NCT04136275

CAR-37 T Cells in Hematologic Malignancies

A Phase I Clinical Trial with CAR-37 T Cells for the Treatment of Patients with Relapsed or Refractory CD37+ Hematologic Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Marcela V. Maus, M.D.,Ph.D. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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 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

Conditions

• Hematologic Malignancy
• Leukemia
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, T-Cell
• Lymphoma, Non-Hodgkin

Interventions

Type	Name	Description
BIOLOGICAL	CAR-37 T cells	CAR-37 is an investigational treatment that uses the participant own immune cells, called T cells, to try to kill the cancerous cells

Timeline

• Start date: 2020-06-19
• Primary completion: 2023-09-30
• Completion: 2024-03-01
• First posted: 2019-10-23
• Last updated: 2024-12-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study