Actively Recruiting
CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell Malignancies
Led by Medical College of Wisconsin · Updated on 2026-02-23
100
Participants Needed
1
Research Sites
458 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase I/II, interventional, single-arm, open-label, treatment study designed to evaluate the safety and efficacy of Interleukin-7 and Interleukin-15 (IL-7/IL-15) manufactured chimeric antigen receptor (CAR)-20/19-T cells as well as the feasibility of a flexible manufacturing schema in adult patients with B cell malignancies that have failed prior therapies.
CONDITIONS
Official Title
CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years with relapsed or refractory B-cell non-Hodgkin lymphoma
- Absolute CD3 count of at least 50 mm^3
- Measurable disease confirmed within 4 weeks before consent
- Karnofsky performance score of 70 or higher
- Adequate liver function with AST and ALT less than 5 times the upper limit of normal
- Absolute neutrophil count of at least 1000 without recent growth factor use
- Platelet count of at least 50,000 without recent transfusion
- Adequate kidney function with creatinine clearance over 60 ml/min and serum creatinine under 1.5 mg/dL
- Able to provide written informed consent
- Agree to use birth control during the study
- Adequate heart and lung function including NYHA class I or II and oxygen saturation of 92% or higher
- Expected survival longer than 12 weeks
- Negative pregnancy test for women of childbearing potential
- No contraindications for central line access
- Demonstrated compliance with prior therapies
- Diagnosis of specific B-cell NHL subtypes or CLL or CNS lymphoma depending on study arm
- For CLL, failed or intolerant to two prior therapies including BTK or BCL2 inhibitors
- For CNS lymphoma, prior adequate CNS-directed therapy and measurable CNS disease
- For mantle cell lymphoma, relapsed or refractory disease after specified prior treatments
You will not qualify if you...
- Positive pregnancy test in females of childbearing potential
- Active HIV, Hepatitis B, or Hepatitis C infection
- Significant or uncontrolled autoimmune disease requiring steroids over 20 mg prednisone daily
- Grade 3 or higher non-blood toxicities from prior treatments not related to disease
- Concurrent enrollment in other therapeutic clinical trials or recent investigational drug use
- Refusal to participate in long-term follow-up
- Active CNS involvement by malignancy except for specific cohort
- Recent allogeneic transplant within 100 days or active graft-versus-host disease
- Prior allogeneic CAR T-cell therapy
- Recent autologous CAR T-cell therapy within 100 days or high residual CAR T-cell levels
- Anti-CD20 or anti-CD19 antibody treatment within 4 weeks before infusion
- Recent cytotoxic chemotherapy or steroid treatment within specified time frames
- Recent oral chemotherapy or antibody treatments within 7 days before cell collection
- History of solid organ transplant with high-grade lymphomas or leukemias
- Concurrent active malignancy other than certain skin cancers
- Failure to meet fertility and contraception requirements as specified
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Medical College of Wisconsin and Froedtert Hospital
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
M
Medical College of Wisconsin Cancer Center Clinical Trials Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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