Neoplasms, Plasma CellPhase 1NCT06271252
A Study to Evaluate the Safety, PK/PD of (OriCAR-017) in Subjects With RR/MM - RIGEL Study
A Phase 1 study testing OriCAR-017 in people with Neoplasms, Plasma Cell and Neoplasms by Histologic Type, run by OriCell Therapeutics Co., Ltd. at 1 site in United States.
Trial summary
The is a first clinical study for Oricell Therapeutics Inc. in the United States to evaluate the safety, PK, PD and preliminary efficacy of our anti-GPRC5D cell product (OriCAR-017) in subjects with relapsed/refractory multiple myeloma. RIGEL Study Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neoplasms, Plasma Cell, Neoplasms by Histologic Type, Neoplasms
- What is being tested?
- OriCAR-017
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2024to 12 Apr 2028
- Phase
- Phase 1
- 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
Who may be able to join
- Capable of giving signed informed consent
- Subjects aged 18 to 75 years (inclusive) at Screening (signing the ICF).
- Expected survival period is >12 weeks.
- Diagnosis of MM according to the IMWG criteria (2016 version).
- One of the following criteria must be met:
- If immunoglobulin (Ig)G type MM, then serum M protein >10 g/L; if IgA, IgD, IgE or IgM type MM, then serum M protein >5 g/L
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- Urine M protein level >200 mg/24 hour
- If light chain type MM, then serum free light chain (sFLC) >100 mg/L and K/λ FLC ratio is abnormal.
- Extramedullary lesions (>1 cm for diameter of the short axis).
- For Phase I (dose-escalation) - Subjects who had received at least 3 prior lines of therapy, had previous exposure to BCMA-Ag+ therapies, and were refractory to the last line of therapy.
- For Phase I (dose-expansion) and Phase II: Subjects with previous exposure to BCMA directed therapies including BCMA bispecific antibody (e.g., teclistamab), BCMA antibody directed conjugate (such as BLENREP), and BCMA-CAR-T (such as CARVYKT1TM)
- Subjects with adequate hematologic, renal, hepatic, pulmonary and cardiac function.
- Subject and partners willing to take and or use effective contraceptive measures until 2 years post IMP infusion.
Who cannot join
- Pregnant or breastfeeding.
- Seropositive for history of human immunodeficiency virus Active Hepatitis B infection and or Hepatitis C infection
- Known active or prior history of CNS involvement
- History of 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 in the past 2 years
- Presence of uncontrolled active infection
- Subjects who received autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks of Screening Visit or who plan to undergo ASCT during the study.
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- Subjects who received allogeneic stem cell therapy.
- Any condition that in the opinion of the Investigator, would interfere with evaluation of the IMP.
- Received Bendamustine treatment 1 year prior to Screening Visit.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northside Hospital
Atlanta, Georgia, 30342
Melhem Solh, 404-255-1930, msolh@bmtga.com
Caitlin Guzowski, 4042551930, caitlin.guzowski@northside.com
About this study
Official title: A Phase I/II, Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of Anti-GPRC5D CAR-T Cell Product (OriCAR-017) in Subjects With Relapsed/Refractory Multiple Myeloma.
The is a first clinical study for Oricell Therapeutics Inc. in the United States to evaluate the safety, PK, PD and preliminary efficacy of our anti-GPRC5D cell product (OriCAR-017) in subjects with relapsed/refractory multiple myeloma.
RIGEL Study
Read the detailed description
This is a Phase I/II, open-label multicenter study to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of anti-GPRC5D CAR-T cell product (OriCAR-017) in subjects with relapsed/refractory multiple myeloma". The study will consist of a Phase I dose escalation stage involving three doses as a single IV infusion) with up to 18 evaluable subjects and a dose expansion stage with 10-15 evaluable subjects, followed by a Phase II stage with up to 48 evaluable subjects.
- Conditions
- Neoplasms, Plasma Cell, Neoplasms by Histologic Type, Neoplasms, Hemostatic Disorders, Vascular Diseases, Cardiovascular Diseases
- Being tested
- OriCAR-017
- Keywords
- R/R MM, CAR-T
- Medical subject headings
- Neoplasms, Plasma Cell, Neoplasms by Histologic Type, Neoplasms, Hemostatic Disorders, Vascular Diseases, Cardiovascular Diseases, Paraproteinemias, Blood Protein Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OriCAR-017Drug
Anti-GPRC5D CAR-T cell product
| Study group | Role | What they receive |
|---|---|---|
| OriCAR-017 | Experimental | Single OriCAR-017 infusion Receives: Drug: OriCAR-017 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) of OriCAR-017 US-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)
A DLT is defined as any of the treatment-emergent adverse events (TEAEs; a TEAE is defined as an adverse event [AE] that starts on or after the first administration of study medication) condition or concomitant medications.
Measured: Up to 28 days
Secondary outcomes (9)
Evaluate PK parameters of OriCAR-017 in subjects with relapsed/refractory MM
Assess concentration of CAR-T cells in peripheral blood
Measured: Up to 2 years
Evaluate PD parameters of OriCAR-017 in subjects with relapsed/refractory MM
Assess PD markers related to CAR-T therapy in peripheral blood.
Measured: Up to 2 years
Assessment of Duration of Response (DOR) of treatment in patients with RR/MM
DOR as assessed by Local Investigators according to the IMWG Criteria
Measured: Up to 2 years
Progress-Free Survival (PFS) of treatment in patients with RR/MM
PFS as assessed by Local Investigators according to the IMWG Criteria
Measured: Up to 2 years
Assessment of Overall Survival (OS) of treatment in patients with RR/MM
OS as assessed by Local Investigators according to the IMWG Criteria
Measured: Up to 2 years
Assessment of MRD negative Rate
Proportion of subjects with MRD negative status by flow cytometry
Measured: Up to 2 years
Assessment of Overall Response Rate (ORR)
Percentage of subjects with PR, + VGPR+ CR + strict complete response (sCR) as assessed by Local Investigator according to the IMWG criteria
Measured: Up to 2 years
Assessment of Disease Control Rate (DCR)
Percentage of subjects with CBR (Clinical Benefit Rate) + Stable Disease as assessed by Local Investigator according to IMWG Criteria
Measured: Up to 2 years
Assessment of Clinical Benefit Rate (CBR)
Percentage of subjects with ORR + Minimal Response by Local Investigator according to IMWG Criteria
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 posted21 Feb 2024
- Study start3 Apr 2024
- Primary completion12 Dec 2026 (estimated)
- Study completion12 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasms, Plasma CellStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 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
- NCT06271252
- Sponsor's protocol ID
- OriCAR-017-US-P1
- Status last verified
- Aug 2024
- First submitted
- 26 Jan 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of Anti-GPRC5D CAR-T Cell Product (OriCAR-017) in Subjects With Relapsed/Refractory Multiple Myeloma.
- ClinicalTrials.gov ID
- NCT06271252
- Acronym / sponsor ID
- OriCAR-017-US-P1
- Conditions
- Neoplasms, Plasma Cell, Neoplasms by Histologic Type, Neoplasms, Hemostatic Disorders, Vascular Diseases, Cardiovascular Diseases
- Keywords
- R/R MM, CAR-T
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- OriCell Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- 12 Dec 2026 (estimated)
- Study completion
- 12 Apr 2028 (estimated)
- First posted
- 21 Feb 2024 (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.
The is a first clinical study for Oricell Therapeutics Inc. in the United States to evaluate the safety, PK, PD and preliminary efficacy of our anti-GPRC5D cell product (OriCAR-017) in subjects with relapsed/refractory multiple myeloma.
RIGEL Study
Detailed description
This is a Phase I/II, open-label multicenter study to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of anti-GPRC5D CAR-T cell product (OriCAR-017) in subjects with relapsed/refractory multiple myeloma". The study will consist of a Phase I dose escalation stage involving three doses as a single IV infusion) with up to 18 evaluable subjects and a dose expansion stage with 10-15 evaluable subjects, followed by a Phase II stage with up to 48 evaluable subjects.
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 | Experimental | Drug: OriCAR-017Single OriCAR-017 infusion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Capable of giving signed informed consent
- Subjects aged 18 to 75 years (inclusive) at Screening (signing the ICF).
- Expected survival period is >12 weeks.
- Diagnosis of MM according to the IMWG criteria (2016 version).
- If immunoglobulin (Ig)G type MM, then serum M protein >10 g/L; if IgA, IgD, IgE or IgM type MM, then serum M protein >5 g/L
Key exclusion criteria (9 listed)
- Pregnant or breastfeeding.
- Seropositive for history of human immunodeficiency virus Active Hepatitis B infection and or Hepatitis C infection
- Known active or prior history of CNS involvement
- History of 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 in the past 2 years
- Presence of uncontrolled active infection
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-017Anti-GPRC5D CAR-T cell product | Drug | OriCAR-017 |
Primary outcome
Maximum tolerated dose (MTD) of OriCAR-017 US-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
A DLT is defined as any of the treatment-emergent adverse events (TEAEs; a TEAE is defined as an adverse event [AE] that starts on or after the first administration of study medication) condition or concomitant medications.
9 secondary outcomes
Evaluate PK parameters of OriCAR-017 in subjects with relapsed/refractory MM
Time frame: Up to 2 years
Evaluate PD parameters of OriCAR-017 in subjects with relapsed/refractory MM
Time frame: Up to 2 years
Assessment of Duration of Response (DOR) of treatment in patients with RR/MM
Time frame: Up to 2 years
Progress-Free Survival (PFS) of treatment in patients with RR/MM
Time frame: Up to 2 years
Assessment of Overall Survival (OS) of treatment in patients with RR/MM
Time frame: Up to 2 years
Assessment of MRD negative Rate
Time frame: Up to 2 years
Assessment of Overall Response Rate (ORR)
Time frame: Up to 2 years
Assessment of Disease Control Rate (DCR)
Time frame: Up to 2 years
Assessment of Clinical Benefit Rate (CBR)
Time frame: Up to 2 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 2 Aug 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OriCAR-017 in people with Neoplasms, Plasma Cell and Neoplasms by Histologic Type, run by OriCell Therapeutics Co., Ltd. at 1 site in United States.
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 13 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 2 Aug 2024. 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 United States. 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?
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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) of OriCAR-017 US-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 2 Aug 2024.