NCT06429150 Frontline Combination CAR-T Cell Therapy for Multiple Myeloma or Plasmacytoma
| NCT ID | NCT06429150 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Shenzhen Geno-Immune Medical Institute |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-05-11 |
| Primary Completion | 2027-07-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2024-05-11 with a primary completion date of 2027-07-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of this clinical trial is to assess the feasibility, safety, and efficacy of CAR-T cell therapy targeting multiple cancer cell antigens in high-risk multiple myeloma or plasmacytoma as part of a frontline treatment regimen for patients. Another goal of the study is to learn more about the persistence and function of these CAR-T cells in the body.
Eligibility Criteria
Inclusion Criteria: * Male and female subjects with multiple myeloma or plasmacytoma * Strictly complete remission (sCR) is a treatment goal * Expected survival \> 12 weeks * After prior auto-SCT is eligible regardless of other prior therapies * Adequate venous access for apheresis, and no other contraindications for leukapheresis * Voluntary informed consent is given and commitment to continued follow-up Exclusion Criteria: * Pregnant or lactating women * Uncontrolled active infection * Active HIV, hepatitis B or hepatitis C infection * Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary. * Any medical conditions that may preclude participation
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06429150 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06429150 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06429150 currently recruiting?
Yes, NCT06429150 is actively recruiting participants. Contact the research team at c@szgimi.org for enrollment information.
Where is the NCT06429150 trial being conducted?
This trial is being conducted at Shenzhen, China.
Who is sponsoring the NCT06429150 clinical trial?
NCT06429150 is sponsored by Shenzhen Geno-Immune Medical Institute. The trial plans to enroll 20 participants.