Multiple Myeloma RefractoryEarly Phase 1NCT07196124
BCMA/GPRC5D CAR-T Therapy for Multiple Myeloma
A Early Phase 1 study testing BCMA/GPRC5D CAR-T in people with Multiple Myeloma Refractory, run by Guangzhou Bio-gene Technology Co., Ltd.
Trial summary
This study is a single-arm, multicenter clinical trial of dose escalation and dose expansion. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Multiple Myeloma Refractory
- What is being tested?
- BCMA/GPRC5D CAR-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2025to 9 Dec 2028
- Phase
- Early Phase 1
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient or their guardian understands and voluntarily signs the informed consent form and expects to complete the follow-up examinations and treatments of the research protocol；
- Age 18-85 years old (inclusive), gender unrestricted;
- In accordance with the standards for the recurrence of multiple myeloma in the 'Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma (Revised 2022)';
- Determine the presence of measurable lesions during screening based on any of the following criteria: serum monoclonal protein (M-protein) level ≥ 1.0 g/dL or urine M protein level ≥ 200 mg/24 hours; or diagnosed with light chain multiple myeloma without measurable lesions in serum or urine: serum immunoglobulin free light chain ≥ 10 mg/dL and serum immunoglobulin κ/γ free light chain ratio abnormal;
- Has previously received at least first-line or higher treatment for multiple myeloma.
- Patients with lymphoma must have at least one measurable lesion from baseline according to the revised IWG criteria for assessing the efficacy of malignant lymphoma；
- The organ functions well；
- ECOG performance status score 0-3 and estimated survival time greater than 3 months.
Who cannot join
- Diagnosed with or treated for other invasive malignant tumors, excluding multiple myeloma, within 3 years;
- Previous anti-tumor treatments (before the collection and preparation of CAR-T blood): received targeted therapy, epigenetic therapy, or experimental drug treatment within 14 days or within at least 5 half-lives (whichever is shorter), or used invasive experimental medical devices; received monoclonal antibody treatment for multiple myeloma within 21 days; received cytotoxic treatment within 14 days; received proteasome inhibitor treatment within 14 days; received immunomodulator treatment within 7 days; received radiotherapy within 14 days (except when the irradiated field covers ≤5% of the bone marrow reserve);
- During screening, individuals with Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes), or primary AL amyloidosis;
- Hepatitis B surface antigen (HBsAg) positive, hepatitis B core antibody (HBcAb) positive and peripheral blood HBV-DNA higher than the detection limit; Hepatitis C virus (HCV) antibody positive; Persons with human immunodeficiency virus (HIV) antibody positive; Cytomegalovirus (CMV) DNA positive cases; EBV-DNA positive patients; The syphilis antibody was positive.
- Those with a history of anaphylaxis [A history of anaphylaxis was defined as an allergic reaction of grade 2 or higher, in which any of the following clinical manifestations occurred: Airway obstruction (rhinorrhea, cough, stridor, dyspnea), Tachycardia, Hypotension, Arrhythmia, Gastrointestinal symptoms (nausea, vomiting), Incontinence, Laryngeal edema, Bronchospasm, Cyanosis, Shock, Respiratory, cardiac arrest] or known to be allergic to any of the drug active ingredients, excipents, or mouse-derived products or xenoproteins included in this trial (including the lymphatic cells clearance protocol).
- Have severe cardiac disease, including but not limited to severe arrhythmia, unstable angina, massive myocardial infarction, New York Heart Association class III or IV cardiac dysfunction, and refractory hypertension.
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- Screen for patients who have had acute/chronic graft-versus-host disease (GVHD) within the past 6 months, or who require immunosuppressive treatment for GVHD;
- Active autoimmune or inflammatory diseases (e.g., Guillain-Barre syndrome (GBS), amyotrophic lateral sclerosis (ALS)) and clinically significant active cerebrovascular diseases (e.g., cerebral edema, posterior reversible encephalopathy syndrome (PRES)).
- Patients with cancer emergencies (such as spinal cord compression, intestinal obstruction, leukostasis, tumor lysis syndrome, etc.) requiring emergency treatment before screening or reinfusion.
- Presence of uncontrolled bacterial, fungal, viral, or other infection requiring antibiotic treatment.
- Patients who had undergone major surgery (excluding diagnostic surgery and biopsy) within 4 weeks before lymphatic cells clearance or planned to undergo major surgery during the study period, or who had not fully healed the surgical wound before enrollment.
- Persons with severe mental illness.
- Within 1 week before the collection of peripheral blood mononuclear cells (PBMC), patients who use granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GM-CSF) and other hematopoietic cytokine drugs that have an impact on the patient's blood picture (if it is a long-acting preparation, it is 2 weeks) and have an impact on cell preparation as judged by the investigator .
- Within 2 weeks before PBMC collection, patients were receiving hormonal or immunosuppressive drugs that were judged by the investigator to have an effect on cell production.
- hormone: subjects who were receiving systemic steroid therapy within 2 weeks before PBMC collection and who required long-term systemic steroid therapy (except inhaled or topical use) as judged by the investigator during the treatment.
- Immunosuppressive agents: those who were receiving immunosuppressive agents within 2 weeks before PBMC collection.
- Vaccination with live (attenuated) virus vaccine within 4 weeks prior to screening.
- Alcoholics or those with a history of substance abuse.
- Patients who, in the investigator's judgment and/or clinical criteria, have contraindications to any study procedure or other medical conditions that may put them at unacceptable risk.
About this study
Official title: Clinical Study Evaluating the Safety and Efficacy of BCMA/GPRC5D CAR-T in Patients With Relapsed/Refractory Multiple Myeloma.
This study is a single-arm, multicenter clinical trial of dose escalation and dose expansion.
Read the detailed description
This study is a single-arm, mult-center clinical trial of dose escalation and dose expansion, primarily aimed at evaluating the safety, tolerability, and preliminary efficacy of BCMA/GPRC5D CAR-T cell infusion in subjects with relapsed/refractory multiple myeloma.
- Conditions
- Multiple Myeloma Refractory
- Being tested
- BCMA/GPRC5D CAR-T
- Keywords
- CAR-T
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCMA/GPRC5D CAR-TBiological
A single infusion of BCMA/GPRC5D CAR-T Injection administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| BCMA/GPRC5D CAR-T cell injection | Experimental | Dose escalation: Three dose levels were designed, and if the maximum tolerated dose (MTD) was not found at the highest level, no further dose escalation was to be performed. Approximately 12-18 subjects were planned to be enrolled in the dose-escalation phase to evaluate the safety and tolerability of CAR-T injection and to determine the MTD and/or the recommended phase II dose (RP2D). Dose Expansion: During or after the dose escalation process, if a certain dose group is determined to have preliminary anti-tumor effects and controllable safety, it can be extended at this dose level to further evaluate the tolerance and safety of CAR-T injection, and to preliminarily evaluate its effectiveness. Receives: Biological: BCMA/GPRC5D CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limited Toxicity Rate
After the infusion of CAR-T, subjects still experienced adverse events, meeting the DLT definition, related to or possibly related to CAR-T infusion after optimal supportive treatment.
Measured: Up to 28 days after CAR-T infusion.
Incidence of Treatment-Emergent Adverse Events
Count the Incidence of adverse events.
Measured: Up to 24 months.
Secondary outcomes (3)
Concentration of CAR-T cells after Infusion (PK)
CAR-T in peripheral blood after infusion
Measured: Up to 24 months.
Concentration of Cytokine after Infusion (PD)
Calculate the change of cytokine concentration in peripheral blood after After CAR-T infusion. Cytokines include IL-2、IL-6 and so on.
Measured: Up to 24 months.
overall response rate, ORR
Measured: Up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start10 Oct 2025 (estimated)
- Primary completion9 Oct 2028 (estimated)
- Study completion9 Dec 2028 (estimated)
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.
- Other trials for Multiple Myeloma RefractoryStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Bio-gene Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07196124
- Sponsor's protocol ID
- YD-005
- Status last verified
- May 2026
- First submitted
- 19 Sep 2025
- Last updated
- 28 May 2026
- 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 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating the Safety and Efficacy of BCMA/GPRC5D CAR-T in Patients With Relapsed/Refractory Multiple Myeloma.
- ClinicalTrials.gov ID
- NCT07196124
- Acronym / sponsor ID
- YD-005
- Conditions
- Multiple Myeloma Refractory
- Keywords
- CAR-T
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to corporate strategic adjustment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Guangzhou Bio-gene Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2025 (estimated)
- Primary completion
- 9 Oct 2028 (estimated)
- Study completion
- 9 Dec 2028 (estimated)
- First posted
- 29 Sep 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 study is a single-arm, multicenter clinical trial of dose escalation and dose expansion.
Detailed description
This study is a single-arm, mult-center clinical trial of dose escalation and dose expansion, primarily aimed at evaluating the safety, tolerability, and preliminary efficacy of BCMA/GPRC5D CAR-T cell infusion in subjects with relapsed/refractory multiple myeloma.
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 CAR-T cell injection | Experimental | Biological: BCMA/GPRC5D CAR-TDose escalation: Three dose levels were designed, and if the maximum tolerated dose (MTD) was not found at the highest level, no further dose escalation was to be performed. Approximately 12-18 subjects were planned to be enrolled in the dose-escalation phase to evaluate the safety and tolerability of CAR-T injection and to determine the MTD and/or the recommended phase II dose (RP2D). Dose Expansion: During or after the dose escalation process, if a certain dose group is determined to have preliminary anti-tumor effects and controllable safety, it can be extended at this dose level to further evaluate the tolerance and safety of CAR-T injection, and to preliminarily evaluate its effectiveness. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The patient or their guardian understands and voluntarily signs the informed consent form and expects to complete the follow-up examinations and treatments of the research protocol；
- Age 18-85 years old (inclusive), gender unrestricted;
- In accordance with the standards for the recurrence of multiple myeloma in the 'Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma (Revised 2022)';
- Determine the presence of measurable lesions during screening based on any of the following criteria: serum monoclonal protein (M-protein) level ≥ 1.0 g/dL or urine M protein level ≥ 200 mg/24 hours; or diagnosed with light chain multiple myeloma without measurable lesions in serum or urine: serum immunoglobulin free light chain ≥ 10 mg/dL and serum immunoglobulin κ/γ free light chain ratio abnormal;
- Has previously received at least first-line or higher treatment for multiple myeloma.
Key exclusion criteria (19 listed)
- Diagnosed with or treated for other invasive malignant tumors, excluding multiple myeloma, within 3 years;
- Previous anti-tumor treatments (before the collection and preparation of CAR-T blood): received targeted therapy, epigenetic therapy, or experimental drug treatment within 14 days or within at least 5 half-lives (whichever is shorter), or used invasive experimental medical devices; received monoclonal antibody treatment for multiple myeloma within 21 days; received cytotoxic treatment within 14 days; received proteasome inhibitor treatment within 14 days; received immunomodulator treatment within 7 days; received radiotherapy within 14 days (except when the irradiated field covers ≤5% of the bone marrow reserve);
- During screening, individuals with Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes), or primary AL amyloidosis;
- Hepatitis B surface antigen (HBsAg) positive, hepatitis B core antibody (HBcAb) positive and peripheral blood HBV-DNA higher than the detection limit; Hepatitis C virus (HCV) antibody positive; Persons with human immunodeficiency virus (HIV) antibody positive; Cytomegalovirus (CMV) DNA positive cases; EBV-DNA positive patients; The syphilis antibody was positive.
- Those with a history of anaphylaxis [A history of anaphylaxis was defined as an allergic reaction of grade 2 or higher, in which any of the following clinical manifestations occurred: Airway obstruction (rhinorrhea, cough, stridor, dyspnea), Tachycardia, Hypotension, Arrhythmia, Gastrointestinal symptoms (nausea, vomiting), Incontinence, Laryngeal edema, Bronchospasm, Cyanosis, Shock, Respiratory, cardiac arrest] or known to be allergic to any of the drug active ingredients, excipents, or mouse-derived products or xenoproteins included in this trial (including the lymphatic cells clearance protocol).
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 CAR-TA single infusion of BCMA/GPRC5D CAR-T Injection administered intravenously. | Biological | BCMA/GPRC5D CAR-T cell injection |
Primary outcome
Dose Limited Toxicity Rate
Time frame: Up to 28 days after CAR-T infusion.
After the infusion of CAR-T, subjects still experienced adverse events, meeting the DLT definition, related to or possibly related to CAR-T infusion after optimal supportive treatment.
Incidence of Treatment-Emergent Adverse Events
Time frame: Up to 24 months.
Count the Incidence of adverse events.
3 secondary outcomes
Concentration of CAR-T cells after Infusion (PK)
Time frame: Up to 24 months.
Concentration of Cytokine after Infusion (PD)
Time frame: Up to 24 months.
overall response rate, ORR
Time frame: Up to 24 months.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing BCMA/GPRC5D CAR-T in people with Multiple Myeloma Refractory, run by Guangzhou Bio-gene Technology Co., Ltd.
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 8 inclusion and 19 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: withdrawn, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Dose Limited Toxicity Rate (time frame: Up to 28 days after 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?
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 28 May 2026.