Multiple MyelomaPhase 2NCT05846737
BCMA CAR-T Cell Therapy in High-risk NDMM Patients With Positive MRD After First-line ASCT
A Phase 2 study testing anti-BCMA CAR-T in people with Multiple Myeloma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
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. 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?
- anti-BCMA CAR-T
- 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
- 29 May 2023to 1 May 2028
- 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
- Age ≥ 18 years.
- Participants with documented NDMM according to IMWG diagnostic criteria.
- High-risk MM, as determined by R2-ISS（J Clin Oncol, 2022,40(29):3406-3418.）, Stage III or Stage IV.
- Has received 3 to 6 cycles of induction therapy, followed by conditioning regimen and ASCT.
- Screening must be completed within 100 days of ASCT.
- For subjects receiving consolidation therapy after ASCT, screening must be completed within 60 days after consolidation therapy, and within 6 months after ASCT.
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- Detectable MRD using EuroFlow or NGS, at 100 days after ASCT (minimum sensitivity of 10-5).
- 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).
- 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%).
- Patients must be able to take prophylactic anticoagulant therapy as recommended by the study.
- 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 cannot join
- Primary plasma cell leukemia.
- Documented active amyloidosis.
- Multiple myeloma with central nervous system (CNS) invasion.
- Has received maintenance therapy.
- Prior exposure to any BCMA-targeted therapy or CAR-T therapy.
- 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.
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- Known intolerance, hypersensitivity, or contraindication to BCMA-CART cellular products.
- Seropositive for human immunodeficiency virus (HIV).
- Hepatitis B infection.
- Hepatitis C infection.
- Life expectancy of <3 months.
- Women who are pregnant or breastfeeding.
- 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.
- Received live attenuated vaccine within 4 weeks prior to study treatment.
- 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.
- Necessary medication or supportive therapy is contraindicated with study treatment.
- Any diseases or complications that may interfere with the study.
- Patients are not willing to or cannot comply with study scheme.
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020
About this study
Official title: 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.
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.
Read the detailed description
The study is a prospective, single-arm, single-centre, phase II study designed to evaluate the efficacy and safety of BCMA CAR-T Cell Therapy in High-risk NDMM Patients With Positive MRD After First-line ASCT. Patients with detectable MRD after undergoing ASCT MRD will be enrolled in this study.
- Conditions
- Multiple Myeloma
- Being tested
- anti-BCMA CAR-T
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-BCMA CAR-TBiological
Autologous BCMA-directed CAR-T cells, infusion intravenously at a target dose of 2-4 x 10^6 anti-BCMA CAR+T cells/kg.
| Study group | Role | What they receive |
|---|---|---|
| BCMA CAR-T in high-risk MM with detectable MRD after first-line ASCT | Experimental | Autologous BCMA-directed CAR-T cells, infusion intravenously at a target dose of 2-4 x 10^6 anti-BCMA CAR+T cells/kg. Receives: Biological: anti-BCMA CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
The incidence of treatment-emergent adverse events (TEAEs)
Measured: Up to 2 year
MRD-negativity rate
Achieving undetectable MRD, as determined by NGF/NGS 3 months after CAR-T cell infusion
Measured: 3 months after CAR-T cell infusion
Secondary outcomes (3)
Complete response rate (CRR)
CR or better is defined as percentage of participants who achieve a CR response or Stringent Complete Response (sCR) response accoording to the IMWG criteria
Measured: 1 month after the CAR-T cell transfusion, after consolidation therapy
Progression free survival (PFS)
Progression free survival is defined as the time from the date of diagnosis to the date of first documented PD, as defined in the IMWG criteria, or death due to any cause, whichever occurs first
Measured: Up to 2 year
Overall Survival (OS)
Overall survival is measured from the date of diagnosis to the date of the participant's death.
Measured: Up to 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start29 May 2023
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2028 (estimated)
Why it stopped: The study was withdrawn due to the inability to enroll participants.
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.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05846737
- Sponsor's protocol ID
- IIT2023012
- Status last verified
- Apr 2026
- First submitted
- 27 Apr 2023
- Last updated
- 29 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05846737
- Acronym / sponsor ID
- IIT2023012
- Conditions
- Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was withdrawn due to the inability to enroll participants.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 29 May 2023 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 6 May 2023 (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 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.
Detailed description
The study is a prospective, single-arm, single-centre, phase II study designed to evaluate the efficacy and safety of BCMA CAR-T Cell Therapy in High-risk NDMM Patients With Positive MRD After First-line ASCT. Patients with detectable MRD after undergoing ASCT MRD will be enrolled in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BCMA CAR-T in high-risk MM with detectable MRD after first-line ASCT | Experimental | Biological: anti-BCMA CAR-TAutologous BCMA-directed CAR-T cells, infusion intravenously at a target dose of 2-4 x 10^6 anti-BCMA CAR+T cells/kg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 18 years.
- Participants with documented NDMM according to IMWG diagnostic criteria.
- High-risk MM, as determined by R2-ISS（J Clin Oncol, 2022,40(29):3406-3418.）, Stage III or Stage IV.
- Has received 3 to 6 cycles of induction therapy, followed by conditioning regimen and ASCT.
- Screening must be completed within 100 days of ASCT.
Key exclusion criteria (18 listed)
- Primary plasma cell leukemia.
- Documented active amyloidosis.
- Multiple myeloma with central nervous system (CNS) invasion.
- Has received maintenance therapy.
- Prior exposure to any BCMA-targeted therapy or CAR-T therapy.
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 |
|---|---|---|
| anti-BCMA CAR-TAutologous BCMA-directed CAR-T cells, infusion intravenously at a target dose of 2-4 x 10^6 anti-BCMA CAR+T cells/kg. | Biological | BCMA CAR-T in high-risk MM with detectable MRD after first-line ASCT |
Primary outcome
Safety and Tolerability
Time frame: Up to 2 year
The incidence of treatment-emergent adverse events (TEAEs)
MRD-negativity rate
Time frame: 3 months after CAR-T cell infusion
Achieving undetectable MRD, as determined by NGF/NGS 3 months after CAR-T cell infusion
3 secondary outcomes
Complete response rate (CRR)
Time frame: 1 month after the CAR-T cell transfusion, after consolidation therapy
Progression free survival (PFS)
Time frame: Up to 2 year
Overall Survival (OS)
Time frame: Up to 5 year
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 29 Apr 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 Phase 2 study testing anti-BCMA CAR-T in people with Multiple Myeloma, run by Institute of Hematology & Blood Diseases Hospital, China 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 11 inclusion and 18 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 29 Apr 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?
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 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?
Safety and Tolerability (time frame: Up to 2 year). 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 29 Apr 2026.