B-cell MalignanciesNCT07515313
Expression of CD274 (PD-L1) and CD276 in B-cell Malignancies: A Study by Flowcytometry
An observational study of B-cell Malignancies, run by Assiut University.
Trial summary
B-cell malignancies include a spectrum of cancers originating from abnormal B lymphocytes at different developmental stages (1) that affect the peripheral blood (PB), bone marrow (BM), and lymphatic system. They can be categorized into leukemias and lymphomas. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- B-cell Malignancies
- How many people
- 159 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 1 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: * Acute B- lymphoblastic leukemia. or * B- lymphoproliferative disorders (whether chronic lymphocytic leukemia or any other disorder)
Who may be able to join
- Newly diagnosed patients of both gender at any age with
- Acute B- lymphoblastic leukemia. or
- B- lymphoproliferative disorders (whether chronic lymphocytic leukemia or any other disorder)
Who cannot join
- Patients with any other type of malignancies.
- Patients that receiving chemotherapy.
- Patients with any autoimmune diseases
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
norhan mostafa mohamed abdelal Doctor, Assistant lecturer contact
About this study
Official title: Expression of CD274 (PD-L1) and CD276 in B-cell Malignancies: A Study by Flowcyometry
B-cell malignancies include a spectrum of cancers originating from abnormal B lymphocytes at different developmental stages (1) that affect the peripheral blood (PB), bone marrow (BM), and lymphatic system. They can be categorized into leukemias and lymphomas. Each has unique characteristics, depending on the type of cells affected, and different behaviors, ranging from chronic conditions with slow progression to aggressive forms that require immediate treatment (2).
Acute lymphoblastic leukemia (ALL) is the most common hematologic malignancy in childhood and the predominant form of precursor B-cell leukemia globally, accounting for 85% of ALL cases. According to recent global burden estimates, ALL incidence increased to over 100 000 cases worldwide by 2021, corresponding to an age-standardized incidence rate of ~1.4 per 100 000 persons per year (3). Its quick course and possibility of systemic involvement make early and prompt diagnosis and efficient treatment essential for enhancing long-term survival, especially in young patients.(4).
Read more
B-Chronic lymphoproliferative disorders (B-CLPDs) are a diverse collection of illnesses that are defined by the uncontrolled and clonal expansion of mature B cells. Although they can range from indolent to aggressive, they usually impact elderly persons and have a slow-growing, indolent clinical history. These conditions account for more than 90% of all chronic lymphoid cancers (5).
B-cell malignancies arise from disruption of immune system regulation through alterations in crucial signaling pathways, such as the B-cell receptor (BCR) signalling defect, imbalance between stimulatory signals (that drive proliferation and differentiation) and inhibitory signals (that enforce tolerance and prevent overstimulation) leading to anti-tumor immunity with development and metastasis of cancer cells (6).
An essential part of the immune regulatory system for malignancies, the B7-H family which is an important immune checkpoint provides new opportunities for modifying the tumor microenvironment (TME). This family is well-known for its several functions in controlling both innate and adaptive immunity. It is also involved in the recruitment and polarization of diverse immune cells and can have co-stimulatory or co-inhibitory effects on T cells, affecting processes like T cell activation, differentiation, and effector functions. Two important members in this family are: B7-H1 (PD-L1) also known CD274 and B7-H3 (CD276) (7).
Firstly, PD-L1 (CD274) which bind to PD-1 . This interaction primarily result in suppresses effector T cell activity while promoting the activity of immunosuppressive regulatory T cells (Tregs), hence negatively regulating the adaptive immune response. However, in malignancy, cancer cells promote the PD-1/PD-L1 axis to cause immune escape in cancer development and progression (8). It was reported that PD-L1 is widely expressed in solid tumors like melanoma and non-small cell lung cancer (9).
Secondly, CD276, also called B7-H3, is abundantly expressed in cancer cells and activated tumor-infiltrating immune cells aiding in the evasion of cytotoxic T-cell and natural killer cell surveillance (10). According to new research, B7-H3 contributes to tumor growth, metastasis, and resistance to treatment, all of which have a negative impact on patient outcomes (11).
Till now, the co-expression and functional relationship of CD274 and CD276 in B-cell malignancies remain poorly recognized. Understanding whether malignant B cells utilize multiple immune checkpoint pathways simultaneously may explain resistance to immunotherapy and identify novel prognostic and therapeutic targets.
- Conditions
- B-cell Malignancies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| B-acute lymphoblastic leukemia | Not described | |
| B-chronic lymphoproliferative disorder | Not described | |
| healthy control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Using CD274 and CD276 in diagnosis of B-cell malignancies using Flowcytometric technique
By flowcytometric technique (Beckman coulter analyzer)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start1 Jul 2026 (estimated)
- Primary completion2 Jul 2029 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for B-cell MalignanciesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 159 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norhan mostafa Mohamed Abdelal, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07515313
- Sponsor's protocol ID
- dyuhufhjdfvhbffd
- Status last verified
- Mar 2026
- First submitted
- 26 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Castellanos JR, Purvis IJ, Labak CM, Guda MR, Tsung AJ, Velpula KK, Asuthkar S. B7-H3 role in the immune landscape of cancer. Am J Clin Exp Immunol. 2017 Jun 15;6(4):66-75. eCollection 2017.
PubMed 28695059Flem-Karlsen K, Fodstad O, Tan M, Nunes-Xavier CE. B7-H3 in Cancer - Beyond Immune Regulation. Trends Cancer. 2018 Jun;4(6):401-404. doi: 10.1016/j.trecan.2018.03.010. Epub 2018 Apr 20.
PubMed 29860983Carbognin L, Pilotto S, Milella M, Vaccaro V, Brunelli M, Calio A, Cuppone F, Sperduti I, Giannarelli D, Chilosi M, Bronte V, Scarpa A, Bria E, Tortora G. Differential Activity of Nivolumab, Pembrolizumab and MPDL3280A according to the Tumor Expression of Programmed Death-Ligand-1 (PD-L1): Sensitivity Analysis of Trials in Melanoma, Lung and Genitourinary Cancers. PLoS One. 2015 Jun 18;10(6):e0130142. doi: 10.1371/journal.pone.0130142. eCollection 2015.
PubMed 26086854Lin X, Kang K, Chen P, Zeng Z, Li G, Xiong W, Yi M, Xiang B. Regulatory mechanisms of PD-1/PD-L1 in cancers. Mol Cancer. 2024 May 18;23(1):108. doi: 10.1186/s12943-024-02023-w.
PubMed 38762484Luo Y, Yuan Y, Liu D, Peng H, Shen L, Chen Y. Targeting novel immune checkpoints in the B7-H family: advancing cancer immunotherapy from bench to bedside. Trends Cancer. 2025 Jun;11(6):540-559. doi: 10.1016/j.trecan.2025.02.007. Epub 2025 Mar 19.
PubMed 40113530Sun H, Huang D, Zhang H, Dong M, Wang S, Sun M, et al. Targeting Immune Checkpoints: Basic Signaling Pathways and Clinical Translation in Cancer Therapeutics. MedComm - Oncology. 2025;4(3):e70030.
Chen C, Gu YD, Geskin LJ. A Review of Primary Cutaneous CD30+ Lymphoproliferative Disorders. Hematol Oncol Clin North Am. 2019 Feb;33(1):121-134. doi: 10.1016/j.hoc.2018.08.003.
PubMed 30497669Fan H, Yang Y, Lu Y, Li J, Huang Z, Ren Z, Zhou B. Global burden of acute lymphoblastic leukemia following the COVID-19 pandemic. Ann Hematol. 2025 Sep;104(9):4713-4727. doi: 10.1007/s00277-025-06639-w. Epub 2025 Oct 11.
PubMed 41074983Jimenez C, Garrote-de-Barros A, Lopez-Portugues C, Hernandez-Sanchez M, Diez P. Characterization of Human B Cell Hematological Malignancies Using Protein-Based Approaches. Int J Mol Sci. 2024 Apr 24;25(9):4644. doi: 10.3390/ijms25094644.
PubMed 38731863Meng X, Min Q, Wang JY. B Cell Lymphoma. Adv Exp Med Biol. 2020;1254:161-181. doi: 10.1007/978-981-15-3532-1_12.
PubMed 32323276
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of CD274 (PD-L1) and CD276 in B-cell Malignancies: A Study by Flowcyometry
- ClinicalTrials.gov ID
- NCT07515313
- Acronym / sponsor ID
- dyuhufhjdfvhbffd
- Conditions
- B-cell Malignancies
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 159 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 2 Jul 2029 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
B-cell malignancies include a spectrum of cancers originating from abnormal B lymphocytes at different developmental stages (1) that affect the peripheral blood (PB), bone marrow (BM), and lymphatic system. They can be categorized into leukemias and lymphomas. Each has unique characteristics, depending on the type of cells affected, and different behaviors, ranging from chronic conditions with slow progression to aggressive forms that require immediate treatment (2).
Acute lymphoblastic leukemia (ALL) is the most common hematologic malignancy in childhood and the predominant form of precursor B-cell leukemia globally, accounting for 85% of ALL cases. According to recent global burden estimates, ALL incidence increased to over 100 000 cases worldwide by 2021, corresponding to an age-standardized incidence rate of ~1.4 per 100 000 persons per year (3). Its quick course and possibility of systemic involvement make early and prompt diagnosis and efficient treatment essential for enhancing long-term survival, especially in young patients.(4).
B-Chronic lymphoproliferative disorders (B-CLPDs) are a diverse collection of illnesses that are defined by the uncontrolled and clonal expansion of mature B cells. Although they can range from indolent to aggressive, they usually impact elderly persons and have a slow-growing, indolent clinical history. These conditions account for more than 90% of all chronic lymphoid cancers (5).
B-cell malignancies arise from disruption of immune system regulation through alterations in crucial signaling pathways, such as the B-cell receptor (BCR) signalling defect, imbalance between stimulatory signals (that drive proliferation and differentiation) and inhibitory signals (that enforce tolerance and prevent overstimulation) leading to anti-tumor immunity with development and metastasis of cancer cells (6).
An essential part of the immune regulatory system for malignancies, the B7-H family which is an important immune checkpoint provides new opportunities for modifying the tumor microenvironment (TME). This family is well-known for its several functions in controlling both innate and adaptive immunity. It is also involved in the recruitment and polarization of diverse immune cells and can have co-stimulatory or co-inhibitory effects on T cells, affecting processes like T cell activation, differentiation, and effector functions. Two important members in this family are: B7-H1 (PD-L1) also known CD274 and B7-H3 (CD276) (7).
Firstly, PD-L1 (CD274) which bind to PD-1 . This interaction primarily result in suppresses effector T cell activity while promoting the activity of immunosuppressive regulatory T cells (Tregs), hence negatively regulating the adaptive immune response. However, in malignancy, cancer cells promote the PD-1/PD-L1 axis to cause immune escape in cancer development and progression (8). It was reported that PD-L1 is widely expressed in solid tumors like melanoma and non-small cell lung cancer (9).
Secondly, CD276, also called B7-H3, is abundantly expressed in cancer cells and activated tumor-infiltrating immune cells aiding in the evasion of cytotoxic T-cell and natural killer cell surveillance (10). According to new research, B7-H3 contributes to tumor growth, metastasis, and resistance to treatment, all of which have a negative impact on patient outcomes (11).
Till now, the co-expression and functional relationship of CD274 and CD276 in B-cell malignancies remain poorly recognized. Understanding whether malignant B cells utilize multiple immune checkpoint pathways simultaneously may explain resistance to immunotherapy and identify novel prognostic and therapeutic targets.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| B-acute lymphoblastic leukemia | – | – |
| B-chronic lymphoproliferative disorder | – | – |
| healthy control | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- * Acute B- lymphoblastic leukemia. or * B- lymphoproliferative disorders (whether chronic lymphocytic leukemia or any other disorder)
Key inclusion criteria (3 listed)
- Newly diagnosed patients of both gender at any age with
- Acute B- lymphoblastic leukemia. or
- B- lymphoproliferative disorders (whether chronic lymphocytic leukemia or any other disorder)
Key exclusion criteria (3 listed)
- Patients with any other type of malignancies.
- Patients that receiving chemotherapy.
- Patients with any autoimmune diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Using CD274 and CD276 in diagnosis of B-cell malignancies using Flowcytometric technique
Time frame: 3 years
By flowcytometric technique (Beckman coulter analyzer)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Background: PubMed 28695059Castellanos JR, Purvis IJ, Labak CM, Guda MR, Tsung AJ, Velpula KK, Asuthkar S. B7-H3 role in the immune landscape of cancer. Am J Clin Exp Immunol. 2017 Jun 15;6(4):66-75. eCollection 2017.
- Background: PubMed 29860983Flem-Karlsen K, Fodstad O, Tan M, Nunes-Xavier CE. B7-H3 in Cancer - Beyond Immune Regulation. Trends Cancer. 2018 Jun;4(6):401-404. doi: 10.1016/j.trecan.2018.03.010. Epub 2018 Apr 20.
- Background: PubMed 26086854Carbognin L, Pilotto S, Milella M, Vaccaro V, Brunelli M, Calio A, Cuppone F, Sperduti I, Giannarelli D, Chilosi M, Bronte V, Scarpa A, Bria E, Tortora G. Differential Activity of Nivolumab, Pembrolizumab and MPDL3280A according to the Tumor Expression of Programmed Death-Ligand-1 (PD-L1): Sensitivity Analysis of Trials in Melanoma, Lung and Genitourinary Cancers. PLoS One. 2015 Jun 18;10(6):e0130142. doi: 10.1371/journal.pone.0130142. eCollection 2015.
- Background: PubMed 38762484Lin X, Kang K, Chen P, Zeng Z, Li G, Xiong W, Yi M, Xiang B. Regulatory mechanisms of PD-1/PD-L1 in cancers. Mol Cancer. 2024 May 18;23(1):108. doi: 10.1186/s12943-024-02023-w.
- Background: PubMed 40113530Luo Y, Yuan Y, Liu D, Peng H, Shen L, Chen Y. Targeting novel immune checkpoints in the B7-H family: advancing cancer immunotherapy from bench to bedside. Trends Cancer. 2025 Jun;11(6):540-559. doi: 10.1016/j.trecan.2025.02.007. Epub 2025 Mar 19.
- BackgroundSun H, Huang D, Zhang H, Dong M, Wang S, Sun M, et al. Targeting Immune Checkpoints: Basic Signaling Pathways and Clinical Translation in Cancer Therapeutics. MedComm - Oncology. 2025;4(3):e70030.
- Background: PubMed 30497669Chen C, Gu YD, Geskin LJ. A Review of Primary Cutaneous CD30+ Lymphoproliferative Disorders. Hematol Oncol Clin North Am. 2019 Feb;33(1):121-134. doi: 10.1016/j.hoc.2018.08.003.
- Background: PubMed 41074983Fan H, Yang Y, Lu Y, Li J, Huang Z, Ren Z, Zhou B. Global burden of acute lymphoblastic leukemia following the COVID-19 pandemic. Ann Hematol. 2025 Sep;104(9):4713-4727. doi: 10.1007/s00277-025-06639-w. Epub 2025 Oct 11.
- Background: PubMed 38731863Jimenez C, Garrote-de-Barros A, Lopez-Portugues C, Hernandez-Sanchez M, Diez P. Characterization of Human B Cell Hematological Malignancies Using Protein-Based Approaches. Int J Mol Sci. 2024 Apr 24;25(9):4644. doi: 10.3390/ijms25094644.
- Background: PubMed 32323276Meng X, Min Q, Wang JY. B Cell Lymphoma. Adv Exp Med Biol. 2020;1254:161-181. doi: 10.1007/978-981-15-3532-1_12.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
norhan mostafa mohamed abdelal Doctor, Assistant lecturer contact
Questions about this trial
What is this clinical trial studying?
An observational study of B-cell Malignancies, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact norhan mostafa mohamed abdelal Doctor, Assistant lecturer (20+ 1060287285, norhanmostafa9998@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Using CD274 and CD276 in diagnosis of B-cell malignancies using Flowcytometric technique (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07515313, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.