CAR T-Cells for B-Cell Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety of a new treatment, h20.19 CAR T cells, for individuals with B-cell lymphoma who haven't responded to other treatments. Researchers aim to determine if these specially modified cells can combat this type of cancer. Participants should have B-cell lymphoma that has relapsed or not responded to previous treatments, such as certain chemotherapy or other cell therapies. Those whose B-cell lymphoma remains stubborn despite previous treatments might be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, and participants could be among the first to receive this new therapy.
Will I have to stop taking my current medications?
The trial requires a 'washout period' (time without taking certain medications) for some treatments. You must stop taking oral chemotherapeutic agents or antibody-directed treatments 7 days before apheresis, and cytotoxic chemotherapy 14 days before lymphodepletion. BTK inhibitors can be taken until 1 day before apheresis.
Is there any evidence suggesting that h20.19 CAR T cells are likely to be safe for humans?
Research has shown that h20.19 CAR T cells have been tested for safety in patients with B-cell lymphomas unresponsive to other treatments. Earlier studies found CAR T-cell therapy generally safe, though some patients experienced side effects. A common side effect was cytokine release syndrome, an immune system reaction affecting about 71% of patients. Approximately 21% experienced other immune-related side effects. Such reactions are typical with CAR T-cell therapies. While some side effects can be serious, many are manageable with medical care. This early study aims to better understand and manage potential risks.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about h20.19 CAR T cells for B-cell lymphoma because they offer a groundbreaking approach by reprogramming a patient's own immune cells to seek and destroy cancer cells. Unlike traditional treatments like chemotherapy and radiation, which indiscriminately attack both healthy and cancerous cells, CAR T-cell therapy is highly targeted, potentially leading to fewer side effects. This treatment harnesses the power of the immune system with a new mechanism of action, potentially offering hope for patients with limited options in the current standard of care.
What evidence suggests that h20.19 CAR T cells might be an effective treatment for B-cell lymphoma?
Research has shown that CAR T-cell therapy, which targets a protein called CD19, yields promising results for treating aggressive B-cell lymphomas. Studies have found that up to 40% of patients with large B-cell lymphoma experienced long-term remission after receiving similar CAR T-cell treatments. This trial will evaluate h20.19 CAR T cells at different dose levels to determine the maximum tolerated dose. Many patients experience side effects like cytokine-release syndrome, a type of immune reaction, but the treatment has generally been well tolerated. These findings suggest that h20.19 CAR T cells could offer hope for those with relapsed B-cell cancers.23678
Who Is on the Research Team?
Nirav Shah, MD
Principal Investigator
Medical College of Wisconsin
Are You a Good Fit for This Trial?
Adults aged 18-80 with relapsed or refractory B-cell malignancies can join this trial. They must have a heart pumping capacity (ejection fraction) of at least 45%, good kidney function, no severe liver issues, and adequate blood counts without recent growth factor support. People with CNS involvement or suspected CNS disease at enrollment cannot participate.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive h20.19 CAR T cells with dose escalation to determine the maximum tolerated dose
Follow-up
Participants are monitored for safety and effectiveness after treatment
Dose Expansion
Evaluation of h20.19 CAR T cells at the maximum tolerated dose in an expanded cohort
What Are the Treatments Tested in This Trial?
Interventions
- h20.19 CAR T cells
Trial Overview
The trial is testing the safety of a new CAR T cell therapy targeting two proteins on B-cells (CD19 and CD20). Patients will receive one of two doses: either 1 million cells per kg or up to the maximum tolerated dose determined during the study.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
The investigators will start at a dose of 1 X 10\^6 cells/kg and escalate based on the presence of toxicities.
The investigators will start at a dose of 1 X 10\^6 cells/kg and escalate based on the presence of toxicities.
The maximum tolerated dose intervention will be updated when it is determined. It will be one of two doses: 1 X 10\^6 cells/kg or 2.5 X 10\^6 cells/kg. After completing the dose escalation cohort, the investigators will open a 12-patient dose-expansion evaluation of h20.19 CAR T cells.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical College of Wisconsin
Lead Sponsor
Citations
Outcomes of CAR T-cell therapy in high-grade B-cell ...
Anti-CD19 chimeric antigen receptor (CAR) T-cell therapy for third-line aggressive large B-cell lymphomas (LBCL) resulted in long-term remission in ≤40% of ...
Real-World Outcomes of Anti-CD19 Chimeric Antigen ...
CAR T-cell therapy was well tolerated, with 58 patients (70.7%) experiencing cytokine-release syndrome and 17 patients (20.7%) experiencing immune effector cell ...
Researchers identify key B-cell lymphoma traits linked with ...
Researchers identify key B-cell lymphoma traits linked with greatest benefit from CD19 CAR T cell therapy. MD Anderson News Release June 18 ...
the phase 2, single-arm ZUMA-14 trial
Chimeric antigen receptor (CAR) T cell therapies have demonstrated notable benefit in persons with aggressive, chemorefractory B cell lymphoma ( ...
Fully Human Bispecific Anti-CD20, Anti-CD19 CAR T Cells ...
The purpose of this study is to determine the safety of fully human lentiviral 20.19 (h20.19) CAR T cells in patients with relapsed, ...
Safety and feasibility of anti-CD19 CAR T cells with fully ...
Anti-CD19 chimeric antigen receptor (CAR)-expressing T cells are effective treatment for B-cell lymphoma but often cause neurologic toxicity.
Safety and feasibility of 4-1BB co-stimulated CD19-specific ...
CD19-BBz CAR-NK cells were feasible and therapeutically safe, capable of inducing durable response in patients with B cell lymphoma.
Johnson & Johnson's dual-targeting CAR T-cell therapy ...
Phase 1b study suggests a promising safety profile and highlights the potential of a novel dual-targeting CD19/CD20 CAR T in patients with relapsed or ...
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