Recurrent Diffuse Large B-Cell LymphomaPhase 1NCT07676877
Lymphodepletion With Low Dose Total Body Irradiation Before Standard of Care Tisagenlecleucel for the Treatment of Relapsed and Recurrent Large B-cell Lymphoma
A Phase 1 study testing Biospecimen Collection, Computed Tomography and Cyclophosphamide in people with Recurrent Diffuse Large B-Cell Lymphoma and Refractory Diffuse Large B-Cell Lymphoma, run by Nathan Denlinger at 1 site in United States.
Trial summary
This phase I trial tests the safety, side effects, and best dose of total body irradiation (TBI) in combination with standard of care lymphodepletion with cyclophosphamide and fludarabine before tisagenlecleucel (Tisa-cel) and how well the combination works in patients with large B-cell lymphoma (LBCL) that has come… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Diffuse Large B-Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma
- What is being tested?
- Biospecimen Collection, Computed Tomography and Cyclophosphamide
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 31 Dec 2027
- 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
- Eligible for standard of care anti-CD19 CAR-T treatment with Tisa-cel
- Age ≥ 18 years
- Biopsy-confirmed relapsed or refractory large B-cell lymphoma after 2 lines of prior therapy
- Qualitative CD19 expression by either immunohistochemistry (IHC) or flow cytometry
- Measurable disease prior to lymphodepletion as determined by Lugano criteria
- Non-RT bridging therapy allowed, but requires re-staging prior to lymphodepletion (LD) to confirm measurable disease
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- Adequate performance status Eastern Cooperative Oncology Group (ECOG) ≤ 2
- Platelets above 75K
- Hemoglobin above 8.0 g/dL without transfusion within 1 week
- Absolute neutrophil count (ANC) above 1,000 without granulocyte colony-stimulating factor (G-CSF) within 1 week
- Total bilirubin < 1.5 x upper limit of normal (ULN)
- Alanine aminotransferase (ALT) =< 3 x ULN
- Glomerular filtration rate (GFR) > 60 ml/min calculated by the Cockcroft - Gault formula
- Oxygen saturation (SpO2) > 92% without supplemental oxygen
- Ejection fraction more than 45%
- Patients 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 12 months after Tisa-cel and until CAR T-cells are no longer present by quantitative polymerase chain reaction (qPCR) on two consecutive tests
- 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 contraceptive s 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 12 months after Tisa-cel infusion and until CAR T-cells are no longer present by qPCR on two consecutive tests. 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 Tisa-cel 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
- For patients with prior irradiation: the study radiation oncologist co-investigator will review the patient's prior history of radiation to confirm that the investigational low dose total body irradiation is feasible and safe to respect the maximum cumulative organ radiation exposure
Who cannot join
- Active central nervous system (CNS) disease at screening or prior to lymphodepletion
- Prior therapy with autologous or allogenic CAR-T or CAR-natural killer (NK) cell therapy
- Prior anti-CD19 therapies (such as, but not limited to tafasitamab or loncastuximab)
- Prior allogeneic stem cell transplant
- Bridging therapy with radiation not allowed
- Any contra-indications to receive low-dose TBI, standard of care lymphodepleting chemotherapy or Tisa-cel per treating physician
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- A minimum of 28 days must have elapsed between prior treatment with investigational agent(s) and start of lymphodepletion
- Uncontrolled major medical problem as infections
- Active malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast). Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial (e.g. low Gleason score prostate cancer)
- Patients 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
- 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 myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy
- Active hepatitis B or C as indicated by serology (for details please refer to Novartis Leukapheresis Reference Manual version [v] 4)
- 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
- History of autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus) with requirement of systemic immunosuppressive medication within 6 months
- Live vaccines given in 28 days prior to lymphodepleting chemotherapy
- Active substance use disorders
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
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Nathan Denlinger, DO, 614-293-3316, Nathan.Denlinger@osumc.edu
Nathan Denlinger, DO
About this study
Official title: A Phase I Trial of Lymphodepletion Intensification With Low Dose Total Body Irradiation With Dose Expansion for Standard-of-Care Tisagenlecleucel in Patients With Large B-Cell Lymphoma
This phase I trial tests the safety, side effects, and best dose of total body irradiation (TBI) in combination with standard of care lymphodepletion with cyclophosphamide and fludarabine before tisagenlecleucel (Tisa-cel) and how well the combination works in patients with large B-cell lymphoma (LBCL) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). TBI is a common treatment that sends radiation (for example, through x-rays) to the entire body. Lymphodepleting chemotherapy, such as cyclophosphamide and fludarabine, along with TBI helps kill cancer cells in the body and helps prepare the body for the Tisa-cel infusion. Tisagenlecleucel is made using a patient's T cells (a type of immune system cell). A gene for a special receptor called chimeric antigen receptor (CAR) is added to the T cells in the laboratory. These changed T cells called CAR T cells are grown in large numbers in the laboratory and given to the patient by infusion. Tisa-cel binds to a protein called CD19, which is found on some leukemia and lymphoma cells. This helps the body's immune system kill cancer cells. Tisa-cel is a type of CAR T-cell therapy. Giving low dose TBI in combination with standard of care lymphodepletion therapy and Tisa-cel may be safe, tolerable, and/or effective in treating patients with relapsed or refractory (R/R) LBCL.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the safety and maximum tolerated dose (MTD) of total body irradiation (TBI) as lymphodepletion intensification for Tisa-cel in R/R large B-cell lymphoma.
SECONDARY OBJECTIVE:
- To determine the efficacy, toxicity, and pharmacokinetics of Tisa-cel with intensified lymphodepletion by low dose TBI.
II. To compare pharmacokinetics of Tisa-cel with intensified to historic control from JULIET trial, provided by Novartis and Navigate.
EXPLORATORY OBJECTIVE:
- Compare the clinical outcomes of Tisa-cel with intensified lymphodepletion by TBI with institutional and Center for International Blood and Marrow Transplant Research (CIBMTR) historic control real world of evidence of standard-of-care Tisa-cel in LBCL.
CORRELATIVE OBJECTIVES:
- To describe the T-cell phenotype, exhaustion, and activation induced cell death markers marker of Tisa-cel with intensified lymphodepletion by low dose total body irradiation.
II. To describe the cytokine profile, immune profile and circulating tumor deoxyribonucleic acid (ctDNA) dynamics following of Tisa-cel with intensified lymphodepletion by low dose total body irradiation.
III. To investigate tumor microenvironment and mechanism of resistance to CAR-T19 in the biopsy at progression post-CAR-T19.
OUTLINE: This is a dose-escalation study of TBI in combination with standard of care lymphodepletion and Tisa-cel followed by a dose-expansion study.
Patients undergo leukapheresis and receive lymphodepleting chemotherapy with cyclophosphamide intravenously (IV) and fludarabine IV on days -5 to -3 per standard of care. Patients also undergo low dose TBI on day -2 and receive standard of care Tisa-cel IV over 5-30 minutes on day 0. Additionally, patients undergo blood sample collection, positron emission tomography (PET)/computed tomography (CT) or CT throughout the study.
After completion of study treatment, patients are followed up at days 1-7, 10, 14, 17, 21, 30, 45, 60, 75, 90, 120, 150, 180 and 270, at 1 year after Tisa-cel infusion then for up to year 15 per standard of care.
- Being tested
- Biospecimen Collection, Computed Tomography, Cyclophosphamide, Fludarabine, Leukapheresis
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo blood sample collection
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo PET/CT or CT
CyclophosphamideDrug
Also called (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Asta B 518, B 518
Given IV
FludarabineDrug
Also called Fluradosa
Given IV
LeukapheresisProcedure or surgery
Also called Leukocyte Adsorptive Apheresis, Leukocytopheresis, Therapeutic Leukopheresis, White Blood Cell Reduction Apheresis
Undergo leukapheresis
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)
Undergo PET/CT
TisagenlecleucelBiological
Also called CART-19, CART19, CTL 019, CTL-019
Given IV
Total-Body IrradiationRadiation
Also called SCT_TBI, TBI, Total Body Irradiation, Whole Body
Undergo low dose TBI
| Study group | Role | What they receive |
|---|---|---|
| Treatment (TBI, lymphodepletion, Tisa-cel) | Experimental | Patients undergo leukapheresis and receive lymphodepleting chemotherapy with cyclophosphamide IV and fludarabine IV on days -5 to -3 per standard of care. Patients also undergo low dose TBI on day -2 and receive standard of care Tisa-cel IV over 5-30 minutes on day 0. Additionally, patients undergo blood sample collection, PET/CT or CT throughout the study. Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Cyclophosphamide; Drug: Fludarabine; Procedure: Leukapheresis; Procedure: Positron Emission Tomography; Biological: Tisagenlecleucel; Radiation: Total-Body Irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicities
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. Cytokine release syndrome and immune effector cell associated neurotoxicity syndrome are graded using American Society for Transplantation and Cellular Therapy (ASTCT) Consensus grading.
Measured: Up to 30 days after infusion
Maximum tolerated dose or recommended phase 2 dose (RP2D)
Will define the dose as the RP2D for which the isotonic estimate of the toxicity rate is closest to the targeted toxicity rate (i.e., 25%). If there is a tie, the higher dose level when the isotonic estimate is lower than the targeted toxicity rate; and will choose the lower dose level when the isotonic estimate is greater than the targeted toxicity rate.
Measured: Up to 30 days after infusion
Secondary outcomes (9)
Incidence of adverse events
Frequency and nature of adverse events of different grades, overall and by dose levels will be described.
Measured: Up to 1 year
Complete remission rate
Will be evaluated with descriptive statistics with proportions used to describe response rates (complete and overall).
Measured: At days 30 and 90 from tisagenlecleucel (Tisa-cel) infusion
Objective response rate
Will be estimated with 95% confidence intervals.
Measured: At 30 and 90 days and 6 months
Median duration of response
Will be calculated using Kaplan Meier method, comparisons between groups will be done using the log rank test.
Measured: Up to 1 year
Progression-free survival
Will be analyzed using Lugano criteria. Will be calculated using Kaplan Meier method, comparisons between groups will be done using the log rank test.
Measured: From Tisa-cel infusion to clinical progression or death as a result of any cause, assessed at 6 months and 1 year
Overall survival
Will be analyzed using Lugano criteria.
Measured: From Tisa-cel infusion to death from any cause, assessed at 6 months and 1 year
Rate and grade of cytokine release syndrome
Will be evaluated using ASTCT Consensus grading.
Measured: Within the first 30 days post-infusion
Rate and grade of immune effector cell associated neurotoxicity syndrome
Will be evaluated using ASTCT Consensus grading.
Measured: Within the first 30 days post-infusion
Rates of grade IV cytopenias
Measured: At days 30 and 90 from Tisa-cel infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start1 Dec 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Diffuse Large B-Cell 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
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nathan Denlinger
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor-investigator, Nathan Denlinger, Ohio State University Comprehensive Cancer Center
- Investigators
- Nathan Denlinger, DO, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07676877
- Sponsor's protocol ID
- OSU-25255
- Other IDs
- NCI-2026-04299
- Status last verified
- Oct 2026
- First submitted
- 23 Jun 2026
- Last updated
- 9 Oct 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 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Lymphodepletion Intensification With Low Dose Total Body Irradiation With Dose Expansion for Standard-of-Care Tisagenlecleucel in Patients With Large B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT07676877
- Acronym / sponsor ID
- OSU-25255
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Nathan DenlingerUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Jun 2026 (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 phase I trial tests the safety, side effects, and best dose of total body irradiation (TBI) in combination with standard of care lymphodepletion with cyclophosphamide and fludarabine before tisagenlecleucel (Tisa-cel) and how well the combination works in patients with large B-cell lymphoma (LBCL) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). TBI is a common treatment that sends radiation (for example, through x-rays) to the entire body. Lymphodepleting chemotherapy, such as cyclophosphamide and fludarabine, along with TBI helps kill cancer cells in the body and helps prepare the body for the Tisa-cel infusion. Tisagenlecleucel is made using a patient's T cells (a type of immune system cell). A gene for a special receptor called chimeric antigen receptor (CAR) is added to the T cells in the laboratory. These changed T cells called CAR T cells are grown in large numbers in the laboratory and given to the patient by infusion. Tisa-cel binds to a protein called CD19, which is found on some leukemia and lymphoma cells. This helps the body's immune system kill cancer cells. Tisa-cel is a type of CAR T-cell therapy. Giving low dose TBI in combination with standard of care lymphodepletion therapy and Tisa-cel may be safe, tolerable, and/or effective in treating patients with relapsed or refractory (R/R) LBCL.
Detailed description
PRIMARY OBJECTIVE:
- To determine the safety and maximum tolerated dose (MTD) of total body irradiation (TBI) as lymphodepletion intensification for Tisa-cel in R/R large B-cell lymphoma.
SECONDARY OBJECTIVE:
- To determine the efficacy, toxicity, and pharmacokinetics of Tisa-cel with intensified lymphodepletion by low dose TBI.
II. To compare pharmacokinetics of Tisa-cel with intensified to historic control from JULIET trial, provided by Novartis and Navigate.
EXPLORATORY OBJECTIVE:
- Compare the clinical outcomes of Tisa-cel with intensified lymphodepletion by TBI with institutional and Center for International Blood and Marrow Transplant Research (CIBMTR) historic control real world of evidence of standard-of-care Tisa-cel in LBCL.
CORRELATIVE OBJECTIVES:
- To describe the T-cell phenotype, exhaustion, and activation induced cell death markers marker of Tisa-cel with intensified lymphodepletion by low dose total body irradiation.
II. To describe the cytokine profile, immune profile and circulating tumor deoxyribonucleic acid (ctDNA) dynamics following of Tisa-cel with intensified lymphodepletion by low dose total body irradiation.
III. To investigate tumor microenvironment and mechanism of resistance to CAR-T19 in the biopsy at progression post-CAR-T19.
OUTLINE: This is a dose-escalation study of TBI in combination with standard of care lymphodepletion and Tisa-cel followed by a dose-expansion study.
Patients undergo leukapheresis and receive lymphodepleting chemotherapy with cyclophosphamide intravenously (IV) and fludarabine IV on days -5 to -3 per standard of care. Patients also undergo low dose TBI on day -2 and receive standard of care Tisa-cel IV over 5-30 minutes on day 0. Additionally, patients undergo blood sample collection, positron emission tomography (PET)/computed tomography (CT) or CT throughout the study.
After completion of study treatment, patients are followed up at days 1-7, 10, 14, 17, 21, 30, 45, 60, 75, 90, 120, 150, 180 and 270, at 1 year after Tisa-cel infusion then for up to year 15 per standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (TBI, lymphodepletion, Tisa-cel) | Experimental | Procedure: Biospecimen Collection, Procedure: Computed Tomography, Drug: Cyclophosphamide, Drug: Fludarabine, Procedure: Leukapheresis, Procedure: Positron Emission Tomography, Biological: Tisagenlecleucel, Radiation: Total-Body IrradiationPatients undergo leukapheresis and receive lymphodepleting chemotherapy with cyclophosphamide IV and fludarabine IV on days -5 to -3 per standard of care. Patients also undergo low dose TBI on day -2 and receive standard of care Tisa-cel IV over 5-30 minutes on day 0. Additionally, patients undergo blood sample collection, PET/CT or CT throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Eligible for standard of care anti-CD19 CAR-T treatment with Tisa-cel
- Age ≥ 18 years
- Biopsy-confirmed relapsed or refractory large B-cell lymphoma after 2 lines of prior therapy
- Qualitative CD19 expression by either immunohistochemistry (IHC) or flow cytometry
- Measurable disease prior to lymphodepletion as determined by Lugano criteria
Key exclusion criteria (17 listed)
- Active central nervous system (CNS) disease at screening or prior to lymphodepletion
- Prior therapy with autologous or allogenic CAR-T or CAR-natural killer (NK) cell therapy
- Prior anti-CD19 therapies (such as, but not limited to tafasitamab or loncastuximab)
- Prior allogeneic stem cell transplant
- Bridging therapy with radiation not allowed
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 |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Treatment (TBI, lymphodepletion, Tisa-cel) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo PET/CT or CT | Procedure or surgery | Treatment (TBI, lymphodepletion, Tisa-cel) |
| CyclophosphamideAlso: (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Asta B 518, B 518Given IV | Drug | Treatment (TBI, lymphodepletion, Tisa-cel) |
| FludarabineAlso: FluradosaGiven IV | Drug | Treatment (TBI, lymphodepletion, Tisa-cel) |
| LeukapheresisAlso: Leukocyte Adsorptive Apheresis, Leukocytopheresis, Therapeutic Leukopheresis, White Blood Cell Reduction ApheresisUndergo leukapheresis | Procedure or surgery | Treatment (TBI, lymphodepletion, Tisa-cel) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)Undergo PET/CT | Procedure or surgery | Treatment (TBI, lymphodepletion, Tisa-cel) |
| TisagenlecleucelAlso: CART-19, CART19, CTL 019, CTL-019Given IV | Biological | Treatment (TBI, lymphodepletion, Tisa-cel) |
| Total-Body IrradiationAlso: SCT_TBI, TBI, Total Body Irradiation, Whole BodyUndergo low dose TBI | Radiation | Treatment (TBI, lymphodepletion, Tisa-cel) |
Primary outcome
Dose-limiting toxicities
Time frame: Up to 30 days after infusion
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. Cytokine release syndrome and immune effector cell associated neurotoxicity syndrome are graded using American Society for Transplantation and Cellular Therapy (ASTCT) Consensus grading.
Maximum tolerated dose or recommended phase 2 dose (RP2D)
Time frame: Up to 30 days after infusion
Will define the dose as the RP2D for which the isotonic estimate of the toxicity rate is closest to the targeted toxicity rate (i.e., 25%). If there is a tie, the higher dose level when the isotonic estimate is lower than the targeted toxicity rate; and will choose the lower dose level when the isotonic estimate is greater than the targeted toxicity rate.
9 secondary outcomes
Incidence of adverse events
Time frame: Up to 1 year
Complete remission rate
Time frame: At days 30 and 90 from tisagenlecleucel (Tisa-cel) infusion
Objective response rate
Time frame: At 30 and 90 days and 6 months
Median duration of response
Time frame: Up to 1 year
Progression-free survival
Time frame: From Tisa-cel infusion to clinical progression or death as a result of any cause, assessed at 6 months and 1 year
Overall survival
Time frame: From Tisa-cel infusion to death from any cause, assessed at 6 months and 1 year
Rate and grade of cytokine release syndrome
Time frame: Within the first 30 days post-infusion
Rate and grade of immune effector cell associated neurotoxicity syndrome
Time frame: Within the first 30 days post-infusion
Rates of grade IV cytopenias
Time frame: At days 30 and 90 from Tisa-cel infusion
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 9 Oct 2026.
- The JameslineLink provided by the sponsor.
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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.
Nathan Denlinger, DO principal investigator
Ohio State University Comprehensive 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 Biospecimen Collection, Computed Tomography and Cyclophosphamide in people with Recurrent Diffuse Large B-Cell Lymphoma and Refractory Diffuse Large B-Cell Lymphoma, run by Nathan Denlinger 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 23 inclusion and 17 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 9 Oct 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 Ohio State University Comprehensive Cancer Center (800-293-5066, OSUCCCClinicaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicities (time frame: Up to 30 days after infusion). 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 9 Oct 2026.