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Low-Dose Radiation with Tisagenlecleucel for Relapsed/Refractory Large B-cell Lymphoma

This study is testing a new way to prepare your body for a type of immunotherapy called tisagenlecleucel (Tisa-cel) if you have large B-cell lymphoma that has come back or hasn't responded to other treatments. Researchers are looking at the safety and best dose of adding low-dose total body irradiation (TBI), which is radiation to the whole body, to the standard preparation of cyclophosphamide and fludarabine. This preparation helps kill cancer cells and makes your body ready for the Tisa-cel. Tisa-cel uses your own immune cells to fight cancer. To join, you must be at least 18, have relapsed or refractory large B-cell lymphoma with CD19 expression, and have measurable disease. The study aims to find out how safe this combination is and what the best dose of TBI is. The status of this study is currently unclear, and it plans to enroll 18 participants.

Study design
This is an interventional study, but the phase is not specified. It plans to enroll 18 participants.
What's involved
You would undergo blood sample collection, PET/CT or CT scans, receive cyclophosphamide and fludarabine intravenously, and have leukapheresis (a procedure to collect your white blood cells).
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints, which measure safety and the best dose, are assessed up to 30 days after the Tisa-cel infusion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07676877

Lymphodepletion With Low Dose Total Body Irradiation Before Standard of Care Tisagenlecleucel for the Treatment of Relapsed and Recurrent Large B-cell Lymphoma

Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatment
Nathan Denlinger
~18 participants
Updated 2026-06-30 on ClinicalTrials.gov
What's tested:Biospecimen CollectionComputed TomographyCyclophosphamideFludarabineLeukapheresisPositron Emission Tomography

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose-limiting toxicities
Measured over Up to 30 days after infusion
+1 more outcome measured

Conditions

Recurrent Diffuse Large B-Cell Lymphoma
Refractory Diffuse Large B-Cell Lymphoma

Explore related trials

Diffuse Large B-Cell LymphomaCD19 Gene

NCT07676877

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohiostudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Nathan Denlinger, DO · PRINCIPAL_INVESTIGATOR · Ohio State University Comprehensive Cancer Center

Who to contact

Ohio State University Comprehensive Cancer Center
[email protected]
800-293-5066
Email the study team

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Eligibility criteria

Inclusion

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
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

Exclusion

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
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

What this trial measures

  • Dose-limiting toxicitiesUp 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)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.