This study aims to evaluate the safety and feasibility of
intravenous systemic infusion of allogeneic NK cells in patients with relapsed or refractory lymphoma.
Design
This is an open-label, non-randomized, interventional, single-group assignment study to assess the safety and feasibility of an allogeneic NK cell therapy derived from donor peripheral blood, in combination with rituximab, or other monoclonal antibodies, on ten patients with relapsed or refractory lymphoma.
Settings and conduct
The study is a single-group clinical trial to evaluate the safety of allogeneic in-vitro expanded Natural Killer Cells for relapsed refractory Lymphoid Malignancies at the Hematology-Oncology-Stem Cell Transplantation Research Center (HORCSCT) of Tehran University.
Participants/Inclusion and exclusion criteria
Adult patients with lymphoid malignancies and adequate organ function who failed to respond to at least two lines of treatment will be included in this study. Patients with brain lymphoma or HIV are excluded from the study.
Intervention groups
All patients will be assigned to the only interventional arm of the study. Patients in the interventional arm of the study will receive a single dose of systemic intravenous infusion of natural killer cells from an allogeneic donor.
Research Institute for Hematology, Oncology and Stem Cell Transplantation,Tehran University of Medic
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2635
Email address
ctu@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-11, 1401/09/20
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Rituximab and Allogeneic Natural Killer Cells for Refractory Lymphoid Malignancies
Public title
Cell therapy for Refractory Lymphoid Malignancies
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 years or older
adequate organ function at the time of infusion
After the failure of at least 2 prior lines of therapy
Histologically confirmed malignant lymphoma
Adequate performance score: KPS >70 or ECOG 0-2
Exclusion criteria:
CNS lymphoma
HIV patients
Patients with a history of autoimmune disease
Age
From 18 years old to 65 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine- Tehran University of Medical Sciences
Street address
Kargar shomali Ave., Shariati hospital
City
Tehran
Province
Tehran
Postal code
1411713131
Approval date
2020-09-20, 1399/06/30
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.500
Health conditions studied
1
Description of health condition studied
Hodgkin lymphoma
ICD-10 code
C81
ICD-10 code description
Hodgkin lymphoma
2
Description of health condition studied
Follicular lymphoma
ICD-10 code
C82
ICD-10 code description
Follicular lymphoma
3
Description of health condition studied
Non-follicular lymphoma
ICD-10 code
C83
ICD-10 code description
Non-follicular lymphoma
Primary outcomes
1
Description
Number of Patients With Grades 3-5 of Natural Killer cell infusion-related Adverse Events
Timepoint
Daily during the first seven days after the injection and then weekly until 28 days after the injection
Method of measurement
History, Physical exam, and lab test
2
Description
Number of Patients With Grades III-IV Acute Graft versus Host Disease
Timepoint
Daily during the first seven days after the injection and then weekly until 3 months after intervention
Method of measurement
History, Physical exam, and lab test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: All patients are included in the only intervention arm of the study. Patients in the intervention arm will receive a dose of 10 million/kg expanded NK cells on the day after the conditioning regimen. The injection of cells will be done within 30 minutes under full supervision and in an isolated room. The process of isolation and preparation of NK cells will be done in a clean room with clinical grade and suitable conditions for producing NK cells. From 21 days before the infusion, 20 to 30 cc of peripheral blood was taken from the third-party donor and after the isolation of mononuclear cells, CD56+/CD3- reproduced. A viability test is done using trypan blue and phenotyping is used to check the absolute number and purity of cells.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hematology- Oncology and Stem Cell Transplantation Research Center, Tehran University of Medical Sci
Full name of responsible person
Maryam Barkhordar
Street address
North Kargar Ave.
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8800 4140
Email
barkhordarm.n@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohamad ٰVaezi
Street address
North Kargar Ave.
City
Tehran
Province
Tehran
Postal code
1417713135
Phone
+98 21 8800 4140
Email
vaezi.mohammad@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohamad Ahmadvand
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Hematology
Street address
North Kargar Ave.
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8800 4140
Email
ahmadvand.mohamad64@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Barkhordar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
North Kargar Ave.
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8800 4140
Email
barkhordarm.n@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohamad Ahmadvand
Position
Tehran
Latest degree
Ph.D.
Other areas of specialty/work
Hematology
Street address
North Kargar Ave.
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8800 4140
Email
madvand.mohamad64@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD