Relapsed and/or Refractory Multiple MyelomaPhase 1/2NCT06182696
OriCAR-017 Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of R/RMM
A Phase 1/2 study testing OriCAR-017 in people with Relapsed and/or Refractory Multiple Myeloma, run by OriCell Therapeutics Co., Ltd. at 5 sites in China.
Trial summary
An open label, dose exploratory clinical study to evaluate the safety, efficacy, and pharmacokinetics of OriCAR-017 in R/RMM Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed and/or Refractory Multiple Myeloma
- What is being tested?
- OriCAR-017
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 5 sitesChina
- Study dates
- 26 Oct 2023to 31 Aug 2028
- Phase
- Phase 1/2
- 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
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:
- Serum M protein >5 g/L;
- Urine M protein level >200 mg/24 hour;
- Serum free light chain (sFLC) >100 mg/L and K/λ FLC ratio is abnormal;
- Primitive immature or monoclonal plasma cells >5% by bone marrow cytology or flow cytometry.
- 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:
- Smoldering myeloma (asymptomatic)
- Multiple myeloma with only extramedullary lesions;
- Plasma cell leukemia;
- Concurrent amyloidosis;
- Central nervous system metastasis, leptomeningeal disease or metastatic central compression;
- HBsAg or HbcAb is 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 is positive; human immunodeficiency virus (HIV) antibody positive; syphilis antibody is positive at Screening; Cytomegalovirus DNA test is positive;
- Had hypersensitivity or intolerance to any drug/excipient (including conditioning chemotherapy) used in this study;
- Previously received treatment targeting GPRC5D, including but not limited to antibodies, ADC, or CAR-T;
- Subjects who received autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks of Screening Visit or who plan to undergo ASCT during the study;
- Any uncontrolled active infection within 4 weeks prior to ICF signing or leukapheresis requires parenteral antibiotic, antiviral, or antifungal treatment
- Major surgery within 28 days prior to Screening Visit with the exception of a biopsy and an insertion of a central venous catheter or during the study;
- Subjects who received allogeneic stem cell therapy;
- Subjects complications or other conditions evaluated by investigators may affect compliance with the protocol or make them unsuitable to participate in this study;
- Pregnant or breastfeeding.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Not yet recruiting
Beijing GoBroad Hospital
Beijing
Kai Hu
- Recruiting
The First Affiliated Hospital College of Medicine Zhejiang University
Hangzhou, Zhejiang, 310003
HE Huang, hehuangyu@126.com
- Not yet recruiting
The First Affiliated Hospital with Nanjing Medical University
Nanjing
Jianyong Li
- Not yet recruiting
Tongji Hospital of Tongji University
Shanghai
Aibin Liang
- Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan
Heng Mei
About this study
Official title: An Open Label,Multi-center Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Autologous T Cell Injection Targeting GPRC5D OriCAR-017 in Patients With Relapsed and/or Refractory Multiplemyeloma
An open label, dose exploratory clinical study to evaluate the safety, efficacy, and pharmacokinetics of OriCAR-017 in R/RMM
Read the detailed description
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).
- Being tested
- OriCAR-017
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OriCAR-017Biological
GPCRC5D-directed chimeric antigen receptor modified T cells
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: OriCAR-017 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 28 days
Dose-limiting toxicity (DLT)
tolerability
Measured: Up to 28 days
Secondary outcomes (5)
Objective Response Rate
Objective response is defined as the participants with a partial response (PR) or better by the RECIST1.1 criteria.
Measured: 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
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
Measured: 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
Measured: 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
Measured: 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
Measured: From date of randomization until the date of first documented date of death from any cause, assessed up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start26 Oct 2023
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed and/or 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OriCell Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182696
- Sponsor's protocol ID
- OriCAR-017-P1
- Status last verified
- Apr 2024
- First submitted
- 11 Dec 2023
- Last updated
- 31 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label,Multi-center Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Autologous T Cell Injection Targeting GPRC5D OriCAR-017 in Patients With Relapsed and/or Refractory Multiplemyeloma
- ClinicalTrials.gov ID
- NCT06182696
- Acronym / sponsor ID
- OriCAR-017-P1
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- OriCell Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Oct 2023 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 27 Dec 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.
An open label, dose exploratory clinical study to evaluate the safety, efficacy, and pharmacokinetics of OriCAR-017 in R/RMM
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OriCAR-017 ( GPCRC5D-directed chimeric antigen receptor modified T cells ) | Experimental | Biological: OriCAR-017Phase 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| OriCAR-017GPCRC5D-directed chimeric antigen receptor modified T cells | Biological | OriCAR-017 ( GPCRC5D-directed chimeric antigen receptor modified T cells ) |
Primary outcome
Maximum tolerated dose of OriCAR-017-P1
Time frame: Up to 28 days
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.
Dose-limiting toxicity (DLT)
Time frame: Up to 28 days
tolerability
5 secondary outcomes
Objective Response Rate
Time frame: 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
Pharmacokinetics (the number of cell copies and cell persistence duration in peripheral blood)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: From date of randomization until the date of first documented date of death from any cause, assessed up to 15 years
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 31 May 2024.
- Individual participant dataSharing planned: No
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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.
5 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 OriCAR-017 in people with Relapsed and/or Refractory Multiple Myeloma, run by OriCell Therapeutics Co., Ltd. at 5 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?
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 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
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?
Contact HE Huang, MD (0571-88208277, hehuangyu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose of OriCAR-017-P1 (time frame: Up to 28 days). 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 31 May 2024.