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Clinical Trial NCT07489534 for Multiple Myeloma is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Study of PD-1Ab21-BCMA CAR-T Therapy for Consolidation of Multiple Myelomawith Renal Dysfunction Phase 2 25 Immunotherapy

Recruiting
Clinical Trial NCT07489534 is designed to study Treatment for Multiple Myeloma. It is a Phase 2 interventional study that is recruiting, having started on 29 September 2025, with plans to enroll 25 participants. Led by Daihong Liu, it is expected to complete by 31 July 2027. The latest data from ClinicalTrials.gov was last updated on 24 March 2026.
Brief Summary
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.
Detailed Description
Renal dysfunction is a poor prognostic factor for multiple myeloma（MM）. Compared with MM patients with normal renal function, MM patients with renal dysfunction have significantly reduced median overall survival. The clinical outcomes of MM patients with improved renal function after treatment have shown some improvement, but are still inferior to those of MM patients with normal renal function. Although renal dysfun...Show More
Official Title

Exploratory Clinical Study on PD-1Ab21-BCMA CAR-T Cells (CD203) for First-line Consolidation Therapy of Multiple Myeloma With Renal Dysfunction

Conditions
Multiple Myeloma
Other Study IDs
  • S2025-670-01
NCT ID Number
NCT07489534
Start Date (Actual)
2025-09-29
Last Update Posted
2026-03-24
Completion Date (Estimated)
2027-07-31
Enrollment (Estimated)
25
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Keywords
multiple myeloma; renal dysfunction; CART; fusion protein; consolidation therapy
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Experimentalmultiple myeloma patients with renal dysfunction who accept PD- 1Ab21-BCMA CAR-T cell immunotherapy
PD-1Ab21-BCMA CAR-T cell immunotherapy
Consolidation therapy with PD-1 antibody and BCMA-targeting CAR-T in multiple myeloma patients with renal impairment.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
1-year progression free survival rate (1-year-PFS)
The 1-year progression free survival rate (1-year-PFSR) of PD-1Ab21-BCMA CAR-T cell immunotherapy for first-line consolidation therapy of multiple myeloma with renal dysfunction refers to the proportion of disease progression that occurs within one year after treatment in patients.
1 year after treatment
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
overall survival (OS)
Overall survival (OS) refers to the time from the start of treatment to the death of the patient for any reason.
2 years after treatment
progression free survival (PFS)
Progression free survival (PFS) refers to the time from treatment to the first myeloma progression or death of the patient for any reason.
2 years after treatment
time to progression (TTP)
Time to progression (TTP) refers to the time from treatment to the first myeloma progression.
2 years after treatment
disease free survival (DFS)
Disease free survival (DFS) refers to the time from treatment to the first myeloma recurrence.
2 years after treatment
duration of response (DOR)
Duration of Response (DOR) refers to the time from the first assessment of a myeloma as a complete or partial response to the first assessment of PD (Progressive Disease) or death from any cause.
2 years after treatment
event free survival (EFS)
Event Free Survival (EFS) is a commonly used endpoint indicator in clinical trials to evaluate the survival time of patients without any adverse events during a specific time period. These adverse events include but are not limited to disease progression, death, treatment plan changes, and the occurrence of serious side effects.
2 years after treatment
recurrence rate
The recurrence rate refers to the proportion of patients with lymphoma recurrence after treatment.
2 years after treatment
safety
The safety of this PD-1Ab21-BCMA CAR-T immunotherapy.
2 years after treatment
Participation Assistant
Eligibility Criteria

Eligible Ages
Child, Adult, Older Adult
Minimum Age
14 Years
Eligible Sexes
All

  1. Age: Over 14 years old

  2. 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.

  3. The hospital examination meets the following indicators:

    1. ECOG physical status score 0-2 or KPS score>80 points
    2. Having sufficient venous access for single or intravenous blood collection, and no other blood cells Separation contraindications
    3. WBC≥1×109/L，LY≥0.3×109/L，
    4. ALT and AST ≤ 2.5 ULN
    5. Serum total bilirubin ≤ 2.0mg/dL (34.2 μmol/L)
    6. PT:INR<1.7 or PT prolonged by<4s compared to normal value

  1. 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);
  2. Any uncontrollable active infection;
  3. Presence of active hepatitis B or C virus infection;
  4. HIV/AIDS infection;
  5. Has neurological disorders;
  6. Within 2 weeks prior to signing the informed consent form, systemic use of steroid drugs (inhalable steroids may be used);
  7. Allergies to immunotherapy and related drugs;
  8. Currently, there are patients with heart disease or poorly controlled hypertension who require treatment;
  9. Currently, patients with unstable or active ulcers or gastrointestinal bleeding;
  10. Patients with a history of organ transplantation or waiting for organ transplantation;
  11. Hyponatremia, blood sodium<125mmol/L;
  12. Baseline blood potassium<3.5mmol/L (potassium can be supplemented before participating in the study to restore blood potassium levels above this level);
  13. The patient needs anticoagulant therapy (such as warfarin or heparin);
  14. The patient requires long-term antiplatelet therapy (aspirin, dose>300mg/d); Clopidogrel, dose>75mg/d).

Additionally,

  1. Patients currently participating in other clinical trials;
  2. Researchers believe that other reasons are not suitable for clinical trial participants.
Daihong Liu logoDaihong Liu
Study Responsible Party
Daihong Liu, Sponsor-Investigator, Dr., Chinese PLA General Hospital
Study Central Contact
Contact: Li-Ping Dou, Dr., 86-010-66937232, [email protected]
1 Study Locations in 1 Countries

Beijing Municipality

Chinese PLA General Hospital, Beijing, Beijing Municipality, 100853, China
Recruiting