Relapsed/Refractory Multiple MyelomaPhase 1NCT04601935
A Single-center Exploratory Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of a BCMA-targeted Universal LCAR-BCX Cells in Patients With Relapsed/Refractory Multiple Myeloma
A Phase 1 study testing LCAR-BCX cells product in people with Relapsed/Refractory Multiple Myeloma, run by Weijun Fu at 1 site in China.
Trial summary
This is a prospective, single-arm, single-center, open-label dose-finding and dose-expansion study that evaluates the safety, tolerability, PK, and anti-tumor efficacy of LCAR-BCX cells in subjects with relapsed/refractory multiple myeloma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Multiple Myeloma
- What is being tested?
- LCAR-BCX cells product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2020to Oct 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is willing to participate in the clinical study; fully understands and informed the study contents, and signs the informed consent form.
- Chinese subjects ≥ 18 years of age.
- Documented initial diagnosis of MM according to IMWG diagnostic criteria.
- Presence of measurable disease at screening.
- Received a PI and an IMiD (except thalidomide).
- Received at least 3 prior lines of therapy for multiple myeloma, undergone at least 1 complete cycle of treatment for each line, unless progressive disease (PD) was documented by IMWG criteria as the best response to the regimen. Also, subjects refractory or intolerant to any PI and any IMiD in their previous treatment afterwards are eligible.
- Expected survival ≥ 3 months.
Who cannot join
- No response to prior BCMA-targeted CAR-T therapy (except for subjects who relapsed after CR to prior CAR-T therapy).
- Prior treatment with any BCMA-targeted monoclonal antibody.
- Diagnosed or previously treated for other invasive malignancies other than multiple myeloma, with the following exceptions:
- Malignancies treated with curative intent and with no known active disease present for ≥ 2 years before enrollment; or
- Adequately treated non-melanoma skin cancer without current evidence of disease.
- Prior anti-tumor therapies as follows (prior to conditioning):
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- Monoclonal antibody treatment for multiple myeloma within 21 days
- Targeted therapy, epigenetic therapy, or treatment with an investigational product, or used an invasive investigational medical device within 14 days or at least 5 half-lives (whichever is less)
- Cytotoxic therapy within 14 days
- Proteasome inhibitor therapy within 14 days
- Radiotherapy within 14 days. However, if the radiation field covers ≤ 5% of bone marrow reserve, the subject is eligible to participate in the study regardless of the end date of radiaotherapy
- Immunomodulatory agent therapy within 7 days.
- Toxicities (excluding hematology and chemistry indicators specified in the inclusion criteria) associated with prior anti-tumor therapy must have recovered to baseline level or to ≤ Grade 1 except for alopecia or peripheral neuropathy.
- Occurrence of the following cardiac disorders:
- NYHA stage III or IV congestive heart failure
- Myocardial infarction or coronary artery bypass graft (CABG) ≤ 6 months prior to enrollment
- History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration
- History of severe non-ischemic cardiomyopathy
- Impaired cardiac function (LVEF < 45%) as assessed by echocardiography or multi-gated acquisition (MUGA) scan (performed ≤ 8 weeks prior to screening).
- Received either of the following treatments:
- An allogeneic stem cell transplantation for multiple myeloma
- An autologous stem cell transplantation ≤ 16 weeks prior to infusion.
- Known active, or prior history of, central nervous system (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma.
- Supplemental oxygen required to maintain adequate oxygen saturation (≥ 95%).
- Uncontrolled diabetes.
- Stroke or epilepsy seizure within 6 months prior to signing ICF (except for old lacunar infarction).
- Plasma cell leukemia (plasma cells > 2.0 × 109/L per standard differential), Waldenström's macroglobulinemia, POEMS syndrome, or primary AL amyloidosis at the time of screening.
- Seropositive for human immunodeficiency virus (HIV).
- Positive for any one of hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), or human immunodeficiency virus antibody (HIV-Ab).
- Vaccinated with live, attenuated vaccine within 4 weeks prior to screening.
- Known life-threatening allergies, hypersensitivity, or intolerance to CAR-T cells or its excipients, including DMSO.
- Serious underlying medical condition, such as:
- Evidence of serious active viral, bacterial, or uncontrolled systemic fungal infection
- Active autoimmune disease or a history of autoimmune disease within 3 years
- Overt clinical evidence of dementia or altered mental status
- Any history of Parkinson's disease or other neurodegenerative disorder.
- Any issue that would impair the ability of the subject to receive or tolerate the planned treatment at the investigational site, to understand the informed consent, or any condition that, in the opinion of the investigator, participation would not be in the best interest of the subject (e.g., compromise the well-being), or any condition that may prevent, limit, or confound protocol-specified assessments.
- Male subjects who plan to father a child while enrolled in the study or within 1 year after receiving study treatment.
- Female subjects who are pregnant, breastfeeding, or plan to become pregnant while enrolled in the study or within 1 year after receiving study treatment.
- Major surgery within 2 weeks prior to screening, or has surgery scheduled during the study or within 2 weeks after study treatment administration. (Note: Subjects who plan to be conducted surgical procedures under local anesthesia may participate in the study.).
- Any condition which, in the opinion of the investigator, renders the subject unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective, single-arm, single-center, open-label dose-finding and dose-expansion study that evaluates the safety, tolerability, PK, and anti-tumor efficacy of LCAR-BCX cells in subjects with relapsed/refractory multiple myeloma
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Being tested
- LCAR-BCX cells product
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCAR-BCX cells productBiological
In this study, LCAR-BCX CAR+ cells will be evaluated at 5 dose levels including 0.25 × 10^6 cells/kg, 0.5 × 10^6 cells/kg, 1.0 × 10^6 cells/kg, 2.0 × 10^6 cells/kg, and 4.0 × 10^6 cells/kg, with 0.25 × 10^6 cells/kg as the starting dose, to determine RP2D for LCAR-BCX cell therapy
| Study group | Role | What they receive |
|---|---|---|
| LCAR-BCX cells product | Experimental | Each subject will be given a single-dose infusion in each dose levelThe dose-finding phase of this study is designed primarily using the Bayesian optimal interval (BOIN) method, which is combined with accelerated titration at the beginning of the study to assess incidence of DLT (dose-limiting toxicity) and estimate MTD (maximum tolerated dose). Receives: Biological: LCAR-BCX cells product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Measured: Within 30 days after cells infusion
Secondary outcomes (1)
Overall Response Rate (ORR)
The ORR is defined as the percentage of participants who achieve partial response (PR) or better according to international myeloma working group (IMWG) criteria.
Measured: Two years after infusion to the last subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start9 Oct 2020
- Primary completionJan 2023 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weijun Fu
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing Legend Biotech Co.
- Responsible party
- Sponsor-investigator, Weijun Fu, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04601935
- Sponsor's protocol ID
- BM2L202004
- Status last verified
- Nov 2021
- First submitted
- 9 Oct 2020
- Last updated
- 2 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Exploratory Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of a BCMA-targeted Universal LCAR-BCX Cells in Patients With Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT04601935
- Acronym / sponsor ID
- BM2L202004
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Weijun FuUniversity, hospital or other
- Collaborators
- Nanjing Legend Biotech Co.
- Study start
- 9 Oct 2020 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 26 Oct 2020 (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 prospective, single-arm, single-center, open-label dose-finding and dose-expansion study that evaluates the safety, tolerability, PK, and anti-tumor efficacy of LCAR-BCX cells in subjects 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 |
|---|---|---|
| LCAR-BCX cells product | Experimental | Biological: LCAR-BCX cells productEach subject will be given a single-dose infusion in each dose levelThe dose-finding phase of this study is designed primarily using the Bayesian optimal interval (BOIN) method, which is combined with accelerated titration at the beginning of the study to assess incidence of DLT (dose-limiting toxicity) and estimate MTD (maximum tolerated dose). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject is willing to participate in the clinical study; fully understands and informed the study contents, and signs the informed consent form.
- Chinese subjects ≥ 18 years of age.
- Documented initial diagnosis of MM according to IMWG diagnostic criteria.
- Presence of measurable disease at screening.
- Received a PI and an IMiD (except thalidomide).
Key exclusion criteria (41 listed)
- No response to prior BCMA-targeted CAR-T therapy (except for subjects who relapsed after CR to prior CAR-T therapy).
- Prior treatment with any BCMA-targeted monoclonal antibody.
- Diagnosed or previously treated for other invasive malignancies other than multiple myeloma, with the following exceptions:
- Prior anti-tumor therapies as follows (prior to conditioning):
- Toxicities (excluding hematology and chemistry indicators specified in the inclusion criteria) associated with prior anti-tumor therapy must have recovered to baseline level or to ≤ Grade 1 except for alopecia or peripheral neuropathy.
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 |
|---|---|---|
| LCAR-BCX cells productIn this study, LCAR-BCX CAR+ cells will be evaluated at 5 dose levels including 0.25 × 10^6 cells/kg, 0.5 × 10^6 cells/kg, 1.0 × 10^6 cells/kg, 2.0 × 10^6 cells/kg, and 4.0 × 10^6 cells/kg, with 0.25 × 10^6 cells/kg as the starting dose, to determine RP2D for LCAR-BCX cell therapy | Biological | LCAR-BCX cells product |
Primary outcome
Number of Participants With Adverse Events
Time frame: Within 30 days after cells infusion
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
1 secondary outcome
Overall Response Rate (ORR)
Time frame: Two years after infusion to the last subject
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 LCAR-BCX cells product in people with Relapsed/Refractory Multiple Myeloma, run by Weijun Fu at 1 site 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 7 inclusion and 41 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: status not confirmed, as of the sponsor's last update on 2 Nov 2021. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (time frame: Within 30 days after cells infusion). 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 Nov 2021.