Actively Recruiting
Study of Kappa Chimeric Antigen Receptor (CAR) T Lymphocytes Co-Expressing the Kappa and CD28 CARs for Relapsed/Refractory Kappa+ Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma.
Led by UNC Lineberger Comprehensive Cancer Center · Updated on 2026-01-20
20
Participants Needed
1
Research Sites
1166 weeks
Total Duration
On this page
Sponsors
U
UNC Lineberger Comprehensive Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study will combine both T cells and antibodies in order to create a more effective treatment. The treatment tested in this study uses modified T-cells called Autologous T Lymphocyte Chimeric Antigen Receptor (ATLCAR) cells targeted against the kappa light chain antibody on cancer cells. For this study, the anti-kappa light chain antibody has been changed so instead of floating free in the blood, a part of it is now joined to the T cells. Only the part of the antibody that sticks to the lymphoma cells is attached to the T cells. When an antibody is joined to a T cell in this way, it is called a chimeric receptor. The kappa light chain chimeric (combination) receptor-activated T cells are called ATLCAR.κ.28 cells. These cells may be able to destroy lymphoma cancer cells. They do not, however, last very long in the body so their chances of fighting the cancer are unknown. Previous studies have shown that a new gene can be put into T cells to increase their ability to recognize and kill cancer cells. A gene is a unit of DNA. Genes make up the chemical structure carrying your 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 an antibody called an anti-kappa light chain. This anti-kappa light chain antibody usually floats around in the blood. The antibody can detect and stick to cancer cells called lymphoma cells because they have a substance on the outside of the cells called kappa light chains. The purpose of this study is to determine whether receiving the ATLCAR.κ.28 cells is safe and tolerable and learn more about the side effects and how effective these cells are in fighting lymphoma. Initially, the study doctors will test different doses of the ATLCAR.κ.28, to see which dose is safer for use in lymphoma patients. Once a safe dose is identified, the study team will administer this dose to more patients, to learn about how these cells affect lymphoma cancer cells and identify other side effects they might have on the body. This is the first time ATLCAR.κ.28 cells are given to patients with lymphoma. The Food and Drug Administration (FDA), has not approved giving ATLCAR.κ.28 as treatment for lymphoma. This is the first step in determining whether giving ATLCAR.κ.28 to others with lymphoma in the future will help them.
CONDITIONS
Official Title
Study of Kappa Chimeric Antigen Receptor (CAR) T Lymphocytes Co-Expressing the Kappa and CD28 CARs for Relapsed/Refractory Kappa+ Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older
- Diagnosis of relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma or histologically confirmed kappa-positive B-cell non-Hodgkin lymphoma including specified aggressive and indolent types
- Subjects with central nervous system disease stable for 3 months are eligible
- Subjects with bone marrow only involvement are eligible
- Subjects relapsed after autologous or allogeneic stem cell transplant are eligible
- Subjects who received prior CD19-directed CAR therapies are eligible if at least 3 months have passed since last CAR-T cell treatment
- Patients with aggressive lymphomas must have had at least 2 prior systemic therapies including an anti-CD20 monoclonal antibody and an anthracycline-containing regimen
- Patients with indolent lymphomas must have received at least 2 prior therapy lines
- Subjects with relapsed/refractory CLL/SLL must have received at least 2 prior therapy regimens including specified agents
- Subjects with prior or concurrent malignancy that does not interfere with study assessments may be eligible
- Kappa-positive expression confirmed on lymphoma or CLL/SLL tissue or flow cytometry at time of cell procurement
- Karnofsky performance status greater than 60%
- Female subjects of childbearing potential must use two methods of birth control or be surgically sterile, or abstain from heterosexual activity during the study and for 6 months after
- Written informed consent and HIPAA authorization
You will not qualify if you...
- History of intolerance to bendamustine or fludarabine (except possible cyclophosphamide substitution at investigator discretion)
- Pregnant or lactating individuals
- Current systemic corticosteroid use at doses 10 mg prednisone daily or higher (lower doses may be allowed at investigator discretion)
- Active uncontrolled infections including HTLV, HCV, or HIV
- Evidence of uncontrolled infection or sepsis prior to lymphodepletion and cell infusion
- Inadequate organ function as defined by protocol criteria
- Abnormal cardiac function or uncontrolled cardiac conditions
- Use of prohibited or contraindicated medications
- Receipt of tumor vaccines within 6 weeks prior to lymphodepletion
- Receipt of investigational or cancer-directed therapy within 3 weeks or 5 half-lives prior to lymphodepletion
- Clinical indication of rapidly progressing disease at time of infusion
- Failure to meet eligibility requirements at procurement, lymphodepletion, or infusion stages
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Lineberger Comprehensive Cancer Center at University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
Research Team
C
Catherine Cheng
CONTACT
K
Kelly Hoye
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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