NCT03271632 Multi-CAR T Cell Therapy in the Treatment of Multiple Myeloma
| NCT ID | NCT03271632 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Shenzhen Geno-Immune Medical Institute |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 2026-06-01 with a primary completion date of 2029-12-31.
⚠ 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 autologous CAR T cell immunotherapy targeting multiple cancer cell surface antigens in relapsed and refractory multiple myeloma patients. Another goal of the study is to learn more about the persistence and function of CAR T cells in the body.
Eligibility Criteria
Inclusion Criteria: * Male and female subjects with surface antigen confirmed multiple myeloma with no available curative treatment options (including autologous or allogeneic SCT). * Complete remission (CR) cannot be achieved after at least 4 prior combination therapy regimens. * MM in CR2 or CR3 and not eligible for allogeneic SCT because of age, comorbid diseases, or lack of available donor. * Less than 1 year between last chemotherapy and progression (i.e. most recent progression free interval \< 1 year). * Relapsed after prior autologous or allogenic SCT MM patients with relapsed or residual disease after at least 1 prior therapy and not eligible for allogeneic SCT. * Residual disease after primary therapy and not eligible for ASCT * Expected survival \> 12 weeks * Creatinine \< 2.5 mg/dl * ALT (alanine aminotransferase)/AST (aspartate aminotransferase) \< 3x normal * Bilirubin \< 2.0 mg/dl * Any relapse after prior SCT is eligible regardless of other prior therapy * Adequate venous access for apheresis, and no other contraindications for leukapheresis * Voluntary informed consent is given Exclusion Criteria: * Pregnant or lactating women * Uncontrolled active infection * Active hepatitis B or hepatitis C infection * Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary. * Previous related CAR-T cell therapy Any uncontrolled active medical disorder that would preclude participation * HIV infection
Contact & Investigator
Lung-Ji Chang
PRINCIPAL INVESTIGATOR
Shenzhen Geno-Immune Medical Institute
Frequently Asked Questions
Who can join the NCT03271632 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 NCT03271632 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 NCT03271632 currently recruiting?
Yes, NCT03271632 is actively recruiting participants. Contact the research team at c@szgimi.org for enrollment information.
Where is the NCT03271632 trial being conducted?
This trial is being conducted at Shenzhen, China.
Who is sponsoring the NCT03271632 clinical trial?
NCT03271632 is sponsored by Shenzhen Geno-Immune Medical Institute. The principal investigator is Lung-Ji Chang at Shenzhen Geno-Immune Medical Institute. The trial plans to enroll 20 participants.