RecruitingPhase 1interventionalRules rewrite

Phase 1: testing Anti-CD33 CAR T-cells for Acute Myeloid Leukemia

This phase I trial tests the safety, side effects, and the best dose of anti-CD33 chimeric antigen receptor (CAR) T-Cell therapy in treating patients with acute myeloid leukemia that has come back (recurrent) or does not respond to treatment (refractory). CAR T-cell therapy is a type of treatment in which a patient or donor's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells.

Official registry: https://clinicaltrials.gov/study/NCT05672147 · City of Hope Medical Center · enrollment listed as 27

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Anti-CD33 CAR T-cells, or Lymphodepletion Therapy. The registry lists allocation as na. This phase I trial tests the safety, side effects, and the best dose of anti-CD33 chimeric antigen receptor (CAR) T-Cell therapy in treating patients with acute myeloid leukemia that has come back (recurrent) or does not respond to treatment (refractory).

They plan to enroll about 27 people at Duarte. Taking part typically means an infusion or injection of a biologic, a procedure as part of the study plus check-ins.

Official title (unrewritten)

Phase I Study of Cellular Immunotherapy Using T Cells Lentivirally Transduced to Express a Cd33-Specific Chimeric Antigen Receptor for Patients With Cd33+ Relapsed/Refractory Acute Myeloid Leukemia

Interventions: Anti-CD33 CAR T-cells, Lymphodepletion Therapy

Primary outcome (registry wording): Participants who achieve measurable residual disease (MRD)

Who it is for (from inclusion criteria)

Ages 18 Years to any
Assent, when appropriate, will be obtained per institutional guidelines
Agreement to allow the use of archival tissue from diagnostic tumor biopsies
If unavailable, exceptions may be granted with Study principal investigator (PI) approval
Karnofsky Performance Scale (KPS) \>= 70
Life expectancy \>= 16 weeks at the time of enrollment
Prior allogeneic transplant allowed if \> 6 months prior to study enrollment
Participant must have a confirmed diagnosis of active CD33+ AML de novo, or secondary OR participants who are at a high risk for disease recurrence

Who the registry excludes

Prior allogeneic transplant if \< 6 months prior to enrollment
Participants with active autoimmune disease, including graft versus host disease (GvHD), requiring systemic immune suppressive should be stopped 28-days prior to enrollment
Participants may not be receiving any other investigational agents and are not dependent on concurrent biological therapy, chemotherapy, or radiation therapy
With exception to Hydrea which must be stopped prior to initiation of lymphodepletion
Research participants on active systemic antifungal treatment within 8 weeks of enrollment are not eligible. However, participants on antifungal prophylaxis are eligible
Not applicable at the time of enrollment if the research participant's donor is undergoing leukapheresis
Subjects with \>= Grade 2 myelofibrosis on bone marrow biopsy

Contact

No central phone on the registry card. Use the official listing to reach a site.

Sites listed on ClinicalTrials.gov

1 listed

City of Hope Medical Center — Duarte, California (recruiting)

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FAQ about this NCT record

Is NCT05672147 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05672147?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05672147?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary