Multiple Myeloma, Plasma Cell LeukemiaPhase 2CAREMM-004NCT07106684
ASCT Combined With BCMA CAR-T and GPRC5D/CD3 BiTEs Maintenance for Transplant-Eligible Primary Plasma Cell Leukemia
A Phase 2 study testing Autologous hematopoietic stem cell transplantation, BCMA CAR-T and GPRC5D/CD3 BiTEs in people with Multiple Myeloma, Plasma Cell Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
This is a prospective, single-arm, phase II study to evaluate the efficacy and safety of autologous stem cell transplantation combined with BCMA CAR-T therapy followed by GPRC5D/CD3 bispecific antibody maintenance in transplant-eligible patients with primary plasma cell leukemia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Myeloma, Plasma Cell Leukemia
- What is being tested?
- Autologous hematopoietic stem cell transplantation, BCMA CAR-T and GPRC5D/CD3 BiTEs
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 9 Aug 2025to 1 Aug 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years and ≤ 70 years.
- Participants with documented newly-diagnosed primary plasma cell leukemia according to IMWG diagnostic criteria.
- Measurable disease at screening, defined as: Serum M-protein level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or Light chain MM without measurable disease in serum or urine: serum Ig free-light chain (FLC) ≥10 mg/dL and abnormal serum Ig kappa lambda FLC ratio.
- Patients deemed eligible for high-dose chemotherapy with ASCT.
- Tumor cells were BCMA and GPRC5D positive.
- Serum total bilirubin <2 x upper limit of normal (ULN), serum AST and ALT <3 x ULN, creatinine clearance ≥ 30mL/min (Cockroft-Gault formula).
- Informed Consent/Assent: All subjects have the ability to understand and the willingness to sign a written informed consent.
Who cannot join
- Active amyloidosis.
- Central nervous system involvement.
- Prior BCMA-targeted therapy or CAR-T therapy.
- Active hepatitis B or hepatitis C virus infection.
- Known HIV infection.
- Life expectancy <6 months.
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- Woman who are pregnant or breastfeeding
- Evidence of uncontrolled dysfunction of heart, lung, brain, and other important organs.
- Any other conditions that are not eligible for the trial in the judgement of the principal investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020
Gang An, 86-022-23909171, angang@ihcams.ac.cn
About this study
Official title: A Prospective, Single-Arm, Phase II Study of Autologous Stem Cell Transplantation Combined With BCMA CAR-T Therapy Followed by GPRC5D/CD3 Bispecific Antibody Maintenance in Transplant-Eligible Patients With Primary Plasma Cell Leukemia
This is a prospective, single-arm, phase II study to evaluate the efficacy and safety of autologous stem cell transplantation combined with BCMA CAR-T therapy followed by GPRC5D/CD3 bispecific antibody maintenance in transplant-eligible patients with primary plasma cell leukemia.
Read the detailed description
All subjects will receive standard induction therapy for up to four cycles prior to screening. Following response evaluation, those who meet the inclusion criteria will be enrolled. Enrolled patients will undergo autologous stem cell transplantation (ASCT) combined with BCMA CAR-T cell therapy, followed by GPRC5D/CD3 bispecific antibody therapy.
Patients who achieve a stringent complete response (sCR) and sustained MRD negativity (≥12 months) may enter a treatment-free observation phase or receive maintenance therapy for 24 months. Patients who experience MRD resurgence or loss of response during observation will resume maintenance therapy.
Patients who do not achieve both sCR and sustained MRD negativity (≥12 months) will continue GPRC5D/CD3 bispecific antibody therapy.
- Conditions
- Multiple Myeloma, Plasma Cell Leukemia
- Being tested
- Autologous hematopoietic stem cell transplantation, BCMA CAR-T, GPRC5D/CD3 BiTEs
- Keywords
- Plasma cell leukemia, CAR-T, ASCT, BiTEs
- Medical subject headings
- Multiple Myeloma, Leukemia, Plasma Cell, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous hematopoietic stem cell transplantationProcedure or surgery
Patients receive transplantation conditioning followed by autologous hematopoietic stem cell transplantation after successful stem cell mobilization and collection.
BCMA CAR-TBiological
Patients will receive BCMA CAR-T single dose infusion 3 days after ASCT.
GPRC5D/CD3 BiTEsDrug
Patients will receive GPRC5D/CD3 BiTEs maintenance therapy at a dose of 54 μg/kg every 4 weeks, starting 3 months after BCMA CAR-T infusion.
| Study group | Role | What they receive |
|---|---|---|
| ASCT Combined With BCMA CAR-T and GPRC5D/CD3 BiTEs Maintenance | Experimental | Patients will receive induction therapy, undergo ASCT followed by BCMA CAR-T infusion. Three month after CAR-T cell infusion, patients will begin GPRC5D/CD3 BiTEs maintenance therapy. Receives: Procedure: Autologous hematopoietic stem cell transplantation; Biological: BCMA CAR-T; Drug: GPRC5D/CD3 BiTEs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained MRD-negative rate
Rate of patients achieving sustained MRD negativity for more than 12 months
Measured: Up to 2 year
MRD negativity rate
Rate of patients achieving MRD negativity
Measured: Up to 2 years
Secondary outcomes (4)
Safety and Tolerability
The incidence of treatment-emergent adverse events (TEAEs)
Measured: Up to 2 year
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: Up to 2 years
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 3 year
Overall survival (OS)
Overall survival is defined as the time from the date of diagnosis to the date of death due to any cause
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 Aug 2025
- Study start9 Aug 2025
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma, Plasma Cell LeukemiaStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07106684
- Sponsor's protocol ID
- IIT2025048
- Acronym
- CAREMM-004
- Status last verified
- Oct 2026
- First submitted
- 30 Jul 2025
- Last updated
- 27 Oct 2026
- Results posted
- 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 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Arm, Phase II Study of Autologous Stem Cell Transplantation Combined With BCMA CAR-T Therapy Followed by GPRC5D/CD3 Bispecific Antibody Maintenance in Transplant-Eligible Patients With Primary Plasma Cell Leukemia
- ClinicalTrials.gov ID
- NCT07106684
- Acronym / sponsor ID
- CAREMM-004 / IIT2025048
- Conditions
- Multiple Myeloma, Plasma Cell Leukemia
- Keywords
- Plasma cell leukemia, CAR-T, ASCT, BiTEs
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 9 Aug 2025 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 6 Aug 2025 (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, phase II study to evaluate the efficacy and safety of autologous stem cell transplantation combined with BCMA CAR-T therapy followed by GPRC5D/CD3 bispecific antibody maintenance in transplant-eligible patients with primary plasma cell leukemia.
Detailed description
All subjects will receive standard induction therapy for up to four cycles prior to screening. Following response evaluation, those who meet the inclusion criteria will be enrolled. Enrolled patients will undergo autologous stem cell transplantation (ASCT) combined with BCMA CAR-T cell therapy, followed by GPRC5D/CD3 bispecific antibody therapy.
Patients who achieve a stringent complete response (sCR) and sustained MRD negativity (≥12 months) may enter a treatment-free observation phase or receive maintenance therapy for 24 months. Patients who experience MRD resurgence or loss of response during observation will resume maintenance therapy.
Patients who do not achieve both sCR and sustained MRD negativity (≥12 months) will continue GPRC5D/CD3 bispecific antibody therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASCT Combined With BCMA CAR-T and GPRC5D/CD3 BiTEs Maintenance | Experimental | Procedure: Autologous hematopoietic stem cell transplantation, Biological: BCMA CAR-T, Drug: GPRC5D/CD3 BiTEsPatients will receive induction therapy, undergo ASCT followed by BCMA CAR-T infusion. Three month after CAR-T cell infusion, patients will begin GPRC5D/CD3 BiTEs maintenance therapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years and ≤ 70 years.
- Participants with documented newly-diagnosed primary plasma cell leukemia according to IMWG diagnostic criteria.
- Measurable disease at screening, defined as: Serum M-protein level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or Light chain MM without measurable disease in serum or urine: serum Ig free-light chain (FLC) ≥10 mg/dL and abnormal serum Ig kappa lambda FLC ratio.
- Patients deemed eligible for high-dose chemotherapy with ASCT.
- Tumor cells were BCMA and GPRC5D positive.
Key exclusion criteria (9 listed)
- Active amyloidosis.
- Central nervous system involvement.
- Prior BCMA-targeted therapy or CAR-T therapy.
- Active hepatitis B or hepatitis C virus infection.
- Known HIV infection.
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 |
|---|---|---|
| Autologous hematopoietic stem cell transplantationPatients receive transplantation conditioning followed by autologous hematopoietic stem cell transplantation after successful stem cell mobilization and collection. | Procedure or surgery | ASCT Combined With BCMA CAR-T and GPRC5D/CD3 BiTEs Maintenance |
| BCMA CAR-TPatients will receive BCMA CAR-T single dose infusion 3 days after ASCT. | Biological | ASCT Combined With BCMA CAR-T and GPRC5D/CD3 BiTEs Maintenance |
| GPRC5D/CD3 BiTEsPatients will receive GPRC5D/CD3 BiTEs maintenance therapy at a dose of 54 μg/kg every 4 weeks, starting 3 months after BCMA CAR-T infusion. | Drug | ASCT Combined With BCMA CAR-T and GPRC5D/CD3 BiTEs Maintenance |
Primary outcome
Sustained MRD-negative rate
Time frame: Up to 2 year
Rate of patients achieving sustained MRD negativity for more than 12 months
MRD negativity rate
Time frame: Up to 2 years
Rate of patients achieving MRD negativity
4 secondary outcomes
Safety and Tolerability
Time frame: Up to 2 year
Complete response rate (CRR)
Time frame: Up to 2 years
Progression free survival (PFS)
Time frame: Up to 3 year
Overall survival (OS)
Time frame: Up to 5 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 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.
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 Autologous hematopoietic stem cell transplantation, BCMA CAR-T and GPRC5D/CD3 BiTEs in people with Multiple Myeloma, Plasma Cell Leukemia, 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 7 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 27 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?
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gang An, PhD&MD (86-022-23909171, angang@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained MRD-negative rate (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 27 Oct 2026.