NeurotoxicityNCT06144151
A Pilot Study for Pupillary Assessment to Predict CAR-T Related Neurotoxicity
An observational study of Neurotoxicity, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn about the relationship between changes in pupil size and reactivity and the start of neurological side effects in patients after receiving CAR-T cell therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurotoxicity
- What is being tested?
- NeurOptics® NPi®-300 Pupillometer
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2024to 1 Apr 2027
- Phase
- Observational
- 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
Study population: MD Anderson Cancer Center
Who may be able to join
- To be considered eligible for study participation, patient will satisfy all relevant inclusion criteria and none of the exclusion criteria.
- Ages Eligible for Study: 18 Years and above (Adult, Older Adult)
- Sexes Eligible for Study: All
- Patient with histologically proven DLBCL, PMBCL or tFL, or follicular Lymphoma receiving axi-cel CAR-T cell therapy in the inpatient setting at MD Anderson Cancer Center
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients who have already been administered CAR-T cell therapy.
- The patient who is unwilling or unable to comply with the requirements of the study including being able to be assessed with pupillometer
- Patient has a condition which places him at an unacceptable risk as determined by the investigator
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
MD Anderson Cancer Center
Houston, Texas, 77030
Ranjit Nair, MD, rnair@mdanderson.org
About this study
To learn about the relationship between changes in pupil size and reactivity and the start of neurological side effects in patients after receiving CAR-T cell therapy.
Read the detailed description
Primary Objective:
To assess the association between the status of NPi drop from baseline (prior to CAR T-cell infusion) to the lowest NPi post Axi-cel (CD19 CAR-T cell) infusion and the status of immune effector cell-associated neurotoxicity onset within 10 days post CD19 CAR-T cell infusion.
Secondary Objective:
To evaluate the largest absolute difference in NPi between two eyes (∆ NPi) and assess its association with severity of clinical symptoms as measured by Immune Effector Cell Encephalopathy (ICE) and or radiographic / EEG findings
Exploratory Objective:
To assess the feasibility and safety of a pupillometer use in patient treated with Axi-cel therapy.
- Conditions
- Neurotoxicity
- Being tested
- NeurOptics® NPi®-300 Pupillometer
- Medical subject headings
- Neurotoxicity Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurOptics® NPi®-300 PupillometerDevice
The pupilometer is a non-invasive device which will be placed in front of your eyes, one at a time. It looks like a handheld spotlight or scanner, with a small plastic guide sticking out that will be placed against your cheek to help keep the device in place during the scan. It will not touch your eye. Both your left and right eyes will be measured with the device each time. Scanning with the pupilometer will take less than 5 minutes total for both eyes.
What is being measured
The primary outcome is the main question the study is designed to answer.
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 posted22 Nov 2023
- Study start8 Feb 2024
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeurotoxicityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ranjit Nair, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06144151
- Sponsor's protocol ID
- 2023-0176
- Other IDs
- NCI-2023-09804
- Status last verified
- Jul 2026
- First submitted
- 16 Nov 2023
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study for Pupillary Assessment to Predict CAR-T Related Neurotoxicity
- ClinicalTrials.gov ID
- NCT06144151
- Acronym / sponsor ID
- 2023-0176
- Conditions
- Neurotoxicity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 22 Nov 2023 (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 learn about the relationship between changes in pupil size and reactivity and the start of neurological side effects in patients after receiving CAR-T cell therapy.
Detailed description
Primary Objective:
To assess the association between the status of NPi drop from baseline (prior to CAR T-cell infusion) to the lowest NPi post Axi-cel (CD19 CAR-T cell) infusion and the status of immune effector cell-associated neurotoxicity onset within 10 days post CD19 CAR-T cell infusion.
Secondary Objective:
To evaluate the largest absolute difference in NPi between two eyes (∆ NPi) and assess its association with severity of clinical symptoms as measured by Immune Effector Cell Encephalopathy (ICE) and or radiographic / EEG findings
Exploratory Objective:
To assess the feasibility and safety of a pupillometer use in patient treated with Axi-cel therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MD Anderson Cancer Center
Key inclusion criteria (5 listed)
- To be considered eligible for study participation, patient will satisfy all relevant inclusion criteria and none of the exclusion criteria.
- Ages Eligible for Study: 18 Years and above (Adult, Older Adult)
- Sexes Eligible for Study: All
- Patient with histologically proven DLBCL, PMBCL or tFL, or follicular Lymphoma receiving axi-cel CAR-T cell therapy in the inpatient setting at MD Anderson Cancer Center
- Ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (3 listed)
- Patients who have already been administered CAR-T cell therapy.
- The patient who is unwilling or unable to comply with the requirements of the study including being able to be assessed with pupillometer
- Patient has a condition which places him at an unacceptable risk as determined by the investigator
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 |
|---|---|---|
| NeurOptics® NPi®-300 PupillometerThe pupilometer is a non-invasive device which will be placed in front of your eyes, one at a time. It looks like a handheld spotlight or scanner, with a small plastic guide sticking out that will be placed against your cheek to help keep the device in place during the scan. It will not touch your eye. Both your left and right eyes will be measured with the device each time. Scanning with the pupilometer will take less than 5 minutes total for both eyes. | Device | – |
Primary outcome
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame: Through study completion; an average of 1 year.
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 16 Jul 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Neurotoxicity
RecruitingObservational study
Cognitive Aftereffects of Neurotoxicity in Children and Young Adults With Relapsed/Refractory Hematologic Malignancies Who Receive CAR T-cell Therapy
Lymphoma, Leukemia
Not yet recruitingObservational study
RPM Signals in Outpatient CAR T Therapy
Cytokine Release Syndrome, Immune Effector Cell-Associated Neurotoxicity Syndrome
RecruitingPhase 2
Intrathecal Chemoprophylaxis to Prevent Neurotoxicity Associated With Blinatumomab Therapy for Acute Lymphoblastic Leukemia
Acute Lymphoblastic Leukemia
RecruitingObservational study
A Study of Voice as a Way to Monitor for Side Effects in People Receiving CAR T-Cell Therapy
Non-hodgkin Lymphoma, Multiple Myeloma
Recruiting
Assessing DCog Short for Neurotoxicity in CAR-T
Neurotoxicity, Neurotoxicity Syndromes
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.
Ranjit Nair, 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?
An observational study of Neurotoxicity, 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 5 inclusion and 3 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 16 Jul 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.
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 Ranjit Nair, MD ((713) 563-4354, rnair@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 (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 16 Jul 2026.