Early Phase 1 Lymphoma Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged between 18 and 70 years old.
• People diagnosed with one of the following blood cancers that tests positive for a protein called CD123: acute myeloid leukaemia (AML), a type of myelodysplastic syndrome (MDS-IB2), blastic plasmacytoid dendritic cell neoplasm (BPDCN), or acute lymphoblastic leukaemia (ALL) — confirmed by laboratory testing.
• People with AML whose disease did not respond to at least 2 cycles of standard chemotherapy, or 1 cycle of intensive salvage chemotherapy, or 4 cycles of a venetoclax-based treatment — OR whose AML has come back for a second or later time — OR whose AML has returned after a bone marrow/stem cell transplant from a donor.
• People with ALL whose disease came back or did not respond after CAR-19 cell therapy — OR whose disease came back without the CD19 protein and for whom certain other standard treatments (TKI inhibitors and inotuzumab ozogamicin) are not considered suitable options.
• People with BPDCN whose disease did not respond to, or came back after, chemotherapy, with or without a donor stem cell transplant.
• People with MDS-IB2 whose disease did not respond to at least four cycles of a drug called azacytidine, or got worse while on an azacytidine-based treatment — OR whose disease did not respond to induction chemotherapy — OR whose disease returned after a stem cell transplant.
• People who have a suitable matched donor available and ready for a stem cell transplant, with donor health checks completed before treatment begins.
• People for whom no standard treatments remain available, or for whom all standard treatment options have already been tried.
• Women who could become pregnant must have a negative pregnancy test at the time of enrolment and again at the first study visit.
• People who are able to understand the study information and sign a consent form.

Who may not be able to join:

• People with a known allergy or sensitivity to any ingredient in the study treatment.
• People who have had a donor stem cell transplant within the 3 months before the study treatment would be given.
• People with a severe, uncontrolled active infection.
• People whose life expectancy is estimated to be less than 8 weeks.
• People who need supplemental oxygen due to breathing difficulties.
• People with significant liver problems, based on specific blood test results being above certain levels (confirm with trial site).
• People with serious kidney problems, including very low urine output or a need for emergency dialysis, or specific blood test results above a certain level (confirm with trial site).
• People with heart failure where the heart's pumping function is below 50%, as measured by an ultrasound of the heart.
• People with active, serious graft-versus-host disease (a complication that can occur after a donor transplant), graded as severe (grade 3–4 acute, or severe chronic).
• People with serious, uncontrolled neurological conditions affecting the brain or nervous system.
• People who have received a live virus vaccine within 4 weeks before the study treatment, or who would need one within 90 days after receiving the study treatment.
• Women who are pregnant or breastfeeding.
• People of childbearing potential who are not willing to use a highly effective form of contraception throughout the study — this applies to women who could become pregnant, and to men whose partners could become pregnant (unless permanent sexual abstinence is their established lifestyle choice).

Important: Always verify eligibility with the trial site directly before applying.