Actively Recruiting
Phase I Trial of Anti-CD19/20/22 CAR T Cells for Relapsed or Refractory Non-Hodgkin Lymphoma, Acute Lymphoblastic Leukemia, and Chronic Lymphocytic Leukemia
Led by Ohio State University Comprehensive Cancer Center · Updated on 2026-04-15
24
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety, side effects, and best dose of TriCAR19.20.22 T cells, a type of CAR T-cell therapy, in adults with relapsed or refractory non-Hodgkin lymphoma, acute lymphoblastic leukemia (ALL), and chronic lymphocytic leukemia (CLL). This phase I trial aims to evaluate how well these CAR T cells, which are modified to target proteins CD19, CD20, and CD22 on cancer cells, work in patients whose disease has returned or not responded to prior treatments. The study also explores the persistence of the infused cells and their effects on disease response and side effects. Participants are assigned to one of two groups. In Cohort A, patients undergo apheresis to collect T cells, receive lymphodepletion chemotherapy with cyclophosphamide and fludarabine, then receive a single infusion of TriCAR19.20.22 T cells. In Cohort B, patients receive similar chemotherapy but get two infusions of the CAR T cells on day 0 and day 7. Both groups undergo echocardiography or multigated acquisition scans, blood sampling, bone marrow biopsies, and PET/CT scans as needed throughout the trial. Participants are monitored closely after treatment at multiple timepoints including days 7, 14, 21, 30, 60, and 90, then at 6 months, 12 months, and yearly for up to 15 years. Researchers assess safety through dose-limiting toxicities and side effects, as well as response rates, overall survival, and progression-free survival. Laboratory tests and imaging help evaluate disease status and CAR T-cell persistence over time, ensuring comprehensive long-term follow-up.
CONDITIONS
Brief Title
Anti-CD19/20/22 Chimeric Antigen Receptor T Cells (TriCAR19.20.22 T Cells) for the Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma, Acute Lymphoblastic Leukemia, and Chronic Lymphocytic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- For Cohort A: Relapsed or refractory non-Hodgkin lymphoma with lesions 5 cm or smaller, indolent lymphomas, or chronic lymphocytic leukemia without Richter's transformation
- For Cohort B: Lymphoid blast crisis from chronic myeloid leukemia, acute lymphoblastic leukemia, chronic lymphocytic leukemia with Richter's transformation, non-Hodgkin lymphoma with lesions larger than 5 cm and/or lymphoblastic lymphoma, or non-Hodgkin lymphoma with circulating lymphoma cells
- Must have been treated with at least two prior therapies; prior CAR T therapy targeting CD19, CD20, or CD22 allowed with conditions
- Relapsed/refractory CLL patients must have received an approved Bruton's tyrosine kinase inhibitor and venetoclax
- Patients relapsing within 12 months after autologous stem cell transplant for refractory high-grade B-cell lymphoma are eligible
- Relapsed/refractory acute B-lymphoblastic leukemia patients must have had at least two prior therapies and be ineligible or failed allogeneic stem cell transplant
- Relapsed/refractory lymphoid blast crisis from chronic myeloid leukemia must have had at least two prior therapies or be ineligible or failed allogeneic stem cell transplant
- Lymphoid malignancy must be positive for CD19, CD20, or CD22
- Age 18 years or older
- ECOG performance status of 2 or less
- Adequate liver, kidney, lung, and heart function as defined in the criteria
- Ability to understand and sign informed consent
- Women of childbearing potential and men must agree to contraception requirements during and after treatment
You will not qualify if you...
- Autologous transplant within 6 weeks before planned CAR T-cell infusion
- Allogeneic stem cell transplant or donor lymphocyte infusion within 2 months before planned CAR T-cell infusion; must be off immunosuppressive agents
- Live vaccines given within 28 days before lymphodepleting chemotherapy
- Active graft versus host disease
- Active malignancy other than certain skin cancers or carcinoma in situ
- Less than 28 days since prior investigational treatment before lymphocyte collection
- Uncontrolled infections or illnesses including heart failure, unstable angina, arrhythmia, lung problems, or psychiatric issues
- Pregnant or breastfeeding women
- Evidence of myelodysplasia on bone marrow biopsy before therapy
- Positive hepatitis B markers requiring antiviral prophylaxis or monitoring
- History of significant central nervous system disorders such as epilepsy, seizures, stroke, dementia, or Parkinson's disease
- Autoimmune diseases requiring immunosuppressive medication within 6 months prior to study
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 7 to 30 days before treatment
Participants undergo apheresis followed by lymphodepletion chemotherapy with cyclophosphamide and fludarabine before receiving CAR T cell infusion.
1 to 2 visits for apheresis and chemotherapy administration
Duration - 1 to 7 days
Participants receive TriCAR19.20.22 T cells infusion intravenously, either once (Cohort A) or twice (Cohort B) depending on cohort assignment.
1 infusion visit for Cohort A; 2 infusion visits for Cohort B
Duration - Up to 15 years
Participants are monitored for safety, response, and long-term outcomes including blood collection, bone marrow biopsies, echocardiography or MUGA scans, and PET/CT as needed.
Visits at 7, 14, 21, 30, 60, 90 days, 6 and 12 months, then yearly up to 15 years
Trial Site Locations
Total: 1 location
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
T
The Ohio State University Comprehensive Cancer Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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