Multiple Myeloma in RelapsePhase 1/2NCT05739188
Safety and Efficacy of Anti-GPRC5D CAR-T Cells Therapy in the Treatment of r/r MM
A Phase 1/2 study testing Anti-GPRC5D CAR-T cells infusion in people with Multiple Myeloma in Relapse and Multiple Myeloma, Refractory, run by 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China at 2 sites in China.
Trial summary
It is a single-center, open-labeled, single-arm, non-randomized investigator-initiated trial evaluating the efficacy and safety of anti-GPRC5D CAR-T cells therapy for relapsed and refractory(r/r) multiple myeloma(MM). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Myeloma in Relapse, Multiple Myeloma, Refractory
- What is being tested?
- Anti-GPRC5D CAR-T cells infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesChina
- Study dates
- 7 Feb 2023to 31 Dec 2025
- Phase
- Phase 1/2
- 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 the informed consent, and is expected to complete the follow-up examination and treatment of the study procedure;
- Age 18-75 years old, gender unlimited;
- Patients diagnosed with multiple myeloma according to International Myeloma Working Group(IMWG) diagnostic criteria;
- Subjects who had failed treatment with at least 3 drugs of different mechanisms (including chemotherapy, proteasome inhibitors, immunomodulators, etc.), or had progressed or relapsed during the last treatment period or within 6 months after the end of treatment;
- The presence of measurable lesions at screening was determined according to any of the following criteria, defined as: (1) serum monoclonal immunoglobulin (M-protein) level ≥1.0 g/dL; (2) urine M protein level ≥200 mg/ 24h; (3) Light chain multiple myeloma diagnosed with no measurable lesion in serum or urine: serum immunoglobulin free light chain ≥10 mg/dL and serum immunoglobulin κ/γ free light chain ratio abnormal;
- The patient has recovered from the toxicity of the prior treatment, i.e., CTCAE toxicity grade < 2 (unless the abnormality is related to the tumor or is stable as judged by the investigator and has little impact on safety or efficacy);
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- Eastern cooperative oncology group (ECOG) score is 0-2;
- Survival is expected to be greater than 3 months;
- Adequate liver , kidney and cardiopulmonary function;
- Willingness to complete the informed consent process and to comply with study procedures and visit schedule.
Who cannot join
- Have been diagnosed with or treated for aggressive malignancies other than multiple myeloma;
- Prior antitumor therapy (prior to blood collection for CAR-T preparation) : targeted therapy, epigenetic therapy, or investigational drug therapy within 14 days or at least 5 half-lives, whichever is shorter;
- It is suspected that MM has involved the central nervous system or meninges and has been confirmed by MRI or CT, or there are other active central nervous system diseases;
- Clinically significant central nervous system diseases, such as epilepsy, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, psychosis, active central nervous system involvement or cancerous meningitis;
- HBsAg or HBcAb are positive, and the quantitative detection of hepatitis B virus(HBV) DNA in peripheral blood is more than 100 copies / L;hepatitis C virus (HCV) antibody and HCV RNA in peripheral blood are positive; HIV antibody positive; Syphilis antibody is positive in the first screening;
- Pregnant or breastfeeding;
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- Severe active viral, bacterial or uncontrolled systemic fungal infections; Hereditary bleeding / coagulation diseases, history of non traumatic bleeding or thromboembolism, other diseases that may increase the risk of bleeding, etc;Patients who received autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks before screening, or who plan to undergo ASCT during the study period;
- Any unstable systemic disease: including but not limited to unstable angina, cerebrovascular accident or transient cerebral ischemia (within 6 months before screening), myocardial infarction (within 6 months before screening), congestive heart failure [New York Heart Association (NYHA) classification ≥ grade III], severe arrhythmia with poor drug control, liver, kidney or metabolic diseases;
- Had hypersensitivity or intolerance to any drug used in this study;
- Persons with serious mental illness;
- Alcoholics or persons with a history of drug abuse;
- Systemic diseases judged by researchers to be unstable: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment;
- Patients with acute/chronic graft-versus-host disease (GVHD) or requiring immunosuppressive therapy for GVHD within 6 months prior to screening;
- Any unsuitable to participate in this trial judged by the investigator.
Trial locations and contacts
2 sites in 1 country.
Sanbin Wang, MD contact
China2 sites, 2 recruiting
- Recruiting
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Kunming, Yunnan, 650100 P.R.China
Sanbin Wang, Doctor, (+86)13187424131, Sanbin1011@163.com
- Recruiting
No.212 Daguan Road, Xishan District
Kunming, Yunnan
About this study
Official title: An Investigator-initiated Trial Evaluating the Efficacy and Safety of Anti-GPRC5D CAR-T Cells Therapy in the Treatment of Relapsed / Refractory(r/r) Multiple Myeloma(MM)
It is a single-center, open-labeled, single-arm, non-randomized investigator-initiated trial evaluating the efficacy and safety of anti-GPRC5D CAR-T cells therapy for relapsed and refractory(r/r) multiple myeloma(MM).
Read the detailed description
This open label, single-arm, Phase I study aims to evaluate the efficacy and safety of Anti-GPRC5D CAR-T in subjects with relapsed and refractory(r/r) multiple myeloma(MM). A leukapheresis procedure will be performed to manufacture Anti-GPRC5D chimeric antigen receptor (CAR) modified T cells. Prior to Anti-GPRC5D CAR-T cells infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide. After infusion, the safety and efficacy of CAR-T therapy was evaluated by investigators.
- Being tested
- Anti-GPRC5D CAR-T cells infusion
- Keywords
- CAR-T, GPRC5D
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-GPRC5D CAR-T cells infusionBiological
This is a"3+3"dose escalation study, in which three dose groups are set three different dose levels of CAR-T cells:
Dose level one: 3.0×10^6 /kg±20%; Dose level two:6.0×10^6 /kg±20%; Dose level three:1.0×10^7 /kg±20%.
| Study group | Role | What they receive |
|---|---|---|
| Anti-GPRC5D CAR-T | Experimental | Subjects who meet the enrollment conditions will receive intravenous infusion of anti--GPRC5D CAR-T Cells after lymphodepleting therapy. Receives: Biological: Anti-GPRC5D CAR-T cells infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events(AE) after infusion
The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included. Description, time, classification, and outcome of AE events resulted from the investigational medical product, delivery method, or emergency measures will be recorded in the case report form.
Measured: Up to 12 months after infusion
Dose limited toxicity (DLT)
Dose limited toxicity(DLT) was defined as the occurrence of any of the following adverse events within 28 days of the infusion of CAR-T cells after optimal supportive treatment, which were discussed with the investigator and determined to be associated or likely to be associated with the infusion.
Measured: Up to 1 month after infusion
Secondary outcomes (4)
Overall Response Rate (ORR)
Overall Response Rate (ORR) is defined as the proportion of subjects achieving strict complete remission(sCR), complete response(CR), very good partial response(VGPR） and partial response(PR).
Measured: Up to 2 years after infusion
Concentration of CAR-T cells
Concentration of CAR-T cells measured by Flow cytometry after CAR-T infusion
Measured: Days 4, 7, 10, 14 and months 2, 3, 6, 9, 12 after infusion
Progression-free survival(PFS)
Progression-free survival(PFS) refers to the time from cell reinfusion to the first assessment of tumor progression or death from any cause.
Measured: Up to 2 years
Overall survival(OS)
Overall survival (OS) refers to the time from the time the patient received an infusion of CAR-T cells until death (from any cause).
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start7 Feb 2023
- Primary completion1 Feb 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma in RelapseStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- This is a"3+3"dose escalation study, in which three dose groups are set three different dose levels of CAR-T cells: Dose level one: 3.0×10\^6 /kg±20%; Dose level two:6.0×10\^6 /kg±20%; Dose level three:1.0×10\^7 /kg±20%.
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanbin Wang, MD, Principal investigator, 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05739188
- Sponsor's protocol ID
- BG-CT-22-012
- Status last verified
- Feb 2023
- First submitted
- 4 Feb 2023
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator-initiated Trial Evaluating the Efficacy and Safety of Anti-GPRC5D CAR-T Cells Therapy in the Treatment of Relapsed / Refractory(r/r) Multiple Myeloma(MM)
- ClinicalTrials.gov ID
- NCT05739188
- Acronym / sponsor ID
- BG-CT-22-012
- Keywords
- CAR-T, GPRC5D
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- 920th Hospital of Joint Logistics Support Force of People's Liberation Army of ChinaUniversity, hospital or other
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Feb 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.
It is a single-center, open-labeled, single-arm, non-randomized investigator-initiated trial evaluating the efficacy and safety of anti-GPRC5D CAR-T cells therapy for relapsed and refractory(r/r) multiple myeloma(MM).
Detailed description
This open label, single-arm, Phase I study aims to evaluate the efficacy and safety of Anti-GPRC5D CAR-T in subjects with relapsed and refractory(r/r) multiple myeloma(MM). A leukapheresis procedure will be performed to manufacture Anti-GPRC5D chimeric antigen receptor (CAR) modified T cells. Prior to Anti-GPRC5D CAR-T cells infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide. After infusion, the safety and efficacy of CAR-T therapy was evaluated by investigators.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a"3+3"dose escalation study, in which three dose groups are set three different dose levels of CAR-T cells: Dose level one: 3.0×10^6 /kg±20%; Dose level two:6.0×10^6 /kg±20%; Dose level three:1.0×10^7 /kg±20%.
| Arm | Type | Receives |
|---|---|---|
| Anti-GPRC5D CAR-T | Experimental | Biological: Anti-GPRC5D CAR-T cells infusionSubjects who meet the enrollment conditions will receive intravenous infusion of anti--GPRC5D CAR-T Cells after lymphodepleting therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The patient or his/her guardian understands and voluntarily signs the informed consent, and is expected to complete the follow-up examination and treatment of the study procedure;
- Age 18-75 years old, gender unlimited;
- Patients diagnosed with multiple myeloma according to International Myeloma Working Group(IMWG) diagnostic criteria;
- Subjects who had failed treatment with at least 3 drugs of different mechanisms (including chemotherapy, proteasome inhibitors, immunomodulators, etc.), or had progressed or relapsed during the last treatment period or within 6 months after the end of treatment;
- The presence of measurable lesions at screening was determined according to any of the following criteria, defined as: (1) serum monoclonal immunoglobulin (M-protein) level ≥1.0 g/dL; (2) urine M protein level ≥200 mg/ 24h; (3) Light chain multiple myeloma diagnosed with no measurable lesion in serum or urine: serum immunoglobulin free light chain ≥10 mg/dL and serum immunoglobulin κ/γ free light chain ratio abnormal;
Key exclusion criteria (14 listed)
- Have been diagnosed with or treated for aggressive malignancies other than multiple myeloma;
- Prior antitumor therapy (prior to blood collection for CAR-T preparation) : targeted therapy, epigenetic therapy, or investigational drug therapy within 14 days or at least 5 half-lives, whichever is shorter;
- It is suspected that MM has involved the central nervous system or meninges and has been confirmed by MRI or CT, or there are other active central nervous system diseases;
- Clinically significant central nervous system diseases, such as epilepsy, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, psychosis, active central nervous system involvement or cancerous meningitis;
- HBsAg or HBcAb are positive, and the quantitative detection of hepatitis B virus(HBV) DNA in peripheral blood is more than 100 copies / L;hepatitis C virus (HCV) antibody and HCV RNA in peripheral blood are positive; HIV antibody positive; Syphilis antibody is positive in the first screening;
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 |
|---|---|---|
| Anti-GPRC5D CAR-T cells infusionThis is a"3+3"dose escalation study, in which three dose groups are set three different dose levels of CAR-T cells: Dose level one: 3.0×10^6 /kg±20%; Dose level two:6.0×10^6 /kg±20%; Dose level three:1.0×10^7 /kg±20%. | Biological | Anti-GPRC5D CAR-T |
Primary outcome
Incidence of adverse events(AE) after infusion
Time frame: Up to 12 months after infusion
The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included. Description, time, classification, and outcome of AE events resulted from the investigational medical product, delivery method, or emergency measures will be recorded in the case report form.
Dose limited toxicity (DLT)
Time frame: Up to 1 month after infusion
Dose limited toxicity(DLT) was defined as the occurrence of any of the following adverse events within 28 days of the infusion of CAR-T cells after optimal supportive treatment, which were discussed with the investigator and determined to be associated or likely to be associated with the infusion.
4 secondary outcomes
Overall Response Rate (ORR)
Time frame: Up to 2 years after infusion
Concentration of CAR-T cells
Time frame: Days 4, 7, 10, 14 and months 2, 3, 6, 9, 12 after infusion
Progression-free survival(PFS)
Time frame: Up to 2 years
Overall survival(OS)
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
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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.
Sanbin Wang, MD contact
Sanbin Wang, MD principal investigator
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Anti-GPRC5D CAR-T cells infusion in people with Multiple Myeloma in Relapse and Multiple Myeloma, Refractory, run by 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China at 2 sites 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 10 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sanbin Wang, MD (13187424131 ext. +86, Sanbin1011@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events(AE) after infusion (time frame: Up to 12 months after 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 23 Feb 2023.