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The Acute Myeloid Leukemia (AML) immune cell therapy using allogeneic ex-vivo expanded Natural Killer Cells (NK cells) transplantation

Phase I/II Clinical Trial (Safety and feasibility) using ex-vivo expanded Haploidentical donor-derived (Natural Killer Cell)-NK Cells against advanced refractory/relapsed Acute Myeloid Leukemia (AML)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200621047859N3
Enrollment
30
Registered
2020-12-30
Start date
2020-09-22
Completion date
Unknown
Last updated
2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia (AML). Acute myeloblastic leukemia

Interventions

Intervention group: Patients with acute resistant myeloid leukemia who receive conditioning regimen 3 days before cell therapy then 5-10 million cell per kilogram of patient weight would be infused in

Sponsors

Motamed Cancer Institute
Lead Sponsor
Modiriat Atiye Bahman Company
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1- Age 18 to 70 years 2. Drug-resistant AML patients with no response to 2 treatments line or recurrent cases that can not be candidates for standard therapies or bone marrow transplants 3- The toxicity of chemotherapy regimens ( such as severe cytopenia) should be assigned and it would be checked as a regimen with no significant side effects. 4- PS=2[Performance Status (PS)] 5- The results of these tests should be available:• [glomerular filtration rate (GFR)] GFR=60 or CR=2 mg / dl• ALT 92% in room air• Cardiac classification status (III> NHC) or [ejection fraction]EF> 50%• Negative pregnancy test• Negative HIV testing

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Possible symptoms of hyper-sensitivity and allergy after injection. Timepoint: Daily until the third day after the injection and then weekly until the day +90 after the injection. Method of measurement: Using CTCAE check list.;Decrease of tumor burden. Timepoint: A week after injection and every month until 3 months. Method of measurement: Physical Examination, Flow cytometry, CBC.;Graft versus host disease (GVHD) symptoms. Timepoint: Daily until the third day after the injection and then weekly until the day +90 after the injection. Method of measurement: Physical examination - Imaging - Laboratory tests.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Ramin Sarrami Forooshani

Iranian academic center for education culture and research

rsf1351@gmail.com+98 21 8879 6003

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026