Solid Tumor MalignanciesPhase 2NCT04668833

ALI Post Radiation Therapy in Patients With Lung and Esophageal Canter

A Phase 2 study testing Autologous lymphocyte infusion (ALI) in people with Solid Tumor Malignancies, run by M.D. Anderson Cancer Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The goal of this clinical research study is to learn if giving autologous lymphocyte infusions to patients who are receiving chemotherapy and radiation for non-small cell lung cancer or esophageal cancer is safe and effective. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Solid Tumor Malignancies
What is being tested?: Autologous lymphocyte infusion (ALI)
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 1 siteUnited States
Study dates: 29 Sep 2020to 24 Oct 2025
Phase: Phase 2
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Histologically or cytologically documented NSCLC or esophageal cancers Stage II-IVA disease where definitive chemoradiation is the standard of care Age 18

Who cannot join

Prior radiotherapy to the chest Life expectancy<6 months Any systemic therapy, aside from standard of care immunotherapy, that is planned to be administered prior to 6 weeks after ALI. Pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site

M D Anderson Cancer Center
Houston, Texas, 77090

Other trials in United States

About this study

Official title: Phase II Study of Autologous Lymphocyte Infusions After Radiation Therapy to Mitigate Radiation Induced Lymphopenia and Enhance Immune Reconstitution in Patients With Solid Tumor Malignancies

Read the detailed description

The purpose of this study is to determine the safety and preliminary efficacy of un-manipulated autologous lymphocyte infusion (ALI) using the patient's own lymphocytes collected using apheresis, and infused after the completion of radiation/chemoradiation. Primary Objective To investigate the preliminary efficacy of autologous lymphocyte infusion (ALI) in improving the absolute lymphocyte counts in lung and esophageal cancer patients who had undergone chemo-radiation (CRT). Secondary Objectives

To evaluate the feasibility and safety of ALI in patients who had undergone chemoradiation.
To identify lymphocyte clonal populations in the tissue that are specific for tumor cells
To identify immune reconstitution in the peripheral blood shaped by ALI.
To conduct clonal analysis using T-cell receptor (TCR) sequencing from tumor and from peripheral blood.

Conditions: Solid Tumor Malignancies
Being tested: Autologous lymphocyte infusion (ALI)

What participants receive

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

Autologous lymphocyte infusion (ALI)Procedure or surgery
On the day after completing the last dose of radiation therapy, the patient will have an appointment scheduled in the Apheresis Unit for the infusion of unmunipulated cryopreserved cells. Patients will be pre medicated with acetaminophen (325-650 mg PO) and diphenhydramine (12.5-25 mg PO or IV) prior to infusion. Cells will be infused without a leukoreduction filter at a rate determined by cell volume.

Study groups in NCT04668833
Study group	Role	What they receive
Treatment (Autologous Lymphocyte Infusions)	Experimental	The purpose of this study is to determine the safety and preliminary efficacy of un-manipulated autologous lymphocyte infusion (ALI) using the patient's own lymphocytes collected using apheresis, and infused after the completion of radiation/chemoradiation. Receives: Procedure: Autologous lymphocyte infusion (ALI)

What is being measured

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

To Evaluate the Absolute Lymphocyte Counts Greater or Equal to 1000 Cells/uL 6 Weeks After ALI
Absolute lymphocyte counts at week 6 (+/- 14 days) - ALC measures the actual number of lymphocytes in blood, which is to assess immune system health.
Measured: 6 weeks +/- 14 days after ALI

Secondary outcomes (1)

To Evaluate the Safety of ALI in Patients Who Had Undergone Chemoradiation.
1. Grades 3-5 allergic reactions related to ALI
2. Grade 3-5 organ toxicity
3. Treatment-related death
Measured: Baseline to 6 weeks

Timeline

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

29 Sep 202024 Oct 2025

First posted16 Dec 2020
Study start29 Sep 2020
Primary completion24 Oct 2025
Study completion24 Oct 2025

Why it stopped: \<75% participation

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 Solid Tumor MalignanciesStudies 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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04668833
Sponsor's protocol ID: 2019-1164
Other IDs: NCI-2020-07836, 1R21CA240881
Status last verified: May 2026
First submitted: 9 Dec 2020
Last updated: 7 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

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

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

All Solid Tumor Malignancies trials

Study at a glance

From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Study of Autologous Lymphocyte Infusions After Radiation Therapy to Mitigate Radiation Induced Lymphopenia and Enhance Immune Reconstitution in Patients With Solid Tumor Malignancies
ClinicalTrials.gov ID: NCT04668833
Acronym / sponsor ID: 2019-1164
Conditions: Solid Tumor Malignancies
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: \<75% participation
Enrolment: 19 participants (actual)
Lead sponsor: M.D. Anderson Cancer CenterUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 29 Sep 2020 (actual)
Primary completion: 24 Oct 2025 (actual)
Study completion: 24 Oct 2025 (actual)
First posted: 16 Dec 2020 (actual)
Results: Posted 7 May 2026

Clinical summary

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

Detailed description

To evaluate the feasibility and safety of ALI in patients who had undergone chemoradiation.
To identify lymphocyte clonal populations in the tissue that are specific for tumor cells
To identify immune reconstitution in the peripheral blood shaped by ALI.
To conduct clonal analysis using T-cell receptor (TCR) sequencing from tumor and from peripheral blood.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment (Autologous Lymphocyte Infusions)	Experimental	Procedure: Autologous lymphocyte infusion (ALI)The purpose of this study is to determine the safety and preliminary efficacy of un-manipulated autologous lymphocyte infusion (ALI) using the patient's own lymphocytes collected using apheresis, and infused after the completion of radiation/chemoradiation.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Histologically or cytologically documented NSCLC or esophageal cancers Stage II-IVA disease where definitive chemoradiation is the standard of care Age 18

Key exclusion criteria (1 listed)

Prior radiotherapy to the chest Life expectancy<6 months Any systemic therapy, aside from standard of care immunotherapy, that is planned to be administered prior to 6 weeks after ALI. Pregnancy

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
Autologous lymphocyte infusion (ALI)On the day after completing the last dose of radiation therapy, the patient will have an appointment scheduled in the Apheresis Unit for the infusion of unmunipulated cryopreserved cells. Patients will be pre medicated with acetaminophen (325-650 mg PO) and diphenhydramine (12.5-25 mg PO or IV) prior to infusion. Cells will be infused without a leukoreduction filter at a rate determined by cell volume.	Procedure or surgery	Treatment (Autologous Lymphocyte Infusions)

Primary outcome

To Evaluate the Absolute Lymphocyte Counts Greater or Equal to 1000 Cells/uL 6 Weeks After ALI
Time frame: 6 weeks +/- 14 days after ALI
Absolute lymphocyte counts at week 6 (+/- 14 days) - ALC measures the actual number of lymphocytes in blood, which is to assess immune system health.

1 secondary outcome

To Evaluate the Safety of ALI in Patients Who Had Undergone Chemoradiation.
Time frame: Baseline to 6 weeks

Results and safety

Results posted to the registry on 7 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Autologous Lymphocyte Infusion (ALI) for Patients With Solid Tumor Malignancies After Radiation.	19	15

Primary outcome: To Evaluate the Absolute Lymphocyte Counts Greater or Equal to 1000 Cells/uL 6 Weeks After ALI

Time frame: 6 weeks +/- 14 days after ALI. Count of participants. Unit: Participants

Measure	Autologous Lymphocyte Infusion (ALI) for Patients With Solid Tumor Malignancies After Radiation. n = 19
Value	5

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Baseline to 6 weeks post ALI. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Autologous Lymphocyte Infusion (ALI) for Patients With Solid Tumor Malignancies After Radiation.	0 of 19 (0%)	6 of 19 (31.6%)	9 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.

Related trials for Solid Tumor Malignancies

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

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.

Gheath Al-Atrash principal investigator

MD Anderson Cancer Center, Houston, Texas

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Autologous lymphocyte infusion (ALI) in people with Solid Tumor Malignancies, 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 7 May 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 7 May 2026). 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?

To Evaluate the Absolute Lymphocyte Counts Greater or Equal to 1000 Cells/uL 6 Weeks After ALI (time frame: 6 weeks +/- 14 days after ALI). 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 NCT04668833.

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 7 May 2026.