Actively Recruiting
Preliminary Safety and Tolerability of CD19x22 CAR T Cells in Adolescent and Adult R/R B-NHL Patients
Led by University of Colorado, Denver · Updated on 2025-12-24
68
Participants Needed
1
Research Sites
310 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This open-label, single arm phase 1 trial aims to determine the safety and tolerability of anti-CD19 and anti-CD22 chimeric antigen receptor-expressing (CAR) T cells (CD19x22 CAR T) in adolescents and adults with relapsed/refractory (R/R) B-cell Non-Hodgkin Lymphoma (B-NHL). This trial will determine the maximum tolerated dose of CD19x22 CAR T cells using a standard 3+3 trial design.
CONDITIONS
Official Title
Preliminary Safety and Tolerability of CD19x22 CAR T Cells in Adolescent and Adult R/R B-NHL Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 16 years or older (first three participants must be 18 or older)
- Histologically confirmed aggressive B-cell NHL, mantle cell lymphoma, or primary/secondary CNS lymphoma as defined
- No signs or symptoms of CNS disease for non-CNS B-NHL cohort; CNS lymphoma must have measurable CNS disease
- Disease progression, stabilization, or recurrence after at least two prior therapies including anthracycline and anti-CD20 antibody for B-NHL, or specified therapies for MCL
- Measurable or evaluable disease as per International Working Group criteria
- Prior stem cell transplantation allowed with specific conditions
- Stable toxicities from prior therapy (≤ grade 1)
- ECOG performance status 0-2 or Karnofsky ≥ 80%
- Adequate organ function as defined by specific blood counts, liver, kidney, cardiac, and pulmonary function
- Negative pregnancy test for females of childbearing potential
- Willingness to use birth control during study and for 12 months after infusion
- Ability to give informed consent and consent to long-term follow-up
You will not qualify if you...
- Age under 16 years
- Intolerance to contrast-enhanced MRI (for CNS lymphoma cohort)
- History of other malignancies unless disease-free for at least 3 years (with exceptions)
- Uncontrolled infections requiring antimicrobials
- Known HIV or hepatitis B or C infection
- Recent significant cardiac events or cardiac lymphoma involvement
- Unstable venous thrombosis or embolism
- Severe hypersensitivity to study agents
- Pregnancy or lactation
- Inability to comply with study procedures or long-term follow-up
- Any medical condition that might interfere with safety or efficacy assessment
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
D
Derek Schatz
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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