Chronic Lymphocytic LeukemiaPhase 1NCT05694364
Dose Escalation/Dose Expansion Study of PRGN-3007 UltraCAR-T Cells in Patients With Advanced Hematologic and Solid Tumor Malignancies
A Phase 1 study testing Fludarabine, Cyclophosphamide and PRGN-3007 in people with Chronic Lymphocytic Leukemia and Mantle Cell Lymphoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The purpose of the study is to find out if an investigational drug called PRGN-3007 UltraCAR-T cells (PRGN-3007 T cells) can help people with ROR1-positive hematologic chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), acute lymphoblastic leukemia (ALL), diffuse large B-cell lymphoma (DLBCL) and solid… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma, Acute Lymphoblastic Leukemia
- What is being tested?
- Fludarabine, Cyclophosphamide and PRGN-3007
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2023to 18 Apr 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Age 18 years and older
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1; or Karnofsky Performance Status (KPS) of ≥ 70%.
- Life expectancy ≥ 12 weeks from the time of enrollment
- Must have adequate organ function, as defined in protocol.
- Patients must be at least 2 weeks or 5 half-lives (whichever is shorter)post systemic steroids prior to enrollment except as premedication for contrast allergy
- Negative serum pregnancy test for women of child bearing potential (WOCBP). Fertile male and female patients must be willing to use a contraceptive method before, during, and for at least 12 months after the last T cell infusion
- All patients must have the ability to understand and willingness to sign a written informed consent form (ICF).
Who cannot join
- Patient has received any of the following treatments prior to leukapheresis: cytotoxic chemotherapy or radiation therapy within 14 days; an antineoplastic monoclonal antibody within prior 4 weeks; prior targeted therapy 14 days or 5 half-lives from the last dose whichever is shorter; or prior systemic inhibitory/stimulatory immune checkpoint molecule therapy (eg, ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists) within 3 half-lives; or has not recovered from (i.e., ≤ grade 1) adverse event (AE) caused by prior treatment. Exceptions include hydroxyurea, single agent vincristine or steroids for uncontrolled ALL.
- Burkitt lymphoma is excluded.
- Prior allogeneic hematopoietic stem cell transplant (HSCT) or donor lymphocyte infusion within 6 months prior to enrollment, current acute graft versus host disease grade 2-4 by Glucksberg criteria or severity B-D by by International Bone Marrow Transplant Registry (IBMTR) index or history of severe (grade 3-4) acute graft versus host disease.
- Patients with a history of immunodeficiency (except for acquired hypogammaglobulinemia), patients with active autoimmune disease requiring systemic immunosuppressive therapy (i.e., > 15 mg of prednisone daily or equivalent), or patients who have received any other form of immunosuppressive therapy within 7 days prior to leukapheresis.
- Patients with a history of autoimmune disease resulting in end-organ injury are not eligible unless attributable to primary disease which is target of this study
- Patient requires treatment with warfarin.
Show all 21Show fewer
- Patients who have contraindication to the lymphodepletion chemotherapy regimen
- Patient received a live vaccine administration within 4 weeks prior to leukapheresis
- Patient is currently participating in another investigation treatment study, or has participated in a study of an investigational agent within 4 weeks prior to leukapheresis.
- Patients with clinically significant pulmonary dysfunction, as determined by medical history and physical exam should undergo pulmonary function testing; those with a forced expiratory volume at one second(FEV1) of ≤ 65% or diffuse capacity lung for carbon monoxide (DLCO; corrected) < 40% will be excluded
- Patients with history of other active malignancy within 1 year prior to enrollment.
- Patients with adequately resected basal or squamous cell carcinoma of the skin, non-melanoma skin cancer or carcinoma in situ (e.g., skin, cervix, bladder, breast), superficial bladder cancer, asymptomatic localized low grade prostate cancer for which watch-and-wait approach is standard of care, or any other cancer that has been in remission are eligible
- History of concomitant genetic syndrome associated with bone marrow failure such as Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome
- Known human immunodeficiency virus (HIV) seropositivity or active hepatitis B or C infection. A history of hepatitis B or C is permitted if the viral load is undetectable by quantitative assay
- Ongoing uncontrolled serious infection, clinically significant cardiac disease (i.e.,symptomatic congestive heart failure, myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, uncontrolled cardiac arrhythmia), poorly controlled pulmonary disease (no clinically significant pleural effusion), or psychiatric illness/social situations that would limit compliance with study requirements within 12 months prior to enrollment.
- History of any central nervous system (CNS) disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, any autoimmune disease with CNS involvement, posterior reversible encephalopathy syndrome, or cerebral edema
- History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to enrollment
- CNS lymphoma, untreated CNS metastases, leptomeningeal disease and/or carcinomatous meningitis; patients with a history of brain metastases that are previously treated, stable, and off systemic steroids for over 30 days prior to screening are eligible
- Patients that have not recovered from major acute infections and/or recent surgical procedures
- Toxicities due to prior therapy must be stable and recovered to ≤ grade 1 (except for clinically non-significant toxicities such as alopecia)
- Patients, who in the opinion of the investigator, may not be able to comply with the monitoring requirements of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1/1b Dose Escalation/Dose Expansion Study of PRGN-3007 UltraCAR-T Cells in Patients With Advanced Hematologic and Solid Tumor Malignancies
The purpose of the study is to find out if an investigational drug called PRGN-3007 UltraCAR-T cells (PRGN-3007 T cells) can help people with ROR1-positive hematologic chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), acute lymphoblastic leukemia (ALL), diffuse large B-cell lymphoma (DLBCL) and solid tumor triple negative breast cancer (TNBC) malignancies.
- Conditions
- Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma, Acute Lymphoblastic Leukemia, Diffuse Large B Cell Lymphoma, Triple Negative Breast Cancer Malignancies
- Being tested
- Fludarabine, Cyclophosphamide, PRGN-3007
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Mantle-Cell, 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.
FludarabineDrug
Also called Fludara
Fludarabine is an antimetabolite given prior to lymphodepletion.
CyclophosphamideDrug
Cyclophosphamide is a nitrogen mustard-derivative, polyfunctional alkylating agent given prior to lymphodepletion.
PRGN-3007Biological
PRGN-3007 T cells are autologous T cells that are genetically modified ex vivo with the Sleeping Beauty (SB) system to express a ROR1-specific chimeric antigen receptor (ROR1 CAR), membrane bound interleukin-15 (mbIL15), a kill switch derived from truncated form of human epidermal growth factor receptor (HER1t) and include a built-in mechanism for intrinsic downregulation of programmed cell death receptor 1 (PD-1) expression on UltraCAR-T cells.The transgenes are delivered from a SB transposon which ensures co-expression all transgenes in all transfected cells. T cells are selected from the apheresis product and can be modified with the SB system to manufacture the T cells with the potential of infusing within 2 days from genetic modification.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Dose Escalation (Group A) | Experimental | Participants from group A (hematologic malignancies) will undergo leukapheresis followed by lymphodepletion and infusion of PRGN-3007. Lymphodepletion will include 3 days of treatment with fludarabine (30 mg/m^2) and cyclophosphamide (500 mg/m^2) prior to study day 0.
Participants will then receive PRGN-3007 in 3 dose levels beginning at Dose Level 1, using a standard 3+3 escalation design to determine Maximum Tolerated Dose (MTD). The target maximum doses infused at each dose level is:
Dose Level 1: 1x10^6 cells/kg Dose Level 2: 3x10^6 cells/kg Dose Level 3: 1x10^7 cells/kg Receives: Drug: Fludarabine; Drug: Cyclophosphamide; Biological: PRGN-3007 |
| Phase 1 Dose Escalation (Group B) | Experimental | Participants from group B (solid tumors) will undergo leukapheresis followed by lymphodepletion and infusion of PRGN-3007. Lymphodepletion will include 2 days of cyclophosphamide (500 mg/m^2) prior to study day 0.
Participants will then receive PRGN-3007 in 3 dose levels beginning at Dose Level 1, using a standard 3+3 escalation design to determine Maximum Tolerated Dose (MTD). The target maximum doses infused at each dose level is:
Dose Level 1: 1x10^6 cells/kg Dose Level 2: 3x10^6 cells/kg Dose Level 3: 1x10^7 cells/kg Receives: Drug: Cyclophosphamide; Biological: PRGN-3007 |
| Phase 1b Dose Expansion (Group A) | Experimental | Participants from group A (hematologic malignancies) will undergo leukapheresis followed by lymphodepletion and infusion of PRGN-3007. Lymphodepletion will include 3 days of treatment with fludarabine (30 mg/m^2) and cyclophosphamide (500 mg/m^2) prior to study day 0. Participants will then receive PRGN-3007 at the dose level determined to be the Maximum Tolerated Dose (MTD) in the dose escalation portion of the study. Receives: Drug: Fludarabine; Drug: Cyclophosphamide; Biological: PRGN-3007 |
| Phase 1b Dose Expansion (Group B) | Experimental | Participants from group B (solid tumors) will undergo leukapheresis followed by lymphodepletion and infusion of PRGN-3007. Lymphodepletion will include 2 days of cyclophosphamide (500 mg/m^2) prior to study day 0.Participants will then receive PRGN-3007 at the dose level determined to be the Maximum Tolerated Dose (MTD) in the dose escalation portion of the study. Receives: Drug: Cyclophosphamide; Biological: PRGN-3007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of PRGN-3007 (Group A)
Maximum Tolerated Dose of of PRGN-3007 in patients with hematologic malignancies.
Measured: Up to 12 months
Maximum Tolerated Dose (MTD) of PRGN-3007 (Group B)
MTD of PRGN-3007 in patients with solid tumors
Measured: Up to 12 months
Secondary outcomes (2)
Overall Response Rate
Overall Response Rate is defined as the rate of the best overall response as complete response (CR) or partial response (PR)
Measured: at 12 months
Disease Control Rate
Disease Control Rate is defined as the proportion of subjects experiencing Complete Response (CR), Partial Response (PR) or Stable Disease (SD).
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start25 Jan 2023
- Primary completion18 Apr 2024
- Study completion18 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Precigen, Inc
- Responsible party
- Sponsor
- Investigators
- Javier Pinilla-Ibarz, MD, PhD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05694364
- Sponsor's protocol ID
- MCC-21622
- Other IDs
- PRGN-3007
- Status last verified
- Feb 2026
- First submitted
- 12 Jan 2023
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/1b Dose Escalation/Dose Expansion Study of PRGN-3007 UltraCAR-T Cells in Patients With Advanced Hematologic and Solid Tumor Malignancies
- ClinicalTrials.gov ID
- NCT05694364
- Acronym / sponsor ID
- MCC-21622
- Conditions
- Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma, Acute Lymphoblastic Leukemia, Diffuse Large B Cell Lymphoma, Triple Negative Breast Cancer Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Precigen, Inc
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- 18 Apr 2024 (actual)
- Study completion
- 18 Apr 2024 (actual)
- First posted
- 23 Jan 2023 (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.
The purpose of the study is to find out if an investigational drug called PRGN-3007 UltraCAR-T cells (PRGN-3007 T cells) can help people with ROR1-positive hematologic chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), acute lymphoblastic leukemia (ALL), diffuse large B-cell lymphoma (DLBCL) and solid tumor triple negative breast cancer (TNBC) malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Dose Escalation (Group A) | Experimental | Drug: Fludarabine, Drug: Cyclophosphamide, Biological: PRGN-3007Participants from group A (hematologic malignancies) will undergo leukapheresis followed by lymphodepletion and infusion of PRGN-3007. Lymphodepletion will include 3 days of treatment with fludarabine (30 mg/m^2) and cyclophosphamide (500 mg/m^2) prior to study day 0. Participants will then receive PRGN-3007 in 3 dose levels beginning at Dose Level 1, using a standard 3+3 escalation design to determine Maximum Tolerated Dose (MTD). The target maximum doses infused at each dose level is: Dose Level 1: 1x10^6 cells/kg Dose Level 2: 3x10^6 cells/kg Dose Level 3: 1x10^7 cells/kg |
| Phase 1 Dose Escalation (Group B) | Experimental | Drug: Cyclophosphamide, Biological: PRGN-3007Participants from group B (solid tumors) will undergo leukapheresis followed by lymphodepletion and infusion of PRGN-3007. Lymphodepletion will include 2 days of cyclophosphamide (500 mg/m^2) prior to study day 0. Participants will then receive PRGN-3007 in 3 dose levels beginning at Dose Level 1, using a standard 3+3 escalation design to determine Maximum Tolerated Dose (MTD). The target maximum doses infused at each dose level is: Dose Level 1: 1x10^6 cells/kg Dose Level 2: 3x10^6 cells/kg Dose Level 3: 1x10^7 cells/kg |
| Phase 1b Dose Expansion (Group A) | Experimental | Drug: Fludarabine, Drug: Cyclophosphamide, Biological: PRGN-3007Participants from group A (hematologic malignancies) will undergo leukapheresis followed by lymphodepletion and infusion of PRGN-3007. Lymphodepletion will include 3 days of treatment with fludarabine (30 mg/m^2) and cyclophosphamide (500 mg/m^2) prior to study day 0. Participants will then receive PRGN-3007 at the dose level determined to be the Maximum Tolerated Dose (MTD) in the dose escalation portion of the study. |
| Phase 1b Dose Expansion (Group B) | Experimental | Drug: Cyclophosphamide, Biological: PRGN-3007Participants from group B (solid tumors) will undergo leukapheresis followed by lymphodepletion and infusion of PRGN-3007. Lymphodepletion will include 2 days of cyclophosphamide (500 mg/m^2) prior to study day 0.Participants will then receive PRGN-3007 at the dose level determined to be the Maximum Tolerated Dose (MTD) in the dose escalation portion of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years and older
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1; or Karnofsky Performance Status (KPS) of ≥ 70%.
- Life expectancy ≥ 12 weeks from the time of enrollment
- Must have adequate organ function, as defined in protocol.
- Patients must be at least 2 weeks or 5 half-lives (whichever is shorter)post systemic steroids prior to enrollment except as premedication for contrast allergy
Key exclusion criteria (21 listed)
- Patient has received any of the following treatments prior to leukapheresis: cytotoxic chemotherapy or radiation therapy within 14 days; an antineoplastic monoclonal antibody within prior 4 weeks; prior targeted therapy 14 days or 5 half-lives from the last dose whichever is shorter; or prior systemic inhibitory/stimulatory immune checkpoint molecule therapy (eg, ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists) within 3 half-lives; or has not recovered from (i.e., ≤ grade 1) adverse event (AE) caused by prior treatment. Exceptions include hydroxyurea, single agent vincristine or steroids for uncontrolled ALL.
- Burkitt lymphoma is excluded.
- Prior allogeneic hematopoietic stem cell transplant (HSCT) or donor lymphocyte infusion within 6 months prior to enrollment, current acute graft versus host disease grade 2-4 by Glucksberg criteria or severity B-D by by International Bone Marrow Transplant Registry (IBMTR) index or history of severe (grade 3-4) acute graft versus host disease.
- Patients with a history of immunodeficiency (except for acquired hypogammaglobulinemia), patients with active autoimmune disease requiring systemic immunosuppressive therapy (i.e., > 15 mg of prednisone daily or equivalent), or patients who have received any other form of immunosuppressive therapy within 7 days prior to leukapheresis.
- Patients with a history of autoimmune disease resulting in end-organ injury are not eligible unless attributable to primary disease which is target of this study
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 |
|---|---|---|
| FludarabineAlso: FludaraFludarabine is an antimetabolite given prior to lymphodepletion. | Drug | Phase 1 Dose Escalation (Group A), Phase 1b Dose Expansion (Group A) |
| CyclophosphamideCyclophosphamide is a nitrogen mustard-derivative, polyfunctional alkylating agent given prior to lymphodepletion. | Drug | Phase 1 Dose Escalation (Group A), Phase 1 Dose Escalation (Group B), Phase 1b Dose Expansion (Group A), Phase 1b Dose Expansion (Group B) |
| PRGN-3007PRGN-3007 T cells are autologous T cells that are genetically modified ex vivo with the Sleeping Beauty (SB) system to express a ROR1-specific chimeric antigen receptor (ROR1 CAR), membrane bound interleukin-15 (mbIL15), a kill switch derived from truncated form of human epidermal growth factor receptor (HER1t) and include a built-in mechanism for intrinsic downregulation of programmed cell death receptor 1 (PD-1) expression on UltraCAR-T cells.The transgenes are delivered from a SB transposon which ensures co-expression all transgenes in all transfected cells. T cells are selected from the apheresis product and can be modified with the SB system to manufacture the T cells with the potential of infusing within 2 days from genetic modification. | Biological | Phase 1 Dose Escalation (Group A), Phase 1 Dose Escalation (Group B), Phase 1b Dose Expansion (Group A), Phase 1b Dose Expansion (Group B) |
Primary outcome
Maximum Tolerated Dose (MTD) of PRGN-3007 (Group A)
Time frame: Up to 12 months
Maximum Tolerated Dose of of PRGN-3007 in patients with hematologic malignancies.
Maximum Tolerated Dose (MTD) of PRGN-3007 (Group B)
Time frame: Up to 12 months
MTD of PRGN-3007 in patients with solid tumors
2 secondary outcomes
Overall Response Rate
Time frame: at 12 months
Disease Control Rate
Time frame: at 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Javier Pinilla-Ibarz, MD, PhD principal investigator
Moffitt Cancer Center
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 Fludarabine, Cyclophosphamide and PRGN-3007 in people with Chronic Lymphocytic Leukemia and Mantle Cell Lymphoma, run by H. Lee Moffitt Cancer Center and Research Institute 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 7 inclusion and 21 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: finished, as of the sponsor's last update on 6 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) of PRGN-3007 (Group A) (time frame: Up to 12 months). The study lists 2 primary outcomes in all. 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 6 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.