T Cell Therapy for Chemotherapy Refractory Multiple Myeloma
Official title: Study of T Cells Targeting CD138/BCMA/CD19/More Antigens (CART-138/BCMA/19/More) for Chemotherapy Refractory and Relapsed Multiple Myeloma
Run by The First Affiliated Hospital of Soochow University · NCT03196414 · Data updated 2026-11-12
This study is testing a new treatment using specially modified immune cells to help adults with hard-to-treat multiple myeloma fight their cancer.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | The First Affiliated Hospital of Soochow University Academic / other |
| Drugs / interventions | CART, chemotherapy, immunotherapy |
| Locations | 1 site (Suzhou, Jiangsu) |
| Status | Recruiting |
| Started | September 2016 |
| Main results expected | September 2026 |
| Study ends | December 2026 |
| Registry record updated | May 2, 2019 |
| Trial ID | NCT03196414 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-75 with relapsed or refractory multiple myeloma who have no available curative treatment options.
✕Probably not a fit
Patients who are pregnant, have uncontrolled infections, or active hepatitis B or C infections may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the use of genetically engineered T cells targeting specific antigens (CD138, BCMA, CD19, and others) to treat adults with relapsed or chemotherapy refractory multiple myeloma. Participants will undergo apheresis to collect lymphocytes, which will then be modified in the laboratory before being infused back into the patient after a short course of chemotherapy. The study aims to assess the safety and efficacy of this approach in generating an immune response against cancer cells. Follow-up will include regular clinic visits and monitoring for up to two years post-infusion.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for patients with limited alternatives for managing multiple myeloma.
How similar studies have gone: Other studies using CAR T-cell therapy have shown promising results in treating hematological malignancies, suggesting potential success for this approach in multiple myeloma.
Who can join: the full rules
Show full inclusion / exclusion 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℃)
Where it's running
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First Affiliated Hospital, Soochow University
Suzhou, Jiangsu, China Recruiting
Study contacts
- Principal investigator: Fu cheng cheng, PhD — First Affiliated Hospital,Soochow University
- Study coordinator: Ling zhi Yan, PhD
- Email: yanlingzhi@suda.edu.cn
- Phone: 13584821140
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Monocytes and CAR‑T Cell Response in Multiple Myeloma
This project will test whether the number and type of monocytes before and after CAR‑T cell therapy help predict how well CAR‑T works for adults with multiple myeloma.
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BCMA CAR-T with or without autologous stem cell transplant for young multiple myeloma patients
This will test whether BCMA-directed CAR-T cell therapy, given with or without autologous stem cell transplant (ASCT), helps young women (ages 18–55) with newly diagnosed multiple myeloma.
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Testing a new CAR-T therapy for multiple myeloma
This study tests a new CAR-T therapy to see if it can help people with tough-to-treat multiple myeloma feel better after other treatments haven't worked.
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Talquetamab treatment for multiple myeloma after BCMA CAR T-cell therapy
This study is testing if talquetamab can help people with multiple myeloma who haven't improved after receiving BCMA CAR T-cell therapy.
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6MW5311 in adults with relapsed or refractory blood cancers
This study tests increasing doses of 6MW5311 in adults with multiple myeloma, AML, or CMML to see if it is safe and tolerable and to find a suitable dose for later studies.
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Tailored exercise program to improve quality of life for adults with hematologic cancers
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.