Solid TumorPhase 1ATTACKNCT05238792
Multi Tumor-Associated Antigen-Specific T Lymphocytes to Treat Patients With High Risk Solid Tumors
A Phase 1 study testing Tumor-associated antigen-specific T cell (TAA-T) in people with Solid Tumor, run by Children's National Research Institute at 1 site in United States.
Trial summary
This is an open-label phase I dose-escalation study to evaluate the safety of partially human leukocyte antigen (HLA)-matched multi tumor-associated antigen-specific T cell (TAA-T) therapy following lymphodepleting conditioning with or without local tumor ablation for pediatric and adult patients with high-risk solid… Read more about this study
- Who is it for?
- Ages 1 year to 70 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Tumor-associated antigen-specific T cell (TAA-T)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2021to Oct 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 1 year to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of high-risk solid tumors known to express at least 2 targeted antigens by either histology or historical reference: Ewing sarcoma, Wilms tumor, neuroblastoma, rhabdomyosarcoma, soft tissue sarcoma, and osteosarcoma.
- HLA type and match through at least one allele with antigen-specific activity.
- Following conventional therapy: refractory disease, residual detectable disease, or relapsed disease.
- Age >= 1 year and <70 years
- Patient or parent/guardian capable of providing informed consent.
- No systemic corticosteroid exposure within 1 week of initiating protocol treatment.
Show all 23Show fewer
- Karnofsky/Lansky score of ≥50%.
- For participant with history of total body irradiation (TBI), radiation to thorax, or treatment with cardiotoxic chemotherapy (anthracycline or equivalent): Left ventricular ejection fraction (LVEF) >50% OR left ventricular fractional shortening (FS) >27% (may be performed within the last 12 months, and after completion of such treatment/s)
- Hemoglobin >7.0 g/dL (level can be achieved with transfusion).
- Direct bilirubin ≤2.5 mg/dL or 3x ULN (whichever is higher).
- Aspartate transaminase (AST)/Alanine transaminase (ALT) ≤5 x the upper limit of normal for age.
- Serum creatinine <1.0 mg/dL or 2x the upper limit of normal for age (whichever is higher).
- Pulse oximetry of >90% on room air.
- Respiratory rate:
- <30 breaths per minute for patients aged <18 years
- <25 breaths per minute for patients aged ≥18 years
- Respiratory rate may be repeated if initial value is thought to be temporarily abnormal. If repeated, 2 values should be obtained ≥30 minutes apart prior to protocol treatment to be eligible.
- Twelve (12) weeks post last radiation dose to the mediastinum/chest with resolution of any respiratory symptoms.
- Negative pregnancy test in female patient of childbearing potential.
- Agree to use contraceptive measures during study protocol participation through 6 months post final TAAT infusion (for FOCBP).
- Prior to cycle #1 only (requisite for receiving lymphodepleting chemotherapy):
- Absolute neutrophil count (ANC) >1000 /ul.
- Platelet count >75,000 /ul.
Who cannot join
- Patients with uncontrolled infections. Uncontrolled infections are defined as bacterial, fungal, or viral infections with either clinical signs of worsening despite standard therapy. Progressing infection is defined as hemodynamic instability, worsening physical signs, or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
- For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection within 7 days prior to protocol treatment.
- For fungal infections, patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection within 7 days prior to initiating protocol treatment.
- Patients who received ATG, Campath or other immunosuppressive T cell monoclonal antibodies within 28 days prior to initiating protocol treatment.
- Exposure to chemotherapy or immunomodulatory medications within the last 2 weeks prior to initiating protocol treatment.
- Pregnant or lactating females.
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
Children's National Hospital
Washington D.C., District of Columbia, 20010
Amy Hont, MBBS, MS, 202-476-3887, ahoughte@childrensnational.org
Amy Hont, MD
About this study
Official title: Phase I Research Study Utilizing Allogeneic Multi Tumor-Associated Antigen-Specific T Lymphocytes to Advance the Care of Patients With High-Risk Solid Tumors
This is an open-label phase I dose-escalation study to evaluate the safety of partially human leukocyte antigen (HLA)-matched multi tumor-associated antigen-specific T cell (TAA-T) therapy following lymphodepleting conditioning with or without local tumor ablation for pediatric and adult patients with high-risk solid tumors due to the presence of refractory, relapsed and/or minimal residual detectable disease following conventional therapy (e.g., chemotherapy, surgery, radiation, autologous stem cell transplant, or targeted therapy).
Read the detailed description
In this dose escalation trial, three dose levels will be tested for safety. TAA-T product will first be administered to patients as monotherapy at dose level 1 to determine safety.
All participants enrolled to DL2 or DL3 will be assigned to one of the following at Screening Eligibility:
- Treatment Regimen 1 (Tx-R1): Lymphodepleting chemotherapy + TAA-T therapy
- Treatment Regimen 2 (Tx-R2): Lymphodepleting chemotherapy + local tumor ablation with cryoablation or PEF (cryoablation/PEF) + TAA-T therapy
In this dose escalation trial, three dose levels will be tested for safety. The protocol-level accrual flow is described briefly as follows: TAA-T product will first be administered to adult patients (Arm A) as monotherapy at dose level 1 (Completed as of Protocol V5.0). Following demonstration of safety at DL1, adults will be enrolled at DL2. Following demonstration of safety at DL2 in adults, enrollment will proceed under the amended protocol to treatment regimens 1 and 2: Tx-R1 at DL3, and Tx-R2 at DL2 (upon approval of ATTACK Protocol V5.0).Tx-R1 and Tx-R2 may accrue in parallel to one another. Each regimen will independently escalate, expand, or de-escalate according to the 3+3 design until the MTD is identified or, if the MTD is not reached, the maximum administered dose, (MAD; DL3) is reached. A total of six patients will then be treated at each regimen's MTD (or MAD, as applicable).
Safety evaluations, including DLT assessment, maximum tolerated dose level (MTD) and recommended dose level (RDL) determination, will be performed separately for each regimen, however, if a protocol-defined stopping rule is met, enrollment and dosing in both regimens will be paused pending review.
The TAA-T product will be assessed for safety and anti-tumor activity.
- Conditions
- Solid Tumor
- Being tested
- Tumor-associated antigen-specific T cell (TAA-T)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor-associated antigen-specific T cell (TAA-T)Biological
Patients will receive cells due to the presence of refractory disease, or high risk for disease relapse and/or minimal residual detectable disease following conventional therapy. The treatment schedule is as follows: Patients will receive an infusion of partially HLA-matched TAA-T any time >1 week after completing most recent course of conventional (noninvestigational) therapy for their disease. For patients enrolled to DL2 or DL3, they will receive protocol-described lymphodepletion (LD) chemotherapy (fludarabine and cyclophosphamide) >2 weeks from most recent course of conventional therapy and post nadir and recovery from the prior therapy. Patients will be enrolled to one of the following TAA-T dose levels:
BSA <1.20 Dose Level 2 (+/- ablation + low dose TAA-T cells) 2x10^7 Dose Level 3 (+/- ablation + high dose TAA-T cells) 4x10^7
BSA>=1.20 Dose Level 2 (+/- ablation + low dose TAA-T cells) 4x10^7 Dose Level 3 (+/- ablation + high dose TAA-T cells) 8x10^7
| Study group | Role | What they receive |
|---|---|---|
| TAA-T Infusion | Experimental | Treatment with partially human leukocyte antigen (HLA)-matched multi tumor-associated antigen-specific T cell (TAA-T) therapy following lymphodepleting conditioning with or without local tumor ablation. Receives: Biological: Tumor-associated antigen-specific T cell (TAA-T) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety of administering partially HLA-matched TAA-T cells
Safety will be evaluated by the incidence of dose-limiting toxicities (DLTs).
Measured: 45 days
Secondary outcomes (1)
Treatment feasibility and impact of TAA-T infusion
Determining anti-tumor activity (tumor response) following TAA-T infusion.
Measured: Within 12 months of TAA-T infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start17 Nov 2021
- Primary completionOct 2028 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Children's National Research InstituteThe 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Hont, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05238792
- Sponsor's protocol ID
- ATTACK
- Acronym
- ATTACK
- Status last verified
- Oct 2026
- First submitted
- 3 Feb 2022
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Research Study Utilizing Allogeneic Multi Tumor-Associated Antigen-Specific T Lymphocytes to Advance the Care of Patients With High-Risk Solid Tumors
- ClinicalTrials.gov ID
- NCT05238792
- Acronym / sponsor ID
- ATTACK / ATTACK
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 14 Feb 2022 (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.
This is an open-label phase I dose-escalation study to evaluate the safety of partially human leukocyte antigen (HLA)-matched multi tumor-associated antigen-specific T cell (TAA-T) therapy following lymphodepleting conditioning with or without local tumor ablation for pediatric and adult patients with high-risk solid tumors due to the presence of refractory, relapsed and/or minimal residual detectable disease following conventional therapy (e.g., chemotherapy, surgery, radiation, autologous stem cell transplant, or targeted therapy).
Detailed description
In this dose escalation trial, three dose levels will be tested for safety. TAA-T product will first be administered to patients as monotherapy at dose level 1 to determine safety.
All participants enrolled to DL2 or DL3 will be assigned to one of the following at Screening Eligibility:
- Treatment Regimen 1 (Tx-R1): Lymphodepleting chemotherapy + TAA-T therapy
- Treatment Regimen 2 (Tx-R2): Lymphodepleting chemotherapy + local tumor ablation with cryoablation or PEF (cryoablation/PEF) + TAA-T therapy
In this dose escalation trial, three dose levels will be tested for safety. The protocol-level accrual flow is described briefly as follows: TAA-T product will first be administered to adult patients (Arm A) as monotherapy at dose level 1 (Completed as of Protocol V5.0). Following demonstration of safety at DL1, adults will be enrolled at DL2. Following demonstration of safety at DL2 in adults, enrollment will proceed under the amended protocol to treatment regimens 1 and 2: Tx-R1 at DL3, and Tx-R2 at DL2 (upon approval of ATTACK Protocol V5.0).Tx-R1 and Tx-R2 may accrue in parallel to one another. Each regimen will independently escalate, expand, or de-escalate according to the 3+3 design until the MTD is identified or, if the MTD is not reached, the maximum administered dose, (MAD; DL3) is reached. A total of six patients will then be treated at each regimen's MTD (or MAD, as applicable).
Safety evaluations, including DLT assessment, maximum tolerated dose level (MTD) and recommended dose level (RDL) determination, will be performed separately for each regimen, however, if a protocol-defined stopping rule is met, enrollment and dosing in both regimens will be paused pending review.
The TAA-T product will be assessed for safety and anti-tumor activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAA-T Infusion | Experimental | Biological: Tumor-associated antigen-specific T cell (TAA-T)Treatment with partially human leukocyte antigen (HLA)-matched multi tumor-associated antigen-specific T cell (TAA-T) therapy following lymphodepleting conditioning with or without local tumor ablation. |
Who may qualify
- Ages
- 1 year to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (23 listed)
- Diagnosis of high-risk solid tumors known to express at least 2 targeted antigens by either histology or historical reference: Ewing sarcoma, Wilms tumor, neuroblastoma, rhabdomyosarcoma, soft tissue sarcoma, and osteosarcoma.
- HLA type and match through at least one allele with antigen-specific activity.
- Following conventional therapy: refractory disease, residual detectable disease, or relapsed disease.
- Age >= 1 year and <70 years
- Patient or parent/guardian capable of providing informed consent.
Key exclusion criteria (6 listed)
- Patients with uncontrolled infections. Uncontrolled infections are defined as bacterial, fungal, or viral infections with either clinical signs of worsening despite standard therapy. Progressing infection is defined as hemodynamic instability, worsening physical signs, or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
- For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection within 7 days prior to protocol treatment.
- For fungal infections, patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection within 7 days prior to initiating protocol treatment.
- Patients who received ATG, Campath or other immunosuppressive T cell monoclonal antibodies within 28 days prior to initiating protocol treatment.
- Exposure to chemotherapy or immunomodulatory medications within the last 2 weeks prior to initiating protocol treatment.
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 |
|---|---|---|
| Tumor-associated antigen-specific T cell (TAA-T)Patients will receive cells due to the presence of refractory disease, or high risk for disease relapse and/or minimal residual detectable disease following conventional therapy. The treatment schedule is as follows: Patients will receive an infusion of partially HLA-matched TAA-T any time >1 week after completing most recent course of conventional (noninvestigational) therapy for their disease. For patients enrolled to DL2 or DL3, they will receive protocol-described lymphodepletion (LD) chemotherapy (fludarabine and cyclophosphamide) >2 weeks from most recent course of conventional therapy and post nadir and recovery from the prior therapy. Patients will be enrolled to one of the following TAA-T dose levels: BSA <1.20 Dose Level 2 (+/- ablation + low dose TAA-T cells) 2x10^7 Dose Level 3 (+/- ablation + high dose TAA-T cells) 4x10^7 BSA>=1.20 Dose Level 2 (+/- ablation + low dose TAA-T cells) 4x10^7 Dose Level 3 (+/- ablation + high dose TAA-T cells) 8x10^7 | Biological | TAA-T Infusion |
Primary outcome
To determine the safety of administering partially HLA-matched TAA-T cells
Time frame: 45 days
Safety will be evaluated by the incidence of dose-limiting toxicities (DLTs).
1 secondary outcome
Treatment feasibility and impact of TAA-T infusion
Time frame: Within 12 months of TAA-T infusion
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 29 Oct 2026.
- Individual participant dataSharing planned: No
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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.
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 Tumor-associated antigen-specific T cell (TAA-T) in people with Solid Tumor, run by Children's National Research Institute 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 23 inclusion and 6 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 29 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 Amy Hont, MD (202-476-3887, ahoughte@childrensnational.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the safety of administering partially HLA-matched TAA-T cells (time frame: 45 days). 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 29 Oct 2026.