Study Details

Open

Study of ATLCAR.CD138 cells for relapsed/refractory Multiple Myeloma

The purpose of this study is to establish a safe dose of autologous CD138-CAR-T cells to infuse after lymphodepletion in adult patients with relapsed / refractory multiple myeloma.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)
Visits can be combined with regular clinical appointments

Location

North Carolina (Statewide)

What will be asked of you

Your blood will be collected so that the manufacturing process to make modified T cells can begin. The modified study cells will hopefully be more effective at killing your cancer cells than your body's normal immune cells. The study team will do blood tests and other procedures to confirm it is safe for you to get the modified study cells. If it is safe, you will complete three days of pre-treatment (chemotherapy) that will prepare your body to accept the study cells better. You will then receive the study cell infusion. You will have to stay near the hospital after infusion and will be seen frequently in clinic for follow-up visits that may include lab tests, imaging, or biopsies of your tumor. You will continue follow up visits based on how well you have responded to the study treatment.

In-person visits:
Minimum of 14 through first year of participation; likely more depending on side effects

Phone or online visits:
Visits all in person unless disease has worsened, then can be contacted by phone during follow up

Total length of participation:
1 year for treatment and initial follow-up, long term follow-up for 15 years

Looking for Specific Volunteers

Able to participate:

Diagnosis of relapsed or refractory multiple myeloma.
Received at least 3 prior lines of therapy that included an immunomodulatory agent, a proteasome inhibitor, and high dose melphalan followed by ASCT or are
Measurable disease as defined as sufficient levels of M-protein in either the serum (blood) or urine, or involved free light chains in the serum AND
Willingness to comply with study requirements, including staying within 30 minutes of driving distance to UNC and have 24/7 caregiver support for the first 4

Not eligible if:

Inadequate renal or hepatic function, cardiac ejection fraction <45%, platelets <50,000/ mm3, or ANC <1000/mm3.
Diagnosis of amyloidosis, POEMS syndrome, or CNS involvement of myeloma, or evidence of inflammatory or infectious gastrointestinal disorder.
Current use of systemic corticosteroids at doses ≥10mg prednisone daily or its equivalent
Active infection with HIV, HTLV, Hepatits B or Hepatitis Cor any other active infection (fungal, bacterial, or viral)

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

UNC Immunotherapy
UNCImmunotherapy@med.unc.edu

Visit Study Website

Primary Visit Location

Lineberger Comprehensive Cancer Center
NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Sascha Tuchman
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Multiple Myeloma)

IRB Number

16-2216

ClinicalTrials.gov

NCT03672318