Relapsed/Refractory Light Chain AmyloidosisEarly Phase 1NCT07626476
Autologous BCMA-targeted CAR-T Cell Injection for Relapsed/Refractory Light Chain Amyloidosis
A Early Phase 1 study testing Targeted BCMA Autologous CART Cell Injection in people with Relapsed/Refractory Light Chain Amyloidosis and AL Amyloidosis, run by Beijing Boren Hospital at 1 site in China.
Trial summary
Systemic light chain amyloidosis (AL amyloidosis) is the most common type of systemic amyloidosis, with diverse clinical manifestations and difficulties in diagnosis and treatment. AL amyloidosis may involve multiple organs; the kidney and heart are the most commonly involved organs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Light Chain Amyloidosis, AL Amyloidosis, Systemic Light Chain Amyloidosis
- What is being tested?
- Targeted BCMA Autologous CART Cell Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 16 Dec 2024to 15 Dec 2029
- Phase
- Early 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
- The participant must personally sign an ethics-committee-approved informed consent form before study start.
- Age ≥18 years.
- Pathologically confirmed light chain amyloidosis.
- Relapsed/refractory light chain amyloidosis previously treated with 2 or more lines of therapy.
- dFLC >50 mg/L.
- Expected survival ≥12 weeks.
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- ECOG score ≤2.
- Diagnosis of AL amyloidosis must meet the following conditions: (1) clinical manifestations, physical examination, laboratory or imaging examinations confirm tissue or organ involvement; (2) tissue biopsy pathology confirms amyloid deposition, and the precursor protein of amyloid protein is immunoglobulin light chain or heavy and light chain; and the participant is relapsed/refractory.
- Female participants of childbearing potential should agree to use effective contraception from the date of signing informed consent until 365 days after infusion. Effective contraception is defined as abstinence or contraception using methods specified in the protocol with an annual failure rate <1%.
- Adequate organ function before enrollment, meeting all of the following:
- Absolute neutrophil count ≥1.0×10^9/L; granulocyte colony-stimulating factor (G-CSF) support is permitted.
- Platelet count ≥50×10^9/L.
- Hemoglobin ≥8 g/dL.
- Bilirubin ≤1.5×upper limit of normal (ULN), except biliary obstruction caused by tumor compression.
- ALT or AST ≤2.5×ULN; for participants with liver involvement, ≤5×ULN.
- Mayo 2004 stage I-IIIa.
- Stable coagulation function: INR ≤1.5 and APTT ≤1.2×ULN, except tumor-related anticoagulant therapy.
- Baseline oxygen saturation on room air >92%.
Who cannot join
- Participants who have received the following prior treatments:
- Prior gene therapy before enrollment.
- Live vaccine injection within 4 weeks before enrollment.
- Other interventional clinical study drug treatment within 12 weeks before leukapheresis.
- Central nervous system involvement or complete intestinal obstruction.
- Moderate or higher pleural effusion or ascites that is difficult to control with conventional treatment and requires continuous catheter drainage.
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- Active malignancy within the past 5 years, unless it is a curable tumor and has been clearly cured.
- HBsAg positivity with abnormal peripheral blood HBV DNA testing; HCV antibody positivity with peripheral blood HCV RNA positivity; HIV antibody positivity; CMV DNA positivity; or positive syphilis RPR test.
- Uncontrolled active infection, except CTCAE grade <2 urogenital infection and upper respiratory tract infection.
- Severe heart disease, including but not limited to unstable angina, myocardial infarction within 6 months before screening, congestive heart failure (New York Heart Association [NYHA] class ≥III), positive six-minute walk test, interventricular septum and left ventricular posterior wall thickness >1.5 cm, or ventricular arrhythmia and atrioventricular block indicated by ambulatory electrocardiography.
- Hypertension that cannot be controlled by medication.
- Toxicity from prior treatment not recovered to baseline or ≤grade 1 according to NCI CTCAE v5.0, except alopecia and clinically insignificant laboratory abnormalities.
- Major surgery within 2 weeks before enrollment, or planned surgery during the waiting period before infusion or within 12 weeks after study treatment, except planned local anesthesia surgery.
- Solid organ transplantation.
- Pregnant or breastfeeding women.
- History of central nervous system disease, such as cerebral aneurysm, epilepsy, stroke, senile dementia or psychiatric disease, or disturbance of consciousness.
- Other systemic disease judged unstable by the investigator, including but not limited to severe hepatic, renal or metabolic disease requiring medication.
- Known life-threatening allergic reaction, hypersensitivity or intolerance to the CAR-T cell product or its components.
- Bleeding or severe thrombosis as judged by the investigator, hereditary/acquired bleeding or severe thrombosis, including hemophilia, coagulopathy, thrombocytopenia and hypersplenism, or current thrombolytic or anticoagulant therapy.
- Other conditions that the investigator considers unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Autologous BCMA-targeted CAR-T Cell Injection in Participants With Relapsed/Refractory Light Chain Amyloidosis
Systemic light chain amyloidosis (AL amyloidosis) is the most common type of systemic amyloidosis, with diverse clinical manifestations and difficulties in diagnosis and treatment. AL amyloidosis may involve multiple organs; the kidney and heart are the most commonly involved organs. The treatment goal is to reduce monoclonal immunoglobulin light-chain levels, prevent further amyloid deposition in important organs, and alleviate or reverse organ dysfunction caused by amyloid deposition. The principal approach to achieve this goal is to eliminate the plasma-cell or B-cell clones producing abnormal light chains. For patients with relapsed/refractory AL amyloidosis, the protocol states that there is currently no suitable treatment method and that participation in clinical trials is recommended.
This study evaluates targeted BCMA autologous CART cell injection in participants with relapsed/refractory light chain amyloidosis. The main purpose is to evaluate safety, preliminarily verify efficacy, and explore in vivo pharmacokinetics, pharmacodynamics, immunogenicity and related characteristics after infusion.
Read the detailed description
This is an open-label, fixed-dose exploratory clinical study to observe the safety and efficacy of targeted BCMA autologous CART cell injection in participants with relapsed/refractory light chain amyloidosis. The study is expected to enroll 30 participants and uses a fixed dose of 1.0×10^6 CAR-T/kg. The safety observation period is 28 days after CAR-T administration.
The study process includes screening, PBMC leukapheresis, pre-lymphodepletion examination, lymphodepleting conditioning, infusion of targeted BCMA autologous CART cell injection with the infusion day defined as Day 0, and the main follow-up period.
Before infusion, participants receive fludarabine plus cyclophosphamide lymphodepleting conditioning from Day -5 to Day -3 for three consecutive days. The recommended regimen is cyclophosphamide 250 mg/m²/day by intravenous infusion once daily for three days and fludarabine 25 mg/m²/day by intravenous infusion once daily for three days. The investigator may adjust the conditioning regimen according to renal function and creatinine clearance, such as replacing fludarabine with bendamustine or reducing the dose.
The targeted BCMA autologous CART cell injection is infused once on Day 0 by intravenous injection and completed within 30 minutes. If an adverse event occurs after conditioning and before infusion and the investigator determines that infusion should be suspended, infusion may be delayed until the adverse event recovers to a state allowing infusion. Before infusion, the investigator should reassess whether repeated lymphodepleting conditioning is needed.
The main follow-up period lasts from infusion of targeted BCMA autologous CART cell injection until the participant meets the criteria for exit from main follow-up or completes the 2-year main follow-up visit at Day 720. Efficacy assessments are performed at Day 28, Day 60 and Day 90, and then every 90 days until the end of main follow-up. Participants who complete the 2-year main follow-up enter long-term follow-up. Participants who meet criteria to exit main follow-up enter long-term visits until death, withdrawal from the study, or 15 years after cell infusion.
- Conditions
- Relapsed/Refractory Light Chain Amyloidosis, AL Amyloidosis, Systemic Light Chain Amyloidosis
- Being tested
- Targeted BCMA Autologous CART Cell Injection
- Keywords
- AL amyloidosis, light chain amyloidosis, relapsed/refractory, BCMA, CAR-T, autologous CAR-T
- Medical subject headings
- Immunoglobulin Light-chain Amyloidosis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted BCMA Autologous CART Cell InjectionBiological
Anti-BCMA chimeric antigen receptor autologous T cells are a BCMA-targeted, gene-modified autologous T-cell (CAR-T cell) immunotherapy derived from the participant's autologous peripheral blood mononuclear cells (PBMCs). The cells are transduced with lentivirus generated using a four-plasmid viral packaging system, with the pCDH-BCMA CAR plasmid as the expression vector. The product is administered as an injection by a single intravenous infusion at a dose of 1.0×10^6 CAR-T cells/kg.
| Study group | Role | What they receive |
|---|---|---|
| Autologous BCMA-targeted CAR-T Cell Injection | Experimental | Targeted BCMA autologous CART cell injection at a fixed dose of 1.0×10^6 CAR-T/kg. Receives: Biological: Targeted BCMA Autologous CART Cell Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest
The number and percentage of participants with adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) will be summarized. AEs and SAEs will be summarized by system organ class (SOC), preferred term (PT), severity, seriousness, relationship to study treatment, and outcome. AESIs include Grade 3 or higher hematologic toxicity lasting more than 30 days, excluding lymphocytopenia; hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS); Grade 3 or higher infections; uncontrolled CAR-T cell expansion; Grade 3 or higher cytokine release syndrome (CRS); Grade 3 or higher immune effector cell-associated neurotoxicity syndrome (ICANS); progressive multifocal leukoencephalopathy; secondary malignancies; and detection of replication-competent lentivirus (RCL). AEs other than CRS and ICANS will be graded per NCI-CTCAE Version 5.0; CRS and ICANS will be graded per 2019 ASTCT criteria.
Measured: From signing of the informed consent form through withdrawal from the study or 2 years after BCMA-targeted autologous CAR-T cell infusion, whichever occurs first.
Secondary outcomes (12)
Objective response rate (ORR)
Proportion of participants whose best efficacy evaluation within 6 months after infusion of BCMA-targeted Autologous CAR-T Cell Injection is partial response (PR) or complete response (CR), according to the National Comprehensive Cancer Network (NCCN) 2023 guideline and evaluation criteria for systemic light-chain amyloidosis.
Measured: Within 6 months after infusion.
Duration of response (DoR)
Time from the first efficacy evaluation of complete response (CR) or partial response (PR) to the first efficacy evaluation of progressive disease (PD)/relapse or death due to the study disease.
Measured: From the first efficacy evaluation of CR/PR until the first efficacy evaluation of PD/relapse or death due to the study disease, assessed until exit from main follow-up or completion of the Day 720 visit.
Time to response (TTR)
Time from infusion of BCMA-targeted Autologous CAR-T Cell Injection to the first efficacy evaluation of partial response (PR) or complete response (CR).
Measured: From infusion until the first efficacy evaluation of PR or CR, assessed until exit from main follow-up or completion of the Day 720 visit.
Progression-free survival (PFS)
Time from infusion of BCMA-targeted Autologous CAR-T Cell Injection to the first efficacy evaluation showing disease progression/relapse or death from any cause.
Measured: From infusion until the first disease progression/relapse or death from any cause, assessed until exit from main follow-up or completion of the Day 720 visit.
Overall survival (OS)
Time from infusion of BCMA-targeted Autologous CAR-T Cell Injection to death from any cause.
Measured: From infusion until death from any cause, assessed until exit from main follow-up or completion of the Day 720 visit.
Changes in peripheral blood viral vector copy number (VCN) levels
Peripheral blood BCMA-CAR viral vector copy number (VCN) is quantitatively detected by PCR.
Measured: Day -12 to -5 before infusion (no later than 1 minute before lymphodepletion); Days 1 and 4 (±8 h), Days 7 and 10 (±1 d), Days 14 and 21 (±2 d), Day 28 (±3 d), Days 60 and 90 and every 90 days thereafter (±14 d) through Day 720.
Changes in peripheral blood CAR-T cell concentration levels
Peripheral blood BCMA-positive CAR-T cells are detected by flow cytometry.
Measured: Day -12 to -5 before infusion (no later than 1 minute before lymphodepletion); Days 1 and 4 (±8 h), Days 7 and 10 (±1 d), Days 14 and 21 (±2 d), Day 28 (±3 d), Days 60 and 90 and every 90 days thereafter (±14 d) through Day 720.
Maximum concentration (Cmax)
Maximum concentration of peripheral blood BCMA-CAR VCN and BCMA-positive CAR-T cells after infusion of BCMA-targeted Autologous CAR-T Cell Injection.
Measured: Calculated from PK assessments conducted from pre-infusion sampling through the last PK assessment during main follow-up, up to Day 720 after infusion.
Time to maximum concentration (Tmax)
Time to reach the maximum concentration of peripheral blood BCMA-CAR VCN and BCMA-positive CAR-T cells after infusion of BCMA-targeted Autologous CAR-T Cell Injection.
Measured: Calculated from PK assessments conducted from pre-infusion sampling through the last PK assessment during main follow-up, up to Day 720 after infusion.
Area under the curve from Day 0 to Day 28 (AUC0-28d)
Area under the concentration-time curve of peripheral blood BCMA-CAR VCN and BCMA-positive CAR-T cells from Day 0 to Day 28 after infusion.
Measured: From Day 0 through Day 28 after infusion.
Area under the curve from Day 0 to Day 90 (AUC0-90d)
Area under the concentration-time curve of peripheral blood BCMA-CAR VCN and BCMA-positive CAR-T cells from Day 0 to Day 90 after infusion.
Measured: From Day 0 through Day 90 after infusion.
Area under the curve from Day 0 to the last PK assessment (AUC0-last)
Area under the concentration-time curve of peripheral blood BCMA-CAR VCN and BCMA-positive CAR-T cells from Day 0 to the last PK assessment time point.
Measured: From Day 0 through the last PK assessment during main follow-up, up to Day 720 after infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start16 Dec 2024
- Primary completion15 Dec 2027 (estimated)
- Study completion15 Dec 2029 (estimated)
Why it stopped: Due to the promulgation of State Council Order No. 818, clinical trials of this category are prohibited.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Light Chain AmyloidosisStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Boren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07626476
- Sponsor's protocol ID
- BJBR-2024-AL-001
- Status last verified
- May 2026
- First submitted
- 22 May 2026
- Last updated
- 13 Oct 2026
- 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 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Autologous BCMA-targeted CAR-T Cell Injection in Participants With Relapsed/Refractory Light Chain Amyloidosis
- ClinicalTrials.gov ID
- NCT07626476
- Acronym / sponsor ID
- BJBR-2024-AL-001
- Conditions
- Relapsed/Refractory Light Chain Amyloidosis, AL Amyloidosis, Systemic Light Chain Amyloidosis
- Keywords
- AL amyloidosis, light chain amyloidosis, relapsed/refractory, BCMA, CAR-T, autologous CAR-T
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to the promulgation of State Council Order No. 818, clinical trials of this category are prohibited.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Beijing Boren HospitalUniversity, hospital or other
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 15 Dec 2029 (estimated)
- First posted
- 4 Jun 2026 (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.
Systemic light chain amyloidosis (AL amyloidosis) is the most common type of systemic amyloidosis, with diverse clinical manifestations and difficulties in diagnosis and treatment. AL amyloidosis may involve multiple organs; the kidney and heart are the most commonly involved organs. The treatment goal is to reduce monoclonal immunoglobulin light-chain levels, prevent further amyloid deposition in important organs, and alleviate or reverse organ dysfunction caused by amyloid deposition. The principal approach to achieve this goal is to eliminate the plasma-cell or B-cell clones producing abnormal light chains. For patients with relapsed/refractory AL amyloidosis, the protocol states that there is currently no suitable treatment method and that participation in clinical trials is recommended.
This study evaluates targeted BCMA autologous CART cell injection in participants with relapsed/refractory light chain amyloidosis. The main purpose is to evaluate safety, preliminarily verify efficacy, and explore in vivo pharmacokinetics, pharmacodynamics, immunogenicity and related characteristics after infusion.
Detailed description
This is an open-label, fixed-dose exploratory clinical study to observe the safety and efficacy of targeted BCMA autologous CART cell injection in participants with relapsed/refractory light chain amyloidosis. The study is expected to enroll 30 participants and uses a fixed dose of 1.0×10^6 CAR-T/kg. The safety observation period is 28 days after CAR-T administration.
The study process includes screening, PBMC leukapheresis, pre-lymphodepletion examination, lymphodepleting conditioning, infusion of targeted BCMA autologous CART cell injection with the infusion day defined as Day 0, and the main follow-up period.
Before infusion, participants receive fludarabine plus cyclophosphamide lymphodepleting conditioning from Day -5 to Day -3 for three consecutive days. The recommended regimen is cyclophosphamide 250 mg/m²/day by intravenous infusion once daily for three days and fludarabine 25 mg/m²/day by intravenous infusion once daily for three days. The investigator may adjust the conditioning regimen according to renal function and creatinine clearance, such as replacing fludarabine with bendamustine or reducing the dose.
The targeted BCMA autologous CART cell injection is infused once on Day 0 by intravenous injection and completed within 30 minutes. If an adverse event occurs after conditioning and before infusion and the investigator determines that infusion should be suspended, infusion may be delayed until the adverse event recovers to a state allowing infusion. Before infusion, the investigator should reassess whether repeated lymphodepleting conditioning is needed.
The main follow-up period lasts from infusion of targeted BCMA autologous CART cell injection until the participant meets the criteria for exit from main follow-up or completes the 2-year main follow-up visit at Day 720. Efficacy assessments are performed at Day 28, Day 60 and Day 90, and then every 90 days until the end of main follow-up. Participants who complete the 2-year main follow-up enter long-term follow-up. Participants who meet criteria to exit main follow-up enter long-term visits until death, withdrawal from the study, or 15 years after cell infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous BCMA-targeted CAR-T Cell Injection | Experimental | Biological: Targeted BCMA Autologous CART Cell InjectionTargeted BCMA autologous CART cell injection at a fixed dose of 1.0×10^6 CAR-T/kg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- The participant must personally sign an ethics-committee-approved informed consent form before study start.
- Age ≥18 years.
- Pathologically confirmed light chain amyloidosis.
- Relapsed/refractory light chain amyloidosis previously treated with 2 or more lines of therapy.
- dFLC >50 mg/L.
Key exclusion criteria (20 listed)
- Participants who have received the following prior treatments:
- Central nervous system involvement or complete intestinal obstruction.
- Moderate or higher pleural effusion or ascites that is difficult to control with conventional treatment and requires continuous catheter drainage.
- Active malignancy within the past 5 years, unless it is a curable tumor and has been clearly cured.
- HBsAg positivity with abnormal peripheral blood HBV DNA testing; HCV antibody positivity with peripheral blood HCV RNA positivity; HIV antibody positivity; CMV DNA positivity; or positive syphilis RPR test.
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 |
|---|---|---|
| Targeted BCMA Autologous CART Cell InjectionAnti-BCMA chimeric antigen receptor autologous T cells are a BCMA-targeted, gene-modified autologous T-cell (CAR-T cell) immunotherapy derived from the participant's autologous peripheral blood mononuclear cells (PBMCs). The cells are transduced with lentivirus generated using a four-plasmid viral packaging system, with the pCDH-BCMA CAR plasmid as the expression vector. The product is administered as an injection by a single intravenous infusion at a dose of 1.0×10^6 CAR-T cells/kg. | Biological | Autologous BCMA-targeted CAR-T Cell Injection |
Primary outcome
Number of Participants With Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest
Time frame: From signing of the informed consent form through withdrawal from the study or 2 years after BCMA-targeted autologous CAR-T cell infusion, whichever occurs first.
The number and percentage of participants with adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) will be summarized. AEs and SAEs will be summarized by system organ class (SOC), preferred term (PT), severity, seriousness, relationship to study treatment, and outcome. AESIs include Grade 3 or higher hematologic toxicity lasting more than 30 days, excluding lymphocytopenia; hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS); Grade 3 or higher infections; uncontrolled CAR-T cell expansion; Grade 3 or higher cytokine release syndrome (CRS); Grade 3 or higher immune effector cell-associated neurotoxicity syndrome (ICANS); progressive multifocal leukoencephalopathy; secondary malignancies; and detection of replication-competent lentivirus (RCL). AEs other than CRS and ICANS will be graded per NCI-CTCAE Version 5.0; CRS and ICANS will be graded per 2019 ASTCT criteria.
12 secondary outcomes
Objective response rate (ORR)
Time frame: Within 6 months after infusion.
Duration of response (DoR)
Time frame: From the first efficacy evaluation of CR/PR until the first efficacy evaluation of PD/relapse or death due to the study disease, assessed until exit from main follow-up or completion of the Day 720 visit.
Time to response (TTR)
Time frame: From infusion until the first efficacy evaluation of PR or CR, assessed until exit from main follow-up or completion of the Day 720 visit.
Progression-free survival (PFS)
Time frame: From infusion until the first disease progression/relapse or death from any cause, assessed until exit from main follow-up or completion of the Day 720 visit.
Overall survival (OS)
Time frame: From infusion until death from any cause, assessed until exit from main follow-up or completion of the Day 720 visit.
Changes in peripheral blood viral vector copy number (VCN) levels
Time frame: Day -12 to -5 before infusion (no later than 1 minute before lymphodepletion); Days 1 and 4 (±8 h), Days 7 and 10 (±1 d), Days 14 and 21 (±2 d), Day 28 (±3 d), Days 60 and 90 and every 90 days thereafter (±14 d) through Day 720.
Changes in peripheral blood CAR-T cell concentration levels
Time frame: Day -12 to -5 before infusion (no later than 1 minute before lymphodepletion); Days 1 and 4 (±8 h), Days 7 and 10 (±1 d), Days 14 and 21 (±2 d), Day 28 (±3 d), Days 60 and 90 and every 90 days thereafter (±14 d) through Day 720.
Maximum concentration (Cmax)
Time frame: Calculated from PK assessments conducted from pre-infusion sampling through the last PK assessment during main follow-up, up to Day 720 after infusion.
Time to maximum concentration (Tmax)
Time frame: Calculated from PK assessments conducted from pre-infusion sampling through the last PK assessment during main follow-up, up to Day 720 after infusion.
Area under the curve from Day 0 to Day 28 (AUC0-28d)
Time frame: From Day 0 through Day 28 after infusion.
Area under the curve from Day 0 to Day 90 (AUC0-90d)
Time frame: From Day 0 through Day 90 after infusion.
Area under the curve from Day 0 to the last PK assessment (AUC0-last)
Time frame: From Day 0 through the last PK assessment during main follow-up, up to Day 720 after infusion.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- 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. 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 Early Phase 1 study testing Targeted BCMA Autologous CART Cell Injection in people with Relapsed/Refractory Light Chain Amyloidosis and AL Amyloidosis, run by Beijing Boren Hospital 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 18 inclusion and 20 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: withdrawn, as of the sponsor's last update on 13 Oct 2026. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 withdrawn before enrolling participants, so there are no results.
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, Serious Adverse Events, and Adverse Events of Special Interest (time frame: From signing of the informed consent form through withdrawal from the study or 2 years after BCMA-targeted autologous CAR-T cell infusion, whichever occurs first.). 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 13 Oct 2026.