Non Hodgkin LymphomaPhase 1NCT05400109
Evaluate the Safety of UF-KURE19 Cells in Non-Hodgkin Lymphomas
A Phase 1 study testing UF-KURE19 CAR-T cells, Fludarabine and Cyclophosphamide in people with Non Hodgkin Lymphoma, run by David Wald at 3 sites in United States.
Trial summary
This study seeks to determine the safety and efficacy of the infusion of autologous CD19 CAR-T cells that are manufactured using an ultra-fast process. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Hodgkin Lymphoma
- What is being tested?
- UF-KURE19 CAR-T cells, Fludarabine and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Apr 2023to 1 Oct 2026
- 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
- Male or female patients aged 18 years or older.
- Participants must have histologically confirmed, CD19 positive (by IHC or flow cytometry) NHL that meets at least one of the following treatment indications.
- Relapsed after 2 or more lines of chemotherapy, (or)
- Refractory to chemotherapy, defined as: Progressive disease while receiving last chemotherapy, or Persistent disease after first line chemotherapy treatment with curative intent or stable disease lasting ≤6 months after last chemotherapy, or relapse within 6 months of last chemotherapy, or disease progression or relapse ≤12 months after prior autologous stem cell transplant, (or)
- Relapsed disease that is ineligible to receive hematopoietic stem cell transplantation due to comorbidities or age or patient preference.
- ECOG Performance status ≤ 2.
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- At least one measurable lesion according to Lugano Revised Response Criteria for Malignant Lymphoma.
- Minimum of 2 weeks since prior radiation therapy or systemic therapy to treat malignancy at the time of leukapheresis.
- Total bilirubin ≤ 1.5X institutional upper limit of normal.
- AST (SGOT)/ALT (SGPT) ≤ 2.5 X institutional upper limit of normal.
- Calculated creatinine clearance ≥ 30mL/min estimated by the Cockcroft - Gault formula.
- Cardiac ejection fraction of ≥45%, and no more than trivial (or trace, minimal or mild) pericardial effusion, as determined by an echocardiogram.
- Adequate pulmonary function, defined as ≤ Grade 1 dyspnea (unless considered secondary to lymphoma) and oxygen saturation (SaO2) ≥ 92% on room air. If pulmonary function tests (PFTs) are performed based on the clinical judgment of the treating physician, patients with forced expiratory volume in 1 second (FEV1)
- ≥ 50% of predicted and diffusing capacity for carbon monoxide (DLCO) (corrected for hemoglobin) of ≥ 40% of predicted will be eligible.
- Participants (or legal guardians) must have the ability to understand and the willingness to sign a written informed consent document.
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of < 1% per year during the treatment period and for at least 90 days after the UF-KURE19 CAR-T cell infusion. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (< 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient.
- Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:
- With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of < 1% per year during the treatment period and for at least 6 months after the UF-KURE19 CAR-T cell infusion. Men must refrain from donating sperm during this same period. With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 6 months after the UF-KURE19 CAR-T cell infusion to avoid potential embryonal or fetal exposure.
- The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
- Subjects must meet all the following inclusion criteria to be eligible for enrollment:
- Male or female patients aged 18 years or older.
- Participants must have histologically confirmed, CD19 positive (by IHC or flow cytometry) NHL that meets at least one of the following treatment indications AND there will be a preference for subjects with LBCL including: Diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.
- Relapsed after 2 or more lines of chemotherapy, (Or)
- Refractory to chemotherapy, defined as: Progressive disease while receiving last chemotherapy, or Persistent disease after first line chemotherapy treatment with curative intent or stable disease lasting ≤6 months after last chemotherapy, or relapse within 6 months of last chemotherapy, or disease progression or relapse ≤12 months after prior autologous stem cell transplant, (Or)
- Relapsed disease that is ineligible to receive hematopoietic stem cell transplantation due to comorbidities or age or patient preference.
- Participants must exhibit both of the following:
- Nodal lesion: >= 1.5 cm or Non-nodal lesion: >= 1.0 cm
- FDG avid disease: Deauville Score of 3, 4, or 5 is required. If Deauville Score of 3, Sponsor must confirm eligibility.
- ECOG Performance status ≤ 2 [See Appendix 1].
- Minimum of 2 weeks since prior radiation therapy or systemic therapy to treat malignancy at the time of leukapheresis.
- Total bilirubin ≤ 1.5X institutional upper limit of normal.
- AST (SGOT)/ALT (SGPT) ≤ 2.5 X institutional upper limit of normal.
- Calculated creatinine clearance ≥ 30mL/min estimated by the Cockcroft - Gault formula. Cardiac ejection fraction of ≥45%, and no more than trivial (or trace, minimal or mild) pericardial effusion, as determined by an echocardiogram.
- Adequate pulmonary function, defined as ≤ Grade 1 dyspnea (unless considered secondary to lymphoma) and oxygen saturation (SaO2) ≥ 92% on room air. If pulmonary function tests (PFTs) are performed based on the clinical judgment of the treating physician, patients with forced expiratory volume in 1 second (FEV1)
- ≥ 50% of predicted and diffusing capacity for carbon monoxide (DLCO) (corrected for hemoglobin) of ≥ 40% of predicted will be eligible.
- Subjects (or legal guardians) must have the ability to understand and the willingness to sign a written informed consent document.
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of < 1% per year during the treatment period and for at least 90 days after the UF-KURE19 CAR-T cell infusion. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (< 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below: With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of < 1% per year during the treatment period and for at least 6 months after the UF-KURE19 CAR-T cell infusion. Men must refrain from donating sperm during this same period. With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 6 months after the UF-KURE19 CAR-T cell infusion to avoid potential embryonal or fetal exposure. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
Who cannot join
- The presence of any of the following will exclude a subject from study enrollment:
- Autologous stem cell transplant within 6 weeks of informed consent.
- History of allogeneic hematopoietic stem cell transplantation.
- Active central nervous system or leptomeningeal involvement by lymphoma. Subjects with untreated brain metastases/CNS disease will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Patients with a history of CNS or meningeal CASE 2422 Page 37 Version 13 02.03.2025 involvement must be in a documented remission by CSF evaluation and contrastenhanced MRI imaging for at least 90 days prior to registration.
- Second active malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast).
- Less than 28 days elapsed between prior treatment with investigational agent(s) and leukapheresis.
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- New York Heart Association class III-IV congestive heart failure. Cardiovascular disorders including unstable angina pectoris, clinically significant cardiac arrhythmias, myocardial infarction or stroke (including transient ischemic attack, or other ischemic event) within 6 months prior to registration.
- Known human immunodeficiency virus infection or acquired immunodeficiency syndrome related illness.
- 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 childbearing 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.
- Evidence of myelodysplastic syndrome or cytogenetic abnormality indicative of myelodysplasia on the most recent bone marrow biopsy prior to initiation of therapy.
- Serologic status reflecting active hepatitis B or C infection. Patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive patients will be excluded).
- Patients 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.
- Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities or psychiatric illness/social situations that would limit compliance with study requirements.
- History of active autoimmune disease (i.e. rheumatoid arthritis, systemic lupus erythematosus) with requirement of systemic immunosuppressive medications other than low dose steroids [i.e. maximum of 15mg prednisone equivalent] within the last 6 months.
- Circulating malignant B cells in peripheral blood detected by complete blood count at the time of subject enrollment.
- Phase Ib Cohort 1
- The presence of any of the following will exclude a subject from study enrollment:
- Autologous stem cell transplant within 6 weeks of informed consent.
- History of allogeneic hematopoietic stem cell transplantation.
- Active central nervous system or leptomeningeal involvement by lymphoma. Subjects with untreated brain metastases/CNS disease will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Patients with a history of CNS or meningeal involvement must be in a documented remission by CSF evaluation and contrast enhanced MRI imaging for at least 90 days prior to registration.
- Second active malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast).
- Less than 28 days elapsed between prior treatment with investigational agent(s) and leukapheresis.
- New York Heart Association class III-IV congestive heart failure.
- Cardiovascular disorders including unstable angina pectoris, clinically significant cardiac arrhythmias, myocardial infarction or stroke (including transient ischemic attack, or other ischemic event) within 6 months prior to registration.
- Known human immunodeficiency virus infection or acquired immunodeficiency syndrome related illness. 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 childbearing 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.
- Evidence of myelodysplastic syndrome or cytogenetic abnormality indicative of myelodysplasia on the most recent bone marrow biopsy prior to initiation of therapy.
- Serologic status reflecting active hepatitis B or C infection. Patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive patients will be excluded).
- Patients 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.
- Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities or psychiatric illness/social situations that would limit compliance with study requirements.
- History of active autoimmune disease (i.e. rheumatoid arthritis, systemic lupus erythematosus) with requirement of systemic immunosuppressive medications other than low dose steroids [i.e. maximum of 15mg prednisone equivalent] within the last 6 months.
- Circulating malignant B cells in peripheral blood detected by complete blood count at the time of subject enrollment.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
About this study
Official title: A Phase 1/1b Multicenter, Open Label Study to Evaluate the Safety of UF-KURE19 Cells in Patients With B Cell Non-Hodgkin Lymphomas
This study seeks to determine the safety and efficacy of the infusion of autologous CD19 CAR-T cells that are manufactured using an ultra-fast process.
Read the detailed description
This treatment uses T cells already present in the participant's body that have been modified outside of the body by a lentivirus and then returned by an infusion to target the cancer. Lentivirus is a family of viruses that can be used by scientists to alter cells. The specific type of cells that will be used is called UF-KURE19 chimeric antigen receptor T cells (CAR-T cells). The CAR-T cells that will be reinfused into the body are modified using a lentivirus that is no longer active. The investigators are evaluating UF-KURE19 because it uses a process that is shorter than other approved CAR-T cells. While the shorter manufacture time can be an advantage, the safety of this approach has not been demonstrated.
- Conditions
- Non Hodgkin Lymphoma
- Being tested
- UF-KURE19 CAR-T cells, Fludarabine, Cyclophosphamide
- Keywords
- UF-KURE19, CD19 CAR-T cells, Non Hodgkin Lymphoma
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UF-KURE19 CAR-T cellsBiological
UF-KURE19 cells are initially generated from a starting autologous apheresis sample. T cells are activated and transduced with Kure19 lentiviral vector that consists of a 3rd generation vector with an scFV (FMC63) that targets CD19. The product is harvested at 17-20hr after culture and cryopreserved
FludarabineDrug
Also called Fludara®, Fludarabine Phosphate
Fludarabine phosphate is rapidly dephosphorylated to 2-fluoro-ara-A and then phosphorylated intracellularly by deoxycytidine kinase to the active triphosphate, 2-fluoro-ara-ATP. This metabolite appears to act by inhibiting DNA polymerase alpha, ribonucleotide reductase and DNA primase, thus inhibiting DNA synthesis.
CyclophosphamideDrug
Also called Cytoxan ®, Endoxan®, Neosar®, Procytox®
The mechanism of action is thought to involve cross-linking of tumor cell DNA
| Study group | Role | What they receive |
|---|---|---|
| UF-KURE19 CAR-T cell infusion | Experimental | The safety and manufacturing feasibility of UF-KURE19 will be determined with up to 10 patients being enrolled. Lymphodepleting therapy will begin on Days -4 to -2 with each weight category of participants receiving 30mg/m2/IV of Fludarabine and 500mg/m2/IV of Cyclophosphamide regardless of the level of UF-KURE19 CAR-T cell dosing.
Dosing:
Participants greater than or equal to 50 kg:
* Level -1: 10 x 10^6 UF-KURE19 CAR-T Cell Dose (CAR positive cells)
* Level 1 : 17.5 x 10^6 UF-KURE19 CAR-T Cell Dose
Participants less than 50 kg:
* Level -1: 6.5 x 10^6 UF-KURE19 CAR-T Cell Dose
* Level 1: 11.5 x 10^6 UF-KURE19 CAR-T Cell Dose Receives: Biological: UF-KURE19 CAR-T cells; Drug: Fludarabine; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Recommended dose(s) of UF-KURE19 CAR-T Cells
Safety will be assessed by the number of DLT experienced at the target dose which is hypothesized to be less than 33%.
Measured: Up to 28 days after treatment
Phase 1: Toxicities associated with the target dose of UF-KURE19 CAR-T Cells
Toxicities will be reported as specific adverse events as a result of the target dose of UF-KURE19 CAR-T Cells. An adverse event (AE) is any unfavorable or unintended event, physical or psychological, associated with a research study, which causes harm or injury to a research participant as a result of the participant's involvement in a research study.
Measured: Up to 12 months after treatment
Phase 1b: Toxicities associated with the target dose of UFKURE19 in patients with Relapsed or Refractory Large B-cell Lymphoma (LBCL).
Measured: Up to 12 months after treatment
Phase 1b: Complete response rate (CRR) with UF-KURE19 in patients with Relapsed or Refractory LBCL.
Measured: Up to 12 months after treatment
Phase 1b: Objective response rate (ORR, CR + PR) with UF-KURE19 in patients with Relapsed or Refractory LBCL.
Measured: Up to 12 months after treatment
Phase 1b: CRR in double/triple hit lymphoma (DHL/THL) patients treated with first-line standard of care chemoimmunotherapy PLUS early intervention of UFKURE19.
Measured: Up to 12 months after treatment
Secondary outcomes (8)
Phase 1: Success rate of semi-automated CAR-T manufacturing process
Defined as the percentage of UF-Kure19 CAR-T patient products manufactured that meet the release criteria.
Measured: Up to 2 weeks after culture of UF-KURE19 CAR-T cells
Phase 1: Objective response rates per Lugano Revised Response Criteria for Malignant Lymphoma after treatment with UF-KURE19 in patients with relapsed or refractory non-Hodgkin lymphoma
Measured: Up to 12 months after treatment
Phase 1: Complete response rates per Lugano Revised Response Criteria for Malignant Lymphoma after treatment with UF-KURE19 in patients with relapsed or refractory non-Hodgkin lymphoma
Measured: Up to 12 months after treatment
Phase 1b cohort of Relapsed or Refractory LBCL: duration of response in patients treated with UF-KURE19
Measured: Up to 12 months after treatment
Phase 1b cohort of Relapsed or Refractory Large B cell Lymphoma(LBCL): Overall survival in patients treated with UF-KURE19
Measured: Up to 12 months after treatment
Phase 1b cohort of Relapsed or Refractory LBCL: Progression-free survival in patients treated with UF-KURE19
Measured: Up to 12 months after treatment
Phase 1b cohort of Relapsed or Refractory LBCL: Manufacturing success rate
Measured: Up to 2 weeks after culture of UF-KURE19 CAR-T cells
Phase 1b cohort of DHL/THL: PFS in DHL/THL patients treated with first-line standard of care chemoimmunotherapy PLUS early intervention of UF-KURE19.
Measured: Up to 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start26 Apr 2023
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Hodgkin LymphomaStudies of the same condition, open and under way.
- 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Wald
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David Wald, Case Comprehensive Cancer Center
- Investigators
- Changchun Deng, MD, PhD, Principal investigator, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05400109
- Sponsor's protocol ID
- CASE2422
- Status last verified
- Apr 2026
- First submitted
- 27 May 2022
- Last updated
- 5 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/1b Multicenter, Open Label Study to Evaluate the Safety of UF-KURE19 Cells in Patients With B Cell Non-Hodgkin Lymphomas
- ClinicalTrials.gov ID
- NCT05400109
- Acronym / sponsor ID
- CASE2422
- Conditions
- Non Hodgkin Lymphoma
- Keywords
- UF-KURE19, CD19 CAR-T cells, Non Hodgkin Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 21 participants (actual)
- Lead sponsor
- David WaldUniversity, hospital or other
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 1 Jun 2022 (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 study seeks to determine the safety and efficacy of the infusion of autologous CD19 CAR-T cells that are manufactured using an ultra-fast process.
Detailed description
This treatment uses T cells already present in the participant's body that have been modified outside of the body by a lentivirus and then returned by an infusion to target the cancer. Lentivirus is a family of viruses that can be used by scientists to alter cells. The specific type of cells that will be used is called UF-KURE19 chimeric antigen receptor T cells (CAR-T cells). The CAR-T cells that will be reinfused into the body are modified using a lentivirus that is no longer active. The investigators are evaluating UF-KURE19 because it uses a process that is shorter than other approved CAR-T cells. While the shorter manufacture time can be an advantage, the safety of this approach has not been demonstrated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UF-KURE19 CAR-T cell infusion | Experimental | Biological: UF-KURE19 CAR-T cells, Drug: Fludarabine, Drug: CyclophosphamideThe safety and manufacturing feasibility of UF-KURE19 will be determined with up to 10 patients being enrolled. Lymphodepleting therapy will begin on Days -4 to -2 with each weight category of participants receiving 30mg/m2/IV of Fludarabine and 500mg/m2/IV of Cyclophosphamide regardless of the level of UF-KURE19 CAR-T cell dosing. Dosing: Participants greater than or equal to 50 kg: * Level -1: 10 x 10^6 UF-KURE19 CAR-T Cell Dose (CAR positive cells) * Level 1 : 17.5 x 10^6 UF-KURE19 CAR-T Cell Dose Participants less than 50 kg: * Level -1: 6.5 x 10^6 UF-KURE19 CAR-T Cell Dose * Level 1: 11.5 x 10^6 UF-KURE19 CAR-T Cell Dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (39 listed)
- Male or female patients aged 18 years or older.
- Participants must have histologically confirmed, CD19 positive (by IHC or flow cytometry) NHL that meets at least one of the following treatment indications.
- ECOG Performance status ≤ 2.
- At least one measurable lesion according to Lugano Revised Response Criteria for Malignant Lymphoma.
- Minimum of 2 weeks since prior radiation therapy or systemic therapy to treat malignancy at the time of leukapheresis.
Key exclusion criteria (31 listed)
- Autologous stem cell transplant within 6 weeks of informed consent.
- History of allogeneic hematopoietic stem cell transplantation.
- Active central nervous system or leptomeningeal involvement by lymphoma. Subjects with untreated brain metastases/CNS disease will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Patients with a history of CNS or meningeal CASE 2422 Page 37 Version 13 02.03.2025 involvement must be in a documented remission by CSF evaluation and contrastenhanced MRI imaging for at least 90 days prior to registration.
- Second active malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast).
- Less than 28 days elapsed between prior treatment with investigational agent(s) and leukapheresis.
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 |
|---|---|---|
| UF-KURE19 CAR-T cellsUF-KURE19 cells are initially generated from a starting autologous apheresis sample. T cells are activated and transduced with Kure19 lentiviral vector that consists of a 3rd generation vector with an scFV (FMC63) that targets CD19. The product is harvested at 17-20hr after culture and cryopreserved | Biological | UF-KURE19 CAR-T cell infusion |
| FludarabineAlso: Fludara®, Fludarabine PhosphateFludarabine phosphate is rapidly dephosphorylated to 2-fluoro-ara-A and then phosphorylated intracellularly by deoxycytidine kinase to the active triphosphate, 2-fluoro-ara-ATP. This metabolite appears to act by inhibiting DNA polymerase alpha, ribonucleotide reductase and DNA primase, thus inhibiting DNA synthesis. | Drug | UF-KURE19 CAR-T cell infusion |
| CyclophosphamideAlso: Cytoxan ®, Endoxan®, Neosar®, Procytox®The mechanism of action is thought to involve cross-linking of tumor cell DNA | Drug | UF-KURE19 CAR-T cell infusion |
Primary outcome
Phase 1: Recommended dose(s) of UF-KURE19 CAR-T Cells
Time frame: Up to 28 days after treatment
Safety will be assessed by the number of DLT experienced at the target dose which is hypothesized to be less than 33%.
Phase 1: Toxicities associated with the target dose of UF-KURE19 CAR-T Cells
Time frame: Up to 12 months after treatment
Toxicities will be reported as specific adverse events as a result of the target dose of UF-KURE19 CAR-T Cells. An adverse event (AE) is any unfavorable or unintended event, physical or psychological, associated with a research study, which causes harm or injury to a research participant as a result of the participant's involvement in a research study.
Phase 1b: Toxicities associated with the target dose of UFKURE19 in patients with Relapsed or Refractory Large B-cell Lymphoma (LBCL).
Time frame: Up to 12 months after treatment
Phase 1b: Complete response rate (CRR) with UF-KURE19 in patients with Relapsed or Refractory LBCL.
Time frame: Up to 12 months after treatment
Phase 1b: Objective response rate (ORR, CR + PR) with UF-KURE19 in patients with Relapsed or Refractory LBCL.
Time frame: Up to 12 months after treatment
Phase 1b: CRR in double/triple hit lymphoma (DHL/THL) patients treated with first-line standard of care chemoimmunotherapy PLUS early intervention of UFKURE19.
Time frame: Up to 12 months after treatment
8 secondary outcomes
Phase 1: Success rate of semi-automated CAR-T manufacturing process
Time frame: Up to 2 weeks after culture of UF-KURE19 CAR-T cells
Phase 1: Objective response rates per Lugano Revised Response Criteria for Malignant Lymphoma after treatment with UF-KURE19 in patients with relapsed or refractory non-Hodgkin lymphoma
Time frame: Up to 12 months after treatment
Phase 1: Complete response rates per Lugano Revised Response Criteria for Malignant Lymphoma after treatment with UF-KURE19 in patients with relapsed or refractory non-Hodgkin lymphoma
Time frame: Up to 12 months after treatment
Phase 1b cohort of Relapsed or Refractory LBCL: duration of response in patients treated with UF-KURE19
Time frame: Up to 12 months after treatment
Phase 1b cohort of Relapsed or Refractory Large B cell Lymphoma(LBCL): Overall survival in patients treated with UF-KURE19
Time frame: Up to 12 months after treatment
Phase 1b cohort of Relapsed or Refractory LBCL: Progression-free survival in patients treated with UF-KURE19
Time frame: Up to 12 months after treatment
Phase 1b cohort of Relapsed or Refractory LBCL: Manufacturing success rate
Time frame: Up to 2 weeks after culture of UF-KURE19 CAR-T cells
Phase 1b cohort of DHL/THL: PFS in DHL/THL patients treated with first-line standard of care chemoimmunotherapy PLUS early intervention of UF-KURE19.
Time frame: Up to 12 months after treatment
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 5 May 2026.
- Individual participant dataSharing planned: No
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Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruitingObservational study
Multi-omics Profiling of Relapsed Extranodal Natural Killer (NK)/T-cell Lymphoma
Extranodal NK/T-cell Lymphoma, Nasal Type
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.
Changchun Deng, MD, PhD principal investigator
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing UF-KURE19 CAR-T cells, Fludarabine and Cyclophosphamide in people with Non Hodgkin Lymphoma, run by David Wald at 3 sites 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 39 inclusion and 31 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: under way, not looking for participants, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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?
Phase 1: Recommended dose(s) of UF-KURE19 CAR-T Cells (time frame: Up to 28 days after treatment). The study lists 6 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 5 May 2026.