Acute Lymphoblastic LeukemiaPhase 1PRODIGYNCT06227026
Pilot Study of Anti-CD19 Chimeric Antigen Receptor T Cells (CAR-T Cells) for the Treatment of Relapsed/Refractory CD19+ Malignancies
A Phase 1 study testing Anti-CD19 CAR-T cells in people with Acute Lymphoblastic Leukemia and Diffuse Large B Cell Lymphoma, run by University of Utah at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Diffuse Large B Cell Lymphoma
- What is being tested?
- Anti-CD19 CAR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2024to May 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Rachel Kingsford, 801-585-0115, Rachel.Kingsford@hci.utah.edu
Sagar Patel, MD
About this study
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.
- Being tested
- Anti-CD19 CAR-T cells
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-CD19 CAR-T cellsBiological
Anti-CD19 CAR-T cells are autologous T cells, engineered to express an extracellular single chain variable fragment (scFv) derived from a murine anti-human CD19 hybridoma clone FMC63 linked in frame to hinge region derived from human CD8, transmembrane domain derived from Tumor Necrosis Factor Receptor Super Family 19 (TNFRSF19) the transactivation costimulatory domain 4-1BB, and CD3 zeta signaling domain (Miltenyi Biotec Inc). Anti-CD19 CAR-T cells will be cryopreserved in infusible cryomedia for a later infusion. Anti-CD19 CAR-T cells will be administered in 1 to 3 bags. Bag aliquoting, cell content and cryomedia composition will be done according to specifications in the CMC.
| Study group | Role | What they receive |
|---|---|---|
| Anti-CD19 CAR-T Cell Infusion | Experimental | Not described Receives: Biological: Anti-CD19 CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 28 days
Secondary outcomes (3)
Objective response rate (ORR) defined as the proportion of subjects achieving a confirmed PR or CR at Day 28 and Month 3.
To assess the objective response rates (ORR) of subjects who have received anti-CD19 CAR-T cells
Measured: 3 months
Disease free survival at 1 year post CAR-T administration based on 2014 Lugano Criteria (NHL patients) , IWCLL criteria (CLL patients) or EWALL recommendations (ALL patients).
To assess disease-free survival (DFS)
Measured: 1 year
Overall survival as defined as the time from CAR-T administration until 6 months and 12 months post CAR-T administration
To assess overall survival (OS)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start20 Feb 2024
- Primary completionJul 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Lentigen Technology, Inc., Huntsman Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Sagar Patel, MD, Principal investigator, Huntsman Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06227026
- Sponsor's protocol ID
- 143560
- Acronym
- PRODIGY
- Status last verified
- Aug 2026
- First submitted
- 17 Jan 2024
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Anti-CD19 Chimeric Antigen Receptor T Cells (CAR-T Cells) for the Treatment of Relapsed/Refractory CD19+ Malignancies
- ClinicalTrials.gov ID
- NCT06227026
- Acronym / sponsor ID
- PRODIGY / 143560
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Lentigen Technology, Inc., Huntsman Cancer Institute
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 26 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-CD19 CAR-T Cell Infusion | Experimental | Biological: Anti-CD19 CAR-T cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (38 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-CD19 CAR-T cellsAnti-CD19 CAR-T cells are autologous T cells, engineered to express an extracellular single chain variable fragment (scFv) derived from a murine anti-human CD19 hybridoma clone FMC63 linked in frame to hinge region derived from human CD8, transmembrane domain derived from Tumor Necrosis Factor Receptor Super Family 19 (TNFRSF19) the transactivation costimulatory domain 4-1BB, and CD3 zeta signaling domain (Miltenyi Biotec Inc). Anti-CD19 CAR-T cells will be cryopreserved in infusible cryomedia for a later infusion. Anti-CD19 CAR-T cells will be administered in 1 to 3 bags. Bag aliquoting, cell content and cryomedia composition will be done according to specifications in the CMC. | Biological | Anti-CD19 CAR-T Cell Infusion |
Primary outcome
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.
Time frame: 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.
3 secondary outcomes
Objective response rate (ORR) defined as the proportion of subjects achieving a confirmed PR or CR at Day 28 and Month 3.
Time frame: 3 months
Disease free survival at 1 year post CAR-T administration based on 2014 Lugano Criteria (NHL patients) , IWCLL criteria (CLL patients) or EWALL recommendations (ALL patients).
Time frame: 1 year
Overall survival as defined as the time from CAR-T administration until 6 months and 12 months post CAR-T administration
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sagar Patel, MD principal investigator
Huntsman Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Anti-CD19 CAR-T cells in people with Acute Lymphoblastic Leukemia and Diffuse Large B Cell Lymphoma, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 38 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Kingsford (801-585-0115, Rachel.Kingsford@hci.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.