Plasma Cell DyscrasiasEarly Phase 1NCT07365059
Safety and Efficacy of GPRC5D CAR-T Cell Therapy in Relapsed/Refractory Plasma Cell Disorders
A Early Phase 1 study testing GPRC5D CAR-T cell intravenous infusion in people with Plasma Cell Dyscrasias, run by Qi deng.
Trial summary
This study is an open-label, single-arm, dose-escalation and expansion, prospective clinical trial. It enrolls patients with relapsed/refractory plasma cell disorders, administers GPRC5D CAR-T cell therapy, follows up to observe adverse reactions after medication, collects relevant data on treatment efficacy… Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- Plasma Cell Dyscrasias
- What is being tested?
- GPRC5D CAR-T cell intravenous infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 25 Jan 2026to 1 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 14 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects must meet all of the following criteria：
- According to the World Health Organization (WHO) Classification of Haematopoietic and Lymphoid Tissue Tumours (2022), patients with relapsed/refractory plasma cell disorders that have received adequate treatment and lack effective therapeutic options, including: multiple myeloma, plasma cell leukemia, extramedullary plasmacytoma, solitary plasmacytoma, or primary amyloidosis.i) Relapsed: Disease progression occurs after one or more prior treatments, requiring salvage therapy, and does not meet the criteria for refractory disease.ii) Refractory: No response to initial treatment regimen or salvage therapy, or disease progression within 60 days after treatment. No response is defined as failure to achieve minimal response (MR) or disease progression during treatment.
- The subject's predicted survival time is not less than three months.
- Tumor cells confirmed to be GPRC5D positive by Flow Cytometry (FCM) or Immunohistochemistry.
- The subject failed autologous and allogeneic hematopoietic stem cell transplantation.
- Age 14-75 years (inclusive), both genders eligible.
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- ECOG performance status ≤ 2.
- HGB≥70g/L(transfusion permitted).
- The functions of vital organs need to meet the following conditions: ①Creatinine ≤ 2.5 × ULN or Cockcroft-Gault creatinine clearance > 50 ml/min (excluding decreased serum creatinine clearance due to lymphoma mass compression), Combination with hemodialysis treatment is permitted. ②LVEF≥50%,② Oxygen saturation ≥90%,③ SCr≤2.5ULN,④ALT and AST≤3ULN,TBil≤2ULN. In the investigator's judgment, if organ dysfunction is associated with the current disease, the enrollment decision will be made by the investigator.
- Subjects intending to conceive must agree to use contraception prior to study enrollment and for six months post-study. In the event of pregnancy or suspected pregnancy, they should promptly notify the investigator.
- The subject or guardian understands and signs the Informed Consent Form (ICF).
Who cannot join
- Any of the following conditions will not be eligible for enrolment:
- Severe heart failure with left ventricular ejection fraction (LVEF) < 50%.
- History of severe pulmonary function impairment.
- Concurrent other progressive malignant tumors.
- Concurrent severe infection that cannot be effectively controlled.
- Concurrent severe autoimmune disease or congenital immunodeficiency.
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- Active hepatitis (hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) positive with HBV DNA copy number greater than the upper limit of normal at the study center; Anti-HCV positive with HCV-RNA copy number greater than the upper limit of normal at the study center).
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection.
- History of severe allergy to biological products (including antibiotics).
- Received inactivated vaccines such as influenza vaccine, COVID-19 vaccine within 4 weeks prior to screening, or received live attenuated vaccines (such as measles, varicella vaccines) within 8 weeks.
- Allogeneic hematopoietic stem cell transplant patients with persistent acute graft-versus-host disease (GVHD) one month after discontinuation of immunosuppressive agents.
- Patients with other severe physical or mental illnesses or laboratory abnormalities that may increase the risk of study participation or interfere with study results, and patients considered unsuitable for this study by the investigator.
About this study
Official title: Clinical Study on Safety and Efficacy of GPRC5D CAR-T Cell Therapy in Relapsed/Refractory Plasma Cell Disorders
This study is an open-label, single-arm, dose-escalation and expansion, prospective clinical trial. It enrolls patients with relapsed/refractory plasma cell disorders, administers GPRC5D CAR-T cell therapy, follows up to observe adverse reactions after medication, collects relevant data on treatment efficacy, evaluates the safety and efficacy of CAR-T cells, and simultaneously investigates the cellular kinetic characteristics of CAR-T cells.
- Conditions
- Plasma Cell Dyscrasias
- Being tested
- GPRC5D CAR-T cell intravenous infusion
- Medical subject headings
- Paraproteinemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GPRC5D CAR-T cell intravenous infusionBiological
GPRC5D CAR-T cell intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| GPRC5D CAR-T cell intravenous infusion | Experimental | Not described Receives: Biological: GPRC5D CAR-T cell intravenous infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monitor and record adverse events
Measured: up to two years after the CAR-T cell infusion
Overall Response Rate
Measured: up to two year after the CAR-T cell infusion
Secondary outcomes (1)
Cell pharmacokinetics Dynamic indicators
CAR-T/T% by flow cytometry
Measured: up to one month after the CAR-T infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start25 Jan 2026 (estimated)
- Primary completion1 Jan 2029 (estimated)
- Study completion1 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 DyscrasiasStudies 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
- Qi deng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qi deng, Tianjin First Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07365059
- Sponsor's protocol ID
- XBAP2025-9
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 26 Jan 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 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Safety and Efficacy of GPRC5D CAR-T Cell Therapy in Relapsed/Refractory Plasma Cell Disorders
- ClinicalTrials.gov ID
- NCT07365059
- Acronym / sponsor ID
- XBAP2025-9
- Conditions
- Plasma Cell Dyscrasias
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Qi dengUniversity, hospital or other
- Study start
- 25 Jan 2026 (estimated)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 26 Jan 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 is an open-label, single-arm, dose-escalation and expansion, prospective clinical trial. It enrolls patients with relapsed/refractory plasma cell disorders, administers GPRC5D CAR-T cell therapy, follows up to observe adverse reactions after medication, collects relevant data on treatment efficacy, evaluates the safety and efficacy of CAR-T cells, and simultaneously investigates the cellular kinetic characteristics of CAR-T cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GPRC5D CAR-T cell intravenous infusion | Experimental | Biological: GPRC5D CAR-T cell intravenous infusion |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects must meet all of the following criteria：
- According to the World Health Organization (WHO) Classification of Haematopoietic and Lymphoid Tissue Tumours (2022), patients with relapsed/refractory plasma cell disorders that have received adequate treatment and lack effective therapeutic options, including: multiple myeloma, plasma cell leukemia, extramedullary plasmacytoma, solitary plasmacytoma, or primary amyloidosis.i) Relapsed: Disease progression occurs after one or more prior treatments, requiring salvage therapy, and does not meet the criteria for refractory disease.ii) Refractory: No response to initial treatment regimen or salvage therapy, or disease progression within 60 days after treatment. No response is defined as failure to achieve minimal response (MR) or disease progression during treatment.
- The subject's predicted survival time is not less than three months.
- Tumor cells confirmed to be GPRC5D positive by Flow Cytometry (FCM) or Immunohistochemistry.
- The subject failed autologous and allogeneic hematopoietic stem cell transplantation.
Key exclusion criteria (12 listed)
- Severe heart failure with left ventricular ejection fraction (LVEF) < 50%.
- History of severe pulmonary function impairment.
- Concurrent other progressive malignant tumors.
- Concurrent severe infection that cannot be effectively controlled.
- Concurrent severe autoimmune disease or congenital 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 |
|---|---|---|
| GPRC5D CAR-T cell intravenous infusionGPRC5D CAR-T cell intravenous infusion | Biological | GPRC5D CAR-T cell intravenous infusion |
Primary outcome
Monitor and record adverse events
Time frame: up to two years after the CAR-T cell infusion
Overall Response Rate
Time frame: up to two year after the CAR-T cell infusion
1 secondary outcome
Cell pharmacokinetics Dynamic indicators
Time frame: up to one month after the CAR-T infusion
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 26 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing GPRC5D CAR-T cell intravenous infusion in people with Plasma Cell Dyscrasias, run by Qi deng.
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 12 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: opening soon, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Monitor and record adverse events (time frame: up to two years after the CAR-T cell infusion). 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 26 Jan 2026.