Multiple MyelomaPhase 1NCT06644118
A Study of OL-101 Injection in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)
A Phase 1 study testing OL-101 infusion in people with Multiple Myeloma, run by Zhejiang University at 3 sites in China.
Trial summary
This clinical trial aims to characterize the safety of OL-101 and establish the recommended dose for future research and to evaluate the efficacy of OL-101 (Dose expansion). 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?
- OL-101 infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 3 sitesChina
- Study dates
- 23 Oct 2024to Oct 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
- Documented diagnosis of multiple myeloma according to the 2014 IMWG diagnostic criteria
- Relapsed/refractory multiple myeloma as defined by:
- 1) Received at least 3 prior lines of MM treatment (must include a PI, an IMiD, and an anti-CD38 antibody).
- 2）Disease progression within 12 months of the most recent anti-MM therapy; or disease progression within the past 6 months and subsequently lack response to the most recent line of therapy.
- Measurable disease at screening as defined by any of the following:
- Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or
Show all 21Show fewer
- Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin free light chain ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio.
- Positive expression of either BCMA or GPRC5D on bone marrow plasma cells; must be GPRC5D expression positive if previously received BCMA targeted therapy
- ECOG 0-1
- Expected life expectancy exceeds 12 weeks
- Adequate bone marrow reserve or organ function meeting the following criteria:
- Hemoglobin ≥ 70 g/L
- Platelet count ≥ 50 × 10^9/L
- Absolute lymphocyte count ≥ 0.3×10^9/L
- Absolute neutrophil count ≥ 1.0 × 10^9/L
- Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal (ULN)
- Total bilirubin ≤ 2 times ULN; except in subjects with congenital bilirubinemia (such as Gilbert syndrome, in which case the direct bilirubin ≤1.5 × ULN is required)
- Creatinine clearance ≥ 60 mL/min (calculated by Cockcroft-Gault equation).
- corrected serum calcium ≤12.5 mg/dL (≤3.1 mmol/L) or free ionized calcium ≤6.5 mg/dl (≤1.6 mmol/L)
- SpO2>92% on room air
- Left ventricular ejection fraction (LVEF) ≥ 50% as assessed by echocardiogram; no clinically meaningful pericardial effusion by ultrasound
Who cannot join
- Solitary plasmacytoma
- Known active central nervous system (CNS) involvement or exhibits clinical signs of CNS involvement of multiple myeloma.
- Received allogeneic stem cell transplant; received autologous stem cell transplant within 12 weeks before screening
- Active second primary malignant tumor, exclude the following: cured non- melanoma skin cancer, non-metastatic prostate cancer, cervical carcinoma in situ, ductal or lobular carcinoma in situ of the breast
- Any other significant medical disease, abnormality, or condition that, in the investigator judgment, may make the patient unsuitable for participation in the study or put the patient at risk.
- Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary AL amyloidosis.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Not yet recruiting
Beijing Gobroad Boren Hospital
Beijing, Beijing Municipality, 100071
Xiequn Chen, MD, PHD, (+86)13991832567, 20203009@nwu.edu.cn
Xiequn Chen, MD, PHD
- Recruiting
The first affiliated hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 3100003
He Huang, MD, PhD, (+86)13605714822, hehuangyu@126.com
- Not yet recruiting
The Affiliated Hospital of Northwest University Xi'an No.3 Hospital
Xi’an, Shanxi, 710016
Yajin Zhang, MD, PHD, (+86)18601333856, zhangyj3@gobroadhealthcare.com
Yajin Zhang, MD, PHD
About this study
Official title: A Pilot Clinical Study of OL-101 Injection in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)
This clinical trial aims to characterize the safety of OL-101 and establish the recommended dose for future research and to evaluate the efficacy of OL-101 (Dose expansion).
Read the detailed description
This study will evaluate the safety and efficacy of OL-101, a chimeric antigen receptor T cell (CAR-T) therapy directed against B-Cell Maturation Antigen (BCMA) and G Protein-Coupled Receptor Class C Group 5 Member D (GPRC5D). This study is a single-arm, open-label, early exploratory clinical trial, conducted in two phases: dose escalation and dose expansion in adults with multiple myeloma. The trial begins with the dose-escalation phase that focus on safety and tolerability, with interval assessments for potential dose escalation or de-escalation. Recommended dose will be selected at the completion of the dose escalation stage in the dose expansion stage. The study aims to assess safety, pharmacokinetic/pharmacodynamic profiles, and efficacy.
- Conditions
- Multiple Myeloma
- Being tested
- OL-101 infusion
- Keywords
- OL-101, Multiple myeloma, Phase 1, single arm
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OL-101 infusionBiological
OL-101 infusion will be administered to patients via IV infusion at the assigned dose.
| Study group | Role | What they receive |
|---|---|---|
| OL-101 infusion | Experimental | This arm provides CAR-T treatment at the dose the patient is assigned to. Receives: Biological: OL-101 infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
Adverse events will be assessed based on the CTCAE 5.0
Measured: Within 28 days post CAR-T infusion
Treatment emergent adverse event (TEAE) incidence and severity
Adverse events will be assessed based on the CTCAE 5.0
Measured: From aphresis till 1 year after CAR-T infusion or start of a new anti-cancer therapy, whichever is earlier
Secondary outcomes (12)
Level of Immunogenicity
To assess the presence of antibodies to OL-101 (ADA)
Measured: Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
Level of RCL
To determine whether Replication Competent Lentivirus (RCL) is present in patient that receive OL-101
Measured: Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
Overall response rate (ORR)
Proportion of subjects with PR or above
Measured: Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
Minimal residual disease (MRD) negative rate
Proportion of subjects with MRD negative status as defined by the IMWG response criteria
Measured: Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
Duration of response (DOR)
The time from the initial response to therapy until the disease progression or relapse.
Measured: Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
Progression-free survival (PFS)
The time from CAR-T cell infusion to the first assessment of disease progression or death from any cause.
Measured: Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
Overall survival (OS)
The time from CAR-T cell infusion to death from any cause.
Measured: Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
Cmax of OL-101
The maximum concentration of the CAR-T cells will be measured to assess OL-101 in vivo expansion and persistence.
Measured: Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
Tmax of OL-101
The time of the maximum concentration will be measured to assess OL-101 in vivo expansion and persistence.
Measured: Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
AUC 0-28days of OL-101
Area under the curve will be measured to assess OL-101 in vivo expansion and persistence.
Measured: Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
Serum cytokines
The levels of cytokines will be measured, such as IL-6 and ferritin.
Measured: Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
Serum soluble circulating BCMA (sBCMA)
Serum soluble circulating BCMA will be measured to explore its potential relationship to response or resistance.
Measured: Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start23 Oct 2024
- Primary completionOct 2027 (estimated)
- Study completionOct 2028 (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
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Overland Therapeutics
- Responsible party
- Principal investigator, He Huang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06644118
- Sponsor's protocol ID
- OL-101-001
- Status last verified
- Nov 2024
- First submitted
- 28 Sep 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- 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 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Clinical Study of OL-101 Injection in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)
- ClinicalTrials.gov ID
- NCT06644118
- Acronym / sponsor ID
- OL-101-001
- Conditions
- Multiple Myeloma
- Keywords
- OL-101, Multiple myeloma, Phase 1, single arm
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Overland Therapeutics
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 16 Oct 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.
This clinical trial aims to characterize the safety of OL-101 and establish the recommended dose for future research and to evaluate the efficacy of OL-101 (Dose expansion).
Detailed description
This study will evaluate the safety and efficacy of OL-101, a chimeric antigen receptor T cell (CAR-T) therapy directed against B-Cell Maturation Antigen (BCMA) and G Protein-Coupled Receptor Class C Group 5 Member D (GPRC5D). This study is a single-arm, open-label, early exploratory clinical trial, conducted in two phases: dose escalation and dose expansion in adults with multiple myeloma. The trial begins with the dose-escalation phase that focus on safety and tolerability, with interval assessments for potential dose escalation or de-escalation. Recommended dose will be selected at the completion of the dose escalation stage in the dose expansion stage. The study aims to assess safety, pharmacokinetic/pharmacodynamic profiles, and efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OL-101 infusion | Experimental | Biological: OL-101 infusionThis arm provides CAR-T treatment at the dose the patient is assigned to. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Documented diagnosis of multiple myeloma according to the 2014 IMWG diagnostic criteria
- Relapsed/refractory multiple myeloma as defined by:
- 1) Received at least 3 prior lines of MM treatment (must include a PI, an IMiD, and an anti-CD38 antibody).
- 2）Disease progression within 12 months of the most recent anti-MM therapy; or disease progression within the past 6 months and subsequently lack response to the most recent line of therapy.
- Measurable disease at screening as defined by any of the following:
Key exclusion criteria (6 listed)
- Solitary plasmacytoma
- Known active central nervous system (CNS) involvement or exhibits clinical signs of CNS involvement of multiple myeloma.
- Received allogeneic stem cell transplant; received autologous stem cell transplant within 12 weeks before screening
- Active second primary malignant tumor, exclude the following: cured non- melanoma skin cancer, non-metastatic prostate cancer, cervical carcinoma in situ, ductal or lobular carcinoma in situ of the breast
- Any other significant medical disease, abnormality, or condition that, in the investigator judgment, may make the patient unsuitable for participation in the study or put the patient at risk.
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 |
|---|---|---|
| OL-101 infusionOL-101 infusion will be administered to patients via IV infusion at the assigned dose. | Biological | OL-101 infusion |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: Within 28 days post CAR-T infusion
Adverse events will be assessed based on the CTCAE 5.0
Treatment emergent adverse event (TEAE) incidence and severity
Time frame: From aphresis till 1 year after CAR-T infusion or start of a new anti-cancer therapy, whichever is earlier
Adverse events will be assessed based on the CTCAE 5.0
12 secondary outcomes
Level of Immunogenicity
Time frame: Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
Level of RCL
Time frame: Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
Overall response rate (ORR)
Time frame: Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
Minimal residual disease (MRD) negative rate
Time frame: Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
Duration of response (DOR)
Time frame: Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
Progression-free survival (PFS)
Time frame: Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
Overall survival (OS)
Time frame: Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
Cmax of OL-101
Time frame: Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
Tmax of OL-101
Time frame: Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
AUC 0-28days of OL-101
Time frame: Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
Serum cytokines
Time frame: Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
Serum soluble circulating BCMA (sBCMA)
Time frame: Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
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 8 Nov 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OL-101 infusion in people with Multiple Myeloma, run by Zhejiang University at 3 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?
The sponsor lists 21 inclusion and 6 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 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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?
Contact He Huang, MD, PhD ((+86)13605714822, hehuangyu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) (time frame: Within 28 days post 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?
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 8 Nov 2024.