Actively Recruiting
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
Led by Ohio State University Comprehensive Cancer Center · Updated on 2026-04-15
24
Participants Needed
1
Research Sites
50 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase I trial tests the safety, side effects and best dose of anti-CD19/20/22 chimeric antigen receptor (CAR) T cells (TriCAR19.20.22 T cells) and how well they work in treating patients with non-Hodgkin lymphoma, acute lymphoblastic leukemia (ALL) and chronic lymphocytic leukemia (CLL) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein, such as CD19, CD20 and CD22, on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a CAR. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Giving TriCAR19.20.22 T cells may be safe, tolerable, and/or effective in treating patients with relapsed or refractory non-Hodgkin lymphoma, ALL and CLL.
CONDITIONS
Official 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...
- Adults aged 18 years or older
- Relapsed or refractory non-Hodgkin lymphoma with lesions 5 cm, indolent lymphomas, or chronic lymphocytic leukemia without Richter's transformation (Cohort A)
- Lymphoid blast crisis from chronic myeloid leukemia, acute lymphoblastic leukemia, chronic lymphocytic leukemia with Richter's transformation, non-Hodgkin lymphoma with lesions > 5 cm and/or lymphoblastic lymphoma, or non-Hodgkin lymphoma with circulating lymphoma cells (Cohort B)
- Treated with at least two lines of therapy; prior CAR T therapy targeting CD19, CD20, or CD22 allowed if at least 30 days have passed and circulating CAR T cells are < 5%
- Relapsed/refractory CLL after at least 2 prior therapies including BTK inhibitor and venetoclax
- Relapsed/refractory acute B-lymphoblastic leukemia after at least 2 prior therapies; failed or ineligible for allogeneic stem cell transplant
- Relapsed/refractory lymphoid blast crisis from chronic myeloid leukemia after at least 2 prior therapies; failed or ineligible for allogeneic stem cell transplant
- Lymphoid malignancy positive for CD19 and/or CD20 and/or CD22 by biopsy or blood test
- ECOG performance status of 0, 1, or 2
- Total bilirubin 1.5 times institutional upper limit
- AST 3 times institutional upper limit
- ALT 3 times institutional upper limit
- Creatinine clearance 50 ml/min
- Pulmonary function with pulse oximetry 92% on room air
- Cardiac function with left ventricular ejection fraction 40%
- Absolute lymphocyte count 100/uL or CD3 count 100/uL if differential not done
- Ability and willingness to sign informed consent
- For women of childbearing potential: agreement to abstain or use effective contraception during and for 6 months after treatment
- For men: agreement to abstain or use contraception and refrain from sperm donation during and for 6 months after treatment
You will not qualify if you...
- Autologous transplant within 6 weeks before planned CAR T infusion
- Allogeneic stem cell transplant or donor lymphocyte infusion within 2 months before planned CAR T infusion; must be off immunosuppressive agents
- Live vaccines within 28 days before lymphodepleting chemotherapy
- Active graft versus host disease
- Active malignancy other than non-melanoma skin cancer or carcinoma in situ
- Less than 28 days since prior investigational agent treatment before lymphocyte collection
- HIV positive without effective anti-retroviral therapy and undetectable viral load within 6 months
- Uncontrolled illness including infection, heart failure, unstable angina, arrhythmia, lung problems, psychiatric illness or social situations limiting compliance
- Pregnant or breastfeeding women
- Evidence of myelodysplasia or related cytogenetic abnormalities
- Positive hepatitis B core antibody or surface antigen without prophylaxis or monitoring
- History of significant central nervous system disorders such as epilepsy, seizures, paresis, aphasia, uncontrolled stroke, brain injuries, dementia, or Parkinson's disease
- Autoimmune disease requiring immunosuppressive drugs within 6 months prior to study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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