Multiple MyelomaPhase 1NCT06705725
Phase I Clinical Study of CBG002 CAR-T Cell in Treatment of Relapsed/refractory Multiple Myeloma
A Phase 1 study testing CBG002 CAR-T Cell Suspension in people with Multiple Myeloma, run by Carbiogene Therapeutics Co. Ltd..
Trial summary
This is a single arm study to evaluate the efficacy and safety of BCMA-targeted CAR-T cells therapy for patients with relapsed/refractory Multiple Myeloma. 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?
- CBG002 CAR-T Cell Suspension
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 26 Dec 2024to 22 Feb 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
- 18 years old≤ subjects < 75 years old, all genders;
- Patients volunteered to participate in the study, and they or their legal guardians signed informed consent form (ICF);
- According to the diagnostic criteria of the "The Guidelines for Diagnosis and Treatment of Multiple Myeloma in China (2022)", patients with multiple myeloma are clearly diagnosed;
- Patients without indications for hematopoietic stem cell transplantation；
- Meet the definition criteria of relapsed or refractory multiple myeloma. Patients failed at least 3-line of anti-multiple myeloma therapy have at least 2 complete treatment cycles per line, unless the best response to the therapy was recorded as disease progression; Must have a record of disease progression during or within 12 months after the last treatment;
- Applicable only in the dose expansion phase: the surface BCMA positive percentage of plasma cells of bone marrow samples by flow cytometry is ≥ 50 %;
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- Patient has one or more measurable multiple myeloma lesions；
- Patients must have appropriate organ function;
- Patients had no contraindications to peripheral blood mononuclear cell collection;
- ECOG score 0-2;
- Expected survival ≥ 12 weeks;
- Female subjects of childbearing potential must have a negative blood pregnancy test within 7 days prior to cell therapy and not be lactating.
Who cannot join
- Have a history of allergies to cyclophosphamide, fludarabine, or any component of the cell product;
- Severe cardiovascular and cerebrovascular diseases;
- Severe comorbidities or diseases that the researchers believe will put the patients at inappropriate risk or interfere with the study;
- Have a history of allogeneic hematopoietic stem cell transplantation, or received autologous hematopoietic stem cell transplantation (ASCT) within 12 weeks prior to signing the ICF;
- Central nervous system (CNS) involvement or symptoms of CNS involvement or CNS metastases;
- Stroke or seizure occurred within 6 months prior to signing the ICF;
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- Previous plasma cell leukemia;
- Multiple myeloma with extramedullary lesions;
- Previous or screening examination showing amyloidosis;
- Malignant tumor cells with T cell origin revealed by previous pathological examination;
- Having autoimmune disease, immunodeficiency or other disease that requires immunosuppressant therapy;
- Within 5 years prior to signing the ICF, patients with malignancies other than multiple myeloma;
- Uncontrolled active infection;
- Systemic disease judged by the investigator to be unstable;
- More than 5 mg/day of prednisone (or equivalent amounts of other corticosteroids) within 1 week prior to apheresis;
- Have used any CAR-T cell products or other genetically modified T cell therapies;
- Previously received anti-tumor therapy against BCMA targets, including but not limited to antibodies, ADCs or CAR-T;
- History of live vaccination (including live attenuated vaccines) within 4 weeks prior to signing the ICF;
- Any non-hematologic toxicity due to prior therapy that cannot be restored to Grade ≤1 or baseline;
- Patients with grade ≥2 acute graft-versus-host disease (GVHD) (Glucksberg criteria) or extensive chronic GVHD (Seattle criteria) requiring treatment within 4 weeks prior to enrollment, or those who may need to receive anti-GVHD treatment during the trial as judged by the investigator;
- History of alcoholism, drug abuse or mental illness requiring drug intervention within 1 year prior to signing the ICF, which may affect the safety evaluation or compliance as judged by the investigator;
- Other conditions that are considered inappropriate by the investigator to participate in this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This is a single arm study to evaluate the efficacy and safety of BCMA-targeted CAR-T cells therapy for patients with relapsed/refractory Multiple Myeloma.
- Conditions
- Multiple Myeloma
- Being tested
- CBG002 CAR-T Cell Suspension
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBG002 CAR-T Cell SuspensionDrug
Single dose of CAR+ T cells will be infused, and classic "3+3" dose escalation will be applied.
| Study group | Role | What they receive |
|---|---|---|
| CBG002 CAR-T Cell Suspension | Experimental | Single dose of CAR+ T cells will be infused, and classic "3+3" dose escalation will be applied. Receives: Drug: CBG002 CAR-T Cell Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
AEs.
The severity and incidence of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), and serious adverse events (SAEs).
Measured: 2 years post infusion
DLT
The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and are specifically defined in study protocol.
Measured: 28 days post infusion
Secondary outcomes (4)
Overall Response Rate (ORR)
ORR at 3 months post infusion as evaluated by the Investigator
Measured: 3 months post infusion
Progression free survival (PFS)
The time from cell infusion to the first assessment of tumor progression or death from any cause
Measured: 2 years post infusion
Overall survival (OS)
The time from cell infusion to death due to any cause
Measured: 2 years post infusion
Duration of remission (DOR)
The time from the first assessment of the tumor for complete response and above efficacy to the first assessment of disease progression or death of any cause
Measured: 2 years post infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start26 Dec 2024 (estimated)
- Primary completion25 Oct 2027 (estimated)
- Study completion22 Feb 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.
- 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
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carbiogene Therapeutics Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jie Jin, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06705725
- Sponsor's protocol ID
- CRKBY-102c
- Status last verified
- Nov 2024
- First submitted
- 23 Oct 2024
- Last updated
- 26 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 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study of CBG002 CAR-T Cell in Treatment of Relapsed/refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06705725
- Acronym / sponsor ID
- CRKBY-102c
- Conditions
- Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Carbiogene Therapeutics Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Dec 2024 (estimated)
- Primary completion
- 25 Oct 2027 (estimated)
- Study completion
- 22 Feb 2028 (estimated)
- First posted
- 26 Nov 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 is a single arm study to evaluate the efficacy and safety of BCMA-targeted CAR-T cells therapy for patients with relapsed/refractory Multiple Myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CBG002 CAR-T Cell Suspension | Experimental | Drug: CBG002 CAR-T Cell SuspensionSingle dose of CAR+ T cells will be infused, and classic "3+3" dose escalation will be applied. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 18 years old≤ subjects < 75 years old, all genders;
- Patients volunteered to participate in the study, and they or their legal guardians signed informed consent form (ICF);
- According to the diagnostic criteria of the "The Guidelines for Diagnosis and Treatment of Multiple Myeloma in China (2022)", patients with multiple myeloma are clearly diagnosed;
- Patients without indications for hematopoietic stem cell transplantation；
- Meet the definition criteria of relapsed or refractory multiple myeloma. Patients failed at least 3-line of anti-multiple myeloma therapy have at least 2 complete treatment cycles per line, unless the best response to the therapy was recorded as disease progression; Must have a record of disease progression during or within 12 months after the last treatment;
Key exclusion criteria (22 listed)
- Have a history of allergies to cyclophosphamide, fludarabine, or any component of the cell product;
- Severe cardiovascular and cerebrovascular diseases;
- Severe comorbidities or diseases that the researchers believe will put the patients at inappropriate risk or interfere with the study;
- Have a history of allogeneic hematopoietic stem cell transplantation, or received autologous hematopoietic stem cell transplantation (ASCT) within 12 weeks prior to signing the ICF;
- Central nervous system (CNS) involvement or symptoms of CNS involvement or CNS metastases;
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 |
|---|---|---|
| CBG002 CAR-T Cell SuspensionSingle dose of CAR+ T cells will be infused, and classic "3+3" dose escalation will be applied. | Drug | CBG002 CAR-T Cell Suspension |
Primary outcome
AEs.
Time frame: 2 years post infusion
The severity and incidence of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), and serious adverse events (SAEs).
DLT
Time frame: 28 days post infusion
The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and are specifically defined in study protocol.
4 secondary outcomes
Overall Response Rate (ORR)
Time frame: 3 months post infusion
Progression free survival (PFS)
Time frame: 2 years post infusion
Overall survival (OS)
Time frame: 2 years post infusion
Duration of remission (DOR)
Time frame: 2 years post infusion
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 26 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.
Jie Jin principal investigator
First Affiliated Hospital of Zhejiang University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CBG002 CAR-T Cell Suspension in people with Multiple Myeloma, run by Carbiogene Therapeutics Co. Ltd..
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 12 inclusion and 22 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: opening soon, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Jie Jin (0571-87236898, jiej0503@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AEs. (time frame: 2 years post 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 26 Nov 2024.