Multiple MyelomaPhase 2CARTIFAN-1NCT03758417
A Study of LCAR-B38M CAR-T Cells, a Chimeric Antigen Receptor T-cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Chinese Participants With Relapsed or Refractory Multiple Myeloma
A Phase 2 study testing LCAR-B38M CAR-T Cell in people with Multiple Myeloma, run by Nanjing Legend Biotech Co. at 11 sites in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of LCAR-B38M chimeric antigen receptor T (CAR-T) cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- LCAR-B38M CAR-T Cell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 11 sitesChina
- Study dates
- 23 Jan 2019to 20 Oct 2025
- Phase
- Phase 2
- 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
- Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
- Measurable disease at Screening
- Received at least 3 prior lines of treatment 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
- Received a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD)
- Participant must have documented evidence of progressive disease based on investigator's determination of response consistent with IMWG criteria on or within 12 months of their last regimen. Non-responsive disease is defined as either failure to achieve minimal response or development of progressive disease (PD) while on therapy. Also, participants with documented evidence of PD disease (as above) within the previous 6 months and who are refractory or non-responsive to their most recent line of treatment afterwards are eligible
- Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 or 1
Who cannot join
- Prior treatment with chimeric antigen receptor T (cells) CAR-T therapy directed at any target
- Any therapy that is targeted to B-cell maturation antigen (BCMA)
- The following cardiac conditions: a) New York Heart Association (NYHA) stage III or IV congestive heart failure b) Myocardial infarction or coronary artery bypass graft (CABG) 6 months prior to enrollment c) History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration d) History of severe non-ischemic cardiomyopathy e) Impaired cardiac function (left ventricular ejection fraction [LVEF] less than [<]45%) as assessed by echocardiogram or multiple-gated acquisition (MUGA) scan (performed less than or equal to (<=) 8 weeks of apheresis)
- Have received a cumulative dose of corticosteroids equivalent to greater than or equal to(>=)70 milligram (mg) of prednisone within 7 days prior to apheresis
- Diagnosed or treated for invasive malignancy other than multiple myeloma, except:
- Malignancy treated with curative intent and with no known active disease present for greater than or equal to (>=) 2 years before enrollment; or
Show all 13Show fewer
- Adequately treated non-melanoma skin cancer without evidence of disease
- Prior antitumor therapy with insufficient washout period
- Toxicity from previous anticancer therapy must resolve to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy
- Received either of the following:
- An allogeneic stem cell transplant for multiple myeloma
- An autologous stem cell transplant less than or equal to (<=) 12 weeks before apheresis
- Known active, or prior history of, central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
China11 sites
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Fujian Medical University Union hospital
Fuzhou, Fujian, 350001
Sun Yat -Sen University Cancer Center
Guandong, Guangzhou, 510060
The First Affiliated Hospital, Medical School of Zhejiang University
Hangzhou, Zhejiang, 310003
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 200003
Ruijin Hospital, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200025
Shanghai Fourth People Hospital
Shanghai, Shanghai Municipality, 200434
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710004
About this study
Official title: A Phase 2, Open-Label Study of LCAR-B38M CAR-T Cells, a Chimeric Antigen Receptor T-cell (CAR-T) Therapy Directed Against BCMA in Chinese Subjects With Relapsed or Refractory Multiple Myeloma
The purpose of this study is to evaluate the efficacy and safety of LCAR-B38M chimeric antigen receptor T (CAR-T) cells.
- Conditions
- Multiple Myeloma
- Being tested
- LCAR-B38M CAR-T Cell
- 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-B38M CAR-T CellBiological
Also called Ciltacabtagene autoleucel
Participants will receive LCAR-B38M CAR-T cells as a single infusion which consists of autologous T lymphocytes transduced with LCAR-B38M, a lentiviral vector to express a chimeric antigen receptor targeting the human B cell maturation antigen (anti-BCMA CAR).
| Study group | Role | What they receive |
|---|---|---|
| LCAR-B38M Chimeric Antigen Receptor T Cell | Experimental | Participants will receive LCAR-B38M CAR-T cells as a single infusion which consists of autologous T lymphocytes transduced with LCAR-B38M, a lentiviral vector to express a chimeric antigen receptor targeting the human B cell maturation antigen (anti-BCMA CAR).
In addition, participants will enroll in additional cohort to further characterize the safety profile and accumulate efficacy data of LCAR-B38M CAR-T cells. Receives: Biological: LCAR-B38M CAR-T Cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
The ORR is defined as the percentage of participants who achieve at least a partial response (PR) or better according to international myeloma working group (IMWG) criteria.
Measured: Minimum 2 years after LCAR-B38M chimeric antigen receptor T (CAR-T) infusion (Day 1)
Secondary outcomes (19)
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: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Chimeric Antigen Receptor T (CAR-T) Positive Cell Concentration
Venous blood samples will be collected for measurement of CAR-T positive cellular concentration.
Measured: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Transgene Levels of LCAR-B38M CAR-T Cells
Transgene Levels of LCAR-B38M CAR-T Cells using sensitive assay methods will be assessed.
Measured: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Systemic Cytokine Concentrations
Serum cytokine concentrations such as Interleukin [IL]-6, IL-15, IL-10 will be measured for biomarker assessment.
Measured: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Number of Participants With Anti- LCAR-B38M CAR-T Cell Antibodies
Number of participants with anti- LCAR-B38M CAR-T cell antibodies will be evaluated.
Measured: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Percentage of Participants with Very Good Partial Response (VGPR) or Better Rate
The VGPR or better rate, defined as the percentage of participants achieving VGPR and complete response (CR) (including stringent complete response [sCR]) according to IMWG criteria during or after the study treatment. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or greater than or equal to (>=) 90 percent (%) reduction in serum Mprotein plus urine M-protein less than (<) 100 milligram (mg)/24 hours, CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells (PCs) in bone marrow. sCR: CR plus normal free light chain (FLC) ratio, and absence of clonal PCs by immunohistochemistry (IHC), immunofluorescence for 2 to 4 color flow cytometry.
Measured: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Percentage of Participants with Complete Response (CR)
Complete response is based on serum M-Protein and bone marrow assessments as per IMWG criteria.
Measured: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Percentage of Participants with Negative Minimal Residual Disease (MRD)
Minimal residual disease negative rate is defined as the percentage of participants who achieve MRD negative status by the respective time point. MRD will be assessed by bone marrow 8-colored flow cytometry.
Measured: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Percentage of Participants who Achieve Clinical Benefit
Clinical Benefit Rate is defined as the percentage of participants who achieve ORR (sCR + CR + VGPR + PR) and minimal response (MR) as per IMWG criteria.
Measured: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Duration of Response (DOR)
Duration of response (DOR) will be calculated among responders (with a PR or better response) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG criteria or death due to any cause, whichever occurs first.
Measured: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Time to Response (TTR)
Time to response (TTR) is defined as the time between date of the initial infusion of LCAR-B38M CAR-T cells and the first efficacy evaluation that the participant has met all criteria for PR or better.
Measured: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Progression-Free Survival (PFS)
PFS defined as time from date of initial infusion of LCAR-B38M CAR-T cells to date of first documented disease progression, defined in the IMWG criteria, or death due to any cause, whichever occurs first.
Measured: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Overall survival (OS)
Overall survival (OS) is measured from the date of infusion of the LCAR-B38M CAR-T cells to the date of the participant's death.
Measured: Mnimum 2 years after LCAR-B38M CART infusion (Day 1)
Levels of CAR-T cell Activation Markers
Levels of CAR-T cell Activation Markers like CD4+, CD8+, and CD25+ will be assessed. An evaluation of cell populations may be performed by flow cytometry.
Measured: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Levels of LCAR-B38M CAR-T cell Expansion (proliferation)
Levels of LCAR-B38M CAR-T cell expansion (proliferation) will be reported.
Measured: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Levels of LCAR-B38M CAR-T Persistence
Levels of LCAR-B38M CAR-T persistence will be evaluated via monitoring CAR-T positive cell counts and CART transgene levels.
Measured: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Percentage of Participants with Stringent Complete Response (sCR)
Stringent Complete Response (sCR) is based on serum M-Protein and bone marrow assessments as per IMWG criteria for complete response(CR) plus normal free light chain (FLC) ratio, and absence of clonal PCs by immunohistochemistry(IHC), or 2 to 4 color flow cytometry.
Measured: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Circulating Soluble B-Cell Maturation Antigen (sBCMA) Levels
Blood samples will be collected for measurement of sBCMA level.
Measured: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Percent Reduction in BCMA Expression Cells
Percent reduction in BCMA Expression Cells will be measured.
Measured: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start23 Jan 2019
- Primary completion10 Jul 2025
- Study completion20 Oct 2025
Why it stopped: The study was terminated early due to a strategic realignment of the sponsor's business plan, not related to safety, efficacy, or data integrity concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Legend Biotech Co.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Responsible party
- Sponsor
- Investigators
- Janssen Research&Development,LLC Clinical Trail, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03758417
- Sponsor's protocol ID
- CR108494
- Other IDs
- 68284528MMY2002
- Acronym
- CARTIFAN-1
- Status last verified
- Dec 2025
- First submitted
- 27 Nov 2018
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Mi JQ, Zhao W, Jing H, Fu W, Hu J, Chen L, Zhang Y, Yao D, Chen D, Schecter JM, Yang F, Tian X, Sun H, Zhuang SH, Ren J, Fan X, Jin J, Niu T, Chen SJ. Phase II, Open-Label Study of Ciltacabtagene Autoleucel, an Anti-B-Cell Maturation Antigen Chimeric Antigen Receptor-T-Cell Therapy, in Chinese Patients With Relapsed/Refractory Multiple Myeloma (CARTIFAN-1). J Clin Oncol. 2023 Feb 20;41(6):1275-1284. doi: 10.1200/JCO.22.00690. Epub 2022 Oct 21.
PubMed 36269898
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-Label Study of LCAR-B38M CAR-T Cells, a Chimeric Antigen Receptor T-cell (CAR-T) Therapy Directed Against BCMA in Chinese Subjects With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT03758417
- Acronym / sponsor ID
- CARTIFAN-1 / CR108494
- Conditions
- Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early due to a strategic realignment of the sponsor's business plan, not related to safety, efficacy, or data integrity concerns.
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Nanjing Legend Biotech Co.Industry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Study start
- 23 Jan 2019 (actual)
- Primary completion
- 10 Jul 2025 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 29 Nov 2018 (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 purpose of this study is to evaluate the efficacy and safety of LCAR-B38M chimeric antigen receptor T (CAR-T) cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LCAR-B38M Chimeric Antigen Receptor T Cell | Experimental | Biological: LCAR-B38M CAR-T CellParticipants will receive LCAR-B38M CAR-T cells as a single infusion which consists of autologous T lymphocytes transduced with LCAR-B38M, a lentiviral vector to express a chimeric antigen receptor targeting the human B cell maturation antigen (anti-BCMA CAR). In addition, participants will enroll in additional cohort to further characterize the safety profile and accumulate efficacy data of LCAR-B38M CAR-T cells. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
- Measurable disease at Screening
- Received at least 3 prior lines of treatment for multiple myeloma
- Received a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD)
- Participant must have documented evidence of progressive disease based on investigator's determination of response consistent with IMWG criteria on or within 12 months of their last regimen. Non-responsive disease is defined as either failure to achieve minimal response or development of progressive disease (PD) while on therapy. Also, participants with documented evidence of PD disease (as above) within the previous 6 months and who are refractory or non-responsive to their most recent line of treatment afterwards are eligible
Key exclusion criteria (13 listed)
- Prior treatment with chimeric antigen receptor T (cells) CAR-T therapy directed at any target
- Any therapy that is targeted to B-cell maturation antigen (BCMA)
- The following cardiac conditions: a) New York Heart Association (NYHA) stage III or IV congestive heart failure b) Myocardial infarction or coronary artery bypass graft (CABG) 6 months prior to enrollment c) History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration d) History of severe non-ischemic cardiomyopathy e) Impaired cardiac function (left ventricular ejection fraction [LVEF] less than [<]45%) as assessed by echocardiogram or multiple-gated acquisition (MUGA) scan (performed less than or equal to (<=) 8 weeks of apheresis)
- Have received a cumulative dose of corticosteroids equivalent to greater than or equal to(>=)70 milligram (mg) of prednisone within 7 days prior to apheresis
- Diagnosed or treated for invasive malignancy other than multiple myeloma, except:
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-B38M CAR-T CellAlso: Ciltacabtagene autoleucelParticipants will receive LCAR-B38M CAR-T cells as a single infusion which consists of autologous T lymphocytes transduced with LCAR-B38M, a lentiviral vector to express a chimeric antigen receptor targeting the human B cell maturation antigen (anti-BCMA CAR). | Biological | LCAR-B38M Chimeric Antigen Receptor T Cell |
Primary outcome
Overall Response Rate (ORR)
Time frame: Minimum 2 years after LCAR-B38M chimeric antigen receptor T (CAR-T) infusion (Day 1)
The ORR is defined as the percentage of participants who achieve at least a partial response (PR) or better according to international myeloma working group (IMWG) criteria.
19 secondary outcomes
Number of Participants With Adverse Events
Time frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Chimeric Antigen Receptor T (CAR-T) Positive Cell Concentration
Time frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Transgene Levels of LCAR-B38M CAR-T Cells
Time frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Systemic Cytokine Concentrations
Time frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Number of Participants With Anti- LCAR-B38M CAR-T Cell Antibodies
Time frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Percentage of Participants with Very Good Partial Response (VGPR) or Better Rate
Time frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Percentage of Participants with Complete Response (CR)
Time frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Percentage of Participants with Negative Minimal Residual Disease (MRD)
Time frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Percentage of Participants who Achieve Clinical Benefit
Time frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Duration of Response (DOR)
Time frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Time to Response (TTR)
Time frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Progression-Free Survival (PFS)
Time frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Overall survival (OS)
Time frame: Mnimum 2 years after LCAR-B38M CART infusion (Day 1)
Levels of CAR-T cell Activation Markers
Time frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Levels of LCAR-B38M CAR-T cell Expansion (proliferation)
Time frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Levels of LCAR-B38M CAR-T Persistence
Time frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Percentage of Participants with Stringent Complete Response (sCR)
Time frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Circulating Soluble B-Cell Maturation Antigen (sBCMA) Levels
Time frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Percent Reduction in BCMA Expression Cells
Time frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Results and safety
The study was stopped early (reason given: The study was terminated early due to a strategic realignment of the sponsor's business plan, not related to safety, efficacy, or data integrity concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Derived from this study: PubMed 36269898Mi JQ, Zhao W, Jing H, Fu W, Hu J, Chen L, Zhang Y, Yao D, Chen D, Schecter JM, Yang F, Tian X, Sun H, Zhuang SH, Ren J, Fan X, Jin J, Niu T, Chen SJ. Phase II, Open-Label Study of Ciltacabtagene Autoleucel, an Anti-B-Cell Maturation Antigen Chimeric Antigen Receptor-T-Cell Therapy, in Chinese Patients With Relapsed/Refractory Multiple Myeloma (CARTIFAN-1). J Clin Oncol. 2023 Feb 20;41(6):1275-1284. doi: 10.1200/JCO.22.00690. Epub 2022 Oct 21.
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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.
Janssen Research&Development,LLC Clinical Trail study director
Janssen Research & Development, LLC
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LCAR-B38M CAR-T Cell in people with Multiple Myeloma, run by Nanjing Legend Biotech Co. at 11 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 7 inclusion and 13 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: stopped early, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 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?
The study was stopped early (reason given: The study was terminated early due to a strategic realignment of the sponsor's business plan, not related to safety, efficacy, or data integrity concerns.). 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?
Overall Response Rate (ORR) (time frame: Minimum 2 years after LCAR-B38M chimeric antigen receptor T (CAR-T) infusion (Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03758417, which also lists 1 linked publication.
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 17 Dec 2025.