CAR-37 T Cells In Hematologic Malignancies
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Hematologic Malignancy
- Leukemia
- Lymphoma
- Lymphoma, B Cell
- Lymphoma Non-Hodgkin
- Lymphoma, T-Cell
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is a two-part, non randomized, open label, single site Phase 1 study. Participants who fulfill eligibility criteria will be entered into the trial Chimeric Antigen Receptor (CAR)-37 T Cells (CAR-37 T Cells). This study consists of 2 parts: Part A (Dose Escalation): The investigators are looking...
This is a two-part, non randomized, open label, single site Phase 1 study. Participants who fulfill eligibility criteria will be entered into the trial Chimeric Antigen Receptor (CAR)-37 T Cells (CAR-37 T Cells). This study consists of 2 parts: Part A (Dose Escalation): The investigators are looking the highest dose of the study intervention that can be administered safely without severe or unmanageable side effects in participants that have relapsed or refractory CD37+ hematologic malignancies, not everyone who participates in this research study will receive the same dose of the study intervention. The dose given will depend on the number of participants who have been enrolled prior and how well the dose was tolerated Part B (Expansion Cohort): Part B: Expansion Cohort: Participants will be treated at the respective dose (at or below the Maximum Tolerated Dose), as determined during Part A (Dose Escalation). A total of 18 participants will be enrolled to this trial This research study is a Phase I clinical trial, which tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies. Investigational" means that the intervention is being studied The U.S. Food and Drug Administration (FDA) has not approved CAR-37 T Cells as a treatment for any disease. This is the first time that CAR-37 T Cells will be given to humans
Tracking Information
- NCT #
- NCT04136275
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Matthew J. Frigault, MD Massachusetts General Hospital