Kappa CD28 T Cells for Leukemia
(CHARKALL Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for individuals whose cancer—specifically Non-Hodgkin Lymphoma (NHL), Multiple Myeloma (MM), or Chronic Lymphocytic Leukemia (CLL)—has returned or not responded to existing therapies. The treatment employs kappa-CD28 T cells, a type of engineered immune cell therapy, designed to attack cancer by combining antibodies (proteins that fight infections) with T cells (blood cells that kill tumor cells). This combination aims to work more effectively against cancer. The trial may suit those with NHL, MM, or CLL who have not succeeded with standard treatments and experience specific symptoms like frequent fevers or significant weight loss. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that PD1/PDL1 inhibitors are allowed if medically indicated, suggesting some medications might be permitted.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that kappa-CD28 T cells, a form of CAR T-cell therapy, hold potential for treating certain cancers such as B-cell lymphoma, chronic lymphocytic leukemia (CLL), and multiple myeloma. These specially modified T cells are combined with antibodies and a protein that aids their growth, and they have undergone safety testing at various doses.
For B-cell lymphoma, studies indicate that CAR T-cells are generally well-tolerated. Researchers have observed positive effects in older patients, suggesting the treatment's safety. Any side effects have been managed effectively, supporting its safety profile.
In CLL, research suggests that CAR T-cell therapy can benefit patients who haven't responded to other treatments. Although specific safety details are not provided, ongoing research indicates it is safe enough to continue studying.
For multiple myeloma, CAR T-cell therapy represents a significant advancement. While detailed safety information is unavailable, continued research and discussions suggest it is considered safe enough for further testing.
Overall, previous studies have demonstrated that different doses of kappa-CD28 T cells were safe for patients. As this treatment remains in early testing, initial safety data is promising, but more research is needed to confirm these findings.12345Why do researchers think this study treatment might be promising?
Researchers are excited about Kappa CD28 T cells for leukemia because they offer a novel approach by harnessing the body's own immune system to target cancer cells. Unlike traditional treatments such as chemotherapy and radiation, which can affect healthy cells, these engineered T cells are designed to specifically recognize and attack cancerous B cells in conditions like B-CLL, B-cell lymphoma, and myeloma. This targeted action could potentially lead to more effective treatments with fewer side effects. Additionally, the flexibility of adjusting dose levels allows for tailored treatment, maximizing effectiveness while minimizing risks.
What evidence suggests that Kappa CD28 T cells might be an effective treatment for leukemia?
Research has shown that CAR T-cell therapy, which includes kappa CD28 T cells, holds promise in fighting cancers such as chronic lymphocytic leukemia (CLL), B-cell lymphoma, and multiple myeloma. In this trial, participants will receive kappa CD28 T cells specifically for one of these conditions. These specially modified T cells can locate and attack cancer cells, offering potential benefits even when other treatments have failed. For CLL, CAR T-cell therapy has helped patients unresponsive to other treatments. In B-cell lymphoma, this therapy proves effective, particularly for older patients with certain types of the disease. For multiple myeloma, CAR T-cell therapy is considered groundbreaking, with positive results from several studies. The kappa CD28 T cells are designed to target specific proteins on cancer cells, potentially leading to longer-lasting and more effective treatment outcomes.12346
Who Is on the Research Team?
Carlos Ramos, MD
Principal Investigator
Baylor College of Medicine - Texas Children's Hospital
Are You a Good Fit for This Trial?
This trial is for patients with certain blood cancers (NHL, MM, CLL) that have relapsed or are treatment-resistant. Participants must be recovered from prior chemotherapy effects, not HIV positive, and willing to use effective birth control. They should have a life expectancy of at least 12 weeks and no recent history of other cancers or active infections.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-treatment
Patients may receive cyclophosphamide and fludarabine to decrease T cell levels before infusion
Treatment
Patients receive an infusion of kappa-CD28 T cells at least 24 hours after chemotherapy
Evaluation
Patients are evaluated for response to treatment through radiological studies, physical exam, and/or symptoms
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are followed for long-term side effects of gene transfer
What Are the Treatments Tested in This Trial?
Interventions
- Kappa CD28 T cells
Find a Clinic Near You
Who Is Running the Clinical Trial?
Baylor College of Medicine
Lead Sponsor
The Methodist Hospital Research Institute
Collaborator
Center for Cell and Gene Therapy, Baylor College of Medicine
Collaborator