Relapsed or Refractory Multiple Myeloma (RRMM)Phase 1NCT07003568
Dual-target BCMA-GPRC5D CAR-T Cell Therapy for RR/MM With Extramedullary Infiltration
A Phase 1 study testing Dual-targeting BCMA-GPRC5D CAR-T cell infusion in people with Relapsed or Refractory Multiple Myeloma (RRMM), run by Beijing GoBroad Hospital at 1 site in China.
Trial summary
This is a multicenter, open-label, non-randomized, single-arm clinical trial. Patients with relapsed/refractory multiple myeloma accompanied by extramedullary infiltration will receive BCMA - GPRC5D CAR-T cell therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed or Refractory Multiple Myeloma (RRMM)
- What is being tested?
- Dual-targeting BCMA-GPRC5D CAR-T cell infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2025to 25 Jun 2027
- Phase
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participate in the trial and have good compliance.
- Aged between 18 and 75 years old, regardless of gender.
- Diagnosed with relapsed or refractory multiple myeloma according to the criteria of the International Myeloma Working Group (IMWG)2, and have measurable extramedullary lesions due to multiple myeloma.
- Positive for BCMA and GPRC5D in flow cytometry of bone marrow or cerebrospinal fluid tumor cells or immunohistochemistry of tumor tissue.
- Organ functions: ① Cardiac function: Left ventricular ejection fraction > 50% (by echocardiogram) in the past 2 weeks. ② Liver function: Alanine aminotransferase and aspartate aminotransferase < 3 times the upper limit of normal (ULN). ③ Renal function: Creatinine clearance rate ≥ 40 mL/min (by Cockcroft and Gault formula). ④ Coagulation function: PT and APPT < 1.5 times the ULN. ⑤ Arterial oxygen saturation (SpO₂) > 95%. ⑥ Pulmonary function: FEV₁% predicted value ≥ 50%.
- Female patients of childbearing age must have a negative serum pregnancy test at screening and before receiving cyclophosphamide and fludarabine or melphalan treatment; male patients should be willing to use effective contraceptive methods for 1 year after receiving the study treatment.
- ECOG score ≤ 2.
- Expected survival time > 3 months.
Who cannot join
- Pregnant or lactating women.
- Active infections that have not been effectively controlled.
- Active autoimmune diseases that have not been effectively controlled.
- Adverse reactions caused by previous treatments have not recovered to CTCAE grade ≤ 1.
- For allogeneic transplant patients, active graft - versus - host disease (GVHD) that has not been effectively controlled.
- Presence of any of the following: HBV - DNA copy number above the lower limit of detection; positive hepatitis C antibody (HCV - Ab) with HCV - RNA copy number above the lower limit of measurability; positive anti - Treponema pallidum antibody (TP - Ab); positive human immunodeficiency virus (HIV) antibody test.
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- Allergic or intolerant to fludarabine or cyclophosphamide.
- Suffering from known symptomatic non - plasma cell infiltrative central nervous system diseases.
- Uncontrollable cardiovascular and cerebrovascular diseases within 6 months, such as: a. New York Heart Association (NYHA) class III or IV congestive heart failure. b. Myocardial infarction occurred or coronary artery bypass grafting (CABG) was received ≤ 6 months before enrollment. c. Clinically significant ventricular arrhythmia or a history of unexplained syncope (excluding cases caused by vasovagal or dehydration). d. A history of severe non - ischemic cardiomyopathy.
- A history of other untreated malignancies within the past 5 years or having other untreated malignancies concurrently.
- The investigator assesses that the subject cannot or is unwilling to comply with the requirements of the study protocol.
- Previous use of a CAR - T vector with the same structure.
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
Shanghai Liquan Hospital
Shanghai
Yao Yao, 86+13101898518, yaoy01@gobroadhealthcare.com
Li Su
About this study
Official title: Practical Clinical Study of Dual-targeting BCMA-GPRC5D CAR-T Cell Therapy for Extramedullary Infiltration in Refractory/Relapsed Multiple Myeloma
This is a multicenter, open-label, non-randomized, single-arm clinical trial. Patients with relapsed/refractory multiple myeloma accompanied by extramedullary infiltration will receive BCMA - GPRC5D CAR-T cell therapy.
The primary objective is to prospectively evaluate the safety of dual-targeting BCMA and GPRC5D CAR - T cell therapy for extramedullary infiltration in relapsed/refractory multiple myeloma. The primary endpoints are to assess the type and incidence of dose-limiting toxicity (DLT) within one month after the reinfusion of BCMA-GPRC5D CAR-T cells in patients, as well as the incidence and severity of adverse events within one month after the reinfusion. It is expected that no more than 18 participants will be recruited.
- Being tested
- Dual-targeting BCMA-GPRC5D CAR-T cell infusion
- 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.
Dual-targeting BCMA-GPRC5D CAR-T cell infusionDrug
Approximately 3-5 days prior to BCMA-GPRC5D CAR-T cell infusion, subjects are treated with FC regimen (fludarabine and cyclophosphamide) for lymphodepletion. CAR-T cell infusion are performed 48 h after completion of chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Dual-targeting BCMA-GPRC5D CAR-T cell therapy | Experimental | Patients receive dual-targeting BCMA-GPRC5D CAR-T cell therapy Receives: Drug: Dual-targeting BCMA-GPRC5D CAR-T cell infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
Incidence and type of dose-limiting toxicity(DLT) within 1 month of BCMA-GPRC5D CAR-T infusion.
Measured: 30 days
Adverse events (AEs）
Total number, incidence and severity of adverse events (AEs) within 30 days of BCMA-GPRC5D CAR-T infusion
Measured: 30 days
Secondary outcomes (4)
Overall remission rate (ORR)
The assessment of ORR by dose group at 90 Days after BCMA-GPRC5D CAR-T infusion.
Measured: 90 days
Event Free Survival (EFS)
Evaluate the EFS of dual-targeting BCMA-GPRC5D CAR-T cell therapy for extramedullary infiltration in relapsed and refractory multiple myeloma
Measured: from enrollment to the end of treatment at 2 years
Duration of Response (DOR)
Evaluate the DOR of dual-targeting BCMA-GPRC5D CAR-T cell therapy for extramedullary infiltration in relapsed and refractory multiple myeloma
Measured: from enrollment to the end of treatment at 2 years
Overall Survival (OS)
Evaluate the OS of dual-targeting BCMA-GPRC5D CAR-T cell therapy for extramedullary infiltration in relapsed and refractory multiple myeloma
Measured: from enrollment to the end of treatment at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start25 May 2025
- Primary completion25 May 2027 (estimated)
- Study completion25 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Multiple Myeloma (RRMM)Studies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing GoBroad Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Liquan Hospital, Ruijin Hospital
- Responsible party
- Principal investigator, Jing Pan, Beijing GoBroad Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07003568
- Sponsor's protocol ID
- BJGBYY-IIT-LCYJ-2025-030
- Status last verified
- Nov 2025
- First submitted
- 23 May 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practical Clinical Study of Dual-targeting BCMA-GPRC5D CAR-T Cell Therapy for Extramedullary Infiltration in Refractory/Relapsed Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07003568
- Acronym / sponsor ID
- BJGBYY-IIT-LCYJ-2025-030
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Beijing GoBroad HospitalUniversity, hospital or other
- Collaborators
- Shanghai Liquan Hospital, Ruijin Hospital
- Study start
- 25 May 2025 (actual)
- Primary completion
- 25 May 2027 (estimated)
- Study completion
- 25 Jun 2027 (estimated)
- First posted
- 4 Jun 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 is a multicenter, open-label, non-randomized, single-arm clinical trial. Patients with relapsed/refractory multiple myeloma accompanied by extramedullary infiltration will receive BCMA - GPRC5D CAR-T cell therapy.
The primary objective is to prospectively evaluate the safety of dual-targeting BCMA and GPRC5D CAR - T cell therapy for extramedullary infiltration in relapsed/refractory multiple myeloma. The primary endpoints are to assess the type and incidence of dose-limiting toxicity (DLT) within one month after the reinfusion of BCMA-GPRC5D CAR-T cells in patients, as well as the incidence and severity of adverse events within one month after the reinfusion. It is expected that no more than 18 participants will be recruited.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dual-targeting BCMA-GPRC5D CAR-T cell therapy | Experimental | Drug: Dual-targeting BCMA-GPRC5D CAR-T cell infusionPatients receive dual-targeting BCMA-GPRC5D CAR-T cell therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Voluntarily participate in the trial and have good compliance.
- Aged between 18 and 75 years old, regardless of gender.
- Diagnosed with relapsed or refractory multiple myeloma according to the criteria of the International Myeloma Working Group (IMWG)2, and have measurable extramedullary lesions due to multiple myeloma.
- Positive for BCMA and GPRC5D in flow cytometry of bone marrow or cerebrospinal fluid tumor cells or immunohistochemistry of tumor tissue.
- Organ functions: ① Cardiac function: Left ventricular ejection fraction > 50% (by echocardiogram) in the past 2 weeks. ② Liver function: Alanine aminotransferase and aspartate aminotransferase < 3 times the upper limit of normal (ULN). ③ Renal function: Creatinine clearance rate ≥ 40 mL/min (by Cockcroft and Gault formula). ④ Coagulation function: PT and APPT < 1.5 times the ULN. ⑤ Arterial oxygen saturation (SpO₂) > 95%. ⑥ Pulmonary function: FEV₁% predicted value ≥ 50%.
Key exclusion criteria (12 listed)
- Pregnant or lactating women.
- Active infections that have not been effectively controlled.
- Active autoimmune diseases that have not been effectively controlled.
- Adverse reactions caused by previous treatments have not recovered to CTCAE grade ≤ 1.
- For allogeneic transplant patients, active graft - versus - host disease (GVHD) that has not been effectively controlled.
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-targeting BCMA-GPRC5D CAR-T cell infusionApproximately 3-5 days prior to BCMA-GPRC5D CAR-T cell infusion, subjects are treated with FC regimen (fludarabine and cyclophosphamide) for lymphodepletion. CAR-T cell infusion are performed 48 h after completion of chemotherapy. | Drug | Dual-targeting BCMA-GPRC5D CAR-T cell therapy |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: 30 days
Incidence and type of dose-limiting toxicity(DLT) within 1 month of BCMA-GPRC5D CAR-T infusion.
Adverse events (AEs）
Time frame: 30 days
Total number, incidence and severity of adverse events (AEs) within 30 days of BCMA-GPRC5D CAR-T infusion
4 secondary outcomes
Overall remission rate (ORR)
Time frame: 90 days
Event Free Survival (EFS)
Time frame: from enrollment to the end of treatment at 2 years
Duration of Response (DOR)
Time frame: from enrollment to the end of treatment at 2 years
Overall Survival (OS)
Time frame: from enrollment to the end of treatment at 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 26 Nov 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dual-targeting BCMA-GPRC5D CAR-T cell infusion in people with Relapsed or Refractory Multiple Myeloma (RRMM), run by Beijing GoBroad Hospital 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 8 inclusion and 12 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 26 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Yao Yao (86+13101898518, yaoy01@gobroadhealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) (time frame: 30 days). 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 26 Nov 2025.