A Phase I/II Trial of ALETA-001 for the Treatment of Participants with B-cell Malignancies
Research type
Research Study
Full title
A Cancer Research UK Phase I/II Trial of ALETA-001 in Participants Who Do Not Achieve or Maintain an Optimal Response to Anti-CD19 CAR T-Cell Therapy for the Treatment of B-cell Malignancies
IRAS ID
1007028
Contact name
Stuart Smith
Contact email
Sponsor organisation
Cancer Research UK
Eudract number
2021-006009-31
Research summary
This clinical trial is looking at ALETA-001. ALETA-001 is a type of drug called a T cell engager. T cell engagers aim to boost the activity of specific T cells in the body. It has been tested in the laboratory and looks promising in treating certain cancers. We want to find out if it will be useful in treating patients with non-Hodgkin’s lymphoma, after they have received a type of CAR T cell therapy called anti-CD19 CAR T cell therapy.
Not all patients’ cancer will be completely destroyed after CAR T cell therapy. ALETA-001 has been designed to does help to boost the activity of the existing CART cells in patients whose cancers have not been completely destroyed. In this trial ALETA-001 will be offered to these patients and will allow us to check how safe and effective it is.
This clinical trial is split into two phases:
Phase I is the Safety Lead-In Phase, where small groups of participants will receive different doses of ALETA-001 to find the safest dose.
Phase II is the Dose Expansion Phase of the trial. In this part of the trial the safest dose found from Phase I will be given to more participants. This will allow us to find out more about whether ALETA-001 does help the CAR T cells work better, if this helps to treat the cancer, and how it does it.
The main aims of the clinical trial are to find out:
- The highest dose of ALETA-001 that can be safely given (Phase I)
- Whether ALETA-001 can help kill the cancer (Phase II)
- Possible side effects of ALETA-001 (both Phase I and II)
- What happens to ALETA-001 inside the body and how it affects cancer cells (both Phase I and II).REC name
South Central - Oxford A Research Ethics Committee
REC reference
23/SC/0139
Date of REC Opinion
27 Jul 2023
REC opinion
Further Information Favourable Opinion