Study Investigating the Safety of CD19 CAR-T Cells in Relapsed/Refractory AML Expressing CD19
Recruiting
Phase 1
Interventional Study
Relapsed Adult AML
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 5 (estimated)
- Sponsor
- University Hospital, Lille · Other
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About This Trial
Refractory/Relapsed (R/R) acute myeloid leukemia (AML) is associated with a dis-mal prognosis.
In some subsets of AML such as AML driven by the t(8;21) translocation, leading to the RUNX1-RUNX1T1 (AML1-ETO) fusion transcript expression, CD19 B-cell antigen is aberrantly expressed on malignant blasts in around 80 % of cases. Interestingly, the expression of the CD19 antigen is also detected in the…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Subject is ≥ 18 years of age at the time of signing the informed consent form,
* Patient with AML that expresses CD19 by Flow-cytometry, (CD19 expression ≥ 70% of AML blasts)
* Patients with R/R AML defined as:
* Primary refractory: absence of remission after two courses of…
Contacts