Relapsed/Refractory Multiple Myelomar/r MMNCT07195617
Clinical Study on Evaluating the Safety and Effectiveness of BCMA-GPRC5D CAR-T in Patients With Relapsed/Refractory Multiple Myeloma Who Have Received Third-line or Above Treatment
A study testing BCMA-GPRC5D CART in people with Relapsed/Refractory Multiple Myeloma, run by Guangzhou Bio-gene Technology Co., Ltd.
Trial summary
This study is a single-arm, single-center clinical study, with the main purpose of IIT clinical trials to evaluate the safety and initial efficacy of BCMA-GPRC5DCAR-T cells in subjects with relapsed/refractory multiple myeloma (r/rMM). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed/Refractory Multiple Myeloma
- What is being tested?
- BCMA-GPRC5D CART
- 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 1 Nov 2027
- 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
- The patient or his/her guardian understands and voluntarily signs informed consent form, and is expected to complete the follow-up examination and treatment of the research procedure;
- Ages 18-75 years old (including the threshold), gender is not limited;
- Patients diagnosed with multiple myeloma according to the IMWG diagnostic criteria;
- Determine that there are measurable lesions during screening according to any of the following criteria: serum single cloned paraprotein (M-protein) level ≥1.0g/dL or urine M-protein level ≥200mg/24 hours; or light chain multiple myeloma diagnosed with serum or urine: serum immunoglobulin free light chain ≥10mg/dL and serum immunoglobulin κ/γ free light chain ratio ;
- Previously received treatment with at least three-line multiple myeloma;
- Materials have proved that the patient's multiple myeloma disease is relapse-refractory or primary-refractory, defined as:
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- relapse-refractory: non-responsive to rescue treatment (no response is defined as the inability to obtain a slight remission [MR] or disease progression in treatment), or disease progression within 60 days of the last treatment, or MR or above remission has occurred;
- primary-refractory: patients who have never obtained MR or above treatment, including patients who have never obtained MR or above remission, but have little change in M protein, have no evidence of clinical progress, and are subject to the definition of progress.
- The patient has recovered from the toxicity of the previous treatment, that is, the CTCAE toxicity grade is < 2 (unless the abnormality is related to the tumor or is judged by the researcher to be in a stable state, and has little impact on safety or efficacy);
- ECOG physical fitness status score 0 to 1 point and the estimated survival period is greater than 3 months;
- Have appropriate organ functions:
- Alanine aminotransferase (ALT) ≤3 times the upper limit of normal value (ULN);
- Alanine aminotransferase (AST) ≤3 times the ULN;
- Total bilirubin ≤1.5 times the ULN;
- Serum creatinine ≤1.5 times the ULN, or creatinine clearance ≥60mL/min;
- Hemoglobin ≥50g/L (no blood transfusion support must be received within 7 days before laboratory examination );
- Indoor oxygen saturation ≥92%;
- Correction of serum calcium ≤12.5 mg/dL (≤3.1 mmol/L) or free ionic calcium ≤6.5 mg/dL (≤1.6 mmol/L);
- Left ventricular ejaculation fraction (LVEF) ≥45%, echocardiography confirms that no pericardial effusion is seen, and no clinically significant electrocardiogram discovery is found;
- There is no clinically significant pleural effusion;
- The venous pathway required for collection can be established, and there are no contraindications for white blood cell collection.
Who cannot join
- Diagnosed or treated with other aggressive malignant tumors other than multiple myeloma within 3 years;
- Previously received anti-tumor treatment (before blood collected for CAR-T preparation): received targeted therapy, epigenetic therapy or experimental drug treatment within 14 days or at least 5 half-life (whichever is shorter) or used for invasive experimental medical devices; treated with monoclonal antibodies within 21 days; received cytotoxic treatment within 14 days; received proteasome inhibitors within 14 days; received immunomodulatory agents within 7 days; received radiotherapy within 14 days (except for 5% bone marrow reserves);
- Suspected that MM has been involved in the central nervous system or meninges and has been confirmed by magnetic or CT, or has other active central nervous system diseases;
- Suffered from Fahrenheit macroglobulinemia, POEMS syndrome (multiple neuropathy, enlarged organs, endocrine lesions, monoclonal protein diseases and skin changes) or primary AL amyloidosis during screening;
- Hepatitis B surface antigen (HBsAg) positive, or hepatitis B core antibody (HBcAb) positive and peripheral blood HBV DNA quantitative test; hepatitis C virus (HCV) antibody positive; human immunodeficiency virus (HIV) antibody positive; cytomegalovirus (CMV) DNA test; EB virus DNA test; syphilis test positive;
- People with a history of severe allergic allergies [the history of severe allergies is defined as a secondary or above all allergic reaction, and any of the following clinical manifestations appear when an allergic reaction occurs: airway obstruction (running nose, cough, Stirrhage, dyspnea), tachycardia, hypotension, arrhythmia, gastrointestinal symptoms (nausea, vomiting), incontinence, laryngeal edema, bronchospasm, cyanosis, shock, respiratory, cardiac arrest] or known to be allergic to any drug active ingredients, excipients or mouse-derived products or xenoproteins contained in this trial (including the clearing regimen);
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- Suffering from severe heart disease, including but not limited to severe arrhythmia, unstable angina, large-area myocardial insufficiency, New York Heart Association Grade III or IV cardiac insufficiency, myocardial infarction ≤6 months before screening or receiving Coronary artery bypass bypass (CABG), a history of syncope with unknown causes and non-vasovagal or dehydration, a history of severe non-ischemic cardiomyopathy, and refractory hypertension (refractory hypertension is defined as: a sufficient amount of ≥3 antihypertensive drugs (including diuretics) that are reasonably tolerated on the basis of improving lifestyle > 1 month of blood pressure still not meet the standards or taking ≥4 antihypertensive drugs to effectively control blood pressure);
- Systemic diseases that are unstable by the researchers: including but not limited to severe liver, kidney or metabolic diseases that require drug treatment;
- Before screening Patients with acute/chronic graft-versus-host disease (GVHD) within 6 months or need to receive immunosuppressants for GVHD;
- Patients with active nervous system autoimmunity or inflammatory diseases (such as: Guillin-Barre syndrome (GBS), amyotrophic lateral sclerosis (ALS)) and clinically significant active cerebrovascular diseases (such as cerebral edema, posterior reversible encephalopathy syndrome (PRES));
- Patients with emergency tumor emergencies (such as spinal cord compression, intestinal obstruction, leukocyte stasis, tumor lysis syndrome, etc.) that require emergency treatment;
- There are uncontrollable bacteria, fungi, viruses or other infections that require antibiotic treatment;
- The screening time has used short-acting hematopoietic cytokine drugs that have an effect on the patient's blood sign within 1 week after the planned blood collection for CAR-T preparation, or long-acting hematopoietic cytokine drugs within 2 weeks, and the researchers have determined that it has an effect on cell preparation.
- During the screening period, hormone or immunosuppressant drugs are being received within 2 weeks of blood collection planned to prepare CAR-T, and the researchers judged that it has an impact on cell preparation:
- Hormones: Subjects who were receiving systemic steroids within 2 weeks of the planned blood collection for CAR-T preparation and who were deemed to require long-term use of systemic steroids during treatment (except inhaled or topical use); and subjects who were using systemic steroids within 72 hours before cell reentering (except inhaled or topical use);
- Immunization Inhibitors: Those who are undergoing immunosuppressors within 2 weeks of the planned blood collection for the preparation of CAR-T during screening;
- Those who have undergone major surgical operations (except diagnostic surgery and biopsy) or major surgery during the study period within 4 weeks before the study period, or those who have not fully healed before the enrollment;
- Those who have received (attenuated) live virus vaccine within 4 weeks before the screening;
- Those who have severe mental illness;
- Those who have alcoholics or have a history of drug abuse;
- Women who are pregnant or breastfeeding, and female subjects who are planning to pregnancy within 2 years after cell rebirth or male subjects who are planning to pregnancy within 2 years after cell rebirth;
- Subjects who have contraindications to any research procedure or who have other medical conditions that may put them at unacceptable risks according to the investigator's judgment and/or clinical standards.
About this study
This study is a single-arm, single-center clinical study, with the main purpose of IIT clinical trials to evaluate the safety and initial efficacy of BCMA-GPRC5DCAR-T cells in subjects with relapsed/refractory multiple myeloma (r/rMM). The dose of this study was set to 2.0×106/kg±50% CAR-T cells, and the infusion method was a single peripheral infusion.
After the screening period (W-8~D-8), blood collection period (W-8~D-8), pretreatment period (D-7~D-3), and pre-infusion evaluation (D-2~D-1), subjects were subjected to infusion of CAR-T cells in D0. After administration, they were subjected to safety, effectiveness and other related examinations according to the follow-up plan. The subjects followed up until 2 years after cell re-infusion or the subject met the withdrawal treatment standards, whichever occurs first.
Read the detailed description
The entire study process was as follows: Screening period (V1) : Informed consent was signed, screening was checked, criteria were evaluated, and baseline demographic information and subject status were recorded. Blood collection period (V2) : For subjects who meet the inclusion and exclusion criteria, the blood required for CAR-T preparation will be obtained by leukocyte isolation monopexy or intravenous collection according to the conditions of the subjects. Preconditioning phase (V3) : cytokine and cell changes. Pre-transfusion assessment (V4) : The investigator assessed that the test results met the cell transfusion criteria, and D0 CAR T cell infusion could be performed with investigator permission. Infusion phase (V5) : CAR-T cells were transfused according to the dosage and method specified in the protocol. Safety and efficacy were followed up on D1, D4, D7, D10, D14, D21, D28, M3, M6, M9, M12, and M24. Subjects were followed up to M24 or those who met the exit criteria withdrew early, whichever happened first.
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Being tested
- BCMA-GPRC5D CART
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCMA-GPRC5D CARTDrug
The entire study process was as follows: Screening period (V1) : Informed consent was signed, screening was checked, criteria were evaluated, and baseline demographic information and subject status were recorded. Blood collection period (V2) : For subjects who meet the inclusion and exclusion criteria, the blood required for CAR-T preparation will be obtained by leukocyte isolation monopexy or intravenous collection according to the conditions of the subjects. Preconditioning phase (V3) : cytokine and cell changes. Pre-transfusion assessment (V4) : The investigator assessed that the test results met the cell transfusion criteria, and D0 CAR T cell infusion could be performed with investigator permission. Infusion phase (V5) : CAR-T cells were transfused according to the dosage and method specified in the protocol. Safety and efficacy were followed up on D1, D4, D7, D10, D14, D21, D28, M3, M6, M9, M12, and M24.
| Study group | Role | What they receive |
|---|---|---|
| BCMA-GPRC5D CAR T cells were transfused | Experimental | Subjects voluntarily signed informed consent and were evaluated during blood collection, pre-treatment and pre-transfusion. Eligible subjects received intravenous infusion of 2×106 /kg±50% CAR T cells. Receives: Drug: BCMA-GPRC5D CART |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint indicator: safety assessment
Safety assessment is carried out for all adverse events and other safety indicators such as laboratory examinations.
Measured: All AE and SAE were collected after cell reinfusion and recorded until 2 years after subjects withdrew from the study or cell reinfusion, whichever occurs first.
Secondary outcomes (3)
Concentration of CAR-T cells after Infusion (PK)
CAR-T in peripheral blood after infusion
Measured: From enrollment to the end of treatment at 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 posted26 Sep 2025
- Study start10 Oct 2025 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (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 Relapsed/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
- Model description
- Subjects signed informed consent voluntarily, and for those who met the inclusion criteria and did not meet the exclusion criteria, intravenous infusion of 2×106 /kg±50% CAR T cells was performed at D0.
- 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)
- Collaborators
- Jiangsu Provincial People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07195617
- Sponsor's protocol ID
- BG-CT-24-015
- Acronym
- r/r MM
- Status last verified
- May 2026
- First submitted
- 9 Apr 2025
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD collected throughout the trial, only IPD used in the results publication
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 on Evaluating the Safety and Effectiveness of BCMA-GPRC5D CAR-T in Patients With Relapsed/Refractory Multiple Myeloma Who Have Received Third-line or Above Treatment
- ClinicalTrials.gov ID
- NCT07195617
- Acronym / sponsor ID
- r/r MM / BG-CT-24-015
- Conditions
- Relapsed/Refractory Multiple Myeloma
- 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)
- Collaborators
- Jiangsu Provincial People's Hospital
- Study start
- 10 Oct 2025 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 26 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, single-center clinical study, with the main purpose of IIT clinical trials to evaluate the safety and initial efficacy of BCMA-GPRC5DCAR-T cells in subjects with relapsed/refractory multiple myeloma (r/rMM). The dose of this study was set to 2.0×106/kg±50% CAR-T cells, and the infusion method was a single peripheral infusion.
After the screening period (W-8~D-8), blood collection period (W-8~D-8), pretreatment period (D-7~D-3), and pre-infusion evaluation (D-2~D-1), subjects were subjected to infusion of CAR-T cells in D0. After administration, they were subjected to safety, effectiveness and other related examinations according to the follow-up plan. The subjects followed up until 2 years after cell re-infusion or the subject met the withdrawal treatment standards, whichever occurs first.
Detailed description
The entire study process was as follows: Screening period (V1) : Informed consent was signed, screening was checked, criteria were evaluated, and baseline demographic information and subject status were recorded. Blood collection period (V2) : For subjects who meet the inclusion and exclusion criteria, the blood required for CAR-T preparation will be obtained by leukocyte isolation monopexy or intravenous collection according to the conditions of the subjects. Preconditioning phase (V3) : cytokine and cell changes. Pre-transfusion assessment (V4) : The investigator assessed that the test results met the cell transfusion criteria, and D0 CAR T cell infusion could be performed with investigator permission. Infusion phase (V5) : CAR-T cells were transfused according to the dosage and method specified in the protocol. Safety and efficacy were followed up on D1, D4, D7, D10, D14, D21, D28, M3, M6, M9, M12, and M24. Subjects were followed up to M24 or those who met the exit criteria withdrew early, whichever happened first.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects signed informed consent voluntarily, and for those who met the inclusion criteria and did not meet the exclusion criteria, intravenous infusion of 2×106 /kg±50% CAR T cells was performed at D0.
| Arm | Type | Receives |
|---|---|---|
| BCMA-GPRC5D CAR T cells were transfused | Experimental | Drug: BCMA-GPRC5D CARTSubjects voluntarily signed informed consent and were evaluated during blood collection, pre-treatment and pre-transfusion. Eligible subjects received intravenous infusion of 2×106 /kg±50% CAR T cells. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- The patient or his/her guardian understands and voluntarily signs informed consent form, and is expected to complete the follow-up examination and treatment of the research procedure;
- Ages 18-75 years old (including the threshold), gender is not limited;
- Patients diagnosed with multiple myeloma according to the IMWG diagnostic criteria;
- Determine that there are measurable lesions during screening according to any of the following criteria: serum single cloned paraprotein (M-protein) level ≥1.0g/dL or urine M-protein level ≥200mg/24 hours; or light chain multiple myeloma diagnosed with serum or urine: serum immunoglobulin free light chain ≥10mg/dL and serum immunoglobulin κ/γ free light chain ratio ;
- Previously received treatment with at least three-line multiple myeloma;
Key exclusion criteria (22 listed)
- Diagnosed or treated with other aggressive malignant tumors other than multiple myeloma within 3 years;
- Previously received anti-tumor treatment (before blood collected for CAR-T preparation): received targeted therapy, epigenetic therapy or experimental drug treatment within 14 days or at least 5 half-life (whichever is shorter) or used for invasive experimental medical devices; treated with monoclonal antibodies within 21 days; received cytotoxic treatment within 14 days; received proteasome inhibitors within 14 days; received immunomodulatory agents within 7 days; received radiotherapy within 14 days (except for 5% bone marrow reserves);
- Suspected that MM has been involved in the central nervous system or meninges and has been confirmed by magnetic or CT, or has other active central nervous system diseases;
- Suffered from Fahrenheit macroglobulinemia, POEMS syndrome (multiple neuropathy, enlarged organs, endocrine lesions, monoclonal protein diseases and skin changes) or primary AL amyloidosis during screening;
- Hepatitis B surface antigen (HBsAg) positive, or hepatitis B core antibody (HBcAb) positive and peripheral blood HBV DNA quantitative test; hepatitis C virus (HCV) antibody positive; human immunodeficiency virus (HIV) antibody positive; cytomegalovirus (CMV) DNA test; EB virus DNA test; syphilis test positive;
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 CARTThe entire study process was as follows: Screening period (V1) : Informed consent was signed, screening was checked, criteria were evaluated, and baseline demographic information and subject status were recorded. Blood collection period (V2) : For subjects who meet the inclusion and exclusion criteria, the blood required for CAR-T preparation will be obtained by leukocyte isolation monopexy or intravenous collection according to the conditions of the subjects. Preconditioning phase (V3) : cytokine and cell changes. Pre-transfusion assessment (V4) : The investigator assessed that the test results met the cell transfusion criteria, and D0 CAR T cell infusion could be performed with investigator permission. Infusion phase (V5) : CAR-T cells were transfused according to the dosage and method specified in the protocol. Safety and efficacy were followed up on D1, D4, D7, D10, D14, D21, D28, M3, M6, M9, M12, and M24. | Drug | BCMA-GPRC5D CAR T cells were transfused |
Primary outcome
Primary endpoint indicator: safety assessment
Time frame: All AE and SAE were collected after cell reinfusion and recorded until 2 years after subjects withdrew from the study or cell reinfusion, whichever occurs first.
Safety assessment is carried out for all adverse events and other safety indicators such as laboratory examinations.
3 secondary outcomes
Concentration of CAR-T cells after Infusion (PK)
Time frame: From enrollment to the end of treatment at 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.
- Individual participant dataSharing planned: Yes. All IPD collected throughout the trial, only IPD used in the results publication
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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 study testing BCMA-GPRC5D CART in people with Relapsed/Refractory Multiple Myeloma, 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 21 inclusion and 22 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.
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?
Primary endpoint indicator: safety assessment (time frame: All AE and SAE were collected after cell reinfusion and recorded until 2 years after subjects withdrew from the study or cell reinfusion, whichever occurs first.). 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.