Actively Recruiting
Phase I Dose Escalation Trial of CD19 Directed CAR-T Cell Therapy for Relapsed/Refractory B Cell Malignancies
Led by Mayo Clinic ยท Updated on 2025-07-01
25
Participants Needed
1
Research Sites
626 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a phase I trial of CD19-directed chimeric antigen receptor (CAR)-T cell therapy called IC19/1563 for patients with B cell cancers that have returned or not responded to treatment. This therapy uses the patient's own T cells, which are modified in the lab to recognize and target cancer cells. The study aims to find the highest safe dose, assess safety, and evaluate how well the treatment works for these difficult-to-treat cancers. Participants receive chemotherapy drugs cyclophosphamide and fludarabine or bendamustine intravenously over a few days before a single infusion of the IC19/1563 CAR-T cells on day 0. The study includes a dose-escalation phase to determine the maximum tolerated dose of the CAR-T cells. Throughout the trial, patients undergo bone marrow biopsies and aspirations, CT/PET or CT scans, MRI scans, and blood and tissue sample collections to monitor their response and safety. After treatment, patients are followed closely with visits on day 60, then every 3 months for 3 years, every 6 months for years 3 to 5, and annually up to 15.5 years. Researchers measure the maximum tolerated dose, response rates, duration of response, progression-free survival, and side effects like neurotoxicity and cytokine release syndrome. The trial also studies the behavior of CAR-T cells in the body, changes in cytokines, and healthcare resource use during long-term follow-up.
CONDITIONS
Brief Title
CD19-Directed CAR-T Cell Therapy for the Treatment of Relapsed/Refractory B Cell Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Relapsed or refractory CD19-positive B cell malignancies including biopsy-proven B-cell non-Hodgkin lymphoma or flow cytometry proven chronic lymphocytic leukemia/small lymphocytic lymphoma
- Prior treatments as specified depending on cancer type, including at least two lines of therapy or specific prior therapies
- Measurable disease by imaging or blood tests as defined
- ECOG performance status of 0 or 1
- Hemoglobin 8.0 g/dL or higher
- Absolute neutrophil count 500/mm3 or higher
- Platelet count 30,000/mm3 or higher
- Total bilirubin 2.0 mg/dL or less (exceptions apply for Gilbert's syndrome)
- ALT and AST 3 times upper limit of normal or less
- Acceptable coagulation parameters or stable anticoagulation
- Calculated creatinine clearance 45 ml/min or higher
- Cardiac ejection fraction 50% or higher with no significant pericardial effusion
- Baseline oxygen saturation 92% or higher on room air
- Negative pregnancy test if applicable
- Women of childbearing potential must use two effective birth control methods during and 12 months after therapy
- Provide written informed consent
- Willing to provide blood samples for research
- Willing to return for follow-up visits
You will not qualify if you...
- Pregnancy or nursing
- Women of childbearing potential unwilling to use effective contraception
- Sexually active males unwilling to use contraception during and 12 months after therapy
- Ability to obtain approved CD19 CAR T-cell therapies
- Live vaccine within 6 weeks before registration
- Recent autologous stem cell transplant within 6 weeks
- Recent allogeneic stem cell transplant within 100 days, active graft-versus-host disease, or ongoing immunosuppression
- History of seizure disorder, stroke, dementia, cerebellar disease, or autoimmune CNS disease
- Primary immunodeficiency
- Need for high-dose systemic corticosteroids
- History of severe allergic reaction to CAR-T cell components or related substances
- History of certain malignancies unless disease-free for 2 years
- Active serious infection or recent IV antibiotics
- Known HIV or unresolved hepatitis B or C infection
- Significant recent cardiovascular events or disease
- Other medical or psychiatric conditions increasing study risk
- Concurrent cancer therapies without required washout periods
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Approximately 1 week including chemotherapy and CAR-T infusion
Participants receive chemotherapy with cyclophosphamide and fludarabine or bendamustine, followed by a single infusion of CAR-T cell therapy (IC19/1563). During this time, they undergo bone marrow biopsy and aspiration, CT/PET or CT scans, MRI, and blood and tissue sample collection.
Multiple visits during days -5 to 0 for chemotherapy and CAR-T cell infusion
Duration - Up to 15.5 years
After treatment, participants are monitored for safety, response to therapy, and long-term outcomes with scheduled visits and assessments.
Visits on day 60, every 3 months up to year 3, every 6 months from years 3 to 5, then annually
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
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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