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Multiple MyelomaEarly Phase 1NCT05016778

A Study of CAR-T Cells Targeting GPRC5D in the Treatment of r/r Multiple Myeloma

A Early Phase 1 study testing GPRC5D-CAR-T in people with Multiple Myeloma, run by Zhejiang University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a single-arm, open-label, dose-escalation study to evaluate the safety, tolerability, cellular kinetics and initial efficacy of CAR-T cell therapy targeting GPRC5D in multiple myeloma subjects who have failed the standard treatments. 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?
GPRC5D-CAR-T
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteChina
Study dates
8 Jun 2021to 30 Jun 2025
Phase
Early 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

  • The subject can understand and have the ability to sign an informed consent form;
  • Male or female subjects, aged 18-75 years;
  • The expected survival period is not less than 12 weeks;
  • ECOG score ≤ 2 ;
  • Diagnosed as multiple myeloma according to the IMWG standard in 2018;
  • The expression of GPRC5D in bone marrow plasma cells is more than 20%, or it is positive in tumor tissue by immunohistochemistry. One of the following criteria must be detected:
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  • If IgG type MM, serum M protein ≥10g/L; if IgA, IgD, IgE or IgM type MM, serum M protein ≥5g/L;
  • Or urine M protein level ≥200mg/24h;
  • Or light chain type MM, serum free light chain (sFLC) ≥ 100mg / L and K/ λ FLC ratio is abnormal;
  • Or there are extramedullary lesions;
  • Subjects who have received at least 3 different mechanism drugs (including chemotherapy, protease inhibitors, immunosuppressive agents, etc.) have failed treatments, or have progressed or recurred during the last treatment or within 6 months after the end of treatment ;
  • Lung function is normal, and oxygen saturation is greater than 92%;
  • No heart disease or coronary heart disease, echocardiogram showed normal diastolic function, left ventricular ejection fraction (LVEF) ≥50%, and no serious arrhythmia;
  • Liver function: TBIL<3×ULN, AST<2.5×ULN, ALT<2.5ULN;
  • Renal function: creatinine clearance rate (estimated by Cockcroft Gault formula) ≥ 30 mL/min;
  • The blood routine meets the following standards:
  • Lymphocyte count>0.5×10e9/L;
  • Neutrophils ≥1.0×10e9/L;
  • Hemoglobin ≥80g/L;
  • Platelet ≥75×10e9/L
  • From the use of study drug to 2 years after treatment, male subjects or female subjects of childbearing age must agree and be able to take effective contraceptive measures.

Who cannot join

  • Pregnant or breastfeeding;
  • HBsAg or HBcAb are positive, and the quantitative detection of HBV DNA in peripheral blood is more than 100 copies / L; HCV antibody and HCV RNA in peripheral blood are positive; HIV antibody positive; Syphilis antibody is positive in the first screening;
  • 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;
  • Patients who received anti-cancer chemotherapy or other medications within 2 weeks before screening;
  • Uncontrolled malignant tumors except MM, excluding malignant tumors that received radical treatment and no active disease was found within 3 years before enrollment;
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  • Clinically significant central nervous system diseases, such as epilepsy, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, psychosis, active central nervous system involvement or cancerous meningitis;
  • In the past two years, autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) caused damage to terminal organs, or required systemic application of immunosuppressive or other drugs;
  • 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;
  • Patients received allogeneic stem cell therapy;
  • Any unsuitable to participate in this trial judged by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The first affiliated hospital of medical college of zhejiang university

    Hangzhou, Zhejiang, 310003

Other trials in China

About this study

Official title: A Single Arm, Open Label Clinical Study of CAR-T Cells Targeting GPRC5D in the Treatment of Relapsed / Refractory Multiple Myeloma(POLARIS)

This is a single-arm, open-label, dose-escalation study to evaluate the safety, tolerability, cellular kinetics and initial efficacy of CAR-T cell therapy targeting GPRC5D in multiple myeloma subjects who have failed the standard treatments.

Being tested
GPRC5D-CAR-T
Keywords
CAR-T, GPRC5D, Multiple Myeloma
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GPRC5D-CAR-TDrug

    After enrollment, subjects complete the PBMC apheresis, then complete the Lymphocyte clearance, and then receive the dose climbing test: 1×10e6/kg，3×10e6/kg，6×10e6/kg.

Study groups in NCT05016778
Study groupRoleWhat they receive
Treatment GroupExperimentalThis is a open label, single arm clinical trial.
Receives: Drug: GPRC5D-CAR-T

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose limited toxicity (DLT)

    Dose limited toxicity

    Measured: From date of initial treatment to Day 28 post GPRC5D CAR-T infusion.

  2. AE and SAE

    Adverse event and serious adverse event

    Measured: From admission to the end of the follow-up, up to 2 years

Secondary outcomes (6)

  1. Concentration of CAR-T cells

    In peripheral blood and bone marrow

    Measured: From admission to the end of the follow-up, up to 2 years

  2. Objective Response Rate, ORR

    Proportion of subjects with complete or partial remission

    Measured: In 3 months of GPRC5D CAR-T cell infusion

  3. Disease control rate, DCR

    The percentage of patients with remission and stable disease after treatment in the total evaluable cases.

    Measured: From Day 28 GPRC5D CAR-T infusion up to 2 years

  4. Duration of remission, DOR

    The time from the first assessment of remission or partial remission of the tumor to the first assessment of disease progression or death from any cause;

    Measured: 24 months post GPRC5D CAR-T cells infusion

  5. Progression-free survival, PFS

    The time from cell reinfusion to the first assessment of tumor progression or death from any cause

    Measured: 24 months post GPRC5D CAR-Tcells infusion

  6. Overall survival, OS

    The time from the cell reinfusion to death due to any cause.

    Measured: From GPRC5D CAR-T infusion to death，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.

  1. First posted23 Aug 2021
  2. Study start8 Jun 2021
  3. Primary completion30 Jun 2024 (estimated)
  4. Study completion30 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05016778
Sponsor's protocol ID
POLARIS
Status last verified
Oct 2022
First submitted
6 Jun 2021
Last updated
1 Nov 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhang M, Wei G, Zhou L, Zhou J, Chen S, Zhang W, Wang D, Luo X, Cui J, Huang S, Fu S, Zhou X, Tang Y, Ding X, Kuang J, He XP, Hu Y, Huang H. GPRC5D CAR T cells (OriCAR-017) in patients with relapsed or refractory multiple myeloma (POLARIS): a first-in-human, single-centre, single-arm, phase 1 trial. Lancet Haematol. 2023 Feb;10(2):e107-e116. doi: 10.1016/S2352-3026(22)00372-6.

    PubMed 36725117

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing GPRC5D-CAR-T in people with Multiple Myeloma, run by Zhejiang University 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 21 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: status not confirmed, as of the sponsor's last update on 1 Nov 2022. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

Dose limited toxicity (DLT) (time frame: From date of initial treatment to Day 28 post GPRC5D CAR-T 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 NCT05016778, 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 1 Nov 2022.

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