Head and Neck CancerPhase 1NCT07101432
Phase I Study of Preconditioning Radiation Therapy With IL-15 Transduced TGFBR2 KO CAR.TROP2-engineered Cord Blood-derived NK Cells in Patients With Advanced Head and Neck Cancer (RADIANCE-NK)
A Phase 1 study testing Fludarabine and Cyclophosphamide in people with Head and Neck Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To find the recommended dose of an investigational therapy called chimeric antigen receptor (CAR).TROP2/interleukin (IL)15-transduced TGFBR2 KO cord blood (CB)-derived natural killer (NK) cells (TROP2 CAR/IL-15 TGFBR2 KO NK cells) that can be given with and without preconditioning radiation therapy in patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Fludarabine and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2025to 31 Dec 2029
- 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
- Patients with histologically confirmed head and neck cancer, either HPV+ or HPV-, that is locally advanced AND unresectable OR metastatic (≤5 sites of disease), which has relapsed or progressed following local standard treatments that are known to prolong survival, or for which no standard treatment is available or are no longer effective, or refused such therapy.
- Patient tumors must demonstrate TROP2 expression of 2+ or 3+ as determined by IHC at the MDACC CAP and CLIA accredited Clinical Laboratories.
- 2 weeks from the last cytotoxic chemotherapy at the time of lymphodepleting chemotherapy; ≥3 days from last TKI or other targeted therapies at the time of lymphodepleting chemotherapy; ≥3 months from any cell therapy for any malignancy at the time of lymphodepleting chemotherapy; prior radiation therapy is allowed at the time of consent.
- RT allowed to ≥1 disease sites prior to the lymphodepleting chemotherapy. If there are additional measurable non-irradiated disease sites, this may be evaluated for response as well. If multiple lesions are irradiated, we advise that a single lesion will be treated to a higher dose and other lesions considered for lower doses, and that one site always remain unirradiated if a patient has ≥2 sites of disease.
- Age ≥18 years. Because no dosing or adverse event data are currently available on the use of TROP2 CAR/IL-15 TGFBR2 KO NK cells in combination with radiation therapy in patients <18 years of age, children are excluded from this study.
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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- Life expectancy ≥3 months per PI or treating physician's discretion.
- A female patient is eligible to participate if at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP). OR
- A WOCBP who agrees to follow the contraceptive guidelines in Appendix 5 during the study treatment period and for 6 months post-TROP2 CAR/IL-15 TGFBR2 KO NK cell infusion.
- WOCBP must have a negative urine pregnancy test within 72 hours prior to the start of lymphodepleting chemotherapy. If a WOCBP has a urine pregnancy test that cannot be confirmed as negative, a serum (beta-human chorionic gonadotropin [B-hCG]) pregnancy test will be required.
- The effects of TROP2 CAR/IL-15 TGFBR2 KO NK cells on the developing human fetus are unknown. Radiation therapy is absolutely contraindicated in pregnant women. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:
- Postmenopausal (no menses in greater than or equal to 12 consecutive months).
- History of hysterectomy or bilateral salpingo-oophorectomy.
- Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
- History of bilateral tubal ligation or another surgical sterilization procedure.
- Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control.
- A female patient who becomes pregnant, or suspects pregnancy while she or her partner is participating in this study, must immediately notify her doctor. Female patients who become pregnant will be taken off study.
- Male patients treated or enrolled on this protocol must agree to follow the contraceptive guidelines in Appendix 5 prior to study entry and for the duration of study participation and for 6 months post-TROP2 CAR/IL-15 TGFBR2 KO NK cell infusion. Male patients who father a child or suspect that they have fathered a child must immediately notify their doctor.
- Patients must have measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Patients must have adequate organ function as defined below within 10 days prior to the start of lymphodepleting chemotherapy:
- Table 1. Adequate Organ Function Laboratory Values
- Systemic Function Test Laboratory Value Hematologic ANC ≥ 1500/µL Platelets ≥ 100,000/µL Hemoglobin ≥9.0 g/dLa Renal Creatinine ≤ 1.5 x ULNb OR CrCl by Cockcroft-Gault ≥30 mL/min for patients with creatinine formula > 1.5 x ULNb Hepatic Total bilirubin ≤1.5 x ULN OR direct bilirubin ≤ ULN for patients with total bilirubin levels >1.5 x ULN AST and ALT ≤2.5 x ULN (≤5 x ULN for patints with liver metastases) Coagulation PT/INR ≤1.5 x ULN unless patien is receiving anticoagulant aPTT therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants
- ALT=alanine aminotransferase; ANC=absolute neutrophil count; aPTT=activated partial thromboplastin time; AST=aspartate aminotransferase; CrCl=creatinine clearance; INR=international normalized ratio; PT=prothrombin time; ULN=upper limit of normal.
- Criteria must be met without erythropoietin dependency and without packed red blood cell transfusion within last 2 weeks of the screening test. Patients may be on a stable dose of erythropoietin (≥ approximately 3 months).
- Serum creatinine and CrCl should be interpreted and calculated per institutional standard.
- Left ventricular ejection fraction >50%.
- Adequate respiratory reserve defined as dyspnea Grade 0 or 1 and saturated oxygen >92% in room air. See Table 2 for a grading scale of dyspnea per the CTCAE v5.0.
- Table 2. Dyspnea grading scale.
- Grade 0 - No shortness of breath Grade 1 - Shortness of breath with moderate exertion Grade 2 - Shortness of breath with minimal exertion; limiting instrumental ADL Grade 3 - Shortness of breath at rest; limiting self-care ADL Grade 4 - Life threatening consequences; urgent intervention indicated Grade 5 - Death
- Prior treatment with TROP2-targeted therapy will be allowed.
- Willing to undergo mandatory blood collections and biopsies as required by the study.
- Willing to sign consent for long-term follow-up on protocol PA17-0483.
- Willing to stay within a 2-hour drive (approximately 100-mile radius) of the study site during the first 4 weeks after the TROP2 CAR/IL-15 TGFBR2 KO NK cell infusion.
- 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.
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Pregnant, breastfeeding, or expecting to conceive within the projected duration of the study, starting with the screening visit through 6 months post TROP2 CAR/IL-15 TGFBR2 KO NK cell infusion.
- Has received systemic anticancer therapy within 2 weeks or 5 half-lives, whichever is shorter, prior to the start of lymphodepleting chemotherapy. For patients treated with monoclonal antibodies, at least 3 weeks must have elapsed prior to the start of lymphodepleting chemotherapy. Patients who have entered the follow-up phase of an investigational study may participate as long as it has been 3 weeks after the last dose of the previous investigational agent.
- Patients must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Patients with ≤Grade 2 neuropathy, alopecia, or other non-relevant AEs may be deemed eligible at the discretion of the principal investigator (PI)/co-PIs. If a patient received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to the start of lymphodepleting chemotherapy.
- If patients receive RT within 2 weeks of the start of lymphodepleting chemotherapy, they must not require corticosteroids, and not have had radiation pneumonitis.
- Has received a live vaccine within 6 weeks prior to TROP2 CAR/IL-15 TGFBR2 KO NK infusion and for at least 24 months post infusion. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine. Seasonal influenza and COVID-19 vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
- Prior CAR T or NK cell or other genetically modified T or NK cell therapy.
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- Has diagnosis of immunodeficiency or receiving chronic systemic steroid therapy (in doses exceeding 10 mg daily of prednisone equivalent).
- History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. The time requirement does not apply to patients who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, in situ cervical cancer, or other in situ cancers.
- Known active CNS metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate if they completed radiation therapy, are clinically stable, and without requirement of steroid treatment for at least 2 weeks prior to study enrollment.
- Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is allowed.
- History of interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD. 12. Active infection requiring systemic therapy.
- 13. Known human immunodeficiency virus (HIV) infection.
- 14. Known active or chronic hepatitis B or hepatitis C virus infection.
- 15. Known history of active tuberculosis (Mycobacterium tuberculosis).
- 16. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
- 17. Patients with psychiatric illness/social situations that would limit compliance with study requirements.
- 18. Has had an allogenic tissue/solid organ transplant.
- 19. Clinically significant cardiovascular disease within 12 months prior to the start of lymphodepleting chemotherapy, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebrovascular event, or cardiac arrhythmia associated with hemodynamic instability. NOTE: medically controlled arrhythmia would be permitted.
- 20. Prolongation of corrected QT interval using Fridericia's formula to >480 milliseconds.
- 21. Patients with bleeding or thrombotic disorders or at risk for severe hemorrhage. Patients with known deep vein thrombosis/pulmonary embolism who are on appropriate anti-coagulation treatment are eligible.
- 22. Patients with history of ≥Grade 3 stomatitis or mucositis with prior therapy.
- 23. History of allergic reactions attributed to compounds of similar chemical or biologic composition to cyclophosphamide and fludarabine or other agents used in study.
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
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
Gohar Manzar, MD, 713-792-4503, gsmanzar@mdanderson.org
Gohar Manzar, MD
About this study
To find the recommended dose of an investigational therapy called chimeric antigen receptor (CAR).TROP2/interleukin (IL)15-transduced TGFBR2 KO cord blood (CB)-derived natural killer (NK) cells (TROP2 CAR/IL-15 TGFBR2 KO NK cells) that can be given with and without preconditioning radiation therapy in patients with advanced head and neck squamous cell carcinoma.
Read the detailed description
Primary Objective:
To determine the safety, tolerability, and recommended Phase 2 dose (RP2D) of chimeric antigen receptor (CAR).TROP2/interleukin (IL)15-transduced TGFBR2 KO cord blood (CB)-derived natural killer (NK) cells (TROP2 CAR/IL-15 TGFBR2 KO NK cells) combined with and without preconditioning RT in patients with advanced head and neck squamous cell carcinoma.
Secondary Objectives:
- To determine the antitumor activity of TROP2 CAR/IL-15 TGFBR2 KO NK cells, including those with pre-CAR-NK bridging SBRT in patients eligible to receive this. Although the clinical benefit of TG TROP2 CAR/IL-15 TGFBR2 KO NK cells has not yet been established (and is currently being investigated in other solid tumors in other clinical trials we have rendered), the intent of offering this treatment is to provide a possible therapeutic benefit and thus, the patient will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability. Efficacy will be determined in each cohort, and for this, we will have a pre-planned subset analysis of patients with metastatic disease where one site is not irradiated.
- To quantify the persistence of infused allogeneic donor CAR-transduced CB-derived NK cells in the peripheral blood of the recipient.
- To conduct comprehensive immune modulation studies by evaluating tissue and bloodbased biomarkers associated with response and resistance to TROP2 CAR/IL-15 TGFBR2 KO NK cell infusion.
- To obtain preliminary data on quality of life and patient experience.
- To evaluate longitudinal changes in circulating tumor DNA (ctDNA).
Exploratory Objectives:
- In patients who do not receive SBRT due to ineligibility, they are still eligible to receive CAR-NK cell therapy. This inadvertent biologic randomization may enable cross-sectional comparison of outcomes and correlatives among the patients who receive RT vs. not.
- To quantify the progression-free survival, overall survival, and the duration of responses of TGFBR2 KO CAR.TROP2/IL15-transduced CB-derived NK cells combined with preconditioning RT in patients with advanced head and neck squamous cell carcinoma.
- Conditions
- Head and Neck Cancer
- Being tested
- Fludarabine, Cyclophosphamide
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FludarabineDrug
Given by infusion
CyclophosphamideDrug
Given by infusion
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 ESC Safety Lead-in - TROP2 CAR/IL-15 TGFBR2 KO NK Cells | Experimental | Participants will receive treatment on an outpatient basis Receives: Drug: Fludarabine; Drug: Cyclophosphamide |
| Phase 1 ESC/EXP - TROP2 CAR/IL-15 TGFBR2 KO NK Cells + RT | Experimental | Participants will receive treatment on an outpatient basis Receives: Drug: Fludarabine; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start19 Dec 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gohar Manzar, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101432
- Sponsor's protocol ID
- 2025-0561
- Other IDs
- NCI-2025-05464
- Status last verified
- Sep 2026
- First submitted
- 28 Jul 2025
- Last updated
- 5 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 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Preconditioning Radiation Therapy With IL-15 Transduced TGFBR2 KO CAR.TROP2-engineered Cord Blood-derived NK Cells in Patients With Advanced Head and Neck Cancer (RADIANCE-NK)
- ClinicalTrials.gov ID
- NCT07101432
- Acronym / sponsor ID
- 2025-0561
- Conditions
- Head and Neck Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 19 Dec 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 3 Aug 2025 (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.
To find the recommended dose of an investigational therapy called chimeric antigen receptor (CAR).TROP2/interleukin (IL)15-transduced TGFBR2 KO cord blood (CB)-derived natural killer (NK) cells (TROP2 CAR/IL-15 TGFBR2 KO NK cells) that can be given with and without preconditioning radiation therapy in patients with advanced head and neck squamous cell carcinoma.
Detailed description
Primary Objective:
To determine the safety, tolerability, and recommended Phase 2 dose (RP2D) of chimeric antigen receptor (CAR).TROP2/interleukin (IL)15-transduced TGFBR2 KO cord blood (CB)-derived natural killer (NK) cells (TROP2 CAR/IL-15 TGFBR2 KO NK cells) combined with and without preconditioning RT in patients with advanced head and neck squamous cell carcinoma.
Secondary Objectives:
- To determine the antitumor activity of TROP2 CAR/IL-15 TGFBR2 KO NK cells, including those with pre-CAR-NK bridging SBRT in patients eligible to receive this. Although the clinical benefit of TG TROP2 CAR/IL-15 TGFBR2 KO NK cells has not yet been established (and is currently being investigated in other solid tumors in other clinical trials we have rendered), the intent of offering this treatment is to provide a possible therapeutic benefit and thus, the patient will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability. Efficacy will be determined in each cohort, and for this, we will have a pre-planned subset analysis of patients with metastatic disease where one site is not irradiated.
- To quantify the persistence of infused allogeneic donor CAR-transduced CB-derived NK cells in the peripheral blood of the recipient.
- To conduct comprehensive immune modulation studies by evaluating tissue and bloodbased biomarkers associated with response and resistance to TROP2 CAR/IL-15 TGFBR2 KO NK cell infusion.
- To obtain preliminary data on quality of life and patient experience.
- To evaluate longitudinal changes in circulating tumor DNA (ctDNA).
Exploratory Objectives:
- In patients who do not receive SBRT due to ineligibility, they are still eligible to receive CAR-NK cell therapy. This inadvertent biologic randomization may enable cross-sectional comparison of outcomes and correlatives among the patients who receive RT vs. not.
- To quantify the progression-free survival, overall survival, and the duration of responses of TGFBR2 KO CAR.TROP2/IL15-transduced CB-derived NK cells combined with preconditioning RT in patients with advanced head and neck squamous cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1 ESC Safety Lead-in - TROP2 CAR/IL-15 TGFBR2 KO NK Cells | Experimental | Drug: Fludarabine, Drug: CyclophosphamideParticipants will receive treatment on an outpatient basis |
| Phase 1 ESC/EXP - TROP2 CAR/IL-15 TGFBR2 KO NK Cells + RT | Experimental | Drug: Fludarabine, Drug: CyclophosphamideParticipants will receive treatment on an outpatient basis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (37 listed)
- Patients with histologically confirmed head and neck cancer, either HPV+ or HPV-, that is locally advanced AND unresectable OR metastatic (≤5 sites of disease), which has relapsed or progressed following local standard treatments that are known to prolong survival, or for which no standard treatment is available or are no longer effective, or refused such therapy.
- Patient tumors must demonstrate TROP2 expression of 2+ or 3+ as determined by IHC at the MDACC CAP and CLIA accredited Clinical Laboratories.
- 2 weeks from the last cytotoxic chemotherapy at the time of lymphodepleting chemotherapy; ≥3 days from last TKI or other targeted therapies at the time of lymphodepleting chemotherapy; ≥3 months from any cell therapy for any malignancy at the time of lymphodepleting chemotherapy; prior radiation therapy is allowed at the time of consent.
- RT allowed to ≥1 disease sites prior to the lymphodepleting chemotherapy. If there are additional measurable non-irradiated disease sites, this may be evaluated for response as well. If multiple lesions are irradiated, we advise that a single lesion will be treated to a higher dose and other lesions considered for lower doses, and that one site always remain unirradiated if a patient has ≥2 sites of disease.
- Age ≥18 years. Because no dosing or adverse event data are currently available on the use of TROP2 CAR/IL-15 TGFBR2 KO NK cells in combination with radiation therapy in patients <18 years of age, children are excluded from this study.
Key exclusion criteria (22 listed)
- 13. Known human immunodeficiency virus (HIV) infection.
- 14. Known active or chronic hepatitis B or hepatitis C virus infection.
- 15. Known history of active tuberculosis (Mycobacterium tuberculosis).
- 16. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
- 17. Patients with psychiatric illness/social situations that would limit compliance with study requirements.
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 |
|---|---|---|
| FludarabineGiven by infusion | Drug | Phase 1 ESC Safety Lead-in - TROP2 CAR/IL-15 TGFBR2 KO NK Cells, Phase 1 ESC/EXP - TROP2 CAR/IL-15 TGFBR2 KO NK Cells + RT |
| CyclophosphamideGiven by infusion | Drug | Phase 1 ESC Safety Lead-in - TROP2 CAR/IL-15 TGFBR2 KO NK Cells, Phase 1 ESC/EXP - TROP2 CAR/IL-15 TGFBR2 KO NK Cells + RT |
Primary outcome
Safety and Adverse Events (AEs)
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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 Oct 2026.
- MD Anderson Cancer Center WebsiteLink 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.
Gohar Manzar, MD principal investigator
M.D. Anderson 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 and Cyclophosphamide in people with Head and Neck Cancer, run by M.D. Anderson Cancer Center 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 37 inclusion and 22 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 5 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 Gohar Manzar, MD (713-792-4503, gsmanzar@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year). 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 Oct 2026.