Actively Recruiting
Phase 1 Study of Bispecific CD19 and CD22 CAR T Cells in Adolescents and Adults With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma
Led by University of Colorado, Denver · Updated on 2025-12-24
68
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of a new therapy using special immune cells called CD19x22 CAR T cells in adolescents and adults with relapsed or refractory B-cell Non-Hodgkin Lymphoma (B-NHL). This phase 1 trial aims to find the highest safe dose of these cells and observe their effects in patients who have not responded to previous treatments, including those who had earlier CAR T cell therapy. The study also looks at how well the therapy can be produced and infused. Participants receive lymphodepleting chemotherapy before getting an infusion of the CD19x22 CAR T cells. The study has three groups based on different lymphoma types and doses, including non-CNS B-NHL, mantle cell lymphoma, and primary or secondary CNS lymphoma. The therapy is given as a single infusion after chemotherapy, and dosing starts at different levels depending on the group. During the study, participants will be closely monitored for safety and side effects for up to 12 months after infusion. Researchers will check response to treatment at 90 days and one year, including complete or partial remission and disease progression. Assessments include physical exams, laboratory tests, imaging, and long-term follow-up. The total study duration depends on individual treatment and monitoring schedules.
CONDITIONS
Brief 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, with the first three subjects being at least 18 years old
- Histologically confirmed aggressive B-cell Non-Hodgkin Lymphoma types as defined by WHO 2008
- No signs or symptoms of CNS disease for Cohort 1; prior CNS disease treated and stable allowed
- Disease progression, stabilization, or recurrence after at least two lines of therapy including anthracycline and anti-CD20 monoclonal antibody
- Measurable or evaluable disease according to International Working Group criteria
- Mantle Cell Lymphoma patients with relapsed/refractory disease after at least two lines of therapy including anti-CD20, BTK inhibitor, anthracycline or bendamustine
- Primary or secondary CNS lymphoma with measurable CNS disease and no measurable disease outside CNS
- Prior autologous stem cell transplantation with progression or relapse allowed
- Allogeneic stem cell transplant recipients eligible if at least 100 days post-transplant and no active graft versus host disease
- Stable toxicities from prior therapy at grade 1 or lower (exceptions apply)
- ECOG performance status 0-2 or Karnofsky score 80% or higher
- Adequate organ function including blood counts, kidney, liver, heart, and lung function
- Negative pregnancy test for females of childbearing potential
- Willingness to use birth control during study and for 12 months after infusion
- Able to give informed consent and agree to long-term follow-up
You will not qualify if you...
- Age under 16 years
- Allergy or intolerance to contrast-enhanced MRI (for Cohort 3 only)
- History of other malignancies unless disease-free for at least 3 years (with exceptions)
- Uncontrolled infections requiring antimicrobial treatment
- Known HIV or hepatitis B or C infection
- Recent significant cardiac disease or involvement of lymphoma in heart
- Unstable venous thrombosis or embolism
- Medical conditions interfering with safety or efficacy assessment
- History of severe allergic reaction to study agents
- Pregnancy or lactation
- Unlikely to complete all study visits or comply with requirements
- Unwillingness to participate in required long-term follow-up
- Failure to meet specific eligibility criteria before lymphodepleting chemotherapy or CAR T cell infusion as defined in protocol
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.
Duration - Up to 12 months post infusion
Participants receive lymphodepleting chemotherapy followed by infusion of CD19x22 CAR T Cells to treat relapsed/refractory B-cell Non-Hodgkin Lymphoma.
1 infusion visit and multiple follow-up visits during the first 12 months
Trial Site Locations
Total: 1 location
1
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
D
Derek Schatz
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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