Actively Recruiting
Genetically Engineered Cells (Anti-CD19/CD20/CD22 CAR T-cells) for the Treatment of Relapsed or Refractory Lymphoid Malignancies
Led by Sumithira Vasu · Updated on 2025-05-16
54
Participants Needed
2
Research Sites
213 weeks
Total Duration
On this page
Sponsors
S
Sumithira Vasu
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase I trial tests the safety, side effects and best infusion dose of genetically engineered cells called anti-CD19/CD20/CD22 chimeric antigen receptor (CAR) T-cells following a short course of chemotherapy with cyclophosphamide and fludarabine in treating patients with lymphoid cancers (malignancies) that have come back (recurrent) or do not respond to treatment (refractory). Lymphoid malignancies eligible for this trial are: non-Hodgkin lymphoma (NHL), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), and B-prolymphocytic leukemia (B-PLL). T-cells (a type of white blood cell) form part of the body's immune system. CAR-T is a type of cell therapy that is used with gene-based therapies. CAR T-cells are made by taking a patient's own T-cells and genetically modifying them with a virus so that they are recognized by a group of proteins called CD19/CD20/CD22 which are found on the surface of cancer cells. Anti-CD19/CD20/CD22 CAR T-cells can recognize CD19/CD20/CD22, bind to the cancer cells and kill them. Giving combination chemotherapy helps prepare the body before CAR T-cell therapy. Giving CAR-T after cyclophosphamide and fludarabine may kill more tumor cells.
CONDITIONS
Official Title
Genetically Engineered Cells (Anti-CD19/CD20/CD22 CAR T-cells) for the Treatment of Relapsed or Refractory Lymphoid Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult subjects with relapsed or refractory non-Hodgkin lymphoma with lesions 5 cm or smaller, indolent lymphomas, chronic lymphocytic leukemia without Richter's transformation, or B-prolymphocytic leukemia (Cohort A)
- Adult subjects with lymphoid blast crisis, 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, B-prolymphocytic leukemia with lesions larger than 5 cm (Cohort B)
- Pediatric subjects with acute lymphoblastic leukemia or non-Hodgkin lymphoma
- Subjects must have been treated with at least two lines of therapy and have disease progression or failure to achieve remission after the last regimen
- Subjects with relapsed/refractory chronic lymphocytic leukemia after at least two prior therapies including BTK inhibitor and venetoclax
- Subjects with refractory high-grade B-cell lymphoma relapsing within 12 months of autologous stem cell transplant
- Subjects with relapsed/refractory B-prolymphocytic leukemia after at least one to two prior therapies and failed or ineligible for allogeneic stem cell transplant
- Subjects with relapsed/refractory acute B-lymphoblastic leukemia after at least two prior therapies or failed or ineligible for allogeneic stem cell transplant
- Lymphoid malignancy positive for at least one target antigen (CD19, CD20, or CD22) by immunohistochemistry or flow cytometry
- Patients who received blinatumomab, inotuzumab, or prior CAR T-cells (if at least 30 days since prior CAR T and less than 5% circulating CD3+ cells express prior CAR)
- Age 2 years or older
- ECOG performance status 2 or lower; Lansky score 50 or higher for patients under 16
- Total bilirubin 1.5 times or less the upper limit of normal for age
- AST and ALT levels 3 times or less the upper limit of normal for age
- Creatinine clearance 50 ml/min or higher
- Adequate pulmonary function with pulse oximetry 92% or higher on room air
- Adequate cardiac function with left ventricular ejection fraction 40% or higher
- Absolute lymphocyte count greater than 100/uL
- Ability to understand and willingness to sign informed consent
- Women of childbearing potential must agree to abstain or use highly effective contraception during treatment and for 6 months after infusion
- Men must agree to abstain or use contraception and avoid sperm donation during treatment and for 6 months after infusion
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 within 28 days before lymphodepleting chemotherapy
- Active graft versus host disease
- Active central nervous system or meningeal involvement by lymphoma or leukemia, or untreated brain metastases/CNS 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 patients must have undetectable viral load on effective anti-retroviral therapy
- Uncontrolled illness including active infection, symptomatic heart failure, unstable angina, arrhythmia, pulmonary abnormalities, or psychiatric/social issues limiting compliance
- Pregnant or breastfeeding women; women of childbearing potential must have negative pregnancy test
- Evidence of myelodysplasia or cytogenetic abnormalities indicative of myelodysplasia
- Positive hepatitis B core antibody or surface antigen requiring prophylaxis or monitoring
- History of clinically relevant CNS pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia, or Parkinson's disease
- History of autoimmune disease requiring immunosuppressive medication within 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Nationwide Children's Hospital
Columbus, Ohio, United States, 43203
Actively Recruiting
2
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
3
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