CD45BE-HSPC + CART-45 Cells for Lymphoma
This study is testing a new treatment for people with certain types of lymphoma that have come back or are hard to treat. The treatment involves two parts: first, you would receive CD45 base edited hematopoietic stem and progenitor cells (CD45BE-HSPC), which are your own modified blood stem cells. Then, you would receive CART-45 cells, which are your own immune cells (T cells) that have been specially modified to fight cancer. This is a Phase 1 study, meaning the main goal is to find out if the treatment is safe, how well it can be given, and what dose works best. Researchers will also look for early signs of how well it works. This study is open to adults aged 18 and older with specific types of B-cell Non-Hodgkin Lymphoma, Richter's Transformation, T-Cell Non-Hodgkin Lymphoma, or Hodgkin Lymphoma. The study plans to enroll 42 participants.
- Study design
- This is a Phase 1, open-label study, meaning both you and the study team will know what treatment you are receiving. The study aims to find the right dose and will enroll 42 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- You would be followed for safety for up to 15 years after receiving the treatment. Researchers will also look at side effects and the best dose for 28 days after the CART-45 cell infusion.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
CD45BE-HSPC + CART-45 Cells
At a glance
Conditions
NCT07451054
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
University of Pennsylvania
Philadelphia, Pennsylvaniastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Noelle Frey, MD · PRINCIPAL_INVESTIGATOR · University of Pennsylvania
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Incidence of Adverse Events as assessed by CTCAE v6.0Up to 15 years post infusion
Type, frequency and severity of adverse events as assessed by CTCAE V6.0. Each disease-specific cohort will be analyzed separately.
- Occurrence of dose-limiting toxicities (DLTs)28 days post-CART-45 infusion
Unacceptable toxicity as defined by the protocol. DLTs will be evaluated separately by each disease-specific cohort.
- Identification of the maximum tolerated dose (MTD)28 days post-CART-45 infusion
Selected based on an isotonic regression model. The MTD will be established separately by disease-specific cohort
- Identification of a recommended dose for expansion (RDE)3 months post-CART-45 infusion
Evaluated by Cohort/dose level using a multi-criteria decision analysis.