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B Cell MalignanciesNCT07499635

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

An observational study of B Cell Malignancies, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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). 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
180 participants
Where
No sites listed yet
Study dates
6 Sep 2026to Mar 2029
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: Assiut University Hospital patients

Who may be able to join

  • - 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.

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

About this study

Official title: Immunophenotypic Evaluation of Inhibitory Immune Receptors CD305 and CD85d in B-Cell Lymphoid Neoplasms

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).

Read more

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.

Read the detailed description

B-cell lymphoproliferative disorders (B LPDs) constitute a wide spectrum of clonal B-cell neoplasms, ranging from indolent chronic illness to more aggressive hematologic malignancies. Clinically, patients may present with lymphadenopathy, splenomegaly, cytopenias, or, in chronic cases, may be diagnosed accidentally by the presence of lymphocytosis during routine complete blood counts, confirmed by immunophenotyping showing a monoclonal B-cell population (1).

According to the World Health Organization Classification of Haematolymphoid Tumours, 5th edition (WHO HAEM5), mature B-cell neoplasms are diagnosed by integrating morphology, immunophenotyping, cytogenetics, and molecular features. Major B-CLPD subtypes include chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), hairy cell leukemia (HCL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), follicular lymphoma (FL), and lymphoplasmacytic lymphoma/Waldenström macroglobulinemia (LPL/WM) (2). Accurate immunophenotypic diagnosis is essential as it helps to identify distinct prognoses and therapeutic approaches.

B-cell acute lymphoblastic leukemia/lymphoma is the most common pediatric leukemia, representing about 85% of ALL cases in children and 75% in adults. B-cell acute lymphoblastic leukemia/lymphoma is a precursor B-lineage neoplasm comprising lymphoblasts that express CD19, CD22, CD79a, and/or PAX5, besides the expression of immaturity markers such as TdT and CD34, while lacking surface immunoglobulin expression (3-5). Its inclusion differentiates the spectrum of B-cell neoplasms from precursor to mature stages.

Management of asymptomatic patients with B-CLPDs commonly follows a "watch and wait" strategy, whereas B-ALL requires prompt therapeutic intervention. Prognostic indicators in B-CLPDs, such as genetic mutations detected by fluorescence in situ hybridization (FISH) (del(17p), del(11q), trisomy 12, del(13q)), IGHV gene somatic hypermutation status, and TP53 mutations, can guide risk stratification and predict time to first treatment (TTFT) (6).

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.

Keywords
CD85d, CD305, B-Cell Lymphoid Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07499635
Study groupRoleWhat they receive
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 individualswill be included as a control group for comparison

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline

Secondary outcomes (1)
  1. Correlate the expression of CD85d and CD305 with different B-cell lymphoproliferative disorders subtypes and B-cell acute lymphoblastic leukemia/lymphoma.

    Correlate the expression level with different subtypes

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2026
  2. Study start6 Sep 2026 (estimated)
  3. Primary completion6 Sep 2028 (estimated)
  4. Study completionMar 2029 (estimated)

Resources

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
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07499635
Sponsor's protocol ID
CD305 and CD85d
Status last verified
Mar 2026
First submitted
24 Mar 2026
Last updated
30 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 24415628
  • 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.

    PubMed 26073983
  • 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.

    PubMed 17266150
  • 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.

    PubMed 36566271
  • 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.

    PubMed 40377367
  • 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.

    PubMed 35269896
  • 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.

    PubMed 35732829
  • 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.

    PubMed 32543070

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 1 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 30 Mar 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 Amira Saber (01063954423, amirasaberh@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Detect the expression of both CD85d and CD305 in B-cell acute lymphoblastic leukemia/lymphoma and B CLPDs. (time frame: Baseline). 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 NCT07499635, which also lists 8 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 30 Mar 2026.

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