B7-H3-Specific Chimeric Antigen Receptor Autologous T-Cell Therapy for Pediatric Patients With Solid Tumors (3CAR)
-
- STATUS
- Recruiting
-
- End date
- Feb 28, 2026
-
- participants needed
- 32
-
- sponsor
- St. Jude Children's Research Hospital
Summary
3CAR is being done to investigate an immunotherapy for patients with solid tumors. It is a Phase I clinical trial evaluating the use of autologous T cells genetically engineered to express B7-H3-CARs for patients ≤ 21 years old, with relapsed/refractory B7-H3+ solid tumors. This study will evaluate the safety and maximum tolerated dose of B7-H3-CAR T cells.The purpose of this study is to find the maximum (highest) dose of B7-H3-CAR T cells that are safe to give to patients with B7-H3-positive solid tumors.
Primary objective
To determine the safety of one intravenous infusion of autologous, B7-H3-CAR T cells in patients (≤ 21 years) with recurrent/refractory B7-H3+ solid tumors after lymphodepleting chemotherapy
Secondary objective
To evaluate the antitumor activity of B7-H3-CAR T cells
Exploratory objectives
- To evaluate the tumor environment after treatment with B7-H3-CAR T cells
- To assess the immunophenotype, clonal structure and endogenous repertoire of B7-H3-CAR T cells and unmodified T cells
- To characterize the cytokine profile in the peripheral blood after treatment with B7-H3-CAR T cells
Description
Treatment will include a single infusion of B7-H3-CAR T cells after lymphodepleting chemotherapy, with dosing based on the number of CAR+ T cells and patient weight. The study will evaluate the safety and maximum tolerated dose (MTD) of B7-H3-CAR T cells, using a standard 3+3 study design and a 6-week evaluation period. The total study duration will be 1 year, at which point patients will enroll on our existing institutional long-term follow-up protocol.
Details
| Condition | Pediatric Solid Tumor, Osteosarcoma, Rhabdomyosarcoma, Neuroblastoma, Ewing Sarcoma, Wilms Tumor, Adrenocortical Cancer, Desmoplastic Small Round Cell Tumor, Germ Cell Cancer, Rhabdoid Tumor, Clear Cell Sarcoma, Hepatoblastoma, Melanoma, Carcinoma, Malignant Peripheral Nerve Sheath Tumors, Soft Tissue Sarcoma |
|---|---|
| Treatment | cyclophosphamide, Fludarabine, MESNA, B7-H3 CAR T cells |
| Clinical Study Identifier | NCT04897321 |
| Sponsor | St. Jude Children's Research Hospital |
| Last Modified on | 8 April 2023 |
How to participate?
,
You have contacted , on
Your message has been sent to the study team at ,
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
You are contacting
Primary Contact
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Browse trials for
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteer