Multiple MyelomaPhase 1NCT05325801
A Study of CAR-T Cells Targeting Both BCMA and GPRC5D in Treatment of Relapsed or Refractory Multiple Myeloma
A Phase 1 study testing BMCA and GPRC5D dual target CAR-T cells(OriC321) in people with Multiple Myeloma, run by Zhejiang University.
Trial summary
An Open-Label, Dose Finding Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of BMCA and GPRC5D dual target CAR-T cells therapy in Patients with relapsed or refractory multiple myeloma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- BMCA and GPRC5D dual target CAR-T cells(OriC321)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- Apr 2022to Mar 2025
- Phase
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated, written informed consent prior to any study specific procedures;
- Estimated life expectancy of minimum of 12 weeks;
- ECOG 0-2;
- Diagnosed as multiple myeloma according to the IMWG criteria;
- Evidence of cell membrane GPRC5D and/or BCMA expression, as determined by a validated immunohistochemistry (IHC) or flow cytometry of tumor tissue; Subjects should have measurable disease. At least meet one of the following criteria:
- If IgG type MM, serum M protein ≥10g/L; if IgA, IgD, IgE or IgM type MM, serum M protein ≥5g/L;
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- urine M protein level ≥0.2g(200mg/24h);
- light chain type MM, serum free light chain (sFLC) ≥ 100mg / L and K/ λ FLC ratio is abnormal;
- there are extramedullary lesions;
- Subjects have had at least 3 prior lines of therapy including chemotherapy based on proteasome inhibitors (PIs) and immunomodulatory agents (IMiDs);
- Adequate organ functions
Who cannot join
- Active smoldering multiple myeloma;
- Active plasma cell leukemia;
- With organ amyloidosis;
- Central nervous system (CNS) involvement;
- Pregnant or breastfeeding;
- 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
- Uncontrolled Hypertension hypertension defined as a blood pressure (BP) ≥150/95 mmHg; Symptomatic heart failure per New York Heart Association Classification Class II, III or IV), Mean resting corrected QT interval corrected by Fridericia's formula (QTcF) > 470 msec (female), 450 msec (male) obtained from ECG; Baseline left ventricular ejection fraction (LVEF) below institution's lower limit of normal (LLN) or <50%;
- Have a history of another primary malignancy within 5 years prior to starting study treatment. Exceptions here are as follows: the disease under study; adequately treated basal or squamous cell carcinoma of the skin; cancer of the cervix in situ.
About this study
Official title: An Open-Label, Dose Finding Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of BMCA and GPRC5D Dual Target CAR-T Cells Therapy in Patients With Relapsed or Refractory Multiple Myeloma
An Open-Label, Dose Finding Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of BMCA and GPRC5D dual target CAR-T cells therapy in Patients with relapsed or refractory multiple myeloma
- Conditions
- Multiple Myeloma
- Being tested
- BMCA and GPRC5D dual target CAR-T cells(OriC321)
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMCA and GPRC5D dual target CAR-T cells(OriC321)Biological
Patients will receive lymphodepleting chemotherapy followed by a single infusion of OriC321
| Study group | Role | What they receive |
|---|---|---|
| BMCA and GPRC5D dual target CAR-T cells （OriC321） | Experimental | Not described Receives: Biological: BMCA and GPRC5D dual target CAR-T cells(OriC321) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, severity AEs/SAEs
Measured: 2 years after CAR-T cell infusion
Secondary outcomes (6)
Concentration of CAR-T cells
Measured: 2 years after CAR-T cell infusion
Objective response rate (ORR)
Measured: 2 years after CAR-T cell infusion
Progression-free survival (PFS)
Measured: 2 years after CAR-T cell infusion
Duration of response (DOR)
Measured: 2 years after CAR-T cell infusion
Overall survival (OS)
Measured: 2 years after CAR-T cell infusion
Percentage of Patients With Negative Minimal Residual Disease (MRD)
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 posted13 Apr 2022
- Study startApr 2022 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- 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
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, He Huang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325801
- Sponsor's protocol ID
- Sirius
- Status last verified
- Apr 2022
- First submitted
- 15 Mar 2022
- Last updated
- 13 Apr 2022
- 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 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Dose Finding Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of BMCA and GPRC5D Dual Target CAR-T Cells Therapy in Patients With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05325801
- Acronym / sponsor ID
- Sirius
- Conditions
- Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- Apr 2022 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 13 Apr 2022 (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.
An Open-Label, Dose Finding Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of BMCA and GPRC5D dual target CAR-T cells therapy in Patients with relapsed or 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 |
|---|---|---|
| BMCA and GPRC5D dual target CAR-T cells （OriC321） | Experimental | Biological: BMCA and GPRC5D dual target CAR-T cells(OriC321) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed and dated, written informed consent prior to any study specific procedures;
- Estimated life expectancy of minimum of 12 weeks;
- ECOG 0-2;
- Diagnosed as multiple myeloma according to the IMWG criteria;
- Evidence of cell membrane GPRC5D and/or BCMA expression, as determined by a validated immunohistochemistry (IHC) or flow cytometry of tumor tissue; Subjects should have measurable disease. At least meet one of the following criteria:
Key exclusion criteria (8 listed)
- Active smoldering multiple myeloma;
- Active plasma cell leukemia;
- With organ amyloidosis;
- Central nervous system (CNS) involvement;
- Pregnant or breastfeeding;
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 |
|---|---|---|
| BMCA and GPRC5D dual target CAR-T cells(OriC321)Patients will receive lymphodepleting chemotherapy followed by a single infusion of OriC321 | Biological | BMCA and GPRC5D dual target CAR-T cells （OriC321） |
Primary outcome
Incidence, severity AEs/SAEs
Time frame: 2 years after CAR-T cell infusion
6 secondary outcomes
Concentration of CAR-T cells
Time frame: 2 years after CAR-T cell infusion
Objective response rate (ORR)
Time frame: 2 years after CAR-T cell infusion
Progression-free survival (PFS)
Time frame: 2 years after CAR-T cell infusion
Duration of response (DOR)
Time frame: 2 years after CAR-T cell infusion
Overall survival (OS)
Time frame: 2 years after CAR-T cell infusion
Percentage of Patients With Negative Minimal Residual Disease (MRD)
Time frame: 2 years after CAR-T cell infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
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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 Phase 1 study testing BMCA and GPRC5D dual target CAR-T cells(OriC321) in people with Multiple Myeloma, run by Zhejiang University.
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 11 inclusion and 8 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 13 Apr 2022. 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?
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?
Results are not available in the source record.
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?
Incidence, severity AEs/SAEs (time frame: 2 years after CAR-T cell infusion). 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 13 Apr 2022.