T Cells Expressing a Novel Fully-Human Anti-BCMA CAR for Treating Multiple Myeloma

Completed · Phase 1

Conditions studied: Myeloma-Multiple, Myeloma, Plasma-Cell

In brief

Background: Multiple myeloma is a cancer of the blood plasma cells. It usually becomes resistant to standard treatments. Researchers have developed a procedure called gene therapy. It uses a person's own T cells, which are part of the immune system. The cells are changed in a lab and then returned to the person. Researchers hope the changed T cells will be better at recognizing and killing tumor cells. Objective: To test the safety of giving changed T cells to people with multiple myeloma. Eligibility: Adults ages 18-73 who have been diagnosed with multiple myeloma that has not been controlled with standard therapies. Design: Participants will be screened with: Medical history Physical exam Blood tests Heart function tests Bone marrow sample taken by needle in a hip bone. Scan of the chest, abdomen, and pelvis. They may have a brain scan. Pregnancy test Participants will have apheresis. Blood will be removed through an arm vein. The blood will be separated, and T cells removed. The rest of the blood will be returned through a vein in the other arm. Participants will have a central line placed in a large vein in the arm or chest. Participants will get 2 chemotherapy drugs by the central line over 3 days. Two days later, participants will get the changed T cells by the central line. They will stay in the hospital at least 9 days. Participants must stay near the hospital for 2 weeks. Participants will have 8 follow-up visits over the next year for blood and urine tests. They may have scans. Participants blood will be collected regularly over the next several years.

Key facts

Study ID

NCT03602612

Run by

National Cancer Institute (NCI)

People needed

35

Starts

2018-09-14

Expected to finish

2026-04-23

Last updated by the study team

2026-06-16

Who can join

Age: 18 and older, up to 73. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Patients on any anticoagulants except aspirin.
• Patients that require urgent therapy due to tumor mass effects or spinal cord compression.
• Patients that have active hemolytic anemia.
• Patients with second malignancies in addition to multiple myeloma are not eligible if the second malignancy has required treatment within the past 3 years or is not in complete remission. There are two exceptions to this criterion: successfully treated non-metastatic basal cell or squamous cell skin carcinoma.
• Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. Women of child-bearing potential cannot have a positive pregnancy test. Women of child-bearing potential are defined as all women except women who are post-menopausal or who have had a hysterectomy. Postmenopausal will be defined as women over the age of 55 who have not had a menstrual period in at least 1 year.
• Active systemic infections (defined as infections causing fevers or requiring anti- microbial treatment), active coagulation disorders or other major uncontrolled medical illnesses of the cardiovascular, respiratory, endocrine, renal, gastrointestinal, genitourinary, neurologic, or immune system, history of myocardial infarction, active cardiac arrhythmias including active atrial fibrillation history of any arrhythmias other than sinus tachycardia, or atrial fibrillation, currently taking any anti-arrythmic or congestive heart failure medications, active obstructive or restrictive pulmonary disease.
• Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
• Systemic corticosteroid steroid therapy of greater than 5 mg/day of prednisone or equivalent dose of another corticosteroid (prednisone, dexamethasone, etc.) is not allowed within 2 weeks prior to either the required leukapheresis or within 2 weeks prior to CAR T-cell infusion (and at any time after the CAR T cell infusion).
• History of severe immediate hypersensitivity reaction to any of the agents used in this study.
• Patient unwilling to undergo intensive care unit treatment including mechanical ventilation, cardiopulmonary resuscitation, vasoactive drugs, and hemodialysis.
• History of allogeneic stem cell transplantation
• Patients with current spinal cord compression (without intradural myeloma involvement).
• Patients who have a history (or current evidence) of cerebrospinal fluid multiple myeloma, or intra-dural central nervous system masse
• Patients with active autoimmune skin diseases such as psoriasis or other active autoimmune diseases such as rheumatoid arthritis.
• Patients must not have required supplemental oxygen within the past month unless it was for a resolved infection.
• Patient must not have received genetically modified cells except on prior National Cancer Institute (NCI) gene therapy protocols.

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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