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Study of ATLCAR.CD138 Cells for Relapsed/Refractory Multiple Myeloma

NCT03672318 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-09-16

No results posted yet for this study

Summary

The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancer. This research study combines two different ways of fighting disease: antibodies and T cells. Antibodies are proteins that protect the body from disease caused by bacteria or toxic substances. Antibodies work by binding those bacteria or substances, which stops them from growing and causing bad effects. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including tumor cells or cells that are infected. Both antibodies and T cells have been used to treat subjects with cancers. They both have shown promise, but neither alone has been sufficient to cure most subjects. This study is designed to combine both T cells and antibodies to create a more effective treatment. The treatment that is being researched is called autologous T lymphocyte chimeric antigen receptor cells targeted against the CD138 antigen (CAR138 T cells).

In previous studies, it has been shown that a new gene can be put into T cells that will increase their ability to recognize and kill cancer cells. A gene is a unit of DNA. Genes make up the chemical structure carrying the subject's genetic information that may determine human characteristics (i.e., eye color, height and sex). The new gene that is put in the T cells in this study makes a piece of an antibody called anti-CD138. This antibody floats around in the blood and can detect and stick to cancer cells called multiple myeloma cells because they have a substance on the outside of the cells called CD138. Anti-CD138 antibodies have been used to treat people with multiple myeloma, but have not been strong enough to cure most subjects. For this study, the anti-CD138 antibody has been changed so that instead of floating free in the blood part of it is now joined to the T cells. Only the part of the antibody that sticks to the multiple myeloma cells is attached to the T cells instead of the entire antibody. When an antibody is joined to a T cell in this way it is called a chimeric receptor. These CD138 chimeric (combination) receptor-activated T cells seem to kill some of the tumor, but they do not last very long in the body and so their chances of fighting the cancer are unknown.

Conditions

Interventions

DRUG

CAR138 T Cells

The MTD is defined as the dose at which approximately 0.20 of subjects experience DLT dose escalation guided by the continual reassessment method (CRM). Six dose levels will be evaluated: Dose level 1: 5X10\^6 cells/m\^2 Dose level 2: 1X10\^7 cells/m\^2 Dose level 3: 2.5X10\^7 cells/m\^2 Dose level 4: 5X10\^7 cells/m\^2 Dose level 5: 1x10\^8 cells/m\^2 Dose level 6: 2x10\^8 cells/m\^2 Six subjects will be enrolled at the MTD to better characterize safety at that dose level. Cell Administration: CAR138 T cells will be given by intravenous injection over through either a peripheral or a central line. The lymphodepletion regimen will consist of intravenous cyclophosphamide 300 mg/m\^2 and fludarabine 30 mg/m\^2 given once daily for three days.

Sponsors & Collaborators

  • Baylor College of Medicine

    collaborator OTHER

  • UNC Lineberger Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Sascha Tuchman, MD, MHS · Assoc. Professor, Dir. of the UNC MM and Amyloidosis Program, UNC LCCC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-14
Primary Completion
2024-10-16
Completion
2039-08-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03672318 on ClinicalTrials.gov