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Metastatic breast cancer immune cell therapy using allogeneic ex-vivo expanded Natural Killer Cell (NK cell) transplantation

Phase I/II Clinical Trial using ex-vivo Expanded Haploidentical Donor-derived NK Cells against metastatic and refractory Breast cancer patients

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200621047859N1
Enrollment
30
Registered
2020-12-28
Start date
2020-08-22
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

Breast Cancer. Malignant neoplasm of breast

Interventions

Intervention group: Metastatic Breast cancer patients with no response to treatment who received a conditioning regimen and two dosages of immune cell infusion a week apart (1-10x10^6 cells/Kg). Natur

Sponsors

Motamed Cancer Institute
Lead Sponsor
Modiriat Atiyeh Bahman Company
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Breast cancer diagnosed with pathological report Approved according to Recist form for metastatic breast cancer [EF=50%]EJECTION FRACTION ElectroCochleoGraphy (ECoG) =0-1 ANC=1500, PH=100,000, GFR=60, T.Bil=1.5xULN, AST, ALT=2xULN bHCG=negative Ability to fill out a consent form and agree to its terms PS=0-1

Exclusion criteria

Exclusion criteria: Receiving any anticancer drug at the same time Major surgery one month before enrollment An active infection that impairs a patient's tolerance for treatment Breastfeeding or pregnancy

Design outcomes

Primary

MeasureTime frame
Symptoms of Hypersensitivity. Timepoint: Every day after infusion until to 1 week and weekly until to 3 months. Method of measurement: Physical examination and MRI-CT.;Tumor size. Timepoint: Every months until to 3 months. Method of measurement: Physical examination- Lab diagnostic tests- MRI-ST scan.;Symptoms of GVHD. Timepoint: Every day after infusion until to 1 week and weekly until to 3 months. Method of measurement: Physical examination- Lab diagnostic tests- MRI-ST scan.;Metastasis. Timepoint: Monthly until to 3 months. Method of measurement: Physical examination- Lab diagnostic tests- MRI-ST scan.

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