SarcomaPhase 1NCT00902044
Her2 Chimeric Antigen Receptor Expressing T Cells in Advanced Sarcoma
A Phase 1 study testing Autologous HER2-specific T cells, Fludarabine and Cyclophosphamide in people with Sarcoma, run by Baylor College of Medicine at 2 sites in United States.
Trial summary
Patients have a type of cancer called sarcoma. Because there is no standard treatment for the patients cancer at this time or because the currently used treatments do not work fully in all cases, patients are being asked to volunteer to take part in a gene transfer research study using special immune cells. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sarcoma
- What is being tested?
- Autologous HER2-specific T cells, Fludarabine and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Feb 2010to Jul 2032
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Procurement Eligibility:
- Diagnosis of refractory HER2-positive sarcoma or metastatic HER2-positive osteosarcoma.
- Karnofsky/Lansky score of 50 or greater
- Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.
- Treatment Eligibility:
- Diagnosis of refractory HER2-positive sarcoma or metastatic HER2-positive sarcoma with disease progression after receiving at least one prior systemic therapy.
Show all 16Show fewer
- Recovered from acute toxic effects of all prior cytotoxic chemotherapy at least 4 weeks before entering this study. PD1/PDL1 inhibitors will be allowed to continue during treatment if medically indicated.
- Normal ECHO (Left ventricular ejection fraction (LVEF) has to be within normal, institutional limits)
- Life expectancy 6 weeks or greater
- Karnofsky/Lansky score of 50 or greater
- Bilirubin 3x or less, AST 3x or less, Serum creatinine 2x upper limit of normal or less, Hgb 7.0 g/dl or greater, WBC greater than 2,000/ul, ANC greater than 1,000/ul, platelets greater than 100,000/ul. Creatinine clearance is needed for patients with creatinine greater than 1.5 times upper limit of normal.
- Pulse oximetry of 90% or greater on room air
- Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the CTL infusion. Male partner should use a condom
- Available autologous transduced T lymphocytes with 15% or more expression of HER2 CAR as determined by flow-cytometry and killing of HER2-positive targets 20 % or greater in cytotoxicity assay.
- Chest radiograph for baseline evaluation of lungs
- Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent
Who cannot join
- At time of Procurement:
- Known HIV positivity
- Severe previous toxicity from cyclophosphamide or fludarabine
- At time of Treatment:
- Severe intercurrent infection
- Known HIV positivity
Show all 9Show fewer
- Pregnant or lactating
- History of hypersensitivity reactions to murine protein-containing products
- Severe previous toxicity from cyclophosphamide or fludarabine
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
About this study
Official title: Administration of Her2 Chimeric Antigen Receptor Expressing T Cells for Subjects With Advanced Sarcoma (HEROS)
Patients have a type of cancer called sarcoma. Because there is no standard treatment for the patients cancer at this time or because the currently used treatments do not work fully in all cases, patients are being asked to volunteer to take part in a gene transfer research study using special immune cells. This research study combines two different ways of fighting disease: antibodies and T cells. Antibodies are proteins that protect the body from diseases caused by germs or toxic substances. They work by binding those germs or substances, which stops them from growing or exerting their toxic effects. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including tumor cells or cells that are infected with germs. Both antibodies and T cells have been used to treat patients with cancers: they both have shown promise, but have not been strong enough to cure most patients. We have found from previous research that we can put a new gene into T cells that will make them recognize cancer cells and kill them. We now want to see if we can put a new gene in these cells that will let the T cells recognize and kill sarcoma cells. The new gene that we will put in makes an antibody specific for HER2 (Human Epidermal Growth Factor Receptor 2) that binds to sarcoma cells. In addition it contains CD28, which stimulated T cells and make them last longer. In other clinical studies using T cells, some investigators found that giving chemotherapy before the T cell infusion can improve the amount of time the T cells stay in the body and therefore the effect the T cells can have. Giving chemotherapy before a T cell infusion is called lymphodepletion since the chemotherapy is specifically chosen to decrease the number of lymphocytes in the body. Decreasing the number of patient's lymphocytes first should allow the T cells we infuse to expand and stay longer in your body, and potentially kill cancer cells more effectively. We will use fludarabine or the combination of cyclophosphamide and fludarabine as the chemotherapy agents for lymphodepletion. Cyclophosphamide and fludarabine are the chemotherapy agents most commonly used for lymphodepletion in immunotherapy clinical trials. The purpose of this study is to find the largest safe dose of chimeric T cells, and to see whether this therapy might help patients with sarcoma. Another purpose is to see if it is safe to give HER2-CD28 T cells after lymphodepleting chemotherapy.
Read the detailed description
Because the cells have a new gene in them the patient will be followed for a total of 15 years to see if there are any long term side effects of gene transfer.
When the patient is enrolled on this study, they will be assigned a dose of HER2-CD28 T cells. Depending on which dose level they are assigned, they will receive one of the following:
HER2-CD28 T cells and fludarabine (patient will receive fludarabine for 5 days followed by injection of HER2-CD28 T cells)
OR
HER2-CD28 T cells, fludarabine and cyclophosphamide (patient will receive fludarabine and cyclophosphamide for 2 days, fludarabine alone for an additional 3 days, and 2 days of rest before receiving the HER2-CD28 T cells.).
The HER2-CD28 T cells will be given into the vein through an IV line. The injection will take between 1 and 10 minutes. The patient will be followed in the clinic after the injection for 1 to 4 hours.
Each patient will be followed for 6 weeks after the T-cell infusion for evaluation of toxicity. They will have standard tests and procedures as well as research blood draws.
If the patient has stable disease (the tumor did not grow) or there is a reduction in the size of the tumor on imaging studies after the T-cell infusion, they can receive additional doses of the T cells at 6 to 12 weeks intervals. For the first two subsequent HER2-specific T-cell infusions, patients will be able to receive additional lymphodepleting chemotherapy according to their dose levels.
- Conditions
- Sarcoma
- Being tested
- Autologous HER2-specific T cells, Fludarabine, Cyclophosphamide, Autologous CAR Positive T cells
- Keywords
- Refractory Sarcoma, Metastatic Sarcoma, Sarcoma, HER2-positive, Gene Therapy, HER2-specific T cells
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous HER2-specific T cellsGenetic
Each patient will receive one intravenous injection of autologous HER2-specific T cells at one of the dose levels. If the patient has stable disease or a reduction in the size of the tumor they can receive additional doses of HER2-specific T cells at 6 to 12 weeks intervals-each of which will consist of the same cell number as their HER2-specific T-cell injection. For the first two subsequent HER2-specific T-cell infusions, patients will be able to receive additional lymphodepleting chemotherapy according to their dose levels.
FludarabineDrug
Also called Fludara
Fludarabine will be administered for 5 days prior to the T cells
The dose:
>10 kg: 25 mg/m2/day;
<10 kg: 1 mg/kg/day IV over 30 minutes
CyclophosphamideDrug
Also called Cytoxan
Cyclophosphamide will be administered for 2 days.
Fludarabine and cyclophosphamide will be given for 2 days, followed by fludarabine alone for the next 3 days, followed by 2 days of rest, before the T cells will be administered.
Cyclophosphamide Dose:
30 mg/kg/day IV over 1 hour (with Mesna and IV hydration)
Fludarabine Dose:
>10 kg: 25 mg/m2/day; <10 kg: 1 mg/kg/day IV over 30 minutes
Autologous CAR Positive T cellsGenetic
Patient will receive one intravenous injection of autologous CAR T cells at dose level 9C. Further CAR T-cell dose escalation at dose level 9C will be done using the lymphodepletion schema as in dose level 9B.
| Study group | Role | What they receive |
|---|---|---|
| Autologous HER2-specific T cells | Experimental | THIS ARM IS CLOSED
Dose Level 1: 1x10^4 cells/m2
Dose Level 2: 3x10^4 cells/m2
Dose Level 3: 1x10^5 cells/m2 (NOT BEING USED)
Dose Level 4: 3x10^5 cells/m2 (NOT BEING USED)
Dose Level 5: 1x10^6 cells/m2
Dose Level 6: 3x10^6 cells/m2
Dose Level 7: 1x10^7 cells/m2
Dose Level 8: 3x10^7 cells/m2
Dose Level 9: 1x10^8 cells/m2 Receives: Genetic: Autologous HER2-specific T cells |
| HER2-specific T cells+fludarabine | Experimental | Autologous HER2-specific T cells+fludarabine:
Dose Level 9A: fludarabine followed by 1x10^8 cells/m^2 Receives: Genetic: Autologous HER2-specific T cells; Drug: Fludarabine |
| HER2-specific T cells+fludarab.+cycloph. | Experimental | Autologous HER2-specific T cells+fludarabine+cyclophosphamide:
Dose Level 9B: fludarabine + cyclophosphamide followed by 1x10^8 cells/m^2 Receives: Genetic: Autologous HER2-specific T cells; Drug: Fludarabine; Drug: Cyclophosphamide |
| CAR Positive cells | Experimental | Dose Level 9C: fludarabine + cyclophosphamide followed by 1x10^8 cells/m^2 CAR positive cells/m^2 Receives: Genetic: Autologous HER2-specific T cells; Drug: Fludarabine; Drug: Cyclophosphamide; Genetic: Autologous CAR Positive T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with dose limiting toxicity after one injection of HER2-specific T cells
To determine the safety of one intravenous injection of autologous T cells expressing HER2-specific chimeric antigen receptor (CAR) in patients with advanced HER2-positive sarcoma.
To determine the safety of one intravenous injection of 1x10^8/m^2 autologous T cells after lymphodepleting chemotherapy.
Measured: 6 weeks
Secondary outcomes (2)
Frequency of HER2-specific T cells pre and post injection
To assess the in vivo expansion and persistence of infused T cells using immunoassays and transgene detection
Measured: 15 years
Change in tumor size from pre to post injection
To assess the anti-tumor effects of the infused HER2-specific T cells
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2009 (estimated)
- Study start11 Feb 2010
- Primary completion6 Dec 2019
- Study completionJul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SarcomaStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Cell and Gene Therapy, Baylor College of Medicine, The Methodist Hospital Research Institute, Cancer Prevention Research Institute of Texas
- Responsible party
- Principal investigator, Nabil Ahmed, Baylor College of Medicine
- Investigators
- Nabil M Ahmed, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00902044
- Sponsor's protocol ID
- 24489-HEROS
- Other IDs
- HEROS
- Status last verified
- Jan 2026
- First submitted
- 13 May 2009
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hegde M, Navai S, DeRenzo C, Joseph SK, Sanber K, Wu M, Gad AZ, Janeway KA, Campbell M, Mullikin D, Nawas Z, Robertson C, Mathew PR, Zhang H, Mehta B, Bhat RR, Major A, Shree A, Gerken C, Kalra M, Chakraborty R, Thakkar SG, Dakhova O, Salsman VS, Grilley B, Lapteva N, Gee A, Dotti G, Bao R, Salem AH, Wang T, Brenner MK, Heslop HE, Wels WS, Hicks MJ, Gottschalk S, Ahmed N. Autologous HER2-specific CAR T cells after lymphodepletion for advanced sarcoma: a phase 1 trial. Nat Cancer. 2024 Jun;5(6):880-894. doi: 10.1038/s43018-024-00749-6. Epub 2024 Apr 24.
PubMed 38658775Hegde M, Joseph SK, Pashankar F, DeRenzo C, Sanber K, Navai S, Byrd TT, Hicks J, Xu ML, Gerken C, Kalra M, Robertson C, Zhang H, Shree A, Mehta B, Dakhova O, Salsman VS, Grilley B, Gee A, Dotti G, Heslop HE, Brenner MK, Wels WS, Gottschalk S, Ahmed N. Tumor response and endogenous immune reactivity after administration of HER2 CAR T cells in a child with metastatic rhabdomyosarcoma. Nat Commun. 2020 Jul 15;11(1):3549. doi: 10.1038/s41467-020-17175-8.
PubMed 32669548
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration of Her2 Chimeric Antigen Receptor Expressing T Cells for Subjects With Advanced Sarcoma (HEROS)
- ClinicalTrials.gov ID
- NCT00902044
- Acronym / sponsor ID
- 24489-HEROS
- Conditions
- Sarcoma
- Keywords
- Refractory Sarcoma, Metastatic Sarcoma, Sarcoma, HER2-positive, Gene Therapy, HER2-specific T cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- 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, Cancer Prevention Research Institute of Texas
- Study start
- 11 Feb 2010
- Primary completion
- 6 Dec 2019 (actual)
- Study completion
- Jul 2032 (estimated)
- First posted
- 14 May 2009 (estimated)
- 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.
Patients have a type of cancer called sarcoma. Because there is no standard treatment for the patients cancer at this time or because the currently used treatments do not work fully in all cases, patients are being asked to volunteer to take part in a gene transfer research study using special immune cells. This research study combines two different ways of fighting disease: antibodies and T cells. Antibodies are proteins that protect the body from diseases caused by germs or toxic substances. They work by binding those germs or substances, which stops them from growing or exerting their toxic effects. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including tumor cells or cells that are infected with germs. Both antibodies and T cells have been used to treat patients with cancers: they both have shown promise, but have not been strong enough to cure most patients. We have found from previous research that we can put a new gene into T cells that will make them recognize cancer cells and kill them. We now want to see if we can put a new gene in these cells that will let the T cells recognize and kill sarcoma cells. The new gene that we will put in makes an antibody specific for HER2 (Human Epidermal Growth Factor Receptor 2) that binds to sarcoma cells. In addition it contains CD28, which stimulated T cells and make them last longer. In other clinical studies using T cells, some investigators found that giving chemotherapy before the T cell infusion can improve the amount of time the T cells stay in the body and therefore the effect the T cells can have. Giving chemotherapy before a T cell infusion is called lymphodepletion since the chemotherapy is specifically chosen to decrease the number of lymphocytes in the body. Decreasing the number of patient's lymphocytes first should allow the T cells we infuse to expand and stay longer in your body, and potentially kill cancer cells more effectively. We will use fludarabine or the combination of cyclophosphamide and fludarabine as the chemotherapy agents for lymphodepletion. Cyclophosphamide and fludarabine are the chemotherapy agents most commonly used for lymphodepletion in immunotherapy clinical trials. The purpose of this study is to find the largest safe dose of chimeric T cells, and to see whether this therapy might help patients with sarcoma. Another purpose is to see if it is safe to give HER2-CD28 T cells after lymphodepleting chemotherapy.
Detailed description
Because the cells have a new gene in them the patient will be followed for a total of 15 years to see if there are any long term side effects of gene transfer.
When the patient is enrolled on this study, they will be assigned a dose of HER2-CD28 T cells. Depending on which dose level they are assigned, they will receive one of the following:
HER2-CD28 T cells and fludarabine (patient will receive fludarabine for 5 days followed by injection of HER2-CD28 T cells)
OR
HER2-CD28 T cells, fludarabine and cyclophosphamide (patient will receive fludarabine and cyclophosphamide for 2 days, fludarabine alone for an additional 3 days, and 2 days of rest before receiving the HER2-CD28 T cells.).
The HER2-CD28 T cells will be given into the vein through an IV line. The injection will take between 1 and 10 minutes. The patient will be followed in the clinic after the injection for 1 to 4 hours.
Each patient will be followed for 6 weeks after the T-cell infusion for evaluation of toxicity. They will have standard tests and procedures as well as research blood draws.
If the patient has stable disease (the tumor did not grow) or there is a reduction in the size of the tumor on imaging studies after the T-cell infusion, they can receive additional doses of the T cells at 6 to 12 weeks intervals. For the first two subsequent HER2-specific T-cell infusions, patients will be able to receive additional lymphodepleting chemotherapy according to their dose levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Autologous HER2-specific T cells | Experimental | Genetic: Autologous HER2-specific T cellsTHIS ARM IS CLOSED Dose Level 1: 1x10^4 cells/m2 Dose Level 2: 3x10^4 cells/m2 Dose Level 3: 1x10^5 cells/m2 (NOT BEING USED) Dose Level 4: 3x10^5 cells/m2 (NOT BEING USED) Dose Level 5: 1x10^6 cells/m2 Dose Level 6: 3x10^6 cells/m2 Dose Level 7: 1x10^7 cells/m2 Dose Level 8: 3x10^7 cells/m2 Dose Level 9: 1x10^8 cells/m2 |
| HER2-specific T cells+fludarabine | Experimental | Genetic: Autologous HER2-specific T cells, Drug: FludarabineAutologous HER2-specific T cells+fludarabine: Dose Level 9A: fludarabine followed by 1x10^8 cells/m^2 |
| HER2-specific T cells+fludarab.+cycloph. | Experimental | Genetic: Autologous HER2-specific T cells, Drug: Fludarabine, Drug: CyclophosphamideAutologous HER2-specific T cells+fludarabine+cyclophosphamide: Dose Level 9B: fludarabine + cyclophosphamide followed by 1x10^8 cells/m^2 |
| CAR Positive cells | Experimental | Genetic: Autologous HER2-specific T cells, Drug: Fludarabine, Drug: Cyclophosphamide, Genetic: Autologous CAR Positive T cellsDose Level 9C: fludarabine + cyclophosphamide followed by 1x10^8 cells/m^2 CAR positive cells/m^2 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Diagnosis of refractory HER2-positive sarcoma or metastatic HER2-positive osteosarcoma.
- Karnofsky/Lansky score of 50 or greater
- Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.
- Diagnosis of refractory HER2-positive sarcoma or metastatic HER2-positive sarcoma with disease progression after receiving at least one prior systemic therapy.
- Recovered from acute toxic effects of all prior cytotoxic chemotherapy at least 4 weeks before entering this study. PD1/PDL1 inhibitors will be allowed to continue during treatment if medically indicated.
Key exclusion criteria (9 listed)
- Known HIV positivity
- Severe previous toxicity from cyclophosphamide or fludarabine
- Severe intercurrent infection
- Known HIV positivity
- Pregnant or lactating
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 HER2-specific T cellsEach patient will receive one intravenous injection of autologous HER2-specific T cells at one of the dose levels. If the patient has stable disease or a reduction in the size of the tumor they can receive additional doses of HER2-specific T cells at 6 to 12 weeks intervals-each of which will consist of the same cell number as their HER2-specific T-cell injection. For the first two subsequent HER2-specific T-cell infusions, patients will be able to receive additional lymphodepleting chemotherapy according to their dose levels. | Genetic | Autologous HER2-specific T cells, CAR Positive cells, HER2-specific T cells+fludarab.+cycloph., HER2-specific T cells+fludarabine |
| FludarabineAlso: FludaraFludarabine will be administered for 5 days prior to the T cells The dose: >10 kg: 25 mg/m2/day; <10 kg: 1 mg/kg/day IV over 30 minutes | Drug | CAR Positive cells, HER2-specific T cells+fludarab.+cycloph., HER2-specific T cells+fludarabine |
| CyclophosphamideAlso: CytoxanCyclophosphamide will be administered for 2 days. Fludarabine and cyclophosphamide will be given for 2 days, followed by fludarabine alone for the next 3 days, followed by 2 days of rest, before the T cells will be administered. Cyclophosphamide Dose: 30 mg/kg/day IV over 1 hour (with Mesna and IV hydration) Fludarabine Dose: >10 kg: 25 mg/m2/day; <10 kg: 1 mg/kg/day IV over 30 minutes | Drug | CAR Positive cells, HER2-specific T cells+fludarab.+cycloph. |
| Autologous CAR Positive T cellsPatient will receive one intravenous injection of autologous CAR T cells at dose level 9C. Further CAR T-cell dose escalation at dose level 9C will be done using the lymphodepletion schema as in dose level 9B. | Genetic | CAR Positive cells |
Primary outcome
Number of patients with dose limiting toxicity after one injection of HER2-specific T cells
Time frame: 6 weeks
To determine the safety of one intravenous injection of autologous T cells expressing HER2-specific chimeric antigen receptor (CAR) in patients with advanced HER2-positive sarcoma. To determine the safety of one intravenous injection of 1x10^8/m^2 autologous T cells after lymphodepleting chemotherapy.
2 secondary outcomes
Frequency of HER2-specific T cells pre and post injection
Time frame: 15 years
Change in tumor size from pre to post injection
Time frame: 6 weeks
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 26 Jan 2026.
- Derived from this study: PubMed 38658775Hegde M, Navai S, DeRenzo C, Joseph SK, Sanber K, Wu M, Gad AZ, Janeway KA, Campbell M, Mullikin D, Nawas Z, Robertson C, Mathew PR, Zhang H, Mehta B, Bhat RR, Major A, Shree A, Gerken C, Kalra M, Chakraborty R, Thakkar SG, Dakhova O, Salsman VS, Grilley B, Lapteva N, Gee A, Dotti G, Bao R, Salem AH, Wang T, Brenner MK, Heslop HE, Wels WS, Hicks MJ, Gottschalk S, Ahmed N. Autologous HER2-specific CAR T cells after lymphodepletion for advanced sarcoma: a phase 1 trial. Nat Cancer. 2024 Jun;5(6):880-894. doi: 10.1038/s43018-024-00749-6. Epub 2024 Apr 24.
- Derived from this study: PubMed 32669548Hegde M, Joseph SK, Pashankar F, DeRenzo C, Sanber K, Navai S, Byrd TT, Hicks J, Xu ML, Gerken C, Kalra M, Robertson C, Zhang H, Shree A, Mehta B, Dakhova O, Salsman VS, Grilley B, Gee A, Dotti G, Heslop HE, Brenner MK, Wels WS, Gottschalk S, Ahmed N. Tumor response and endogenous immune reactivity after administration of HER2 CAR T cells in a child with metastatic rhabdomyosarcoma. Nat Commun. 2020 Jul 15;11(1):3549. doi: 10.1038/s41467-020-17175-8.
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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.
Nabil M Ahmed, 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 Autologous HER2-specific T cells, Fludarabine and Cyclophosphamide in people with Sarcoma, 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 16 inclusion and 9 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 26 Jan 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?
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?
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 patients with dose limiting toxicity after one injection of HER2-specific T cells (time frame: 6 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 NCT00902044, which also lists 2 linked publications.
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 26 Jan 2026.