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Study of CAR.k.28 for Relapsed/Refractory Kappa+ Non-Hodgkin Lymphoma and CLL/SLL

This study is testing a new treatment called CAR.k.28 for people with certain types of lymphoma (Mantle Cell, Follicular, Splenic Marginal Zone, Extranodal Marginal Zone, Nodal Marginal Zone) that have come back or haven't responded to other treatments. CAR.k.28 uses your own modified immune cells (T cells) to find and destroy cancer cells that have a specific marker called kappa light chain. Before receiving CAR.k.28, you will get chemotherapy with Fludarabine and Cyclophosphamide or Bendamustine. The main goal is to see how safe CAR.k.28 is and what side effects it might cause. The study is planning to enroll 20 participants, but its current recruitment status is unclear. You must be at least 18 years old to participate.

Study design
This is a single-center, open-label (meaning you and your doctors will know what treatment you are receiving) Phase 1 study. It aims to enroll up to 20 participants to test different doses of the CAR.k.28 treatment.
What's involved
You will receive chemotherapy with Fludarabine and Cyclophosphamide or Bendamustine, followed by a single infusion of CAR.k.28 cells. You may also receive additional standard chemotherapy while waiting for your CAR.k.28 cells to be made.
Compensation
Not stated in the trial record.
Follow-up
The study will measure side effects and safety for at least 4 weeks after you receive the CAR.k.28 cells.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04223765

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.

Recruiting
PHASE1Ages 18+InterventionalTreatment
UNC Lineberger Comprehensive Cancer Center
~20 participants
Updated 2026-01-20 on ClinicalTrials.gov
What's tested:CAR.k.28FludarabineCyclophosphamideBendamustine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with adverse events as a measure of safety and tolerability of CAR.κ.28 ATL cells
Measured over 4 weeks

Conditions

Mantle Cell Lymphoma
Follicular Lymphoma
Splenic Marginal Zone Lymphoma
Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue
Nodal Marginal Zone Lymphoma
Indolent Non-hodgkin Lymphoma

Explore related trials

Burkitt LymphomaChronic Lymphocytic LeukemiaDiffuse Large B-Cell LymphomaExtranodal Marginal Zone LymphomaFollicular LymphomaHematologic NeoplasmMantle Cell LymphomaNodal Marginal Zone LymphomaSmall Lymphocytic LymphomaSplenic Marginal Zone LymphomaImmunoglobulin Light Chain, Kappa

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Natalie Grover, MD · PRINCIPAL_INVESTIGATOR · UNC Lineberger Comprehensive Cancer Center

Who to contact

Catherine Cheng
[email protected]
919-445-4208
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

DLBCL not otherwise specified (NOS)
T cell/histiocyte rich large B cell lymphoma; primary cutaneous DLBCL, leg type; EBV-positive DLBCL NOS; DLBCL associated with chronic inflammation; Lymphomatoid granulomatosis; Large B-cell lymphoma with IRF4 rearrangement; Intravascular large B-cell lymphoma; ALK-positive large B-cell lymphoma
Primary mediastinal (thymic) large B-cell lymphoma
High grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangement; high grade B-cell lymphoma, NOS
B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma
Transformation of indolent lymphoma or CLL to DLBCL will also be included
Burkitt lymphoma
Follicular lymphoma grade 1-3b
Splenic marginal zone lymphoma
Extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue
Nodal marginal zone lymphoma
Mantle cell lymphoma
Subjects with central nervous system (CNS) disease will not be excluded as long as it has been stable for 3 months
An anti-CD20 monoclonal antibody
An anthracycline containing chemotherapy regimen (if eligible)
An autologous stem cell transplant (if eligible) 7. For indolent lymphomas, subjects must have received at least 2 prior lines of therapy for their lymphoma 8. Subjects with specifically relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma must have received at least 2 prior therapy regimens which can include, but not limited to:
A combination of an anti-CD20 monoclonal antibody and an alkylating agent, OR
A Bruton's Tyrosine Kinase Inhibitor, OR
A BCL-2 inhibitor in combination with an anti-CD20 monoclonal antibody 9. Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial at the investigator's discretion. 10. Kappa-positive expression on lymphoma or CLL/SLL tissue sample, or kappa restriction on flow cytometry (archival or fresh) as confirmed by institutional hematopathology standard (result must be confirmed at the time of cell procurement). 11. Karnofsky score of \> 60% 12. Female subjects of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study, and for 6 months after the study is concluded. Female subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year. The two birth control methods can be composed of: two barrier methods or a barrier method plus a hormonal method to prevent pregnancy. Female subjects of childbearing potential will also be instructed to tell their male partners to use a condom.

Exclusion

Total bilirubin \<1.5 × ULN (subjects with Gilbert's syndrome may be enrolled despite a total bilirubin level \>1.5 mg/dL if their conjugated bilirubin is \<1.5 × ULN)
AST and ALT \< 5x ULN
Pulse oximetry of \>90% on room air
Creatinine ≤ 2 x ULN 3. Imaging results from within 120 days prior to procurement to assess presence of active disease. 4. Confirmed kappa-positive expression on lymphoma or CLL/SLL tissue or bone marrow sample (archival or fresh) as confirmed by pathology. 5. Subject has adequate cardiac function, defined as:
No ECG evidence of acute ischemia
No ECG evidence of active, clinically significant conduction system abnormalities
Prior to study entry, any ECG abnormality at screening not felt to put the subject at risk has to be documented by the investigator as not medically significant
No uncontrolled angina or severe ventricular arrhythmia
Left ventricular ejection fraction (LVEF) \>40% as measured by ECHO, with no additional evidence of decompensated heart failure, performed within 30 days prior to procurement 6. In women of child-bearing potential, negative serum pregnancy test within 72 hours prior to procurement or documentation that the subject is post-menopausal. Post-menopausal status must be confirmed with documentation of absence of menses for \> 1 year.
Adequate bone marrow function, as defined by:
ANC \>1.0 × 109/L
Platelets \>50 × 109/L unless related to lymphoma involvement (independent of transfusion within 7 days of lymphodepletion)
Total bilirubin ≤1.5 × ULN (subjects with Gilbert's syndrome may be enrolled despite a total bilirubin level \>1.5 mg/dL if their conjugated bilirubin is \<1.5× ULN)
AST and ALT ≤ 5× ULN
Pulse oximetry of \> 90% on room air
Creatinine ≤2 x ULN
If subjects display any clinical signs or symptoms of cardiac dysfunction after receiving bridging chemotherapy, they will undergo repeat ECG and ECHO to reassess their cardiac function and status 5. In female subjects of childbearing potential, a negative serum pregnancy test within 72 hours prior to l ymphodepletion or documentation that the subject is post-menopausal or has been surgically sterilized.

What this trial measures

  • Number of participants with adverse events as a measure of safety and tolerability of CAR.κ.28 ATL cells4 weeks

    Toxicity is classified and graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 5.0). Grade 1 Mild; asymptomatic or mild symptoms; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to Adverse Event (AE). Immune effector cell-associated neurotoxicity syndrome (ICANS) symptoms will be graded per American Society for Blood and Marrow Transplantation (ASBMT) ICANS Consensus Grading for Adults (scale from 1-mild to 4-critical) and cytokine release syndrome (CRS) symptoms will be graded according to ASBMT CRS Consensus Grading (a scale from 1-mild to 5-death).