Actively Recruiting
Phase I Trial of Anti-CD19/CD20/CD22 CAR T-Cells for Relapsed or Refractory Lymphoid Malignancies including Non-Hodgkin Lymphoma, Leukemias, and B-Prolymphocytic Leukemia
Led by Sumithira Vasu · Updated on 2026-05-29
54
Participants Needed
2
Research Sites
N/A
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
Researchers are evaluating the safety, side effects, and best dose of genetically engineered anti-CD19/CD20/CD22 CAR T-cells following chemotherapy in patients with relapsed or refractory lymphoid cancers. These cancers include non-Hodgkin lymphoma, acute lymphoblastic leukemia, chronic lymphocytic leukemia, and B-prolymphocytic leukemia. CAR T-cells are made by modifying a patient's own immune cells to target proteins found on cancer cells, potentially improving cancer cell killing after chemotherapy prepares the body. The study involves three groups receiving different treatment schedules. All patients receive chemotherapy with cyclophosphamide and fludarabine before CAR T-cell infusion. Cohort A patients get one infusion of CAR T-cells on day 0, Cohorts B and C receive two infusions on days 0 and 7 with varying chemotherapy timing. Patients undergo heart scans and may have tissue biopsies, blood collection, and bone marrow tests throughout the study. Participants have follow-up visits at multiple time points from days 1 to 90, then months 6, 24, 36, 48, and 60, continuing annually for up to 15 years. Researchers monitor safety, immune cell behavior, treatment response, survival, and possible side effects. Various tests include echocardiography or MUGA scans, apheresis for cell collection, biopsies, and blood sampling. The study aims to find the recommended dose and better understand this CAR T-cell therapy in these blood cancers.
CONDITIONS
Brief 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...
- Adults 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)
- Adults with lymphoid blast crisis, acute lymphoblastic leukemia, chronic lymphocytic leukemia with Richter's transformation, non-Hodgkin lymphoma with lesions larger than 5 cm or lymphoblastic lymphoma, or non-Hodgkin lymphoma with circulating lymphoma cells, or B-prolymphocytic leukemia with lesions larger than 5 cm (Cohort B)
- Pediatric subjects with acute lymphoblastic leukemia or non-Hodgkin lymphoma
- Treated with at least two prior therapies with disease progression or failure to achieve complete remission
- Relapsed/refractory chronic lymphocytic leukemia after at least 2 prior therapies including a BTK inhibitor and venetoclax
- Refractory high-grade B-cell lymphoma relapsed within 12 months of autologous stem cell transplant
- Relapsed/refractory B-prolymphocytic leukemia with 1-2 prior therapies and ineligible or failed allogeneic stem cell transplant
- Relapsed/refractory acute B-lymphoblastic leukemia with 2 prior therapies or ineligible or failed allogeneic stem cell transplant
- Malignancy positive for CD19, CD20, or CD22 by recent testing
- Prior treatment with blinatumomab, inotuzumab, or CAR T-cells allowed with restrictions
- Age 2 years or older
- ECOG performance status 0-2; Lansky score 50 or higher if under 16
- Adequate liver, kidney, lung, heart function
- Absolute lymphocyte count above 100/uL
- Ability to consent
- Agrees to use reliable contraception or abstinence during and 6 months after treatment
You will not qualify if you...
- Autologous transplant within 6 weeks of planned CAR-T infusion
- Allogeneic stem cell transplant or donor lymphocyte infusion within 2 months before CAR-T and use of immunosuppressants
- Live vaccines within 28 days before lymphodepleting chemotherapy
- Active graft versus host disease
- Active central nervous system or meningeal cancer involvement or untreated brain metastases
- Active malignancy other than certain skin or in situ cancers
- Less than 28 days since prior investigational treatment before lymphocyte collection
- HIV infection without controlled viral load
- Uncontrolled infections, heart failure, angina, arrhythmias, lung problems, psychiatric illness limiting study compliance
- Pregnant or breastfeeding women
- Evidence of myelodysplasia in bone marrow
- Positive hepatitis B without proper antiviral management
- History of significant CNS disorders like epilepsy or dementia
- Recent autoimmune disease requiring immunosuppressive drugs
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, including undergoing echocardiography or MUGA scan and possibly tissue biopsy.
1 visit (in-person) for screening procedures
Duration - 4 to 6 days
Participants receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine intravenously before CAR T-cell therapy.
Daily visits for 4 to 6 days for chemotherapy administration
Duration - 1 to 8 days depending on cohort
Participants receive anti-CD19/CD20/CD22 CAR T-cells intravenously. Cohort A receives a single infusion on day 0. Cohorts B and C receive infusions on day 0 and day 7.
1 to 2 infusion visits depending on cohort assignment
Duration - Up to 15 years
Participants are monitored with visits including bone marrow biopsy, aspiration, blood sample collection, and clinical assessments to evaluate safety, response, and long-term outcomes.
Multiple visits including daily visits in the first month, then periodic visits up to 15 years
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
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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