Relapsed/Refractory Multiple MyelomaPhase 1NCT05759793
A Study of CAR-GPRC5D in Patients With Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia
A Phase 1 study testing CAR-GPRC5D in people with Relapsed/Refractory Multiple Myeloma and Plasma Cell Leukemia, run by Nanjing IASO Biotechnology Co., Ltd. at 1 site in China.
Trial summary
This study is a single-center, open-label, dose-escalation study to observe the safety and efficacy of different doses of CAR-GPRC5D in patients with R/R MM or Plasma Cell Leukemia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed/Refractory Multiple Myeloma, Plasma Cell Leukemia
- What is being tested?
- CAR-GPRC5D
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2023to 1 Oct 2026
- 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
- Subjects must satisfy all the following criteria to be enrolled in the study:
- age 18 to 75 years old, male or female.
- Subjects have had at least 3 prior lines of therapy including chemotherapy based on proteasome inhibitors (PIs) and immunomodulatory agents (IMiDs).
- According to the International Myeloma Working Group (IMWG) consensus (2016) standard on multiple myeloma, the disease has recurred, progressed or is refractory, or according to the IMWG consensus (2013) standard on plasma cell leukemia (Appendix 4), the disease appears relapse, progress or refractory;
- Evidence of cell membrane GPRC5D expression, as determined by a validated immunohistochemistry (IHC) or flow cytometry of tumor tissue (e.g., bone marrow biopsies, or plasmacytoma).
- The subjects should have measurable disease based on at least one of the following parameters:
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- The proportion of primitive immature or monoclonal plasma cells detected by bone marrow cytology, bone marrow biopsy, or flow cytometry is ≥ 10%.
- Serum M-protein ≥ 10 g/L for IgG type, serum M-protein ≥ 5 g/L for other types, such as IgA, IgD, IgM, IgE.
- Urine M-protein ≥ 200 mg/24 hrs.
- For those whose Serum or Urine M-protein does not meet the measurable criteria but the light chain type, serum free light chain (sFLC) : involved sFLC level ≥ 10mg/dL (100 mg/L) provided serum FLC ratio is abnormal.
- In subjects with extramedullary myeloma, if there are no other evaluable lesions, require extramedullary lesions with a maximum diameter of ≥2cm
- ECOG performance score 0-2.
- Estimated life expectancy ≥ 12 weeks.
- Subjects should have adequate organ function:
- Hematology: Absolute neutrophil count (ANC) ≥1×10^9 /L (prior use of growth factor support is permitted, but subjects must not have received supportive treatment within 7 days prior to laboratory examination); absolute lymphocyte count (ALC) ≥0.3×10^9 /L; platelets ≥40×10^9 /L (subjects must not have received blood transfusion support within 7 days prior to laboratory examination); hemoglobin ≥60 g/L (subjects must not have received transfusion of red blood cells [RBC] within 7 days prior to laboratory examination; the use of recombinant human erythropoietin is permitted).
- Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×upper limit of normal (ULN); total serum bilirubin ≤ 1.5×ULN.
- Renal function: Creatinine clearance rate (CrCl) calculated according to Cockcroft-Gault formula ≥ 40 ml/min.
- Coagulation function: Fibrinogen ≥ 1.0 g/L; activated partial thromboplastin time (APTT) ≤ 1.5×ULN, prothrombin time (PT) ≤1.5×ULN.
- SpO2 > 91%.
- Left ventricular ejection fraction (LVEF) ≥ 50%.
- The subject and his/her spouse agree to use an effective contraceptive tool or medication (excluding safety period contraception) for one year from the date of the subject's informed consent to the date of CAR T cell infusion.
- Subject must sign the informed consent form approved by ethics board in person before starting any screening procedure.
Who cannot join
- The presence of any of the following will exclude a subject from enrollment:
- Subjects who are known to have GVHD or need long-term immunosuppressive therapy.
- Subjects have received any anti-cancer treatment as follows:
- monoclonal antibody for treating multiple myeloma within 21 days before leukapheresis, or cytotoxic therapy or proteasome inhibitors within 14 days before leukapheresis, or immunomodulatory agents within 7 days before leukapheresis. or anti-tumor treatments other than those listed above within 30 days before leukapheresis.
- Subjects who were receiving a used therapeutic dose of corticosteroid treatment (defined as prednisone or equivalent > 20mg) within 7 days prior to screening, except for physiological alternatives, inhalation, or topical use.
- Subjects with hypertension that cannot be controlled by medication.
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- Subjects with serious heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (NYHA classification ≥III), and severe arrhythmias.
- Subjects with systemic diseases that the investigator determined to be unstable include, but are not limited to, severe liver and kidney or metabolic diseases requiring medical treatment.
- Subjects with second malignancies in addition to MM within the past 5 years before the screening, exceptions to this criterion: successfully treated cervical carcinoma in situ and non-metastatic basal or squamous cell skin carcinoma, local prostate cancer after radical surgery, and ductal carcinoma in situ of the breast after radical surgery.
- Subjects with a history of organ transplantation.
- Subjects have received major surgery within 2 weeks prior to leukapheresis or plan to receive surgery during the study or within 2 weeks after the study treatment (excluding local anesthesia).
- Subjects participated in another interventional clinical study 1 months before signing the informed consent (ICF);
- Subjects with any uncontrolled active infection needed to receive systemic therapy within 7 days before leukapheresis collection (excluding # CTCAE grade 2 urogenital infection and upper respiratory infection).
- Positive for any of the following tests:
- Hepatitis B virus (HBV) surface antigen (HBsAg) or hepatitis B core antibody-positive and detectable HBV DNA in peripheral blood; Hepatitis C virus (HCV) antibody and hepatitis C virus RNA in peripheral blood; Human immunodeficiency virus (HIV) antibody; Cytomegalovirus (CMV) DNA; Treponema Pallidum antibody
- Pregnant or lactating women.
- Subjects with mental illness or consciousness disorder or disease of the central nervous system
- Other conditions that researchers consider inappropriate for inclusion.
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
Ruijin Hospital Affiliated with Shanghai Jiao Tong University School of Medicine
Shanghai
Jianqing Mi, MD, +86 13524488296, jianqingmi@shsmu.edu.cn
About this study
Official title: An Exploratory Study of Fully Human Anti-GPRC5D Chimeric Antigen Receptor T Cells (CAR-GPRC5D) in Patients With Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia
This study is a single-center, open-label, dose-escalation study to observe the safety and efficacy of different doses of CAR-GPRC5D in patients with R/R MM or Plasma Cell Leukemia.
Read the detailed description
Apheresis will be performed to manufacture CAR-GPRC5D CAR-T cells. Bridging therapy is allowed between apheresis and lymphodepletion. Lymphodepletion with fludarabine and cyclophosphamide was performed for three consecutive days. Then, subjects will receive a single dose infusion of CAR-GPRC5D at 1.0, 2.0, or 3.0 x 10^6 CAR-T cells/Kg. Subjects will be followed in the study for a minimum of 2 years after infusion. Long-term follow-up for lentiviral vector safety will be followed for up to 15 years after infusion.
- Being tested
- CAR-GPRC5D
- Keywords
- GPRC5D, RRMM, PCL
- Medical subject headings
- Multiple Myeloma, Leukemia, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-GPRC5DDrug
CAR-GPRC5D (RD118) is an individualized, gene-modified autologous T-cell immunotherapy product targeting GPRC5D that identifies and eliminates malignant and normal cells expressing GPRC5D. The CAR structure comprises a fully human single-domain antibody fragment (VHH) targeting GPRC5D, fused with intracellular co-stimulatory (4-1BB) and activation (CD3ζ) signaling domains.
| Study group | Role | What they receive |
|---|---|---|
| CAR-GPRC5D cells | Experimental | After lymphodepletion, CAR-GPRC5D will be administered as a single infusion. Receives: Drug: CAR-GPRC5D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicity (DLT) by dose group
Dose limiting toxicity will be assessed after infusion in each dose group
Measured: 28 days after CAR-T cell infusion
Type and incidence of adverse events (AEs) and serious adverse events (SAEs) by dose group
Calculate type and incidence of adverse events (AE), serious adverse event (SAE), including those happened after lymphodepletion and after infusion, those related to study drug and lymphodepletion, or those that led to withdrawal from the study. They will also be aggregated by systematic organ classification (SOC), preferred term (PT), and severity
Measured: 2 years after CAR-T cell infusion
Secondary outcomes (16)
Objective response rate (ORR)
The percentage of participants who achieved PR or better response.
Measured: 2 years after CAR-T cell infusion
Overall survival (OS)
OS is measured from the date of the initial infusion of CAR-GPRC5D to the date of the participant's death
Measured: 2 years after CAR-T cell infusion
Duration of response (DOR) after administration
DOR will be calculated among responders (with a PR or better response) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG criteria
Measured: 2 years after CAR-T cell infusion
Progression-free survival (PFS)
PFS is measured from the date of the initial infusion of CAR-GPRC5D of participants to the first time of disease progression or death for any reason
Measured: 2 years after CAR-T cell infusion
Time to response (TTR)
The time interval between the first treatment of CAR-GPRC5D and the time of first recording of sCR or CR or VGPR or PR of the participants
Measured: 2 years after CAR-T cell infusion
Time to complete Response (TTCR)
Time from CAR-GPRC5D infusion to first documentation of complete response of the participants
Measured: 2 years after CAR-T cell infusion
Percentage of Participants With Negative Minimal Residual Disease (MRD)
MRD negative rate is defined as the proportion of participants who achieve MRD negative status by the respective time point
Measured: 2 years after CAR-T cell infusion
Pharmacokinetics - Cmax
The maximum transgene level at Tmax
Measured: 2 years after CAR-T cell infusion
Pharmacokinetics - Tmax
Time to peak transgene level
Measured: 2 years after CAR-T cell infusion
Pharmacokinetics - AUC0-28days
Area under the curve of CAR-T cells from time zero to Day 28
Measured: 2 years after CAR-T cell infusion
Pharmacokinetics - AUC0-90days
Area under the curve of CAR T cells from time zero to Day 90
Measured: 2 years after CAR-T cell infusion
PD endpoints - the level of free CAR-GPRC5D
The content of free CAR-GPRC5D in peripheral blood will be detected at each time point
Measured: 2 years after CAR-T cell infusion
PD endpoints - the levels of CAR-T-related serum cytokines
The concentration levels of CAR-T-related serum cytokines (such as IL-6) will be detected at each time point
Measured: 2 years after CAR-T cell infusion
Health-related quality of life assessment
HRQoL will be assessed by the European Organization for Cancer Research and Treatment Quality of Life Questionnaire (EORTC-QLQ-C30)
Measured: 2 years after CAR-T cell infusion
Evaluation of lymphocyte subsets
Lymphocyte subsets will be assessed by FACS
Measured: 2 years after CAR-T cell infusion
Levels of immunoglobulins
Immunoglobulins in peripheral blood will be assessed to monitor changes
Measured: 2 years after CAR-T cell infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start30 Mar 2023
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Oct 2026 (estimated)
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/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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study pre-defined three dose levels of 1.0×10\^6 CAR-T/Kg, 2.0×10\^6 CAR-T/Kg, 3.0×10\^6 CAR-T/Kg. Each dose level will enroll 3-6 subjects, and the estimated total number of subjects will be 9-18. This study is to observe the characteristics of dose-limiting toxicity (DLT), pharmacokinetics, pharmacodynamics, and immunogenicity of CAR-GPRC5D in different dose groups. And to preliminarily observe the efficacy in small samples of patients with R/R MM or Plasma cell leukemia and confirm the recommended phase II dose (RP2D).
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing IASO Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ruijin Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05759793
- Sponsor's protocol ID
- RD138CI002
- Status last verified
- May 2025
- First submitted
- 26 Feb 2023
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pan M, Wang D, Xu J, Jin S, Wang Y, Tao Y, Liu Y, Ouyang W, Weng X, Yi H, Huang Y, Cao X, Li S, Zhang F, Zhang W, Li C, Mi JQ. The fully human anti-GPRC5D CAR T-cell therapy RD118 induces durable remissions in relapsed/refractory multiple myeloma. Blood. 2026 Jan 29;147(5):513-519. doi: 10.1182/blood.2025030559.
PubMed 41118600
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Fully Human Anti-GPRC5D Chimeric Antigen Receptor T Cells (CAR-GPRC5D) in Patients With Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia
- ClinicalTrials.gov ID
- NCT05759793
- Acronym / sponsor ID
- RD138CI002
- Keywords
- GPRC5D, RRMM, PCL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Nanjing IASO Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Ruijin Hospital
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 8 Mar 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 study is a single-center, open-label, dose-escalation study to observe the safety and efficacy of different doses of CAR-GPRC5D in patients with R/R MM or Plasma Cell Leukemia.
Detailed description
Apheresis will be performed to manufacture CAR-GPRC5D CAR-T cells. Bridging therapy is allowed between apheresis and lymphodepletion. Lymphodepletion with fludarabine and cyclophosphamide was performed for three consecutive days. Then, subjects will receive a single dose infusion of CAR-GPRC5D at 1.0, 2.0, or 3.0 x 10^6 CAR-T cells/Kg. Subjects will be followed in the study for a minimum of 2 years after infusion. Long-term follow-up for lentiviral vector safety will be followed for up to 15 years after infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study pre-defined three dose levels of 1.0×10^6 CAR-T/Kg, 2.0×10^6 CAR-T/Kg, 3.0×10^6 CAR-T/Kg. Each dose level will enroll 3-6 subjects, and the estimated total number of subjects will be 9-18. This study is to observe the characteristics of dose-limiting toxicity (DLT), pharmacokinetics, pharmacodynamics, and immunogenicity of CAR-GPRC5D in different dose groups. And to preliminarily observe the efficacy in small samples of patients with R/R MM or Plasma cell leukemia and confirm the recommended phase II dose (RP2D).
| Arm | Type | Receives |
|---|---|---|
| CAR-GPRC5D cells | Experimental | Drug: CAR-GPRC5DAfter lymphodepletion, CAR-GPRC5D will be administered as a single infusion. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- age 18 to 75 years old, male or female.
- Subjects have had at least 3 prior lines of therapy including chemotherapy based on proteasome inhibitors (PIs) and immunomodulatory agents (IMiDs).
- According to the International Myeloma Working Group (IMWG) consensus (2016) standard on multiple myeloma, the disease has recurred, progressed or is refractory, or according to the IMWG consensus (2013) standard on plasma cell leukemia (Appendix 4), the disease appears relapse, progress or refractory;
- Evidence of cell membrane GPRC5D expression, as determined by a validated immunohistochemistry (IHC) or flow cytometry of tumor tissue (e.g., bone marrow biopsies, or plasmacytoma).
- The subjects should have measurable disease based on at least one of the following parameters:
Key exclusion criteria (18 listed)
- Subjects who are known to have GVHD or need long-term immunosuppressive therapy.
- Subjects have received any anti-cancer treatment as follows:
- monoclonal antibody for treating multiple myeloma within 21 days before leukapheresis, or cytotoxic therapy or proteasome inhibitors within 14 days before leukapheresis, or immunomodulatory agents within 7 days before leukapheresis. or anti-tumor treatments other than those listed above within 30 days before leukapheresis.
- Subjects who were receiving a used therapeutic dose of corticosteroid treatment (defined as prednisone or equivalent > 20mg) within 7 days prior to screening, except for physiological alternatives, inhalation, or topical use.
- Subjects with hypertension that cannot be controlled by medication.
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 |
|---|---|---|
| CAR-GPRC5DCAR-GPRC5D (RD118) is an individualized, gene-modified autologous T-cell immunotherapy product targeting GPRC5D that identifies and eliminates malignant and normal cells expressing GPRC5D. The CAR structure comprises a fully human single-domain antibody fragment (VHH) targeting GPRC5D, fused with intracellular co-stimulatory (4-1BB) and activation (CD3ζ) signaling domains. | Drug | CAR-GPRC5D cells |
Primary outcome
Incidence of dose-limiting toxicity (DLT) by dose group
Time frame: 28 days after CAR-T cell infusion
Dose limiting toxicity will be assessed after infusion in each dose group
Type and incidence of adverse events (AEs) and serious adverse events (SAEs) by dose group
Time frame: 2 years after CAR-T cell infusion
Calculate type and incidence of adverse events (AE), serious adverse event (SAE), including those happened after lymphodepletion and after infusion, those related to study drug and lymphodepletion, or those that led to withdrawal from the study. They will also be aggregated by systematic organ classification (SOC), preferred term (PT), and severity
16 secondary outcomes
Objective response rate (ORR)
Time frame: 2 years after CAR-T cell infusion
Overall survival (OS)
Time frame: 2 years after CAR-T cell infusion
Duration of response (DOR) after administration
Time frame: 2 years after CAR-T cell infusion
Progression-free survival (PFS)
Time frame: 2 years after CAR-T cell infusion
Time to response (TTR)
Time frame: 2 years after CAR-T cell infusion
Time to complete Response (TTCR)
Time frame: 2 years after CAR-T cell infusion
Percentage of Participants With Negative Minimal Residual Disease (MRD)
Time frame: 2 years after CAR-T cell infusion
Pharmacokinetics - Cmax
Time frame: 2 years after CAR-T cell infusion
Pharmacokinetics - Tmax
Time frame: 2 years after CAR-T cell infusion
Pharmacokinetics - AUC0-28days
Time frame: 2 years after CAR-T cell infusion
Pharmacokinetics - AUC0-90days
Time frame: 2 years after CAR-T cell infusion
PD endpoints - the level of free CAR-GPRC5D
Time frame: 2 years after CAR-T cell infusion
PD endpoints - the levels of CAR-T-related serum cytokines
Time frame: 2 years after CAR-T cell infusion
Health-related quality of life assessment
Time frame: 2 years after CAR-T cell infusion
Evaluation of lymphocyte subsets
Time frame: 2 years after CAR-T cell infusion
Levels of immunoglobulins
Time frame: 2 years after CAR-T cell infusion
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 20 May 2025.
- Derived from this study: PubMed 41118600Pan M, Wang D, Xu J, Jin S, Wang Y, Tao Y, Liu Y, Ouyang W, Weng X, Yi H, Huang Y, Cao X, Li S, Zhang F, Zhang W, Li C, Mi JQ. The fully human anti-GPRC5D CAR T-cell therapy RD118 induces durable remissions in relapsed/refractory multiple myeloma. Blood. 2026 Jan 29;147(5):513-519. doi: 10.1182/blood.2025030559.
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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.
Ruijin Hospital Affiliated with Shanghai Jiao Tong University School of Medicine
Shanghai, China
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 CAR-GPRC5D in people with Relapsed/Refractory Multiple Myeloma and Plasma Cell Leukemia, run by Nanjing IASO Biotechnology 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 22 inclusion and 18 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 20 May 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose-limiting toxicity (DLT) by dose group (time frame: 28 days after CAR-T cell 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 NCT05759793, 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 20 May 2025.