Skip to main content
TTrialFinderData
TrialFinderData is for informational purposes only and does not provide medical advice. Always talk to your doctor.

Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

BCMA CAR-T Cell Therapy in High-risk NDMM Patients With Positive MRD After First-line ASCT

Safety and Efficiency of BCMA CAR-T Cell Therapy in High-risk NDMM Patients With Positive MRD After First-line ASCT: a Prospective, Single-arm, Single-center, Phase II Study.

BCMA CAR-T Cell Therapy in High-risk NDMM Patients With Positive MRD After First-line ASCT (NCT05846737) is a Phase 2 interventional studying Multiple Myeloma, sponsored by Institute of Hematology & Blood Diseases Hospital, China. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This study is a open-label, single-center Phase 2 study to evaluate the efficacy and safety of BCMA CAR-T Cell Therapy in High-risk NDMM Patients With Positive MRD After First-line ASCT. A total of 40 subjects will be enrolled into this study.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Multiple Myeloma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 20 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age ≥ 18 years. 2. Participants with documented NDMM according to IMWG diagnostic criteria. 3. High-risk MM, as determined by R2-ISS（J Clin Oncol, 2022,40(29):3406-3418.）, Stage III or Stage IV. 4. Has received 3 to 6 cycles of induction therapy, followed by conditioning regimen and ASCT. 5. Screening must be completed within 100 days of ASCT. 6. For subjects receiving consolidation therapy after ASCT, screening must be completed within 60 days after consolidation therapy, and within 6 months after ASCT. 7. Detectable MRD using EuroFlow or NGS, at 100 days after ASCT (minimum sensitivity of 10-5). 8. All screening blood biochemistry: tests should be performed according to the protocol and within 14 days before enrollment. Screening laboratory values must meet the following criteria: a.TBIL\<1.5 x upper limit of normal (ULN) (\<3 x ULN in patients with Gilbert's syndrome); b.AST and ALT \<3 x ULN.; c. Creatinine clearance \> 60mL/min (calculated using the Cockroft-Gault formula). 9. Routine blood tests (performed within 7 days, no RBC transfusion, no G-CSF/GM-CSF/platelet agonists, no drug correction within 14 days before screening, no PLT transfusion within 7 days) : WBC ≥ 1.5 x 109/L, white blood cell count (ANC) at least 1.0 x 109/L, Hb ≥ 85 g/L PLT ≥ 75 x 109/L (if BMPC \< 50%) or PLT ≥ 50 x 109/L (if BMPC ≥ 50%). 10. Patients must be able to take prophylactic anticoagulant therapy as recommended by the study. 11. The woman is not breastfeeding, is not pregnant and agrees not to be pregnant during the study period and for the following 12 months. Male patients agreed that their spouse would not become pregnant during the study period and for 12 months thereafter. Who Should NOT Join This Trial: 1. Primary plasma cell leukemia. 2. Documented active amyloidosis. 3. Multiple myeloma with central nervous system (CNS) invasion. 4. Has received maintenance therapy. 5. Prior exposure to any BCMA-targeted therapy or CAR-T therapy. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Age ≥ 18 years. 2. Participants with documented NDMM according to IMWG diagnostic criteria. 3. High-risk MM, as determined by R2-ISS（J Clin Oncol, 2022,40(29):3406-3418.）, Stage III or Stage IV. 4. Has received 3 to 6 cycles of induction therapy, followed by conditioning regimen and ASCT. 5. Screening must be completed within 100 days of ASCT. 6. For subjects receiving consolidation therapy after ASCT, screening must be completed within 60 days after consolidation therapy, and within 6 months after ASCT. 7. Detectable MRD using EuroFlow or NGS, at 100 days after ASCT (minimum sensitivity of 10-5). 8. All screening blood biochemistry: tests should be performed according to the protocol and within 14 days before enrollment. Screening laboratory values must meet the following criteria: a.TBIL\<1.5 x upper limit of normal (ULN) (\<3 x ULN in patients with Gilbert's syndrome); b.AST and ALT \<3 x ULN.; c. Creatinine clearance \> 60mL/min (calculated using the Cockroft-Gault formula). 9. Routine blood tests (performed within 7 days, no RBC transfusion, no G-CSF/GM-CSF/platelet agonists, no drug correction within 14 days before screening, no PLT transfusion within 7 days) : WBC ≥ 1.5 x 109/L, ANC ≥ 1.0 x 109/L, Hb ≥ 85 g/L PLT ≥ 75 x 109/L (if BMPC \< 50%) or PLT ≥ 50 x 109/L (if BMPC ≥ 50%). 10. Patients must be able to take prophylactic anticoagulant therapy as recommended by the study. 11. The woman is not breastfeeding, is not pregnant and agrees not to be pregnant during the study period and for the following 12 months. Male patients agreed that their spouse would not become pregnant during the study period and for 12 months thereafter. Exclusion Criteria: 1. Primary plasma cell leukemia. 2. Documented active amyloidosis. 3. Multiple myeloma with central nervous system (CNS) invasion. 4. Has received maintenance therapy. 5. Prior exposure to any BCMA-targeted therapy or CAR-T therapy. 6. Patients with peripheral neuropathy greater than grade 2 or peripheral neuropathy greater than grade 2 with pain at baseline, regardless of whether they were currently receiving medical therapy. 7. Known intolerance, hypersensitivity, or contraindication to BCMA-CART cellular products. 8. Seropositive for human immunodeficiency virus (HIV). 9. Hepatitis B infection. 10. Hepatitis C infection. 11. Life expectancy of \<3 months. 12. Women who are pregnant or breastfeeding. 13. Subjects had major surgery within 2 weeks before randomization (for example, general anesthesia), or is not fully recovered from the surgery, or surgery is arranged during study period. 14. Received live attenuated vaccine within 4 weeks prior to study treatment. 15. According to the researcher's judgment, any condition including but not limited to serious mental illness, medical illness, or other symptoms/conditions that may affect study treatment, compliance, or the capability of providing informed consent. 16. Necessary medication or supportive therapy is contraindicated with study treatment. 17. Any diseases or complications that may interfere with the study. 18. Patients are not willing to or cannot comply with study scheme.

Treatments Being Tested

BIOLOGICAL

anti-BCMA CAR-T

Autologous BCMA-directed CAR-T cells, infusion intravenously at a target dose of 2-4 x 10\^6 anti-BCMA CAR+T cells/kg.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05846737), the sponsor (Institute of Hematology & Blood Diseases Hospital, China), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05846737 clinical trial studying?

This study is a open-label, single-center Phase 2 study to evaluate the efficacy and safety of BCMA CAR-T Cell Therapy in High-risk NDMM Patients With Positive MRD After First-line ASCT. A total of 40 subjects will be enrolled into this study. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05846737?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05846737?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05846737. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05846737. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.