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CAR T-cell Therapy

CAR T-Cell Therapy for Lymphoma

Phase 1
Recruiting
Led By Natalie Grover, MD
Research Sponsored by UNC Lineberger Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma
Diagnosis of relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma OR histologically confirmed B-cell NHL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 years
Awards & highlights

Study Summary

This trial will use T cells and antibodies to create a more effective treatment for cancer.

Who is the study for?
This trial is for adults over 18 with certain types of B-cell lymphoma or chronic lymphocytic leukemia/small lymphocytic lymphoma that have relapsed or are not responding to treatment. Participants must have adequate organ function, no uncontrolled infections, and women of childbearing potential must use birth control. Those with active hepatitis, HIV, certain other cancers, or intolerance to specific drugs cannot join.Check my eligibility
What is being tested?
The study tests a new therapy using T cells engineered to carry a chimeric antigen receptor (CAR) targeting the kappa light chain on cancer cells. It aims to determine the safety and effectiveness of these modified T cells (ATLCAR.κ.28) in treating lymphoma by starting with various doses before settling on one for further evaluation.See study design
What are the potential side effects?
Potential side effects may include immune reactions due to CAR T cell infusion such as fever, fatigue, headache; risk of infection; possible damage to organs where kappa light chains are present; allergic reactions from components used in cell modification process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lymphoma is between DLBCL and Hodgkin.
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I have been diagnosed with a type of blood cancer that has come back or didn’t respond to treatment.
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My lymphoma or CLL/SLL shows kappa-positive expression.
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My organs are functioning well.
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I can receive standard chemotherapy while waiting for my CAR T-cell therapy.
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My T-cells have been modified and meet specific quality standards.
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I haven't had chemotherapy or immunotherapy in the last 3 weeks.
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I am not on any medication that this study does not allow.
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I do not have any ongoing serious infections.
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My lymphoma or CLL/SLL is kappa-positive.
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My last treatment was over 3 weeks ago before starting lymphodepletion.
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I do not have any ongoing serious infections.
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My cancer is only in my bone marrow.
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My cancer returned after a stem cell transplant.
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My lymphoma is high grade with specific genetic changes.
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I have a specific type of large B-cell lymphoma.
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I have had at least 2 treatments for my slow-growing lymphoma.
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I am 18 years old or older.
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I have had CD19 CAR therapy for my relapsed or hard-to-treat disease.
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I am using two birth control methods or am not having sex to join this study.
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My aggressive lymphoma has not responded to at least 2 previous treatments.
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I have had at least 2 treatments for my chronic leukemia or lymphoma.
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I am mostly able to care for myself but may need occasional help.
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I have been diagnosed with primary mediastinal large B-cell lymphoma.
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I meet the specific requirements to participate in this study.
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My diagnosis is diffuse large B-cell lymphoma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with adverse events as a measure of safety and tolerability of CAR.κ.28 ATL cells
Secondary outcome measures
Heart rate
Overall survival (OS) after administration of CAR.κ.28 cells
Progression free survival (PFS) after infusion of CAR.κ.28 cells
Other outcome measures
Duration of response after administration of CAR.κ.28 cells

Trial Design

1Treatment groups
Experimental Treatment
Group I: CAR.k.28/CAR.k.4-1BBExperimental Treatment4 Interventions
Up to 12 patients will receive a single infusion of CAR.k.28. The starting dose will be 2.5x10^5 cells/kg of each product. Up to 3 dose levels of CAR.k.28 cells will be tested with at least 3 patients enrolled at each dose cohort before dose escalation is considered based on the incidence of dose limiting toxicity (DLT). An expansion cohort will enroll up to 8 patients at the recommended phase 2 dose. Prior to receiving the infusions, patients will undergo lymphodepletion with fludarabine and bendamustine. Patients with a known history of intolerance to bendamustine may be considered for lymphodepletion with fludarabine and cyclophosphamide.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1100
Cyclophosphamide
1995
Completed Phase 3
~3780
Bendamustine
2015
Completed Phase 3
~2950

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,626 Previous Clinical Trials
40,927,615 Total Patients Enrolled
11 Trials studying Nodal Marginal Zone Lymphoma
557 Patients Enrolled for Nodal Marginal Zone Lymphoma
UNC Lineberger Comprehensive Cancer CenterLead Sponsor
348 Previous Clinical Trials
88,151 Total Patients Enrolled
Natalie Grover, MDPrincipal InvestigatorUNC Lineberger Comprehensive Cancer Center
8 Previous Clinical Trials
268 Total Patients Enrolled

Media Library

CAR.k.28 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04223765 — Phase 1
Nodal Marginal Zone Lymphoma Research Study Groups: CAR.k.28/CAR.k.4-1BB
Nodal Marginal Zone Lymphoma Clinical Trial 2023: CAR.k.28 Highlights & Side Effects. Trial Name: NCT04223765 — Phase 1
CAR.k.28 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04223765 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what medical condition is CAR.k.28 typically prescribed?

"CAR.k.28 has been used with some success to treat multiple sclerosis, leukemia, myelocytic disorders, acute illnesses and retinoblastoma."

Answered by AI

How many participants have signed on to participate in this research project?

"Yes, the evidence available on clinicaltrials.gov reveals that this medical trial is presently recruiting volunteers. The study was first published on November 12th 2020 and was most recently edited on November 28th 2022. 20 individuals need to be recruited at 1 site in order for the research to move forward."

Answered by AI

Is the opportunity to participate in this clinical trial still available?

"Affirmative. According to clinicaltrials.gov, this experimental trial which commenced on November 12th 2020 is now looking for participants. 20 individuals need to be enrolled from a single medical facility."

Answered by AI

Is there any precedent of utilizing CAR.k.28 in prior investigations?

"At the moment, 946 clinical trials are currently underway to investigate CAR.k.28 with 176 of those in Phase 3. Despite being mainly concentrated around Philadelphia, Pennsylvania, a total of 32476 sites have studies pertaining to this therapeutic intervention."

Answered by AI

Are there associated risks when using CAR.k.28?

"The safety of CAR.k.28 is rated at 1 due to the lack of evidence supporting its efficacy and limited data on the drug's potential adverse effects in Phase 1 clinical trials."

Answered by AI
~11 spots leftby Mar 2028