Plasma Cell NeoplasmsEarly Phase 1NCT07586709
In Vivo BCMA/GPRC5D Tandem Dual CAR-T Therapy for Relapsed/Refractory Plasma Cell Neoplasms
A Early Phase 1 study testing In vivo BCMA/GPRC5D Tandem Dual CAR-T cell in people with Plasma Cell Neoplasms, run by Liping Dou at 1 site in China.
Trial summary
This study aims to assess the safety profile of in vivo BCMA/GPRC5D-targeted CAR-T cell immunotherapy in patients with relapsed or refractory plasma cell neoplasms. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Plasma Cell Neoplasms
- What is being tested?
- In vivo BCMA/GPRC5D Tandem Dual CAR-T cell
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 9 May 2026to 31 Mar 2029
- Phase
- Early Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary signing of informed consent by the subject or legally authorized representative, with willingness and ability to comply with scheduled visits, study treatment, laboratory tests, and other study procedures.
- Diagnosis of relapsed or refractory plasma cell neoplasms meeting the following criteria:
- Clonal plasma cells confirmed to be BCMA and/or GPRC5D positive by flow cytometry or immunohistochemistry;
- Previously treated with at least 2 lines of anti-plasma cell neoplasms therapy, with at least 1 complete treatment cycle for each line, and evidence of disease progression within 12 months after the most recent anti-plasma cell neoplasms treatment, or being refractory to both immunomodulatory drugs and proteasome inhibitors, with disease progression within 2 months after the most recent anti-plasma cell neoplasms treatment (according to the IMWG diagnostic criteria)
- Age 18 to 75 years (inclusive), male or female.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
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- Life expectancy > 3 months from the date of informed consent.
- Hemoglobin (HGB) ≥ 60 g/L (transfusion allowed).
- Adequate organ function (hepatic, renal, cardiac, and pulmonary):
- Creatinine ≤ 2 × ULN;
- Left ventricular ejection fraction (LVEF) ≥ 50%;
- Oxygen saturation > 90%;
- Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN.
- Willingness to use highly effective contraception from signing of informed consent until 1 year after SL4903 infusion.
Who cannot join
- Severe cardiac dysfunction with left ventricular ejection fraction (LVEF) < 50%.
- History of severe pulmonary impairment.
- Concurrent diagnosis of another active malignancy.
- Uncontrolled active infection.
- History of severe autoimmune disease or primary immunodeficiency.
- Active hepatitis (defined as HBV DNA or HCV RNA above the lower limit of detection).
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- Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), or active syphilis.
- History of severe hypersensitivity to biological products (including antibiotics).
- Allogeneic hematopoietic stem cell transplant recipients with ongoing acute graft-versus-host disease (GVHD) despite discontinuation of immunosuppressive therapy for at least one month prior to screening.
- Any other severe comorbidities or laboratory abnormalities that, in the investigator's opinion, would increase the risk to the subject or interfere with study results, rendering the subject unsuitable for participation.
- Pregnant or breastfeeding women (including women of childbearing potential who are pregnant or lactating).
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
Chinese PLA General Hospital
Beijing, 100853
Bo Peng, 86-18701099687, lipingruirui@163.com
About this study
Official title: A Clinical Study on the Safety of in Vivo-CAR-T Cell Immunotherapy Targeting BCMA/GPRC5D for the Treatment of Relapsed/Refractory Plasma Cell Neoplasms
This study aims to assess the safety profile of in vivo BCMA/GPRC5D-targeted CAR-T cell immunotherapy in patients with relapsed or refractory plasma cell neoplasms.
Read the detailed description
This is a single-center, open-label, single-arm, prospective study designed to evaluate the safety of in vivo BCMA/GPRC5D-targeted CAR-T cell immunotherapy in patients with relapsed or refractory plasma cell neoplasms. The study employs a dose-escalation design to assess safety, tolerability, and preliminary efficacy. Safety assessments primarily focus on potential adverse events (AEs) following infusion of SL4903 injection, including the number of cases, incidence rates, and severity of cytokine release syndrome, immune effector cell therapy-related neurotoxicity, hematologic toxicity, organ toxicity, ect. Efficacy assessments will include overall objective response rate (ORR), event-free survival (EFS), overall survival (OS), progression-free survival (PFS), duration of complete remission, relapse rate, and mortality rate. Exploratory analyses will focus on characterizing the in vivo kinetics of CAR-T cells and the clonal evolution of plasma cell neoplasms during and after consolidation treatment.
- Conditions
- Plasma Cell Neoplasms
- Being tested
- In vivo BCMA/GPRC5D Tandem Dual CAR-T cell
- Keywords
- in vivo CAR-T Cell Therapy, BCMA, GPRC5D, plasma cell neoplasms
- Medical subject headings
- Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In vivo BCMA/GPRC5D Tandem Dual CAR-T cellDrug
Also called SL4903
Administration of in vivo BCMA/GPRC5D tandem dual CAR-T cells. Three dose levels (dose A, dose B, dose C) will be evaluated using a standard 3+3 dose-escalation design.
| Study group | Role | What they receive |
|---|---|---|
| In vivo BCMA/GPRC5D Tandem Dual CAR-T | Experimental | Participants receive treatment of In vivo BCMA/GPRC5D Tandem Dual CAR-T cell following a 3+3 dose-escalation design. Receives: Drug: In vivo BCMA/GPRC5D Tandem Dual CAR-T cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and incidence rate with Each Grade of Cytokine Release Syndrome (CRS)
CRS severity will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading. The grade ranges from 1 to 4, where a higher grade indicates a worse outcome.
Measured: 1 month after treatment
Dose-limiting toxicities (DLTs)
Dose limiting toxicity will be assessed after injection
Measured: 1 month after treatment
Number and incidence rate of Each Grade of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
ICANS severity is graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading, which incorporates the Immune Effector Cell-Associated Encephalopathy (ICE) assessment. The ICE score ranges from 0 to 10, with higher scores indicating better cognitive function. ICANS grade ranges from 1 to 4, where a higher grade indicates a worse outcome.
Measured: 1 month after treatment
Number and incidence rate of Treatment-Associated Adverse Events (AEs)
All other AEs would be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).
Measured: 1 years after treatment
Secondary outcomes (9)
Overall Objective Response Rate (ORR)
Overall objective response rate (ORR) refers the sum of the proportions of complete remission (CR) and partial remission (PR).
Measured: Day 14, Day 28, Month 2 , Month 3, Month 6, Month 9, Month 12, Month 18, Month24 after the treatment
overall survival (OS)
Overall survival (OS) refers to the time from the start of treatment to the death of the patient for any reason.
Measured: 2 years after treatment
progression free survival (PFS)
Progression free survival (PFS) refers to the time from treatment to the first disease progression or death of the patient for any reason.
Measured: 2 years after treatment
duration of response (DOR)
Duration of Response (DOR) refers to the time from the first assessment of plasma cell neoplasms as a complete or partial response to the first assessment of PD (Progressive Disease) or death from any cause.
Measured: 2 years after treatment
time to progression (TTP)
Time to progression (TTP) refers to the time from treatment to the first plasma cell neoplasms progression.
Measured: 2 years after treatment
recurrence rate
The recurrence rate refers to the proportion of patients with plasma cell neoplasms recurrence after treatment.
Measured: 2 years after treatment
Cmax of CAR-T Cells
CAR-T kinetics would be detected by flow cytometry or qPCR in peripheral blood or bone marrow at each important time points. Cmax is the peak expansion value of CAR-T cells. Cmax is the peak expansion value of CAR-T cells.
Measured: 1 month after treatment
Tmax of CAR-T Cells
CAR-T kinetics would be detected by flow cytometry or qPCR in peripheral blood bone marrow at each important time points. Tmax is the time of the occurrence of expansion peak.
Measured: 1 month after treatment
AUC(0-28d)
AUC(0-28d) is the area under the peripheral blood CAR-T cell concentration versus time curve calculated from the time of treatment to 28 days post-treatment, using the linear trapezoidal method.
Measured: 1 month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start9 May 2026
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasma Cell NeoplasmsStudies 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
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liping Dou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Liping Dou, Chinese PLA General Hospital
- Investigators
- Liping DOU, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07586709
- Sponsor's protocol ID
- 2026-172-02
- Status last verified
- Oct 2026
- First submitted
- 20 Apr 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Safety of in Vivo-CAR-T Cell Immunotherapy Targeting BCMA/GPRC5D for the Treatment of Relapsed/Refractory Plasma Cell Neoplasms
- ClinicalTrials.gov ID
- NCT07586709
- Acronym / sponsor ID
- 2026-172-02
- Conditions
- Plasma Cell Neoplasms
- Keywords
- in vivo CAR-T Cell Therapy, BCMA, GPRC5D, plasma cell neoplasms
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Liping DouUniversity, hospital or other
- Study start
- 9 May 2026 (actual)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 14 May 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.
This study aims to assess the safety profile of in vivo BCMA/GPRC5D-targeted CAR-T cell immunotherapy in patients with relapsed or refractory plasma cell neoplasms.
Detailed description
This is a single-center, open-label, single-arm, prospective study designed to evaluate the safety of in vivo BCMA/GPRC5D-targeted CAR-T cell immunotherapy in patients with relapsed or refractory plasma cell neoplasms. The study employs a dose-escalation design to assess safety, tolerability, and preliminary efficacy. Safety assessments primarily focus on potential adverse events (AEs) following infusion of SL4903 injection, including the number of cases, incidence rates, and severity of cytokine release syndrome, immune effector cell therapy-related neurotoxicity, hematologic toxicity, organ toxicity, ect. Efficacy assessments will include overall objective response rate (ORR), event-free survival (EFS), overall survival (OS), progression-free survival (PFS), duration of complete remission, relapse rate, and mortality rate. Exploratory analyses will focus on characterizing the in vivo kinetics of CAR-T cells and the clonal evolution of plasma cell neoplasms during and after consolidation treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| In vivo BCMA/GPRC5D Tandem Dual CAR-T | Experimental | Drug: In vivo BCMA/GPRC5D Tandem Dual CAR-T cellParticipants receive treatment of In vivo BCMA/GPRC5D Tandem Dual CAR-T cell following a 3+3 dose-escalation design. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Voluntary signing of informed consent by the subject or legally authorized representative, with willingness and ability to comply with scheduled visits, study treatment, laboratory tests, and other study procedures.
- Diagnosis of relapsed or refractory plasma cell neoplasms meeting the following criteria:
- Age 18 to 75 years (inclusive), male or female.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Life expectancy > 3 months from the date of informed consent.
Key exclusion criteria (11 listed)
- Severe cardiac dysfunction with left ventricular ejection fraction (LVEF) < 50%.
- History of severe pulmonary impairment.
- Concurrent diagnosis of another active malignancy.
- Uncontrolled active infection.
- History of severe autoimmune disease or primary immunodeficiency.
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 |
|---|---|---|
| In vivo BCMA/GPRC5D Tandem Dual CAR-T cellAlso: SL4903Administration of in vivo BCMA/GPRC5D tandem dual CAR-T cells. Three dose levels (dose A, dose B, dose C) will be evaluated using a standard 3+3 dose-escalation design. | Drug | In vivo BCMA/GPRC5D Tandem Dual CAR-T |
Primary outcome
Number and incidence rate with Each Grade of Cytokine Release Syndrome (CRS)
Time frame: 1 month after treatment
CRS severity will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading. The grade ranges from 1 to 4, where a higher grade indicates a worse outcome.
Dose-limiting toxicities (DLTs)
Time frame: 1 month after treatment
Dose limiting toxicity will be assessed after injection
Number and incidence rate of Each Grade of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
Time frame: 1 month after treatment
ICANS severity is graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading, which incorporates the Immune Effector Cell-Associated Encephalopathy (ICE) assessment. The ICE score ranges from 0 to 10, with higher scores indicating better cognitive function. ICANS grade ranges from 1 to 4, where a higher grade indicates a worse outcome.
Number and incidence rate of Treatment-Associated Adverse Events (AEs)
Time frame: 1 years after treatment
All other AEs would be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).
9 secondary outcomes
Overall Objective Response Rate (ORR)
Time frame: Day 14, Day 28, Month 2 , Month 3, Month 6, Month 9, Month 12, Month 18, Month24 after the treatment
overall survival (OS)
Time frame: 2 years after treatment
progression free survival (PFS)
Time frame: 2 years after treatment
duration of response (DOR)
Time frame: 2 years after treatment
time to progression (TTP)
Time frame: 2 years after treatment
recurrence rate
Time frame: 2 years after treatment
Cmax of CAR-T Cells
Time frame: 1 month after treatment
Tmax of CAR-T Cells
Time frame: 1 month after treatment
AUC(0-28d)
Time frame: 1 month after treatment
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 2 Oct 2026.
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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.
Liping DOU principal investigator
Chinese PLA General Hospital
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 In vivo BCMA/GPRC5D Tandem Dual CAR-T cell in people with Plasma Cell Neoplasms, run by Liping Dou 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 14 inclusion and 11 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 2 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?
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 Yu ZHAO (13601051848, zhaoyu301@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and incidence rate with Each Grade of Cytokine Release Syndrome (CRS) (time frame: 1 month after treatment). The study lists 4 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 2 Oct 2026.