Pediatric Solid TumorPhase 1NCT04483778
B7H3 CAR T Cell Immunotherapy for Recurrent/Refractory Solid Tumors in Children and Young Adults
A Phase 1 study testing second generation 4-1BBζ B7H3-EGFRt-DHFR, second generation 4-1BBζ B7H3-EGFRt-DHFR(selected) and a second generation 4-1BBζ CD19-Her2tG and Pembrolizumab in people with Pediatric Solid Tumor and Germ Cell Tumor, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
This is a phase I, open-label, non-randomized study that will enroll pediatric and young adult research participants with relapsed or refractory non-CNS solid tumors to evaluate the safety, feasibility, and efficacy of administering T cell products derived from the research participant's blood that have been… Read more about this study
- Who is it for?
- Ages 0 to 26 years
- Conditions the study is for
- Pediatric Solid Tumor, Germ Cell Tumor, Retinoblastoma
- What is being tested?
- second generation 4-1BBζ B7H3-EGFRt-DHFR, second generation 4-1BBζ B7H3-EGFRt-DHFR(selected) and a second generation 4-1BBζ CD19-Her2tG and Pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2020to Dec 2040
- 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 0 to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants age ≤ 26 years at the time of consent for study participation; the first 2 participants enrolled and treated with CAR T cells in both Arms A and B will be ≥ 15 years. and ≤ 26 years at time of consent for study participation
- Histologically diagnosed malignant, non-primary CNS solid tumor
- Evidence of refractory or recurrent disease
- Lansky or Karnofsky score ≥ 50
- Life expectancy ≥ 8 weeks
- Recovered from significant acute toxic effects of all prior chemotherapy, immunotherapy and radiotherapy
Show all 17Show fewer
- If no apheresis product or usable T cell product is available, all chemotherapy has been discontinued ≥ 7 days prior to enrollment
- If no apheresis or usable T cell product is available, all biologic therapy has been discontinued ≥ 7 days prior to enrollment
- If no apheresis product or T cell product is available, all systemic corticosteroid therapy has been discontinued ≥ 7 days prior to enrollment (physiologic replacement dosing is allowed)
- If no apheresis product or usable T cell product is available, at least 3 half-lives or 30 days (whichever is shorter) from time of last dose of anti-tumor directed antibody therapy (including checkpoint inhibitor) at time of enrollment
- If no apheresis product or usable T cell product is available, at least 6 weeks post last dose of myeloablative therapy and autologous and/or allogeneic stem cell transplant, or non-myeloablative therapy and allogeneic stem cell transplant (all timed from stem cell infusion). Participants who receive autologous stem cell infusion following non-myeloablative therapy are eligible once all other eligibility requirements are met.
- If no apheresis product or usable T cell product is available, participants who have received genetically modified cell therapy must be at least 30 days from most recent cell infusion prior to enrollment
- If no apheresis product or usable T cell product is available, participants with neuroblastoma must be at least 12 weeks from I131 MIBG therapy.
- Adequate organ function
- Adequate laboratory values
- Participant is able to tolerate apheresis (including placement of temporary apheresis catheter, if necessary), or already has an apheresis product available for use in manufacturing.
- Participants of childbearing potential must agree to use highly effective contraception
Who cannot join
- Presence of active malignancy other than primary malignant solid tumor diagnosis
- Current relevant CNS pathology
- Receiving external beam radiation therapy at time of enrollment
- Presence of active GVHD, or receiving immunosuppressive therapy for treatment or prevention of GVHD within 4 weeks prior to enrollment
- Participant is pregnant or breastfeeding
- Participant has presence of active severe infection
Show all 9Show fewer
- Participant has presence of any condition that, in the option of an investigator, would prohibit the participant from undergoing treatment under this protocol
- Participant has primary immunodeficiency syndrome
- Unwilling or unable to provide consent/assent for participation in the study and 15 year follow up period
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
Official title: Phase I Study of B7H3 CAR T Cell Immunotherapy for Recurrent/Refractory Solid Tumors in Children and Young Adults
This is a phase I, open-label, non-randomized study that will enroll pediatric and young adult research participants with relapsed or refractory non-CNS solid tumors to evaluate the safety, feasibility, and efficacy of administering T cell products derived from the research participant's blood that have been genetically modified to express a B7H3-specific receptor (chimeric antigen receptor, or CAR) that will target and kill solid tumors that express B7H3. On Arm A of the study, research participants will receive B7H3-specific CAR T cells only. On Arm B of the study, research participants will receive CAR T cells directed at B7H3 and CD19, a marker on the surface of B lymphocytes, following the hypothesis that CD19+ B cells serving in their normal role as antigen presenting cells to T cells will promote the expansion and persistence of the CAR T cells. Arm A CAR T cells include the protein EGFRt and Arm B CAR T cells include the protein HER2tG. These proteins can be used to both track and destroy the CAR T cells in case of undue toxicity. The primary objectives of the study will be to determine the feasibility of manufacturing the cell products, the safety of the T cell product infusion, to determine the maximum tolerated dose of the CAR T cells products, to describe the full toxicity profile of each product, and determine the persistence of the modified cell in the participant's body on each arm. Participants will receive a single dose of T cells comprised of two different subtypes of T cells (CD4 and CD8 T cells) felt to benefit one another once administered to the research participants for improved potential therapeutic effect. The secondary objectives of this protocol are to study the number of modified cells in the patients and the duration they continue to be at detectable levels. The investigators will also quantitate anti-tumor efficacy on each arm. Participants who experience significant and potentially life-threatening toxicities (other than clinically manageable toxicities related to T cells working, called cytokine release syndrome) will receive infusions of cetuximab (an antibody commercially available that targets EGFRt) or trastuzumab (an antibody commercially available that targets HER2tG) to assess the ability of the EGFRt on the T cells to be an effective suicide mechanism for the elimination of the transferred T cell products.
- Conditions
- Pediatric Solid Tumor, Germ Cell Tumor, Retinoblastoma, Hepatoblastoma, Wilms Tumor, Rhabdoid Tumor
- Being tested
- second generation 4-1BBζ B7H3-EGFRt-DHFR, second generation 4-1BBζ B7H3-EGFRt-DHFR(selected) and a second generation 4-1BBζ CD19-Her2tG, Pembrolizumab
- Keywords
- CAR T cell, Pediatric, Young adults, Non-CNS solid tumor
- Medical subject headings
- Neoplasms, Germ Cell and Embryonal, Retinoblastoma, Hepatoblastoma, Wilms Tumor, Rhabdoid Tumor, Carcinoma, Osteosarcoma, Sarcoma, Ewing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
second generation 4-1BBζ B7H3-EGFRt-DHFRBiological
Autologous CD4+ and CD8+ T-cells lentivirally transduced to express a second generation 4-1BBζ B7H3-EGFRt-DHFR
second generation 4-1BBζ B7H3-EGFRt-DHFR(selected) and a second generation 4-1BBζ CD19-Her2tGBiological
Autologous CD4+ and CD8+ T-cells lentivirally transduced to express a second generation 4-1BBζ B7H3-EGFRt-DHFR(selected) and a second generation 4-1BBζ CD19-Her2tG
PembrolizumabDrug
SCRI-CARB7H3(s)x19 plus pembrolizumab
| Study group | Role | What they receive |
|---|---|---|
| SCRI-CARB7H3(s) | Experimental | Autologous CD4+ and CD8+ T-cells genetically modified to express an B7H3-specific CAR Receives: Biological: second generation 4-1BBζ B7H3-EGFRt-DHFR |
| SCRI-CARB7H3(s)x19 | Experimental | Autologous CD4+ and CD8+ T-cells genetically modified to a bispecific B7H3xCD19 CAR Receives: Biological: second generation 4-1BBζ B7H3-EGFRt-DHFR(selected) and a second generation 4-1BBζ CD19-Her2tG |
| SCRI-CARB7H3(s)x19 plus pembrolizumab | Experimental | Autologous CD4+ and CD8+ T-cells genetically modified to express a bispecific B7H3xCD19 CAR given in combination with pembrolizumab Receives: Biological: second generation 4-1BBζ B7H3-EGFRt-DHFR(selected) and a second generation 4-1BBζ CD19-Her2tG; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the safety and tolerability of cellular immunotherapy utilizing ex-vivo expanded autologous T cells genetically modified to express B7H3-specific CAR (Arm A)
Type, frequency, severity, and duration of adverse events will be tabulated and summarized
Measured: 28 days
Assess the safety and tolerability of cellular immunotherapy utilizing ex-vivo expanded autologous T cells genetically modified to express a bispecific B7H3xCD19 CAR (Arm B)
Type, frequency, severity, and duration of adverse events will be tabulated and summarized
Measured: 28 days
To assess the safety and tolerability of cellular immunotherapy utilizing ex-vivo expanded autologous T cells genetically modified to express a bispecific B7H3xCD19 CAR given in combination with pembrolizumab (Arm C)
Type, frequency, severity, and duration of adverse events will be tabulated and summarized to determine maximal tolerated dose
Measured: 28 days
To determine the maximum tolerated dose (MTD) of B7H3-specific CAR (Arm A)
Type, frequency, severity, and duration of adverse events will be tabulated and summarized to determine maximal tolerated dose
Measured: 28 days
To determine the maximum tolerated dose of bispecific B7H3xCD19 CAR (Arm B)
Type, frequency, severity, and duration of adverse events will be tabulated and summarized
Measured: 28 days
To determine the feasibility of administration of pembrolizumab in combination with bispecific B7H3xCD19 CAR (Arm C)
Type, frequency, severity, and duration of adverse events will be tabulated and summarized
Measured: 28 days
To assess the dose limiting toxicities (DLTs) and describe the full toxicity profile for each study arm
Type, frequency, severity, and duration of adverse events will be tabulated and summarized
Measured: 28 days
To assess the feasibility of manufacturing B7H3 specific CARs from patient-derived lymphocytes
Type, frequency, severity, and duration of adverse events will be tabulated and summarized
Measured: 28 days
To assess the feasibility of manufacturing B7H3xCD19 bispecific CARs from patient-derived lymphocytes
Type, frequency, severity, and duration of adverse events will be tabulated and summarized
Measured: 28 days
Secondary outcomes (4)
Determine the duration of in vivo persistence of adoptively transferred T cells in the peripheral blood and compare engraftment between T cell products and treatment arms
Presence of CAR T cells in the peripheral blood will be assessed
Measured: 84 days
Determine the magnitude of in vivo persistence of adoptively transferred T cells in the peripheral blood and compare engraftment between T cell products
Number of CAR T cells in the peripheral blood will be assessed
Measured: 84 days
Quantitate anti-tumor responses by measuring changes in tumor burden using disease-specific evaluations
Presence of CAR T cells in the peripheral blood will be assessed
Measured: 84 days
Describe the relative expansion and persistence of the CAR T cell product and retention of function for B7H3xCD19 bispecific CARs determined by maintenance of B cell aplasia (BCA) with and without pembrolizumab
Presence of CAR T cells in the peripheral blood will be assessed
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start13 Jul 2020
- Primary completionDec 2040 (estimated)
- Study completionDec 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric Solid TumorStudies of the same condition, open and under way.
- 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Colleen Annesley, Seattle Children's Hospital
- Investigators
- Catherine Albert, MD, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04483778
- Sponsor's protocol ID
- STRIvE-02
- Status last verified
- Nov 2025
- First submitted
- 14 Jul 2020
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pinto N, Albert CM, Taylor MR, Ullom HB, Wilson AL, Huang W, Wendler J, Pattabhi S, Seidel K, Brown C, Gustafson JA, Rawlings-Rhea SD, Cheeney SHE, Burleigh K, Gustafson HH, Orentas RJ, Vitanza NA, Gardner RA, Jensen MC, Park JR. STRIvE-02: A First-in-Human Phase I Study of Systemically Administered B7-H3 Chimeric Antigen Receptor T Cells for Patients With Relapsed/Refractory Solid Tumors. J Clin Oncol. 2024 Dec 10;42(35):4163-4172. doi: 10.1200/JCO.23.02229. Epub 2024 Sep 10.
PubMed 39255444
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of B7H3 CAR T Cell Immunotherapy for Recurrent/Refractory Solid Tumors in Children and Young Adults
- ClinicalTrials.gov ID
- NCT04483778
- Acronym / sponsor ID
- STRIvE-02
- Conditions
- Pediatric Solid Tumor, Germ Cell Tumor, Retinoblastoma, Hepatoblastoma, Wilms Tumor, Rhabdoid Tumor
- Keywords
- CAR T cell, Pediatric, Young adults, Non-CNS solid tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- Dec 2040 (estimated)
- Study completion
- Dec 2040 (estimated)
- First posted
- 23 Jul 2020 (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 a phase I, open-label, non-randomized study that will enroll pediatric and young adult research participants with relapsed or refractory non-CNS solid tumors to evaluate the safety, feasibility, and efficacy of administering T cell products derived from the research participant's blood that have been genetically modified to express a B7H3-specific receptor (chimeric antigen receptor, or CAR) that will target and kill solid tumors that express B7H3. On Arm A of the study, research participants will receive B7H3-specific CAR T cells only. On Arm B of the study, research participants will receive CAR T cells directed at B7H3 and CD19, a marker on the surface of B lymphocytes, following the hypothesis that CD19+ B cells serving in their normal role as antigen presenting cells to T cells will promote the expansion and persistence of the CAR T cells. Arm A CAR T cells include the protein EGFRt and Arm B CAR T cells include the protein HER2tG. These proteins can be used to both track and destroy the CAR T cells in case of undue toxicity. The primary objectives of the study will be to determine the feasibility of manufacturing the cell products, the safety of the T cell product infusion, to determine the maximum tolerated dose of the CAR T cells products, to describe the full toxicity profile of each product, and determine the persistence of the modified cell in the participant's body on each arm. Participants will receive a single dose of T cells comprised of two different subtypes of T cells (CD4 and CD8 T cells) felt to benefit one another once administered to the research participants for improved potential therapeutic effect. The secondary objectives of this protocol are to study the number of modified cells in the patients and the duration they continue to be at detectable levels. The investigators will also quantitate anti-tumor efficacy on each arm. Participants who experience significant and potentially life-threatening toxicities (other than clinically manageable toxicities related to T cells working, called cytokine release syndrome) will receive infusions of cetuximab (an antibody commercially available that targets EGFRt) or trastuzumab (an antibody commercially available that targets HER2tG) to assess the ability of the EGFRt on the T cells to be an effective suicide mechanism for the elimination of the transferred T cell products.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SCRI-CARB7H3(s) | Experimental | Biological: second generation 4-1BBζ B7H3-EGFRt-DHFRAutologous CD4+ and CD8+ T-cells genetically modified to express an B7H3-specific CAR |
| SCRI-CARB7H3(s)x19 | Experimental | Biological: second generation 4-1BBζ B7H3-EGFRt-DHFR(selected) and a second generation 4-1BBζ CD19-Her2tGAutologous CD4+ and CD8+ T-cells genetically modified to a bispecific B7H3xCD19 CAR |
| SCRI-CARB7H3(s)x19 plus pembrolizumab | Experimental | Biological: second generation 4-1BBζ B7H3-EGFRt-DHFR(selected) and a second generation 4-1BBζ CD19-Her2tG, Drug: PembrolizumabAutologous CD4+ and CD8+ T-cells genetically modified to express a bispecific B7H3xCD19 CAR given in combination with pembrolizumab |
Who may qualify
- Ages
- 0 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (17 listed)
- Participants age ≤ 26 years at the time of consent for study participation; the first 2 participants enrolled and treated with CAR T cells in both Arms A and B will be ≥ 15 years. and ≤ 26 years at time of consent for study participation
- Histologically diagnosed malignant, non-primary CNS solid tumor
- Evidence of refractory or recurrent disease
- Lansky or Karnofsky score ≥ 50
- Life expectancy ≥ 8 weeks
Key exclusion criteria (9 listed)
- Presence of active malignancy other than primary malignant solid tumor diagnosis
- Current relevant CNS pathology
- Receiving external beam radiation therapy at time of enrollment
- Presence of active GVHD, or receiving immunosuppressive therapy for treatment or prevention of GVHD within 4 weeks prior to enrollment
- Participant is pregnant or breastfeeding
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 |
|---|---|---|
| second generation 4-1BBζ B7H3-EGFRt-DHFRAutologous CD4+ and CD8+ T-cells lentivirally transduced to express a second generation 4-1BBζ B7H3-EGFRt-DHFR | Biological | SCRI-CARB7H3(s) |
| second generation 4-1BBζ B7H3-EGFRt-DHFR(selected) and a second generation 4-1BBζ CD19-Her2tGAutologous CD4+ and CD8+ T-cells lentivirally transduced to express a second generation 4-1BBζ B7H3-EGFRt-DHFR(selected) and a second generation 4-1BBζ CD19-Her2tG | Biological | SCRI-CARB7H3(s)x19, SCRI-CARB7H3(s)x19 plus pembrolizumab |
| PembrolizumabSCRI-CARB7H3(s)x19 plus pembrolizumab | Drug | SCRI-CARB7H3(s)x19 plus pembrolizumab |
Primary outcome
Assess the safety and tolerability of cellular immunotherapy utilizing ex-vivo expanded autologous T cells genetically modified to express B7H3-specific CAR (Arm A)
Time frame: 28 days
Type, frequency, severity, and duration of adverse events will be tabulated and summarized
Assess the safety and tolerability of cellular immunotherapy utilizing ex-vivo expanded autologous T cells genetically modified to express a bispecific B7H3xCD19 CAR (Arm B)
Time frame: 28 days
Type, frequency, severity, and duration of adverse events will be tabulated and summarized
To assess the safety and tolerability of cellular immunotherapy utilizing ex-vivo expanded autologous T cells genetically modified to express a bispecific B7H3xCD19 CAR given in combination with pembrolizumab (Arm C)
Time frame: 28 days
Type, frequency, severity, and duration of adverse events will be tabulated and summarized to determine maximal tolerated dose
To determine the maximum tolerated dose (MTD) of B7H3-specific CAR (Arm A)
Time frame: 28 days
Type, frequency, severity, and duration of adverse events will be tabulated and summarized to determine maximal tolerated dose
To determine the maximum tolerated dose of bispecific B7H3xCD19 CAR (Arm B)
Time frame: 28 days
Type, frequency, severity, and duration of adverse events will be tabulated and summarized
To determine the feasibility of administration of pembrolizumab in combination with bispecific B7H3xCD19 CAR (Arm C)
Time frame: 28 days
Type, frequency, severity, and duration of adverse events will be tabulated and summarized
To assess the dose limiting toxicities (DLTs) and describe the full toxicity profile for each study arm
Time frame: 28 days
Type, frequency, severity, and duration of adverse events will be tabulated and summarized
To assess the feasibility of manufacturing B7H3 specific CARs from patient-derived lymphocytes
Time frame: 28 days
Type, frequency, severity, and duration of adverse events will be tabulated and summarized
To assess the feasibility of manufacturing B7H3xCD19 bispecific CARs from patient-derived lymphocytes
Time frame: 28 days
Type, frequency, severity, and duration of adverse events will be tabulated and summarized
4 secondary outcomes
Determine the duration of in vivo persistence of adoptively transferred T cells in the peripheral blood and compare engraftment between T cell products and treatment arms
Time frame: 84 days
Determine the magnitude of in vivo persistence of adoptively transferred T cells in the peripheral blood and compare engraftment between T cell products
Time frame: 84 days
Quantitate anti-tumor responses by measuring changes in tumor burden using disease-specific evaluations
Time frame: 84 days
Describe the relative expansion and persistence of the CAR T cell product and retention of function for B7H3xCD19 bispecific CARs determined by maintenance of B cell aplasia (BCA) with and without pembrolizumab
Time frame: 84 days
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 28 Apr 2026.
- Derived from this study: PubMed 39255444Pinto N, Albert CM, Taylor MR, Ullom HB, Wilson AL, Huang W, Wendler J, Pattabhi S, Seidel K, Brown C, Gustafson JA, Rawlings-Rhea SD, Cheeney SHE, Burleigh K, Gustafson HH, Orentas RJ, Vitanza NA, Gardner RA, Jensen MC, Park JR. STRIvE-02: A First-in-Human Phase I Study of Systemically Administered B7-H3 Chimeric Antigen Receptor T Cells for Patients With Relapsed/Refractory Solid Tumors. J Clin Oncol. 2024 Dec 10;42(35):4163-4172. doi: 10.1200/JCO.23.02229. Epub 2024 Sep 10.
- 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. This study is not recruiting at the moment.
Catherine Albert, MD principal investigator
Seattle Children's Hospital
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 second generation 4-1BBζ B7H3-EGFRt-DHFR, second generation 4-1BBζ B7H3-EGFRt-DHFR(selected) and a second generation 4-1BBζ CD19-Her2tG and Pembrolizumab in people with Pediatric Solid Tumor and Germ Cell Tumor, run by Seattle Children's Hospital 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 17 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 28 Apr 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?
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?
Assess the safety and tolerability of cellular immunotherapy utilizing ex-vivo expanded autologous T cells genetically modified to express B7H3-specific CAR (Arm A) (time frame: 28 days). The study lists 9 primary outcomes in all. 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 NCT04483778, which also lists 1 linked publication.
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 28 Apr 2026.