B7-H3.CD28Z.CART in Solid Tumors
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age9-30
SponsorRobbie Majzner
About this trial
The goal of this research study is to test if a new cell therapy (B7-H3.CD28Z.CART / B7-H3 CAR T cells) is safe and effective in treating children and young adults with solid cancers whose tumors have returned or stopped responding to standard treatments (relapsed or refractory) and have been identified with a B7-H3 marker.
The names of the treatment interventions used in this study are:
* B7-H3.CD28Z.CART / B7-H3 CAR T cells * Fludarabine * Cyclophosphamide
Eligibility criteria
Qualifiers
Participants must have histologically confirmed diagnosis of a solid tumor that is relapsed or refractory for which standard curative measures do not exist or are no longer effective.
Participant must have adequate pre-trial tumor material available to determine B7-H3 status. Tumor tissue from the most recent resection or biopsy of recurrent disease is preferred. If unavailable, tumor tissue from prior recurrences or from the time of initial diagnosis is acceptable.
Age >=9 months and <30 years.
Lansky/Karnofsky performance status ≥50% (see Appendix A)
Disqualifiers
Participants who are receiving any other investigational agents.
Participants with known current brain metastases or leptomeningeal disease. Prior CNS metastatic disease is allowable if prior resection and/or radiation occurred at least 8 weeks prior to enrollment, without any intervening CNS metastasis, progression or recurrence, and participants are clinically stable as evidenced by no requirements for corticosteroids, no evolving neurologic deficits, and no progression of residual brain abnormalities.
Participants with any prior immunodeficiency or history of autoimmune disease requiring systemic steroids/ immunosuppressive medication/ disease modifying agents within the last 2 years
Prior solid organ transplant. Prior allogeneic or autologous stem cell transplant is permitted as outlined in Section 3.2.
Trial design
Treatments tested in this trial
- B7-H3.CD28Z.CART
- Fludarabine
- Cyclophosphamide
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Robbie Majzner
Lead sponsor
Dana-Farber Cancer Institute
Sponsor institution
Band of Parents
Collaborator
Source ClinicalTrials.gov