RecruitingNon Hodgkin LymphomaDiffuse Large B Cell LymphomaFollicular Lymphoma
LV20.19 CAR T-Cells in Combination With Pirtobrutinib for Relapsed, Refractory B-cell Malignancies
Eligible age
18–81 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
This is a phase I, interventional, single arm, open label, treatment study designed to evaluate the safety and efficacy of LV20.19 CAR -T cells with pirtobrutinib bridging and maintenance in adult patients with B cell malignancies that have failed prior therapies.
Sponsor: Medical College of Wisconsin
You may qualify if…
- ✓ 1. Absolute neutrophil count (ANC) ≥1000 with no G-CSF within 7 days or pegylated G-CSF within 14 days unless patient has biopsy proven bone marrow involvement.
- ✓ 2. Platelets≥50,000 with no transfusion within 7 days unless patient has biopsy proven bone marrow involvement.
- ✓ 3. Hemoglobin ≥8g/dL (≥80 g/L) \[blood transfusions are allowable to reach this goal\].
- ✓ 4. Adequate hepatic function, defined as aspartate aminotransferase (AST) and alanine transaminase (ALT) \<3 x upper limit of normal (ULN) or \< 5 x ULN with documented liver involvement; serum bilirubin \<1.5 x ULN or \<3 x ULN with documented liver involvement , or considered not clinically significant as per the clinical PIs discretion (e.g. Gilbert's or indirect hyperbilirubinemia) or felt to be due to underlying disease.
- ✓ 5. Adequate renal function, defined as creatinine clearance≥50 ml/min.
- ✓ 1. No IV hydration within 24 hours of eligibility.
- ✓ 2. No dialysis dependent renal failure.
- ✓ 1. Recovery of neutrophils count after CAR T-cell infusion with ANC ≥1000/dL without G-CSF within the last 7 days.
You may not qualify if…
- ✕ A potential subject who meets any of the following exclusion criteria is ineligible to participate in the study.
- ✕ 1. Positive beta-human chorionic gonadotropin (HCG) in female of child-bearing potential or plan to become pregnant during the study or within 1 month of the last dose of study treatment and women who are current lactating or plan to breastfeed during the study or within 1 week of the last dose of study treatment.
- ✕ 2. Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection based on criteria below:
- ✕ 1. HBV: Patients with positive hepatitis B surface antigen (HBsAg) are excluded. Patients with positive hepatitis B core antibody (anti-HBc) and negative HBsAg require hepatitis B polymerase chain reaction (PCR) evaluation before randomization. Patients who are hepatitis B PCR positive will be excluded.
- ✕ 2. Hepatitis C virus (HCV): positive hepatitis C antibody. If positive hepatitis C antibody result, patient will need to have a negative result for hepatitis C ribonucleic acid (RNA) before randomization. Patients who are hepatitis C RNA positive will be excluded.
- ✕ 3. Known active cytomegalovirus (CMV) infection (Unknown or negative status are eligible).
- ✕ 4. History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon requiring steroid therapy defined as \>20 mg of prednisone or equivalent daily.
- ✕ 5. Presence of ≥ grade 3 non-hematologic toxicities as per CTCAE version 5.0 from any previous treatment unless it is felt to be due to underlying disease.
Where it's recruiting
Wisconsin
Milwaukee
Source: ClinicalTrials.gov · NCT05990465 · last updated 2026-08-06