NCT03196414 Study of T Cells Targeting CD138/BCMA/CD19/More Antigens (CART-138/BCMA/19/More) for Chemotherapy Refractory and Relapsed Multiple Myeloma
| NCT ID | NCT03196414 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | The First Affiliated Hospital of Soochow University |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2016-09 |
| Primary Completion | 2026-09 |
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 10 participants in total. It began in 2016-09 with a primary completion date of 2026-09.
⚠ 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
Placing a tumor antigen chimeric receptor that has been created in the laboratory into patient autologous or donor-derived T cells may make the body build immune response to kill cancer cells. Genetically engineered lymphocyte (CART) therapy has showed good safety and efficacy in treatment of lymphoma and acute lymphoblastic leukemia. Researchers want to see if this helps people with multiple myeloma.To test the safety and efficacy of giving targeting CD138 or B-cell maturation antigen or CD19 or more antigens T cells in treating patients with multiple myeloma that is refractory to further chemotherapy or relapsed(after stem cell transplantation or intensive chemotherapy).
Eligibility Criteria
Inclusion Criteria: * CD138 or BCMA antigen positive multiple myeloma in patients with no available curative treatment options (such as autologous or allogeneic SCT). * Relapsed and/or refractory multiple myeloma. * Relapsed after prior autologous or allogenic SCT. * Expected survival ≥ 3 months * Creatinine \< 2.0 mg/dl * Blood coagulation function: PT and APTT \< 2x normal * Arterial blood oxygen saturation \> 92% * Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) \< 3x normal * Karnofsky scores ≥ 60 and ECOG score ≤ 2 * Adequate venous access for apheresis, and no other contraindications for leukapheresis * Patients should not take system chemotherapy in one month and immunotherapy in three months prior to CART cells infusion. * 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. * Previously treatment with any gene therapy products * Any uncontrolled active medical disorder that would preclude participation as outlined. * HIV infection. * History of myocardial infarction and severe arrhythmia in half a year * Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease). * Patients with fever of unknown origin (T \> 38℃)
Contact & Investigator
Fu cheng cheng, PhD
PRINCIPAL INVESTIGATOR
First Affiliated Hospital,Soochow University
Frequently Asked Questions
Who can join the NCT03196414 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 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 NCT03196414 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 NCT03196414 currently recruiting?
Yes, NCT03196414 is actively recruiting participants. Contact the research team at yanlingzhi@suda.edu.cn for enrollment information.
Where is the NCT03196414 trial being conducted?
This trial is being conducted at Suzhou, China.
Who is sponsoring the NCT03196414 clinical trial?
NCT03196414 is sponsored by The First Affiliated Hospital of Soochow University. The principal investigator is Fu cheng cheng, PhD at First Affiliated Hospital,Soochow University. The trial plans to enroll 10 participants.