NCT07489534RecruitingPhase 2
Study of PD-1Ab21-BCMA CAR-T Therapy for Consolidation of Multiple Myelomawith Renal Dysfunction
Exploratory Clinical Study on PD-1Ab21-BCMA CAR-T Cells (CD203) for First-line Consolidation Therapy of Multiple Myeloma With Renal Dysfunction
Source: ClinicalTrials.gov · Last updated 24 Mar 2026
Brief summary (registry, in English)
The purpose of this study is to determine the efficacy and safety of targeted BCMA CART cells secreting PD1 and interleukin 21 fusion protein immunotherapy for first-line consolidation therapy of multiple myeloma with renal dysfunction.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 18 Mar 2026
- Start date
- 29 Sept 2025
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- Daihong Liu
- Diseases
- Multiple myeloma, Childhood cancers
- NCT number
- NCT07489534
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 25
- From 29 Sept 2025 to the primary completion date, 31 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Within 2 weeks prior to signing the informed consent form, systemic use of steroid drugs (inhalable steroids may be used);
- The patient needs anticoagulant therapy (such as warfarin or heparin);
- The patient requires long-term antiplatelet therapy (aspirin, dose\>300mg/d); Clopidogrel, dose\>75mg/d).
- Additionally,
Other illness
- Any uncontrollable active infection;
- Presence of active hepatitis B or C virus infection;
- HIV/AIDS infection;
- Has neurological disorders;
- Allergies to immunotherapy and related drugs;
- Currently, there are patients with heart disease or poorly controlled hypertension who require treatment;
- Currently, patients with unstable or active ulcers or gastrointestinal bleeding;
- Patients with a history of organ transplantation or waiting for organ transplantation;
Lab values
- Pregnant or lactating women (the safety of this treatment for unborn babies is unknown, and the assessment of pregnancy status for female participants is negative in serum or urine pregnancy tests within 48 hours prior to infusion);
- Hyponatremia, blood sodium\<125mmol/L;
- Baseline blood potassium\<3.5mmol/L (potassium can be supplemented before participating in the study to restore blood potassium levels above this level);
Other
- Patients currently participating in other clinical trials;
- Researchers believe that other reasons are not suitable for clinical trial participants.
Who the study is looking for
- Age: Over 14 years old
- Diagnosed with multiple myeloma accompanied by renal dysfunction, received ≥ 2 courses of clinical first-line treatment, evaluated efficacy above PR, and predicted survival of more than three months.
- The hospital examination meets the following indicators:
- ECOG physical status score 0-2 or KPS score\>80 points
- Having sufficient venous access for single or intravenous blood collection, and no other blood cells Separation contraindications
- WBC≥1×109/L,LY≥0.3×109/L,
- ALT and AST ≤ 2.5 ULN
- Serum total bilirubin ≤ 2.0mg/dL (34.2 μmol/L)
- PT:INR\<1.7 or PT prolonged by\<4s compared to normal value
Age in the registry: 14 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chinese PLA General Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.