Actively Recruiting
Pilot Study of Anti-CD19 Chimeric Antigen Receptor T Cells (CAR-T Cells) for the Treatment of Relapsed/Refractory CD19+ Malignancies
Led by University of Utah · Updated on 2026-02-17
10
Participants Needed
1
Research Sites
166 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open label, non-randomized, phase 1 study of anti-CD19 CAR-T cells against relapsed CD19 positive NHL, CLL and ALL based in a lymphodepletion regimen (fludarabine and cyclophosphamide) and using a CellReGen-based process for manufacturing CAR-T cells. This study will utilize a staggered enrollment design with a safety observation period.
CONDITIONS
Official Title
Pilot Study of Anti-CD19 Chimeric Antigen Receptor T Cells (CAR-T Cells) for the Treatment of Relapsed/Refractory CD19+ Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with relapsed or refractory CD19-positive malignancy, including non-Hodgkin lymphoma, acute lymphoblastic leukemia, or chronic lymphocytic leukemia/Richter's syndrome, confirmed by testing
- Disease has relapsed or is refractory after at least two prior lines of therapy
- ECOG Performance Status of 2 or less
- Life expectancy greater than 12 weeks
- Willing to consent to 15 years of follow-up
- Adequate organ function: ANC at least 500/mm3, platelet count at least 10,000/mm3, hemoglobin at least 8 g/dL
- Liver function within limits: total bilirubin no more than 1.5 times upper normal limit, AST/ALT no more than 3 times upper normal limit
- Kidney function within limits: serum creatinine no more than twice upper normal limit or eGFR above 30 ml/min/1.73m2
- For those who can bear children: negative pregnancy test or confirmed post-menopausal or permanently sterilized
- Use of effective contraception if of childbearing potential or having a partner who is
- Recovery to baseline or less than or equal to grade 2 toxicity from prior cancer therapy unless stable
- Adequate venous access
- Able to provide informed consent and sign approved consent form
- Confirmation of successful CAR-T manufacturing and no infection within 7 days before lymphodepletion
- Stable clinical status without infection or worsening condition before lymphodepletion and before CAR-T therapy
- Compliance with required medication washout periods
You will not qualify if you...
- Stem cell transplant or CAR-T therapy within 6 weeks before planned CAR-T infusion
- Active infection requiring systemic treatment
- Autoimmune disease requiring immunosuppressive medication within 6 months
- Pregnant or breastfeeding women
- Receiving other investigational agents
- Major surgery within 4 weeks prior to study drug or not recovered from surgery
- Second malignancy diagnosed within 2 years except for certain low-risk cancers
- Known brain metastases or cranial epidural disease unless treated and stable for at least 4 weeks
- Uncontrolled significant illness including serious heart conditions, stroke, prolonged QTc, low ejection fraction, uncontrolled hypertension
- Other medical or psychological conditions that would interfere with study participation
- Active infections including tuberculosis, hepatitis B or C, or HIV unless resolved or controlled
- Severe allergy to the investigational product or its components
- Taking prohibited medications without completing washout periods
- History of significant central nervous system disorders such as epilepsy, seizures, severe brain injuries, dementia, or Parkinson's disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
R
Rachel Kingsford
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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