Myelodysplastic Syndromes Clinical Trial
Official title:
An Open-label, Phase I Study to Assess the Safety of NKR-2 Treatment Administered Concurrently With 5-azacytidine in Treatment-naïve Acute Myeloid Leukemia or Myelodysplastic Syndrome Patients Not Candidates for Intensive Therapy
This open-label Phase I study aims to define the recommended dose for further clinical
development the NKR-2 treatment administered concurrently with AZA in treatment-naïve AML/MDS
patients not candidates for intensive chemotherapy or hematopoietic stem cell
transplantation.
This Phase I study is divided into three sequential cohorts evaluating three different
dose-levels of NKR-2 (1x108, 3x108 and 1x109 NKR-2 per injection) using a 3+3 design
evaluate. Further patients will be enrolled at the RecD to reach 9 evaluable patients in
total at the RecD.
The study consists of a screening phase, a treatment administration phase and a follow-up
phase divided into treatment follow-up (TFU) and long-term safety follow-up (LTSFU). For each
patient who received at least one NKR-2 administration, the overall study duration will be 15
years after first NKR-2 administration.
This open-label Phase I study aims to define the recommended dose for further clinical
development the NKR-2 treatment administered concurrently with AZA in treatment-naïve AML/MDS
patients not candidates for intensive induction chemotherapy. The treatment consists in six
consecutive cycles of AZA, administered at days
1. to 7 of a 28-day cycle. Patients will be treated with 8 injections of NKR-2 at day 9 and
23 of AZA cycles 2-3-4 and 5.
This Phase I study is divided into three sequential cohorts evaluating three different
dose-levels of NKR-2 (1x108, 3x108 and 1x109 NKR-2 per injection) using a 3+3 design.
Further patients will be enrolled at the RecD to reach 9 evaluable patients in total at
the RecD. The study consists of a screening phase, a treatment administration phase and
a follow-up phase divided into treatment follow-up (TFU) and long-term safety follow-up
(LTSFU). For each patient who received at least one NKR-
2. administration, the overall study duration will be 15 years after first NKR-
2 administration. Patients will be asked to complete a total of 54 visits during the
treatment administration phase, and 5 visits during the treatment follow-up phase. During the
LTSFU, yearly visits will be scheduled (up to Visit Y15).
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