Actively Recruiting

Phase 2
Age: 14Years +
All Genders
NCT07489534

Study of PD-1Ab21-BCMA CAR-T Therapy for Consolidation of Multiple Myelomawith Renal Dysfunction

Led by Daihong Liu · Updated on 2026-03-24

25

Participants Needed

1

Research Sites

95 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Study of PD-1Ab21-BCMA CAR-T Therapy for Consolidation of Multiple Myelomawith Renal Dysfunction

Who Can Participate

Age: 14Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 14 years
  • Diagnosed with multiple myeloma with renal dysfunction
  • Received at least 2 courses of first-line treatment with efficacy evaluated as partial response or better
  • Predicted survival longer than 3 months
  • ECOG performance status score between 0 and 2 or Karnofsky score over 80
  • Adequate venous access for blood collection and no contraindications for blood cell separation
  • White blood cell count at least 1 x 10^9/L and lymphocyte count at least 0.3 x 10^9/L
  • Liver enzymes ALT and AST less than or equal to 2.5 times the upper limit of normal
  • Serum total bilirubin less than or equal to 2.0 mg/dL (34.2 μmol/L)
  • Prothrombin time INR less than 1.7 or PT prolonged by less than 4 seconds compared to normal
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • Any uncontrolled active infection
  • Active hepatitis B or C virus infection
  • HIV/AIDS infection
  • Neurological disorders
  • Use of systemic steroids within 2 weeks before consent (inhaled steroids allowed)
  • Allergic reactions to immunotherapy or related drugs
  • Heart disease or poorly controlled high blood pressure requiring treatment
  • Unstable or active ulcers or gastrointestinal bleeding
  • History of organ transplantation or awaiting transplantation
  • Low blood sodium below 125 mmol/L
  • Low blood potassium below 3.5 mmol/L (potassium must be corrected before participation)
  • Need for anticoagulant therapy such as warfarin or heparin
  • Need for long-term antiplatelet therapy (aspirin over 300 mg/day or clopidogrel over 75 mg/day)
  • Participation in other clinical trials
  • Any other reason deemed unsuitable by researchers

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Chinese PLA General Hospital

Beijing, Beijing Municipality, China, 100853

Actively Recruiting

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Research Team

L

Li-Ping Dou, Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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