Actively Recruiting

Phase 1
Phase 2
Age: 21Years - 90Years
All Genders
NCT07032129

Sequential CAR-T Cells Targeting BCMA/GPRC5D in Patients With Relapsed/ Refractory Multiple Myeloma

Led by Essen Biotech · Updated on 2025-06-22

60

Participants Needed

1

Research Sites

191 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is an open, single-arm, clinical study to evaluate the efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) targeting BCMA or GPRC5D or both sequentially in the treatment of Relapsed/ Refractory Multiple myeloma

CONDITIONS

Official Title

Sequential CAR-T Cells Targeting BCMA/GPRC5D in Patients With Relapsed/ Refractory Multiple Myeloma

Who Can Participate

Age: 21Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Expected survival time of at least 3 months
  • Diagnosed with relapsed or refractory Multiple Myeloma who have failed standard treatments or lack effective treatment
  • Histological evidence of non-suppurative destructive cholangitis and small bile duct destruction
  • Liver and kidney function within specified limits: creatinine  1.5 times upper limit of normal (ULN); total bilirubin  2 times ULN; ALT and AST  2.5 times ULN (or up to 5 times ULN if due to disease)
  • Electrocardiogram shows no clinically significant abnormalities
  • Blood oxygen saturation above 91% without oxygen support
  • No serious mental disorders
  • Able to understand the study and provide signed informed consent
Not Eligible

You will not qualify if you...

  • Malignant tumors other than relapsed/refractory autoimmune disease (AID) within 5 years prior to screening, except certain treated cancers
  • Positive for hepatitis B surface antigen or core antibody without normal viral levels, hepatitis C antibody and RNA positive, HIV antibody positive, or syphilis positive
  • Serious heart disease including unstable angina, recent myocardial infarction or surgery within 6 months, congestive heart failure class III or higher, or severe arrhythmia
  • Unstable systemic diseases such as severe liver, kidney, or metabolic conditions requiring treatment
  • Active or uncontrolled infections requiring systemic therapy within 7 days prior to treatment
  • Pregnant or lactating women, or planning pregnancy within 2 years after cell transfusion
  • Previous CAR-T or gene-modified cell therapy before screening
  • Participation in other clinical studies within 1 month before screening
  • Evidence of central nervous system invasion
  • Mental health issues including depression or suicidal thoughts
  • Other situations deemed unsuitable by investigators

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

District One Hospital

Beijing, Beijing Municipality, China, 086-373

Actively Recruiting

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Research Team

R

Rhoda M Smith, Phd

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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