Pilot Study of Anti-CD19 CAR-T Cells for Relapsed/Refractory CD19+ Malignancies
This study is testing a treatment called Anti-CD19 CAR-T cells for people with certain types of blood cancers that have come back or are not responding to other treatments. These cancers include acute lymphoblastic leukemia (ALL) and diffuse large B cell lymphoma (DLBCL). Anti-CD19 CAR-T cells are your own immune cells (T cells) that have been specially changed in a lab to find and fight cancer cells that have a specific marker called CD19. To join, you must be at least 18 years old and have a confirmed CD19+ cancer. The main goal of this study is to see if the CAR-T cells can be successfully made and given to patients, and to check for serious side effects within 28 days of treatment. This is a small study aiming to enroll 10 participants.
- Study design
- This is an open-label, non-randomized pilot study, meaning everyone knows what treatment is being given, and participants are not randomly assigned to different groups. It's a Phase 1 study, which typically focuses on safety and dosage.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will specifically look at side effects within 28 days after you receive the CAR-T cell treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06227026
Pilot Study of Anti-CD19 Chimeric Antigen Receptor T Cells (CAR-T Cells) for the Treatment of Relapsed/Refractory CD19+ Malignancies
Recruiting
PHASE1Ages 18+InterventionalTreatmentUniversity of UtahInvestigator-initiated
~10 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:Anti-CD19 CAR-T cells
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Production and infusion of CAR-T therapy in 5/6 patients who have undergone successful apheresis and no more than 3/6 patients with ≥ grade 3 non-hematological CAR-T related toxicities or events of special interest within 28 days of CAR-T administration.
Measured over 28 days
Conditions
Where it's being run
1 sites across 1 statesUtah1
Study leadership
- Sagar Patel, MD · PRINCIPAL_INVESTIGATOR · Huntsman Cancer Institute
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Subjects aged ≥ 18 years.
Histologically confirmed relapsed or refractory CD-19+ malignancy, including: non-Hodgkin lymphoma (NHL), acute lymphoblastic leukemia (ALL), Chronic Lymphocytic Leukemia (CLL)/Richter's syndrome, primary CNS lymphoma. CD-19+ must be confirmed by immunohistochemistry or flow cytometry analysis.
Subjects who are relapsed or refractory to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy.
ECOG Performance Status ≤ 2.
Life expectancy \> 12 weeks.
Willing to consent to 15 years of follow-up as part of IRB 110692: Long-Term Evaluation of the Biology and Outcomes of Hematopoietic Stem Cell Transplantation
Adequate organ function as defined as:
Hematologic:
Absolute neutrophil count (ANC) ≥ 500/mm3
Platelet count ≥ 10,000/mm3
Hemoglobin ≥ 8 g/dL
Hepatic:
Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN).
AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN
Renal:
Serum Creatinine ≤ 2 x institutional upper limit of normal (ULN) or eGFR \>30 ml/min/1.73m2
For subjects of childbearing potential: Negative pregnancy test or evidence of post-menopausal status or evidence of permanent surgical sterilization. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause or having undergone surgical sterilization (bilateral oophorectomy or hysterectomy). The following age-specific requirements apply:
Subjects \< 50 years of age:
Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and
Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution
Subjects ≥ 50 years of age:
Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or
Had radiation-induced menopause with last menses \>1 year ago; or
Had chemotherapy-induced menopause with last menses \>1 year ago
Subjects of childbearing potential and subjects with a sexual partner of childbearing potential must agree to use a highly effective method of contraception as described in Section 5.4.1.
Recovery to baseline or ≤ Grade 2 CTCAE v5.0 from toxicities related to any prior cancer therapy, unless considered stable by the treating investigator.
Adequate venous access.
Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
Step 2 Eligibility Confirmation
The following criteria must be confirmed within 7 days prior to lymphodepletion. If all criteria are not met, lymphodepletion should be delayed.
Confirmation of successful CAR-T manufacturing.
No evidence or suspicion of an infection.
Serum Creatinine ≤ 2 x institutional upper limit of normal (ULN) or eGFR \>30 ml/min/1.73m2
No worsening of clinical status compared to either the initial eligibility criteria that would, in the opinion of the treating physician, significantly increase the risk from lymphodepleting chemotherapy or exclude them from treatment with study CAR-T therapy.
Step 3 Eligibility Confirmation
The following criteria must be confirmed prior to CAR-T therapy. If all criteria are not met, CAR-T therapy should be delayed.
No worsening of clinical status compared to either the initial eligibility criteria that would, in the opinion of the treating physician, significantly increase the risks from treatment with CAR-T therapy.
Confirmation that washout periods outlined in section 6.6 and Appendix 10 have been followed.
Exclusion
Autologous or allogeneic stem cell transplant or CAR-T therapy within 6 weeks of planned CAR-T cell infusion.
Subjects with active infection that requires systemic treatment
History of autoimmune disease (i.e. rheumatoid arthritis, systemic lupus erythematosus) with requirement of immunosuppressive medication within 6 months.
Pregnant or breastfeeding women are excluded from this study because CAR-T cell therapy may be associated with the potential for teratogenic or abortifacient effects. Women of child bearing potential must have a negative serum pregnancy test. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with CAR-T cells, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study.
Receiving other investigational agents.
Confirmation that washout periods listed in Appendix 10 have been followed.
Major surgery 4 weeks prior to starting study drug or who have not fully recovered from major surgery.
The diagnosis of another malignancy within ≤ 2 years before study enrollment, except for those considered to be adequately treated with no evidence of disease or symptoms and/or will not require therapy during the study duration (i.e., basal cell or squamous cell skin cancer, carcinoma in situ of the breast, bladder or of the cervix, or low-grade prostate cancer with Gleason Score ≤ 6). Patients with transformed disease are allowed.
Known brain metastases or cranial epidural disease. Note: Brain metastases or cranial epidural disease adequately treated with radiotherapy and/or surgery and stable for at least 4 weeks before the first dose of study treatment will be allowed on trial. Subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of the first dose of study treatment.
Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions:
Cardiovascular disorders:
Congestive heart failure New York Heart Association Class III or IV, unstable angina pectoris, serious cardiac arrhythmias.
Stroke (including transient ischemic attack \[TIA\]), myocardial infarction (MI), or other ischemic events, or thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 3 months before the first dose.
QTc prolongation defined as a QTcF \> 500 ms.
Known congenital long QT.
Left ventricular ejection fraction \< 55%.
Uncontrolled hypertension defined as ≥ 140/90 as assessed from the mean of three consecutive blood pressure measurements taken over 10 minutes.
Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, \[subjects may not receive the drug through a feeding tube\], social/ psychological issues, etc.)
Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination, radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or seropositive HIV. Note: Subjects with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \[anti-HBc\] and absence of HBsAg) are eligible. Subjects positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
Medical, psychiatric, cognitive, or other conditions that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol or complete the study.
Known prior severe hypersensitivity to investigational product (IP) or any component in its formulations (NCI CTCAE v5.0 Grade ≥ 3).
Subjects taking prohibited medications as described in Section 6.6 and Appendix 10. Unless otherwise stated, a washout period of prohibited medications for a period of at least five half-lives or as clinically indicated should occur before the start of treatment.
Subjects with history of clinically relevant CNS pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia and Parkinson's disease.
What this trial measures
- Production and infusion of CAR-T therapy in 5/6 patients who have undergone successful apheresis and no more than 3/6 patients with ≥ grade 3 non-hematological CAR-T related toxicities or events of special interest within 28 days of CAR-T administration.28 days
To assess the feasibility of administering CAR-T cells targeting CD19 for the treatment of relapsed/refractory B cell lymphomas, relapsed/refractory chronic lymphocytic leukemia (CLL), Richter's Syndrome, or relapsed/refractory acute lymphoblastic leukemia (ALL). Feasibility is defined as production and infusion of CAR-T therapy in 5/6 patients who have undergone successful apheresis and no more than 3/6 patients with ≥ grade 3 non-hematological CAR-T related toxicities or Events of Special Interest within 28 days of CAR-T administration.