Immunophenotypic Evaluation of CD305 and CD85d in B-Cell Lymphoid Neoplasms

NCT07499635 | Not Yet Recruiting

• 1 other identifier: CD305 and CD85d
• Study Type: observational
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

Inhibitory immune receptors, including CD85d and CD305 (LAIR-1), act as immune checkpoint-like molecules. They contain immunoreceptor tyrosine-based inhibitory motifs (ITIMs) that recruit SH2-domain phosphatases (e.g., SHP-1), which suppress cellular activation (7,8). CD85d is predominantly expressed in myeloid cells, including monocytes, macrophages, dendritic cells, and granulocytes. It is also differentially expressed on NK, T, B cells, and neutrophils. It is expressed at high levels in tumor cells, facilitating immune escape by promoting immune suppression, allowing for tumor evasion (9). CD85d is widely expressed across AML, so it is a top candidate, due to its traditional association with myeloid phenotypes and limited expression in normal haematopoiesis (10). It was reported to be expressed in B cells of CLL patients in contrast to normal B cells. Its expression in CLL patients denotes a distinctive feature, which may be acquired during malignant transformation (8). Therefore, CD85d may have significant prognostic, mechanistic, and therapeutic roles in hematologic malignancies (11). As a novel biomarker in solid malignant tumors to predict the prognosis of patients, upregulation of CD85d in tumors is associated with worse tumor phenotypes. Targeting CD85d may be an effective tool for targeted cancer therapy (12). Concerning CD305, it has been reported in about 60% of CLL patients and may be used as an effective prognostic marker to predict TTFT in CLL patients (13). Despite their potential clinical significance, the expression patterns of CD85d and CD305 across B-cell lymphoid neoplasms subtypes remain incompletely identified. Illustrating their role may help to determine TTFT, prognosis, therapeutic targeting, and refinement of B-cell neoplasms classification in line with WHO-HAEM5 standards.

Conditions

B Cell Malignancies

Keywords

CD85d, CD305, B-Cell Lymphoid Neoplasms

Outcome Measures

Primary Outcomes (1)

• Detect the expression of both CD85d and CD305 in B-cell acute lymphoblastic leukemia/lymphoma and B CLPDs.

  detect the expression level in comparison to normal

  Baseline

Secondary Outcomes (1)

• Correlate the expression of CD85d and CD305 with different B-cell lymphoproliferative disorders subtypes and B-cell acute lymphoblastic leukemia/lymphoma.

  Baseline

Study Arms (3)

60 patients diagnosed with B-cell lymphoproliferative disorders (B LPDs).

B-cell lymphoproliferative disorders (B LPDs), including chronic B-cell neoplasms diagnosed by flow cytometry

60 patients diagnosed with B-cell acute lymphoblastic leukemia/lymphoma.

B-cell acute lymphoblastic leukemia/lymphoma diagnosed by flow cytometry

(control group): 60 apparently healthy individuals

will be included as a control group for comparison

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Assiut University Hospital patients

You may qualify if:

• \- Newly diagnosed cases of B-cell acute lymphoblastic leukemia/lymphoma or B CLPDs according to the WHO classification and established by morphology, immunophenotyping, and, if available, cytogenetic/molecular findings.

You may not qualify if:

• Patients diagnosed with hematologic malignancies other than B-cell acute lymphoblastic leukemia/lymphoma or B CLPDs.
• Patients who have received prior therapy, including chemotherapy or immunomodulatory treatment.
• Patients refused to sign informed consent.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (8)

• Perbellini O, Falisi E, Giaretta I, Boscaro E, Novella E, Facco M, Fortuna S, Finotto S, Amati E, Maniscalco F, Montaldi A, Alghisi A, Aprili F, Bonaldi L, Paolini R, Scupoli MT, Trentin L, Ambrosetti A, Semenzato G, Pizzolo G, Rodeghiero F, Visco C. Clinical significance of LAIR1 (CD305) as assessed by flow cytometry in a prospective series of patients with chronic lymphocytic leukemia. Haematologica. 2014 May;99(5):881-7. doi: 10.3324/haematol.2013.096362. Epub 2014 Jan 10.

  PMID: 24415628 BACKGROUND

• Carosella ED, Rouas-Freiss N, Tronik-Le Roux D, Moreau P, LeMaoult J. HLA-G: An Immune Checkpoint Molecule. Adv Immunol. 2015;127:33-144. doi: 10.1016/bs.ai.2015.04.001. Epub 2015 May 27.

  PMID: 26073983 BACKGROUND

• Colovai AI, Tsao L, Wang S, Lin H, Wang C, Seki T, Fisher JG, Menes M, Bhagat G, Alobeid B, Suciu-Foca N. Expression of inhibitory receptor ILT3 on neoplastic B cells is associated with lymphoid tissue involvement in chronic lymphocytic leukemia. Cytometry B Clin Cytom. 2007 Sep;72(5):354-62. doi: 10.1002/cyto.b.20164.

  PMID: 17266150 BACKGROUND

• Mansouri L, Thorvaldsdottir B, Sutton LA, Karakatsoulis G, Meggendorfer M, Parker H, Nadeu F, Brieghel C, Laidou S, Moia R, Rossi D, Catherwood M, Kotaskova J, Delgado J, Rodriguez-Vicente AE, Benito R, Rigolin GM, Bonfiglio S, Scarfo L, Mattsson M, Davis Z, Gogia A, Rani L, Baliakas P, Foroughi-Asl H, Jylha C, Skaftason A, Rapado I, Miras F, Martinez-Lopez J, de la Serna J, Rivas JMH, Thornton P, Larrayoz MJ, Calasanz MJ, Fesus V, Matrai Z, Bodor C, Smedby KE, Espinet B, Puiggros A, Gupta R, Bullinger L, Bosch F, Tazon-Vega B, Baran-Marszak F, Oscier D, Nguyen-Khac F, Zenz T, Terol MJ, Cuneo A, Hernandez-Sanchez M, Pospisilova S, Mills K, Gaidano G, Niemann CU, Campo E, Strefford JC, Ghia P, Stamatopoulos K, Rosenquist R. Different prognostic impact of recurrent gene mutations in chronic lymphocytic leukemia depending on IGHV gene somatic hypermutation status: a study by ERIC in HARMONY. Leukemia. 2023 Feb;37(2):339-347. doi: 10.1038/s41375-022-01802-y. Epub 2022 Dec 24.

  PMID: 36566271 BACKGROUND

• Kantarjian H, Jabbour E. Adult Acute Lymphoblastic Leukemia: 2025 Update on Diagnosis, Therapy, and Monitoring. Am J Hematol. 2025 Jul;100(7):1205-1231. doi: 10.1002/ajh.27708. Epub 2025 May 16.

  PMID: 40377367 BACKGROUND

• Lejman M, Chalupnik A, Chilimoniuk Z, Dobosz M. Genetic Biomarkers and Their Clinical Implications in B-Cell Acute Lymphoblastic Leukemia in Children. Int J Mol Sci. 2022 Mar 2;23(5):2755. doi: 10.3390/ijms23052755.

  PMID: 35269896 BACKGROUND

• Alaggio R, Amador C, Anagnostopoulos I, Attygalle AD, Araujo IBO, Berti E, Bhagat G, Borges AM, Boyer D, Calaminici M, Chadburn A, Chan JKC, Cheuk W, Chng WJ, Choi JK, Chuang SS, Coupland SE, Czader M, Dave SS, de Jong D, Du MQ, Elenitoba-Johnson KS, Ferry J, Geyer J, Gratzinger D, Guitart J, Gujral S, Harris M, Harrison CJ, Hartmann S, Hochhaus A, Jansen PM, Karube K, Kempf W, Khoury J, Kimura H, Klapper W, Kovach AE, Kumar S, Lazar AJ, Lazzi S, Leoncini L, Leung N, Leventaki V, Li XQ, Lim MS, Liu WP, Louissaint A Jr, Marcogliese A, Medeiros LJ, Michal M, Miranda RN, Mitteldorf C, Montes-Moreno S, Morice W, Nardi V, Naresh KN, Natkunam Y, Ng SB, Oschlies I, Ott G, Parrens M, Pulitzer M, Rajkumar SV, Rawstron AC, Rech K, Rosenwald A, Said J, Sarkozy C, Sayed S, Saygin C, Schuh A, Sewell W, Siebert R, Sohani AR, Tooze R, Traverse-Glehen A, Vega F, Vergier B, Wechalekar AD, Wood B, Xerri L, Xiao W. The 5th edition of the World Health Organization Classification of Haematolymphoid Tumours: Lymphoid Neoplasms. Leukemia. 2022 Jul;36(7):1720-1748. doi: 10.1038/s41375-022-01620-2. Epub 2022 Jun 22.

  PMID: 35732829 BACKGROUND

• Debord C, Wuilleme S, Eveillard M, Theisen O, Godon C, Le Bris Y, Bene MC. Flow cytometry in the diagnosis of mature B-cell lymphoproliferative disorders. Int J Lab Hematol. 2020 Jun;42 Suppl 1:113-120. doi: 10.1111/ijlh.13170.

  PMID: 32543070 BACKGROUND

Study Officials

• Hesham Abdel-Raheem Abdel-Baset, Professor

  Assiut University

  STUDY DIRECTOR

• Al Shaimaa Mokhtar Selim

  Assiut University

  PRINCIPAL INVESTIGATOR

• Zeinab Albadry Zahran

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amira Saber

CONTACT

01063954423; amirasaberh@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 30, 2026
• Study Start (Estimated): September 6, 2026
• Primary Completion (Estimated): September 6, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: March 30, 2026

Record last verified: 2026-03