Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
An open label, dose exploratory clinical study to evaluate the safety, efficacy, and pharmacokinetics of OriCAR-017 in R/RMM
This is a Phase I and Phase II, open-label, multi-center study to assess the safety, pharmacokinetics, and efficacy of GPRC5D directed chimeric antigen receptor modified T cells injection (OriCAR-017) in n patients with relapsed and/or refractory multiplemyeloma (R/RMM).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OriCAR-017 ( GPCRC5D-directed chimeric antigen receptor modified T cells ) | Experimental | Phase I (Dose-Escalation) The subjects enrolled will be sequentially assigned to the corresponding dose level to determin the RP2D. The dose-escalation part of the study will adopt the the standard 3+3 design, wherein 3 dose levels are planned to be evaluated. Phase I (Dose-Expansion) After determining the RP2D, one of the dose levels will be selected for further evaluation during the dose-expansion part. Up to 10 to 15 additional subjects who are diagnosed with relapsed/refractory MM will be enrolled to further explore the anti-tumor activity of Ori-CAR-017. Phase II The Phase II part of the study will be initiated at the RP2D of OriCAR-017 which will be selected based on the clinical data obtained during the Phase I part of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OriCAR-017 | Biological | GPCRC5D-directed chimeric antigen receptor modified T cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose of OriCAR-017-P1 | The MTD is defined as the highest dose with an observed incidence of DLT in no more than one out of six patients treated at a particular dose level. | Up to 28 days |
| Dose-limiting toxicity (DLT) | tolerability | Up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Objective response is defined as the participants with a partial response (PR) or better by the RECIST1.1 criteria. | From date of randomization until the date of first documented progression or date of death from any cause or withdraw, whichever came first, assessed up to 2 Years |
Not provided
Main Inclusion Criteria:
Diagnosis of R/RMM according to the IMWG criteria;
Expected survival period is >12 weeks;
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 or 2 at the time of ICF signature;
The expression of GPRC5D in bone marrow plasma cells membrane is more than 20% by flow cytometry and/or immunohistochemistry, multiple myeloma with measurable lesions, and at least one of the following criteria must be met:
Subjects who had received at least 3 prior lines of therapy including (but not limited to) immunomodulatory drugs (IMiDs), proteasome inhibitors, anti-CD38 monoclonal antibodies, etc., but have failed treatment, including those who have experienced relapse (within 12 months), refractory or intolerant to the last line treatment regimen.
Main Exclusion Criteria:
18-75
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| HE Huang, MD | Contact | 0571-88208277 | hehuangyu@126.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital College of Medicine Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310003 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Pharmacokinetics (the number of cell copies and cell persistence duration in peripheral blood) |
CAR-GPRC5D DNA in peripheral blood detected by q-PCR at each visit after infusion |
| From date of randomization until the date of first documented progression or date of death from any cause or withdraw, whichever came first, assessed up to 2 years |
| Antitumor efficacy-Progression-free survival (PFS) | The period from the day when the subject receives the infusion of cells to the first recorded tumor progression | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years |
| Antitumor efficacy-Duration of response (DOR) | The period from the first evaluation of sCR or CR or VGPR or PR or MR to the first evaluation of PD or death of any cause | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years |
| Long term survival follow up | The period from randomization until the date of death | From date of randomization until the date of first documented date of death from any cause, assessed up to 15 years |
| Beijing GoBroad Hospital | Not yet recruiting | Beijing | China |
|
| The First Affiliated Hospital with Nanjing Medical University | Not yet recruiting | Nanjing | China |
|
| Tongji Hospital of Tongji University | Not yet recruiting | Shanghai | China |
|
| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Recruiting | Wuhan | China |
|