Clinical trial · Interventional
Investigating Marrow Infiltrating Lymphocytes in Renal Cell Carcinoma
Investigating Marrow Infiltrating Lymphocytes as a Source of Adoptive Cellular Therapy in Renal Cell Carcinoma and Urothelial Carcinoma
NCT04341740CI-TRIAL-00072200WindMIL-001terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study funding was withdrawn.
Summary
Brief summary (as posted)
The purpose of this research is to collect health-related information as well as bone marrow and blood specimens to determine if a new form of treatment for patients with kidney and bladder cancer may be possible.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bone Marrow Aspirate | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Renal Cell Carcinoma or Urothelial Carcinoma Patients
- description
- Patients in both cohorts (RCC or UC) will undergo bone marrow aspiration under conscious sedation to withdraw 60 mL bone marrow aspirate and 75 ml of peripheral blood sample.
- interventionNames
- Procedure: Bone Marrow Aspirate
Primary outcomes (1)
- measure
- Proportion of subjects with successful isolation and ex-vivo expansion of MILs
- timeFrame
- 30 days
- description
- A successful expansion will be greater than or equal to 50% viable and greater than or equal to 50% CD3 positive.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years * Histologically-confirmed, locally advanced unresectable or metastatic RCC (cohort A) or UC (cohort B). * ECOG performance status of ≤1 * Adequate bone marrow function: * Platelet count ≥ 100 × 10\^9/L * ANC ≥ 1.0 ×10\^9/L * Lymphocyte count ≥ 0.5 ×10\^9/L * Willingness to undergo bone marrow aspiration (BMA) Exclusion Criteria: * Prior hematopoietic stem cell transplantation * Prior radiation to the pelvic region * Use of systemic corticosteroids within 28 days of BMA * History of another primary malignancy that has been diagnosed or required therapy within the past 2 years (except completely resected basal cell and squamous cell skin cancer, curatively treated localized prostate cancer, and completely resected carcinoma in situ of any site). * Presence of an autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosis) requiring active systemic treatment. If the autoimmune disease has been treated, it must be stable clinically. (Hypothyroidism without evidence of Grave's disease or Hashimoto's thyroiditis is not considered an exclusion criterion.) * Pregnant females as documented by a serum beta human chorionic gonadotropin (β-hCG) pregnancy test consistent with pregnancy, obtained within 21 days of BMA * Infection requiring treatment with antibiotics, antifungal, or antiviral agents within 7 days of BMA * Known diagnosis of HIV or CMV infection or active viral hepatitis * Administration of hematopoietic growth factor support within 14 days before bone marrow aspiration * Chemotherapy administration within 28 days of BMA * Unwilling or unable to comply with the protocol * Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the Investigator's opinion, could affect the safety of the subject.
References
Publications (0)
Data not yet available
No reference posted for this study.