T Cell Therapy for Chemotherapy Refractory Multiple Myeloma

Study of T Cells Targeting CD138/BCMA/CD19/More Antigens (CART-138/BCMA/19/More) for Chemotherapy Refractory and Relapsed Multiple Myeloma

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
• Enrollment: 10 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Soochow University (Academic / other)
• Drugs / interventions: CART, chemotherapy, immunotherapy
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT03196414 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with relapsed or refractory multiple myeloma who have no available curative treatment options.

Not a fit: Patients who are pregnant, have uncontrolled infections, or active hepatitis B or C infections may not benefit from this study.

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 performed: Other studies using CAR T-cell therapy have shown promising results in treating hematological malignancies, suggesting potential success for this approach in multiple myeloma.

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℃)

Where this trial is running

Suzhou, Jiangsu

• 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

Conditions Multiple Myeloma