| Trial ID: | L1440 |
| Source ID: | NCT06056102
|
| Associated Drug: |
Cyclophosphamide
|
| Title: |
CAR-T Cell Therapy for Desensitization in Kidney Transplantation
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Kidney Transplant|Kidney Failure|End Stage Renal Failure on Dialysis
|
| Interventions: |
DRUG: Cyclophosphamide|BIOLOGICAL: CART-BCMA|BIOLOGICAL: huCART19|DRUG: Fludarabine
|
| Outcome Measures: |
Primary: The timing of adverse events after infusion of Chimeric antigen receptor T - B cell maturation antigen (CART-BCMA) with CD19 Targeted Humanized CAR T Cell (huCART-19), Adverse events will be categorized and described according to CTCAE v5.0. Specific safety outcomes will include but are not limited to: 1. Cytokine release syndrome, as defined by American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading 2. Neurotoxicity (ICANS), as defined by ASTCT consensus grading 3. Delayed hematopoetic recovery: proportion of subjects achieving ANC \>1,000/microL and Platelets \>75,000/microL at 60 days after first CART cell infusion 4. Dose limiting toxicity, From time of lymphodepletion to 12 months|The frequency of adverse events after infusion of Chimeric antigen receptor T - B cell maturation antigen (CART-BCMA) with CD19 Targeted Humanized CAR T Cell (huCART-19), Adverse events will be categorized and described according to CTCAE v5.0. Specific safety outcomes will include but are not limited to: 1. Cytokine release syndrome, as defined by ASTCT consensus grading 2. Neurotoxicity (ICANS), as defined by ASTCT consensus grading 3. Delayed hematopoetic recovery: proportion of subjects achieving ANC \>1,000/microL and Platelets \>75,000/microL at 60 days after first CART cell infusion 4. Dose limiting toxicity, From time of lymphodepletion to 12 months|The severity of adverse events after infusion of Chimeric antigen receptor T - B cell maturation antigen (CART-BCMA) with CD19 Targeted Humanized CAR T Cell (huCART-19), Adverse events will be categorized and described according to CTCAE v5.0. Specific safety outcomes will include but are not limited to: 1. Cytokine release syndrome, as defined by ASTCT consensus grading 2. Neurotoxicity (ICANS), as defined by ASTCT consensus grading 3. Delayed hematopoetic recovery: proportion of subjects achieving ANC \>1,000/microL and Platelets \>75,000/microL at 60 days after first CART cell infusion 4. Dose limiting toxicity, From time of lymphodepletion to 12 months|The proportion of apheresed subjects who receive the planned Chimeric antigen receptor T (CAR T) cell dose in the respective cohort, From time of lymphodepletion to 12 months | Secondary: The proportion of subjects meeting the predefined Calculated Panel Reactive Antibody (cPRA) reduction criteria after the infusion of CART-BCMA + huCART-19, 26 weeks after the infusion|Duration of Calculated Panel Reactive Antibody (cPRA) response, From time of infusion to 12 months|For subjects who are transplanted, the proportion of subjects experiencing acute cellular rejection or antibody mediated rejection, delayed graft function (as well as AKI), graft loss OR De Novo donor specific antibody, 3 years after transplantation|The proportion of subjects with opportunistic infections, From time of infusion to 12 months or 3 years after transplantation
|
| Sponsor/Collaborators: |
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Collaborators: University of Pennsylvania Clinical Cell and Vaccine Production Facility (CVPF)
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
20
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2024-05-09
|
| Completion Date: |
2042-12-15
|
| Results First Posted: |
|
| Last Update Posted: |
2025-01-30
|
| Locations: |
Massachusetts General Hospital: Transplantation (Site #: 71107), Boston, Massachusetts, 02114, United States|NYU Langone Health (Site #: 71177), New York, New York, 10016, United States|University of Pennsylvania Medical Center (Site #: 71111), Philadelphia, Pennsylvania, 19104, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT06056102
|
