Exploring immune responses to cell therapy in tumors
A Prospective Trial to Evaluate Immune Determinants of the Response and the Toxicity to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
This study is testing how the immune system reacts to a new cell therapy in patients with different types of tumors to see if these reactions can help predict how well the treatment works and what side effects might occur.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 2 Years and up |
| Sex | All |
| Sponsor | Gustave Roussy, Cancer Campus, Grand Paris Academic / other |
| Locations | 1 site (Villejuif, Val De Marne) |
| Trial ID | NCT05481502 on ClinicalTrials.gov |
What this trial studies
This study investigates the immune responses to adoptive cell therapy in patients with solid and hematologic tumors. It focuses on analyzing the phenotypic and transcriptional changes in tumor cells, blood, and bone marrow following treatment. The goal is to correlate these changes with clinical outcomes and side effects, ultimately identifying specific immune profiles that predict responses to therapy.
Who should consider this trial
Good fit: Ideal candidates include patients with accessible tumor lesions who are over 2 years old and can provide informed consent.
Not a fit: Patients with coagulation abnormalities that prevent biopsies or those who are pregnant or nursing may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and personalized treatments for patients with various types of cancer.
How similar studies have performed: While similar studies have explored immune responses to cell therapies, this specific approach focusing on phenotypic and transcriptional profiling is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient affiliated to a social security regimen * Tumor lesion accessible to core biopsies * Patient who is fully informed, able to comply with the protocol and who signed the informed consent * Pediatric patients \> than 2 years old can be included * No restriction about the Eastern Cooperative Oncology Group (ECOG) status Exclusion Criteria: * Coagulation abnormality prohibiting a biopsy (but patients can still give their consent for blood and bone marrow samples). * Tumor lesion not accessible to core biopsies. * Pregnant or nursing women cannot participate in this study.
Where this trial is running
Villejuif, Val De Marne
- Gustave Roussy Cancer Campus Grand Paris — Villejuif, Val De Marne, France (Recruiting)
Study contacts
- Study coordinator: Camille BIGENWALD, MD
- Email: camille.bigenwald@gustaveroussy.fr
- Phone: +33 (0)1 42 11 42 29
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.