Actively Recruiting
Evaluating the Safety and Efficacy of DuoCAR20.19.22-D95 in Adult Patients With Relapsed or Refractory B-cell Malignancies
Led by University of Kansas Medical Center · Updated on 2026-05-14
54
Participants Needed
1
Research Sites
778 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This multicenter phase 1 trial with "3 + 3" dose escalation design seeks to examine the feasibility and safety of the administration of autologous T cells that have been modified through the introduction of chimeric antigen receptors targeting the B cell surface antigens CD19/20/22 following administration of a chemotherapy lymphodepletion regimen in adults with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL) or Non-Hodgkin's lymphoma (NHL). The overall goals of this study are to estimate maximum tolerated dose (MTD) level, establish the overall safety profile and evaluate initial efficacy of administering duo-CAR-T cell treatment in this patient population.
CONDITIONS
Official Title
Evaluating the Safety and Efficacy of DuoCAR20.19.22-D95 in Adult Patients With Relapsed or Refractory B-cell Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand the study and sign informed consent
- Women of childbearing potential must have a negative pregnancy test within 48 hours before preparatory treatment
- Histologically confirmed aggressive B-cell ALL or NHL with specific antigen expression (CD19, CD20, CD22)
- Relapsed or refractory disease as defined by specific criteria including prior therapies and disease status
- Prior CAR T therapy allowed if completed at least 3 months before
- At least 1 measurable lesion per lymphoma response criteria
- At least 3 months from allogeneic stem cell transplant and off immunosuppressive medications for at least 4 weeks
- Meet institutional criteria for leukapheresis or have stored leukapheresis product
- ECOG performance status 0 to 2
- Adequate blood counts and organ function
- Adults aged 18 years or older with no upper age limit
- Life expectancy longer than 2 months
- Agreement to use contraception or sexual abstinence from consent until 12 months after infusion or until CAR T cells are undetectable
You will not qualify if you...
- Diagnosis of CLL, Richter's transformation, or Burkitt lymphoma
- Active central nervous system involvement by cancer
- Chemotherapy other than lymphodepleting agents within 2 weeks of infusion
- Use of investigational drugs within 30 days before screening
- Use of certain medications including therapeutic steroids or immunosuppressants close to infusion
- Prior radiation therapy within 2 weeks of infusion
- Active hepatitis B or C infection, HIV positive status (except false positive due to prior CAR T)
- Uncontrolled serious infections
- Recent heart attack or unstable angina within 6 months
- Other active or recent cancers except specified exceptions
- Participation in other therapeutic clinical trials
- Pregnant or breastfeeding
- Intolerance to cell product components
- Uncontrolled cardiac arrhythmia
- Active COVID-19 infection
- Active graft-versus-host disease requiring systemic steroids
- Active neurological autoimmune or inflammatory disorders
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Kansas Cancer Center
Westwood, Kansas, United States, 66205
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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