Hodgkin DiseasePhase 1MABELNCT02287311

Most Closely Matched 3rd Party Rapidly Generated LMP, BARF1 And EBNA1 Specific CTL, EBV-Positive Lymphoma (MABEL)

A Phase 1 study testing MABEL CTLs, Cyclophosphamide and Fludarabine in people with Hodgkin Disease and Non-Hodgkin Lymphoma, run by Baylor College of Medicine at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Any age
Conditions the study is for: Hodgkin Disease, Non-Hodgkin Lymphoma, Severe Chronic Active Epstein Barr Virus
What is being tested?: MABEL CTLs, Cyclophosphamide and Fludarabine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 2 sitesUnited States
Study dates: Feb 2015to Mar 2029
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

SCREENING
Any patient regardless of age or sex, with diagnosis of either:
EBV positive Hodgkin's lymphoma
EBV Positive non-Hodgkin's Lymphoma (regardless of histologic subtype)
EBV (associated)-T/NK-lymphoproliferative disease
Severe Chronic Active EBV (CAEBV) -- CAEBV is defined as patients with high EBV viral load in plasma or PBMC (>4000 genomes per ug PBMC DNA) and/or biopsy tissue positive for EBV

Show all 36Show fewer

Other EBV positive malignancies (e.g. nasopharyngeal carcinoma, smooth muscle tumors, etc.)
AND
in first or subsequent relapse (Group A)
with active disease persisting despite therapy (Group B)
with active disease if immunosuppressive chemotherapy is contraindicated e.g. patients who develop Hodgkin disease after solid organ transplantation or if the lymphoma is a second malignancy e.g. a Richter's transformation of CLL. (Group C)
EBV positive tumor
Weighs at least 12kg
Informed consent (and assent as applicable) obtained from patient/guardian.
TREATMENT
Any patient regardless of age or sex, with diagnosis of either:
EBV positive Hodgkin's lymphoma
EBV Positive non-Hodgkin's Lymphoma (regardless of histologic subtype)
EBV (associated)-T/NK-lymphoproliferative disease
Severe Chronic Active EBV (CAEBV) -- CAEBV is defined as patients with high EBV viral load in plasma or PBMC (>4000 genomes per ug PBMC DNA) and/or biopsy tissue positive for EBV
Other EBV positive malignancies (e.g. nasopharyngeal carcinoma, smooth muscle tumors, etc.)
AND
in first or subsequent relapse (Group A)
with active disease persist despite therapy (Group B)
with active disease if immunosuppressive chemotherapy is contraindicated e.g. patients who develop Hodgkin disease after solid organ transplantation or if the lymphoma is a second malignancy e.g. a Richter's transformation of CLL. (Group C)
EBV positive tumor
Patients with life expectancy greater than or equal to 6 weeks
Patients with bilirubin less than or equal to 3x upper limit of normal
AST less than or equal to 5x upper limit of normal
Hemoglobin greater than or equal to 7.0 (may be a transfused value)
Patients with a creatinine less than or equal to 2x upper limit of normal for age
Pulse oximetry of > 90% on room air
Patients should have been off other investigational therapy for 30 days prior to infusion.
Patients with a Karnofsky/Lansky score of more than or equal to 50.
Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. The male partner should use a condom.
Informed consent (and assent as applicable) obtained from patient/guardian.

Who cannot join

TREATMENT
Pregnant or lactating
Severe intercurrent infection
Current use of systemic corticosteroids more than 0.5 mg/kg/day
Patients receiving ATG, Campath, or other immunosuppressive T cell monoclonal antibodies within 30 days.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Houston Methodist Hospital
Houston, Texas, 77030
Texas Children's Hospital
Houston, Texas, 77030

Other trials in United States

About this study

Official title: ADMINISTRATION OF MOST CLOSELY MATCHED THIRD PARTY RAPIDLY GENERATED LMP, BARF1 and EBNA1 SPECIFIC CYTOTOXIC T-LYMPHOCYTES TO PATIENTS WITH EBV-POSITIVE LYMPHOMA AND OTHER EBV-POSITIVE MALIGNANCIES

The subject has a type of cancer or lymph gland disease associated with a virus called Epstein Barr Virus (EBV), which has come back, is at risk of coming back, or has not gone away after standard treatments. This research study uses special immune system cells called LMP, BARF-1 and EBNA1- specific cytotoxic T lymphocytes (MABEL CTLs).

Some patients with Lymphoma (such as Hodgkin (HD) or non-Hodgkin Lymphoma (NHL)), T/NK-lymphoproliferative disease, or CAEBV, or solid tumors such as nasopharyngeal carcinoma (NPC), smooth muscle tumors, and leiomyosarcomas show signs of a virus called EBV before or at the time of their diagnosis. EBV causes mononucleosis or glandular fever ("mono" or the "kissing disease"). EBV is found in the cancer cells of up to half the patients with HD and NHL, suggesting that it may play a role in causing Lymphoma. The cancer cells (in lymphoma) and some immune system cells (in CAEBV) infected by EBV are able to hide from the body's immune system and escape destruction. EBV is also found in the majority of NPC and smooth muscle tumors, and some leiomyosarcomas. Investigators want to see if special white blood cells (MABEL CTLs) that have been trained to kill EBV infected cells can survive in patients blood and affect the tumor.

In previous studies, EBV CTLs were generated from the blood of the patient, which was often difficult if the patient had recently received chemotherapy. Also, it took up to 1-2 months to make the cells, which is not practical when a patient needs more urgent treatment. To address these issues, the MABEL CTLs were made in the lab in a simpler, faster, and safer way. The MABEL CTLs will still see LMP proteins but also two other EBV proteins called EBNA-1 and BARF. To ensure these cells are available for use in patients in urgent clinical need, investigators have generated MABEL CTLs from the blood of healthy donors and created a bank of these cells, which are frozen until ready for use. Investigators have previously successfully used frozen T cells from healthy donors to treat EBV lymphoma and virus infections and we now have improved our production method to make it faster.

In this study, investigators want to find out if they can use banked MABEL CTLs to treat HD, NHL, T/NK-lymphoproliferative disease, CAEBV, NPC, smooth muscle tumors or leiomyosarcoma. Investigators will search the bank to find a MABEL CTL line that is a partial match with the subject.

MABEL CTLs are investigational and not approved by the Food and Drug Administration.

Read the detailed description

A healthy donor has given blood to make LMP/BARF1/EBNA-1 MABEL CTLs in the lab. Investigators made the cells by first growing a special type of cells called activated T cells to stimulate the T cells. Investigators then added specially produced mixtures of proteins that include the LMP, EBNA1 and BARF proteins. These were used to stimulate T cells. As the T cells grew, investigators added some of the healthy donor cells expressing these proteins to stimulate them. Investigators also added a cell called K562 that has had new genes put inside it so it expresses proteins that stimulate the immune system to encourage the T cells to grow. K562 cells are cancer cells that have been treated with radiation so they cannot grow. This stimulation trained the MABEL CTLs to kill cells with EBV proteins on their surface. These cells were grown and frozen.

For the subject's treatment, the MABEL CTLs will be thawed and infused into the subject over 1-10 minutes. Initially, two doses of MABEL CTLs will be given two weeks apart. Subjects may be eligible to receive additional doses of the MABEL CTLs up to 6 times.

All of the treatments will be given by the Center for Cell and Gene Therapy at Texas Children's Hospital or Houston Methodist Hospital.

Medical tests before treatment:

Before being treated, the subject will receive a series of standard medical tests:

Physical exam; Blood tests to measure blood cells, kidney and liver function; Tumor measurements by routine imaging studies: Computer Tomogram (CT), Magnetic Resonance Imaging (MRI), or Positron Emission Tomography (PET/CT); Pregnancy test for females who are able to have children.

Several studies suggest that the infused T cells need room to be able to proliferate and accomplish their functions and that this may not happen if there are too many other T cells in circulation. Because of that, if the patient's level of circulating T cells is relatively high, s/he may require treatment with cyclophosphamide (Cytoxan) and fludarabine before s/he receives MABEL CTLs.

Medical tests during and after treatment:

Blood tests to measure blood cells, kidney and liver function; Imaging study 8 weeks after the 1st CTL infusion. If the subject receives additional doses they will also have an imaging study at 1 to 3 months after their final dose.

Subjects will either be seen in the clinic or will be contacted by research staff yearly for 5 years.

Conditions: Hodgkin Disease, Non-Hodgkin Lymphoma, Severe Chronic Active Epstein Barr Virus, T/NK-lymphoproliferative Disease, Nasopharyngeal Carcinoma, Smooth Muscle Tumor
Being tested: MABEL CTLs, Cyclophosphamide, Fludarabine
Keywords: EBV positive diseases, cytotoxic T lymphocytes
Medical subject headings: Hodgkin Disease, Lymphoma, Non-Hodgkin, Nasopharyngeal Carcinoma, Smooth Muscle Tumor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MABEL CTLsBiological
Also called LMP, BARF-1 and EBNA1 specific cytotoxic T lymphocytes, MABEL Cytotoxic T cells
Dose escalation:
DL1:2x10^7 cells/m2+2x10^7 cells/m2
DL2:2x10^7cells/m2+5x10^7 cells/m2
DL3:5x10^7 cells/m2+1x10^8 cells/m2
*Doses are based on total CD3+cells/m2
Patients with active disease that have apparent clinical benefit at the 8 wk post 1st infusion (6 wks after 2nd infusion) or subsequent evaluations may receive up to 6 additional doses of CTLs at intervals at least 6 wks apart, each of which will consist of the same cell number as their second injection or below the original dose if there is not enough product available for the original dose. Patients may receive lymphodepleting chemotherapy (Cy/Flu) before additional infusions. Patients cannot receive additional doses until the initial safety profile is completed at 6 wks following the second infusion.
CyclophosphamideDrug
Also called Cytoxan
If the patient's level of circulating T cells is relatively high, s/he may require treatment with cyclophosphamide (Cytoxan) and Fludarabine before s/he receives MABEL CTLs.
3 daily doses of cyclophosphamide (Cy: 500 mg/m2/day) together with fludarabine (Flu: 30 mg/m2) to induce lymphopenia, finishing at least 24 hours before CTL infusion.
FludarabineDrug
Also called Fludara
If the patient's level of circulating T cells is relatively high, s/he may require treatment with cyclophosphamide and fludarabine before s/he receives MABEL CTLs.
3 daily doses of cyclophosphamide (Cy: 500 mg/m2/day) together with fludarabine (Flu: 30 mg/m2) to induce lymphopenia, finishing at least 24 hours before CTL infusion.

Study groups in NCT02287311
Study group	Role	What they receive
Group A: MABEL CTLs	Experimental	Patients with 1st or subsequent relapse. Three different dosing schedules will be evaluated. Two to four patients will be evaluated on each dosing schedule. Each patient will receive 2 injections, 14 days apart. If the patient's level of circulating T cells is relatively high, s/he may require treatment with cyclophosphamide (Cytoxan) and Fludarabine before s/he receives MABEL CTLs. Receives: Biological: MABEL CTLs; Drug: Cyclophosphamide; Drug: Fludarabine
Group B: MABEL CTLs	Experimental	Patients with persistent active disease despite therapy. Three different dosing schedules will be evaluated. Two to four patients will be evaluated on each dosing schedule. Each patient will receive 2 injections, 14 days apart. If the patient's level of circulating T cells is relatively high, s/he may require treatment with cyclophosphamide (Cytoxan) and Fludarabine before s/he receives MABEL CTLs. Receives: Biological: MABEL CTLs; Drug: Cyclophosphamide; Drug: Fludarabine
Group C: MABEL CTLs	Experimental	Patients with active disease if immunosuppressive chemotherapy is contraindicated. Three different dosing schedules will be evaluated. Two to four patients will be evaluated on each dosing schedule. Each patient will receive 2 injections, 14 days apart. If the patient's level of circulating T cells is relatively high, s/he may require treatment with cyclophosphamide (Cytoxan) and Fludarabine before s/he receives MABEL CTLs. Receives: Biological: MABEL CTLs; Drug: Cyclophosphamide; Drug: Fludarabine

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With a Dose-limiting Toxicity (DLT)
To evaluate the safety of administering escalating doses of banked allogeneic, partially HLA-matched rapid EBV specific T cells.
Measured: 8 weeks

Secondary outcomes (1)

Percent of Patients Whose Best Response is Either Complete Remission or Partial Remission
To measure anti-tumor and anti-viral effects of ESTs
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2015Mar 2029

First posted10 Nov 2014 (estimated)
Study startFeb 2015
Primary completion12 Jan 2024
Study completionMar 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hodgkin DiseaseStudies of the same condition, open and under way.
More trials run by Baylor College of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02287311
Sponsor's protocol ID: H-35253 MABEL
Other IDs: MABEL
Acronym: MABEL
Status last verified: Mar 2026
First submitted: 6 Nov 2014
Last updated: 23 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ADMINISTRATION OF MOST CLOSELY MATCHED THIRD PARTY RAPIDLY GENERATED LMP, BARF1 and EBNA1 SPECIFIC CYTOTOXIC T-LYMPHOCYTES TO PATIENTS WITH EBV-POSITIVE LYMPHOMA AND OTHER EBV-POSITIVE MALIGNANCIES
ClinicalTrials.gov ID: NCT02287311
Acronym / sponsor ID: MABEL / H-35253 MABEL
Conditions: Hodgkin Disease, Non-Hodgkin Lymphoma, Severe Chronic Active Epstein Barr Virus, T/NK-lymphoproliferative Disease, Nasopharyngeal Carcinoma, Smooth Muscle Tumor
Keywords: EBV positive diseases, cytotoxic T lymphocytes
Phase: Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 38 participants (actual)
Lead sponsor: Baylor College of MedicineUniversity, hospital or other
Collaborators: Center for Cell and Gene Therapy, Baylor College of Medicine, The Methodist Hospital Research Institute
Study start: Feb 2015
Primary completion: 12 Jan 2024 (actual)
Study completion: Mar 2029 (estimated)
First posted: 10 Nov 2014 (estimated)
Results: Posted 24 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

MABEL CTLs are investigational and not approved by the Food and Drug Administration.

Detailed description

All of the treatments will be given by the Center for Cell and Gene Therapy at Texas Children's Hospital or Houston Methodist Hospital.

Medical tests before treatment:

Before being treated, the subject will receive a series of standard medical tests:

Medical tests during and after treatment:

Subjects will either be seen in the clinic or will be contacted by research staff yearly for 5 years.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Group A: MABEL CTLs	Experimental	Biological: MABEL CTLs, Drug: Cyclophosphamide, Drug: FludarabinePatients with 1st or subsequent relapse. Three different dosing schedules will be evaluated. Two to four patients will be evaluated on each dosing schedule. Each patient will receive 2 injections, 14 days apart. If the patient's level of circulating T cells is relatively high, s/he may require treatment with cyclophosphamide (Cytoxan) and Fludarabine before s/he receives MABEL CTLs.
Group B: MABEL CTLs	Experimental	Biological: MABEL CTLs, Drug: Cyclophosphamide, Drug: FludarabinePatients with persistent active disease despite therapy. Three different dosing schedules will be evaluated. Two to four patients will be evaluated on each dosing schedule. Each patient will receive 2 injections, 14 days apart. If the patient's level of circulating T cells is relatively high, s/he may require treatment with cyclophosphamide (Cytoxan) and Fludarabine before s/he receives MABEL CTLs.
Group C: MABEL CTLs	Experimental	Biological: MABEL CTLs, Drug: Cyclophosphamide, Drug: FludarabinePatients with active disease if immunosuppressive chemotherapy is contraindicated. Three different dosing schedules will be evaluated. Two to four patients will be evaluated on each dosing schedule. Each patient will receive 2 injections, 14 days apart. If the patient's level of circulating T cells is relatively high, s/he may require treatment with cyclophosphamide (Cytoxan) and Fludarabine before s/he receives MABEL CTLs.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (36 listed)

SCREENING
Any patient regardless of age or sex, with diagnosis of either:
AND
EBV positive tumor
Weighs at least 12kg

Key exclusion criteria (5 listed)

TREATMENT
Pregnant or lactating
Severe intercurrent infection
Current use of systemic corticosteroids more than 0.5 mg/kg/day
Patients receiving ATG, Campath, or other immunosuppressive T cell monoclonal antibodies within 30 days.

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
MABEL CTLsAlso: LMP, BARF-1 and EBNA1 specific cytotoxic T lymphocytes, MABEL Cytotoxic T cellsDose escalation: DL1:2x10^7 cells/m2+2x10^7 cells/m2 DL2:2x10^7cells/m2+5x10^7 cells/m2 DL3:5x10^7 cells/m2+1x10^8 cells/m2 *Doses are based on total CD3+cells/m2 Patients with active disease that have apparent clinical benefit at the 8 wk post 1st infusion (6 wks after 2nd infusion) or subsequent evaluations may receive up to 6 additional doses of CTLs at intervals at least 6 wks apart, each of which will consist of the same cell number as their second injection or below the original dose if there is not enough product available for the original dose. Patients may receive lymphodepleting chemotherapy (Cy/Flu) before additional infusions. Patients cannot receive additional doses until the initial safety profile is completed at 6 wks following the second infusion.	Biological	Group A: MABEL CTLs, Group B: MABEL CTLs, Group C: MABEL CTLs
CyclophosphamideAlso: CytoxanIf the patient's level of circulating T cells is relatively high, s/he may require treatment with cyclophosphamide (Cytoxan) and Fludarabine before s/he receives MABEL CTLs. 3 daily doses of cyclophosphamide (Cy: 500 mg/m2/day) together with fludarabine (Flu: 30 mg/m2) to induce lymphopenia, finishing at least 24 hours before CTL infusion.	Drug	Group A: MABEL CTLs, Group B: MABEL CTLs, Group C: MABEL CTLs
FludarabineAlso: FludaraIf the patient's level of circulating T cells is relatively high, s/he may require treatment with cyclophosphamide and fludarabine before s/he receives MABEL CTLs. 3 daily doses of cyclophosphamide (Cy: 500 mg/m2/day) together with fludarabine (Flu: 30 mg/m2) to induce lymphopenia, finishing at least 24 hours before CTL infusion.	Drug	Group A: MABEL CTLs, Group B: MABEL CTLs, Group C: MABEL CTLs

Primary outcome

Number of Participants With a Dose-limiting Toxicity (DLT)
Time frame: 8 weeks
To evaluate the safety of administering escalating doses of banked allogeneic, partially HLA-matched rapid EBV specific T cells.

1 secondary outcome

Percent of Patients Whose Best Response is Either Complete Remission or Partial Remission
Time frame: 8 weeks

Results and safety

Results posted to the registry on 24 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A Cohort 1	3	0
Group A Cohort 2	0	0
Group A Cohort 3	0	0
Group B Cohort 1	5	0
Group B Cohort 2	0	0
Group B Cohort 3	0	0
Group C Cohort 1	2	0
Group C Cohort 2	0	0
Group C Cohort 3	0	0

Primary outcome: Number of Participants With a Dose-limiting Toxicity (DLT)

Time frame: 8 weeks. Count of participants. Unit: Participants

Measure	Group A Cohort 1 n = 2	Group A Cohort 2 n = 3	Group A Cohort 3 n = 4	Group B Cohort 1 n = 4	Group B Cohort 2 n = 2	Group B Cohort 3 n = 4	Group C Cohort 1 n = 2	Group C Cohort 2 n = 2	Group C Cohort 3 n = 2
Value	0	0	0	0	0	0	0	0	0

Population analysed: All DLT evaluable participants were included in the analysis. DLT evaluable refers to participants who received two infusions and either completed the 8 weeks toxicity evaluation period without experiencing a DLT or developed a DLT during this period. Ten participants were not evaluable for DLT and were excluded from the analysis, including one participant who was later re-enrolled and became evaluable for DLT at the 2nd enrollment.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were recorded for 6 weeks, whereas serious adverse events were recorded for 1 year after the last EBV specific T cell infusion. All-cause mortality data were collected over a 5-year period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A Cohort 1	1 of 3 (33.3%)	3 of 3 (100%)	2 of 3
Group A Cohort 2	0 of 3 (0%)	3 of 3 (100%)	2 of 3
Group A Cohort 3	5 of 6 (83.3%)	6 of 6 (100%)	4 of 6
Group B Cohort 1	3 of 5 (60%)	5 of 5 (100%)	3 of 5
Group B Cohort 2	2 of 3 (66.7%)	3 of 3 (100%)	2 of 3
Group B Cohort 3	3 of 7 (42.9%)	7 of 7 (100%)	4 of 7
Group C Cohort 1	0 of 2 (0%)	2 of 2 (100%)	1 of 2
Group C Cohort 2	2 of 4 (50%)	4 of 4 (100%)	2 of 4
Group C Cohort 3	1 of 3 (33.3%)	3 of 3 (100%)	2 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rayne H Rouce, MD principal investigator

Baylor College of Medicine

2 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 MABEL CTLs, Cyclophosphamide and Fludarabine in people with Hodgkin Disease and Non-Hodgkin Lymphoma, run by Baylor College of Medicine at 2 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 36 inclusion and 5 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 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

Yes. Results are posted in the registry (first posted 24 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With a Dose-limiting Toxicity (DLT) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02287311.

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 23 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.