Ignite Creation Date:
2024-05-06 @ 1:48 PM
Last Modification Date:
2024-10-26 @ 1:20 PM
Study NCT ID:
NCT04136275
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2019-10-19
Brief Title:
CAR-37 T Cells In Hematologic Malignancies
Sponsor:
Marcela V Maus MDPhD
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Phase I Clinical Trial With CAR-37 T Cells for the Treatment of Patients With Relapsed or Refractory CD37 Hematologic Malignancies
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research study is studying Chimeric Antigen Receptor CAR-37 T Cells CAR-37 T Cells for treating people with relapsed or refractory CD37 hematologic malignancies and to understand the side effects when treated with CAR-37 T Cells
- Chimeric Antigen Receptor CAR-37 T Cells CAR-37 T Cells is an investigational treatment
- Chimeric Antigen Receptor CAR-37 T Cells CAR-37 T Cells is an investigational treatment
Detailed 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 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 US 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
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 US 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None