE toxicity grade ≤2 (unless the abnormality is related to the tumor or is deemed stable by the investigator with no significant impact on safety or efficacy).
- 7. ECOG performance status score of 0-2 and an expected survival of more than 3 months.
- 8. Adequate organ function, including:
- ALT (alanine transaminase) ≤3 times the upper limit of normal (ULN).
- AST (aspartate transaminase) ≤3 times ULN.
- Total bilirubin ≤1.5 times ULN.
- Serum creatinine ≤1.5 times ULN or creatinine clearance ≥30 mL/min (calculated by Cockcroft-Gault formula).
- Oxygen saturation ≥92%.
- Left ventricular ejection fraction (LVEF) ≥45%, confirmed by echocardiography with no evidence of pericardial effusion and no clinically significant electrocardiographic findings.
- No clinically significant pleural effusion.
- 9. Establishing a required venous access for collection without any leukapheresis contraindications.
Who cannot join
- 1. Diagnosis or treatment of invasive malignancies other than multiple myeloma within 3 years, unless the malignancy has been curatively treated and there is no known active disease within 3 years before enrollment, or unless the patient has been fully treated for non-melanoma skin cancer with no evidence of disease.
- 2. Prior treatment with the following anti-cancer therapies (before leukapheresis for CAR-T cell production): received targeted therapy, epigenetic therapy, or investigational drug treatment within 14 days or at least 5 half-lives (whichever is shorter); received monoclonal antibody therapy within 21 days; received proteasome inhibitor therapy within 14 days; received immunomodulatory drug therapy within 7 days; received radiation therapy within 14 days (excluding bone marrow radiation ≤5% of bone marrow reserve).
- 3. Underwent hematopoietic stem cell transplantation within 2 months prior to screening.
- 4. History of central nervous system disorders.
- 5. Clinical signs of active central nervous system (CNS) involvement or manifestations of multiple myeloma meningeal involvement.
- 6. Diagnosed with Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes), or primary AL amyloidosis.
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- 7. Positive for hepatitis B surface antigen (HBsAg) or positive for hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA quantification, positive for hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, cytomegalovirus (CMV) DNA, syphilis test, or Epstein-Barr virus DNA.
- 8. History of severe allergies (defined as Grade 2 or higher reactions) or known hypersensitivity to any active ingredients, excipients, mouse-derived products, or heterologous proteins included in this trial, including the conditioning regimen.
- 9. Severe cardiac diseases, including but not limited to severe arrhythmias, unstable angina, extensive myocardial infarction, New York Heart Association class III or IV heart failure, myocardial infarction within ≤6 months prior to screening, coronary artery bypass grafting (CABG) performed, except for non-vascular vagal syncope or dehydration, severe non-ischemic cardiomyopathy, and resistant hypertension.
- 10. Unstable systemic diseases, as judged by the investigator, including but not limited to severe liver, kidney, or metabolic diseases requiring drug treatment.
- 11. Had acute or chronic graft-versus-host disease (GVHD) within 6 months prior to screening or required immunosuppressive treatment for GVHD.
- 12. Active autoimmune or inflammatory neurological diseases (e.g., Guillain-Barré syndrome, amyotrophic lateral sclerosis) and clinically significant active cerebrovascular diseases (e.g., cerebral edema, posterior reversible encephalopathy syndrome) at screening.
- 13. Requires emergency treatment for tumor emergencies at screening (e.g., spinal cord compression, intestinal obstruction, leukostasis, tumor lysis syndrome).
- 14. Has uncontrollable bacterial, fungal, viral, or other infections requiring antibiotic treatment.
- 15. Received blood transfusions or hematopoietic cytokine drugs affecting the patient's blood counts within 2 weeks prior to screening for planned CAR-T cell production, as determined by the investigator to affect cell preparation.
- 16. Receiving steroids or immunosuppressive drugs within 2 weeks of screening for planned CAR-T cell production:
- a) Steroids: Received systemic corticosteroid treatment within 2 weeks of screening and judged by the investigator to require long-term systemic corticosteroid treatment (excluding inhalation or topical use); and received systemic corticosteroid treatment within 72 hours before cell infusion (excluding inhalation or topical use).
- b) Immunosuppressive drugs: Receiving immunosuppressive drugs within 2 weeks of screening.
- 17. Underwent major surgery (excluding diagnostic surgery and biopsy) within 4 weeks prior to screening or has unhealed surgical wounds before enrollment.
- 18. Received (attenuated) live virus vaccines within 4 weeks before screening.
- 19. Has severe mental illness.
- 20. History of alcohol abuse or substance abuse.
- 21. Pregnant or lactating women and participants planning to become pregnant within 2 years after cell infusion or their partners planning to become pregnant within 2 years after cell infusion.
- 22. Patients who have contraindications to any study procedure or have other medical conditions that may place them at unacceptable risk according to the investigator 's judgment and/or clinical criteria.
Trial locations and contacts
1 site in 1 country.
China1 site
Shenzhen Qianhai Shekou Free Trade Zone Hospital
Shenzhen, Guangdong, 518000
About this study
Official title: A Single-Arm, Single-Center Clinical Study to Evaluate the Safety and Efficacy of CAR-T in the Treatment of Relapsed or Refractory Multiple Myeloma
This is a single arm, single center clinical study evaluating the safety and efficacy of CAR-T treatment for relapsed or refractory multiple myeloma.
Read the detailed description
This study is a single arm, single center study targeting patients with relapsed or refractory multiple myeloma (r/rMM). The study plans to enroll 40 subjects, with a sample size based on actual occurrence and a dosage of 3×10^6/kg±20%~1×10^7/kg ±20% CAR positive T cells.
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Being tested
- BCMA/GPRC5D dual CAR-T
- Keywords
- Multiple Myeloma, BCMA, GPRC5D
- Medical subject headings
- Recurrence, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCMA/GPRC5D dual CAR-TBiological
BCMA/GPRC5D dual CAR-T is a new type CAR-T cells therapy for patients with Relapsed or Refractory Multiple Myeloma.
| Study group | Role | What they receive |
|---|---|---|
| BCMA/GPRC5D dual CAR-T | Experimental | The study plans to enroll 40 subjects, with a sample size based on actual occurrence and a dosage of 3 × 106/kg ± 20%~1 × 107/kg ± 20% CAR positive T cells Receives: Biological: BCMA/GPRC5D dual CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Safety
Count the Incidence of adverse events
Measured: Up to 2 years after BCMA/GPRC5D dual CAR-T infusion
Changes in cytokine level
Calculate the change of cytokine level in peripheral blood by flow cytometry after BCMA/GPRC5D dual CAR-T infusion. Cytokines include IL-2、IL-6、IL-10、IFN-γ
Measured: Up to 2 years after BCMA/GPRC5D dual CAR-T infusion
Secondary outcomes (6)
Complete response rate(CR)
Subjects whose serum and urine immunofixation electrophoresis are negative, and there is no soft tissue plasma cell tumor, with bone marrow plasma cells<5%.
Measured: Up to 2 years after BCMA/GPRC5D dual CAR-T infusion
Strict complete response rate(SCR)
Subjects who achieved complete response with normal FLC ratio and confirmed absence of clonal plasma cells in bone marrow by immunohistochemistry.
Measured: Up to 2 years after BCMA/GPRC5D dual CAR-T infusion
Very good partial response rate(VGPR)
Subjects who detected serum and urine M protein in immunofixation, but did not detect it from electrophoresis; Or M protein decrease ≥ 90% and urine M protein<100 mg/24h.
Measured: Up to 2 years after BCMA/GPRC5D dual CAR-T infusion
Partial response(PR)
Subjects who met the following requirements:
- （1） A decrease of ≥ 50% in serum M protein and ≥ 90% or<200 mg/24h in urine M protein;
- （2） If M protein in serum and urine cannot be detected, it is required to reduce the difference between affected and unaffected serum FLC by ≥ 50%;
- （3） If M protein and serum FLC in serum and urine cannot be measured, and the baseline bone marrow plasma cell ratio is ≥ 30%, a reduction of ≥ 50% in the number of bone marrow plasma cells is required;
- （4） In addition to the above criteria, if there is a baseline presence of soft tissue plasmacytomas, it is required that the sum of the maximum vertical diameter product (SPD) of the measurable lesion be reduced by ≥ 50%.
Measured: Up to 2 years after BCMA/GPRC5D dual CAR-T infusion
Minimal response(MR)
Subjects whose serum M protein decreased by 25%~49% and 24-hour urine M protein decreased by 50%~89%; In addition to the above criteria, if there is a baseline presence of soft tissue plasmocytoma, a measurable reduction in lesion SPD of ≥ 50% is required.
Measured: Up to 2 years after BCMA/GPRC5D dual CAR-T infusion
Overall response(OR)
Defined as subjects who achieve sCR, CR, VGPR, and PR.
Measured: Up to 2 years after BCMA/GPRC5D dual 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 posted5 Oct 2023
- Study start21 Sep 2023
- Primary completion2 Feb 2024
- Study completion2 Feb 2024
Why it stopped: Due to corporate strategic adjustment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsed or Refractory 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
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Bio-gene Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shenzhen Nanshan District Shekou People's Hospital
- Responsible party
- Sponsor
- Investigators
- Yang Xiao, MD, Principal investigator, Shenzhen Nanshan District Shekou People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06068400
- Sponsor's protocol ID
- BG-CT-22-008
- Status last verified
- Mar 2026
- First submitted
- 28 Sep 2023
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wei L, Xiao X, Jing X, Zheng Y, Sun X, Bai W, Li M, Luo M, Xiao Y. Case Report: Summary of multiple CAR-T expansions in anti-BCMA/GPRC5D bispecific CAR-T cell therapy for multiple myeloma. Front Immunol. 2025 Jun 6;16:1607778. doi: 10.3389/fimmu.2025.1607778. eCollection 2025.
PubMed 40547010
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Single-Center Clinical Study to Evaluate the Safety and Efficacy of CAR-T in the Treatment of Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06068400
- Acronym / sponsor ID
- BG-CT-22-008
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Keywords
- Multiple Myeloma, BCMA, GPRC5D
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to corporate strategic adjustment.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Guangzhou Bio-gene Technology Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Shenzhen Nanshan District Shekou People's Hospital
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 2 Feb 2024 (actual)
- First posted
- 5 Oct 2023 (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 single arm, single center clinical study evaluating the safety and efficacy of CAR-T treatment for relapsed or refractory multiple myeloma.
Detailed description
This study is a single arm, single center study targeting patients with relapsed or refractory multiple myeloma (r/rMM). The study plans to enroll 40 subjects, with a sample size based on actual occurrence and a dosage of 3×10^6/kg±20%~1×10^7/kg ±20% CAR positive T cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BCMA/GPRC5D dual CAR-T | Experimental | Biological: BCMA/GPRC5D dual CAR-TThe study plans to enroll 40 subjects, with a sample size based on actual occurrence and a dosage of 3 × 106/kg ± 20%~1 × 107/kg ± 20% CAR positive T cells |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 1. Patients or their guardians understand and voluntarily sign an informed consent form and are expected to complete the follow-up examinations and treatments related to the study.
- 2. Aged 18-75 years, any gender.
- 3. Diagnosed with multiple myeloma according to IMWG diagnostic criteria.
- 4. Documented evidence that the patient's multiple myeloma is refractory or relapsed, defined as:
- 5. Measurable disease at screening based on any of the following criteria: serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours, or diagnosed with light-chain multiple myeloma in the absence of measurable disease in serum or urine: serum immunoglobulin free light chain ≥10 mg/dL and an abnormal κ/γ free light chain ratio, extramedullary measurable lesions, or presence of tumor cells in bone marrow biopsy.
Key exclusion criteria (24 listed)
- 1. Diagnosis or treatment of invasive malignancies other than multiple myeloma within 3 years, unless the malignancy has been curatively treated and there is no known active disease within 3 years before enrollment, or unless the patient has been fully treated for non-melanoma skin cancer with no evidence of disease.
- 2. Prior treatment with the following anti-cancer therapies (before leukapheresis for CAR-T cell production): received targeted therapy, epigenetic therapy, or investigational drug treatment within 14 days or at least 5 half-lives (whichever is shorter); received monoclonal antibody therapy within 21 days; received proteasome inhibitor therapy within 14 days; received immunomodulatory drug therapy within 7 days; received radiation therapy within 14 days (excluding bone marrow radiation ≤5% of bone marrow reserve).
- 3. Underwent hematopoietic stem cell transplantation within 2 months prior to screening.
- 4. History of central nervous system disorders.
- 5. Clinical signs of active central nervous system (CNS) involvement or manifestations of multiple myeloma meningeal involvement.
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/GPRC5D dual CAR-TBCMA/GPRC5D dual CAR-T is a new type CAR-T cells therapy for patients with Relapsed or Refractory Multiple Myeloma. | Biological | BCMA/GPRC5D dual CAR-T |
Primary outcome
Evaluation of Safety
Time frame: Up to 2 years after BCMA/GPRC5D dual CAR-T infusion
Count the Incidence of adverse events
Changes in cytokine level
Time frame: Up to 2 years after BCMA/GPRC5D dual CAR-T infusion
Calculate the change of cytokine level in peripheral blood by flow cytometry after BCMA/GPRC5D dual CAR-T infusion. Cytokines include IL-2、IL-6、IL-10、IFN-γ
6 secondary outcomes
Complete response rate(CR)
Time frame: Up to 2 years after BCMA/GPRC5D dual CAR-T infusion
Strict complete response rate(SCR)
Time frame: Up to 2 years after BCMA/GPRC5D dual CAR-T infusion
Very good partial response rate(VGPR)
Time frame: Up to 2 years after BCMA/GPRC5D dual CAR-T infusion
Partial response(PR)
Time frame: Up to 2 years after BCMA/GPRC5D dual CAR-T infusion
Minimal response(MR)
Time frame: Up to 2 years after BCMA/GPRC5D dual CAR-T infusion
Overall response(OR)
Time frame: Up to 2 years after BCMA/GPRC5D dual CAR-T infusion
Results and safety
The study was stopped early (reason given: Due to corporate strategic adjustment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Derived from this study: PubMed 40547010Wei L, Xiao X, Jing X, Zheng Y, Sun X, Bai W, Li M, Luo M, Xiao Y. Case Report: Summary of multiple CAR-T expansions in anti-BCMA/GPRC5D bispecific CAR-T cell therapy for multiple myeloma. Front Immunol. 2025 Jun 6;16:1607778. doi: 10.3389/fimmu.2025.1607778. eCollection 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. This study is not recruiting at the moment.
Yang Xiao, MD principal investigator
Shenzhen Nanshan District Shekou People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BCMA/GPRC5D dual CAR-T in people with Relapsed or Refractory Multiple Myeloma, run by Guangzhou Bio-gene Technology Co., Ltd 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 18 inclusion and 24 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: stopped early, as of the sponsor's last update on 17 Mar 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?
The study was stopped early (reason given: Due to corporate strategic adjustment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Safety (time frame: Up to 2 years after BCMA/GPRC5D dual CAR-T 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?
On the ClinicalTrials.gov record for NCT06068400, which also lists 1 linked publication.
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 17 Mar 2026.