dibotatug (DR-01) / Dren Bio - LARVOL DELTA

Anti-CD94 Monoclonal Antibody Dibotatug-Induced Response in a Refractory Primary CNS T-Cell Lymphoma. (PubMed, JCO Precis Oncol) - No abstract available

Journal • Hematological Malignancies • Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • KLRD1

Initial clinical data from the phase 1 study of DR-01, a non-fucosylated anti-CD94 antibody in patients with large granular lymphocytic leukemia (ASH 2025) - P1/2 | "Prior therapies includedmethotrexate in 29 (94%), cyclophosphamide in 15 (48%), cyclosporine in 13 (42%), and alemtuzumab in 4(13%), with 17 (55%) pts also receiving some other treatment including investigational agents. Preliminary safety and efficacy data show that DR-01 is well-tolerated with a promisingresponse rate and durable responses, supporting continued development of DR-01 as a therapy forLGLL."

Clinical data • P1 data • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Neutropenia • CD8 • GZMB • KLRD1

Updated Clinical Data From the Phase 1 Study of Dibotatug (DR-01), a Nonfucosylated Anti-CD94 Antibody, in Patients With Large Granular Lymphocytic Leukemia (SOHO 2026) - P1/2 | "Prior therapies included methotrexate (n = 46; 89%), cyclophosphamide (n = 25; 48%), and cyclosporine (n = 23; 44%). This abstract was accepted and previously presented at the 2026 EHA Congress. C1D1/D8/D15: cycle 1 day 1/day 8/day 15, CRs: complete responses, IgG: immunoglobulin G, ORR: objective response rate, PRs: partial responses."

Clinical data • P1 data • Hematological Malignancies • Leukemia • Oncology • CD8 • GZMB • KLRD1

Updated Clinical Data From the Phase 1/2 Study of Dibotatug (DR-01), a Non-Fucosylated Anti-CD94 Antibody, in Patients With Relapsed/Refractory Cytotoxic T/NK Cell Lymphomas (SOHO 2026) - P1/2 | "AE: adverse event, C: cycle, CD: cluster of differentiation, CR: complete response, CTL: cytotoxic T/NK cell lymphoma, D: day, HSTCL: hepatosplenic T-cell lymphoma, IgG: immunoglobulin G, MEITL: monomorphic epitheliotropic intestinal T-cell lymphoma, NK: natural killer, ORR: objective response rate, PR: partial response, R/R: relapsed/refractory, SPTCL: subcutaneous panniculitis-like T-cell lymphoma, TIA1: T-cell intracellular antigen 1. Abstract was previously accepted and presented at the European Hematology Association 2026 Annual Congress."

Clinical data • P1/2 data • Extranodal Natural Killer/T-cell Lymphoma • Hematological Malignancies • Hepatosplenic T-cell Lymphoma • Lymphoma • Natural Killer/T-cell Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • CD8 • GZMB • KLRD1

BMF: A Phase 1/2 Study to Evaluate the Safety and Efficacy of Dibotatug (DR-01) in Adults With Bone Marrow Failure Syndromes (clinicaltrials.gov) - P1/2 | N=60 | Not yet recruiting | Sponsor: Dren Bio

New P1/2 trial • Anemia • Aplastic Anemia • Hematological Disorders

UPDATED CLINICAL DATA FROM THE PHASE 1 STUDY OF DIBOTATUG (DR-01), A NON-FUCOSYLATED ANTI-CD94 ANTIBODY, IN PATIENTS WITH LARGE GRANULAR LYMPHOCYTIC LEUKEMIA (EHA 2026) - P1/2 | "Prior therapies included methotrexate (n=46 [89%]), cyclophosphamide (25 [48%]), cyclosporine (23 [44%]), and alemtuzumab (6 [12%)). Summary/Conclusion Preliminary safety and efficacy data show that dibotatug is well-tolerated. Response rates are promising with deep and durable responses which support continued dibotatug development as a novel therapy for LGLL."

Clinical data • P1 data • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Neutropenia • CD8 • GZMB • KLRD1

UPDATED CLINICAL DATA FROM THE PHASE 1/2 STUDY OF DIBOTATUG (DR-01), A NON-FUCOSYLATED ANTI-CD94 ANTIBODY, IN PATIENTS WITH RELAPSED/REFRACTORY CYTOTOXIC T/NK CELL LYMPHOMAS (EHA 2026) - P1/2 | "By C2D1, dibotatug treatment had markedly depleted CD94 + cells in patient samples. Summary/Conclusion Dibotatug continues to demonstrate promising safety and efficacy with responses across CTL histologies, supporting development as a targeted therapy in patients with R/R CTL."

Clinical data • P1/2 data • Extranodal Natural Killer/T-cell Lymphoma • Hematological Malignancies • Hepatosplenic T-cell Lymphoma • Lymphoma • Natural Killer/T-cell Lymphoma • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • CD8 • GZMB • KLRD1

Availability of Dibotatug (DR-01) Outside Clinical Trials Via Expanded Access for Eligible Participants (clinicaltrials.gov) - P=N/A | N=0 | Available | Sponsor: Dren Bio

New trial

A Study of DR-01 in Subjects With Alopecia Areata and Vitiligo (clinicaltrials.gov) - P1 | N=81 | Active, not recruiting | Sponsor: Dren Bio | Recruiting ➔ Active, not recruiting | Trial completion date: Sep 2026 ➔ May 2027 | Trial primary completion date: Sep 2026 ➔ May 2027

Enrollment closed • Trial completion date • Trial primary completion date • Alopecia • Dermatology • Immunology • Vitiligo

DR-01-ONC-001: A Study of DR-01 in Subjects With Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas (clinicaltrials.gov) - P1/2 | N=200 | Recruiting | Sponsor: Dren Bio | N=69 ➔ 200

Enrollment change • First-in-human • Cutaneous T-cell Lymphoma • Hematological Malignancies • Hepatosplenic T-cell Lymphoma • Leukemia • Lymphoma • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

Updated clinical data and biomarker analyses from the phase 1 study of DR-01, a non-fucosylated anti-CD94 antibody in patients with relapsed/refractory cytotoxic lymphomas (ASH 2025) - P1/2 | "DR-01 continues to demonstrate promising safety and efficacy, supporting its developmentas a potential treatment option for CTL. Biomarker analyses show that CD94 is widely expressed acrossmost CTL. Notably, the preliminary data suggest that patients with CTL may benefit from DR-01regardless of baseline positive CD94 expression by IHC."

Biomarker • Clinical data • P1 data • Bone Marrow Transplantation • Hematological Malignancies • Lymphoma • Natural Killer/T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • CD8 • GZMB • KLRD1

Results from the First Phase 1 Clinical Study of DR-01, a Non-Fucosylated Anti-CD94 Targeting Antibody in Patients with Relapsed/Refractory Cytotoxic Lymphomas: Dose Escalation and Optimization (ASH 2024) - P1/2 | "An encouraging response rate including 3 durable CRs points to the potential for DR-01 as a viable treatment option for CTL. Study DR-01-ONC-001 is currently enrolling an international cohort of patients with CTL into phase 2, part B2 of the trial."

Clinical • P1 data • Bone Marrow Transplantation • Constipation • Extranodal Natural Killer/T-cell Lymphoma • Fatigue • Gastroenterology • Gastrointestinal Disorder • Hematological Malignancies • Lymphoma • Oncology • CD8 • KLRD1

A Study of Subcutaneous DR-01 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Dren Bio | Active, not recruiting ➔ Completed

Trial completion

A Study of Subcutaneous DR-01 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=32 | Active, not recruiting | Sponsor: Dren Bio | Recruiting ➔ Active, not recruiting

Enrollment closed

FIRST-IN-HUMAN PHASE 1 STUDY OF DR-01, A NON-FUCOSYLATED ANTI-CD94 ANTIBODY IN PATIENTS WITH RELAPSED/REFRACTORY CYTOTOXIC LYMPHOMAS: DOSE ESCALATION AND OPTIMIZATION (ICML 2025) - P1/2 | "DR-01 demonstrates promising safety and efficacy, supporting its development as a potential treatment option for CTL."

Clinical • P1 data • Hematological Malignancies • Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • CD8 • KLRD1

A Study of DR-01 in Subjects With Alopecia Areata and Vitiligo (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: Dren Bio | N=60 ➔ 80

Enrollment change • Alopecia • Dermatology • Immunology • Vitiligo

A Study of Subcutaneous DR-01 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Dren Bio | Not yet recruiting ➔ Recruiting

Enrollment open

A Study of DR-01 in Subjects With Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas (clinicaltrials.gov) - P1/2 | N=69 | Recruiting | Sponsor: Dren Bio | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2024 ➔ Dec 2026

Trial completion date • Trial primary completion date • Cutaneous T-cell Lymphoma • Gastrointestinal Disorder • Hematological Malignancies • Hepatosplenic T-cell Lymphoma • Leukemia • Lymphoma • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

A Study of Subcutaneous DR-01 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Dren Bio

New P1 trial

City of Hope Reveals New Data on Cancer Immunotherapies, Microbiome and Other Innovative Topics at 2024 American Society of Hematology (ASH) Annual Meeting (Businesswire) - "City of Hope....announced today that its doctors and scientists will take part in 100 oral and poster presentations, scientific symposia/workshops, education programs and other events at ASH annual meeting from Dec. 7 to 10 in San Diego."

Clinical data

A Study of DR-01 in Subjects With Alopecia Areata and Vitiligo (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Dren Bio | Not yet recruiting ➔ Recruiting

Enrollment open • Alopecia • Dermatology • Immunology • Vitiligo

A Study of DR-01 in Subjects With Alopecia Areata and Vitiligo (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: Dren Bio

New P1 trial • Alopecia • Dermatology • Immunology • Vitiligo

DR-01, a Non-Fucosylated Anti-CD94 Antibody, Depletes Leukemic Cells in Ex Vivo and In Vivo Models of Large Granular Lymphocyte Leukemia (ASH 2022) - "In addition, treatments are limited to standard immunosuppressive therapy such as methotrexate, cyclosporine or cyclophosphamide, with complete response rates of only 50% or less for each agent. Additional profiling and evaluation of DR-01 in LGLL patient samples ex vivo as part of a pre-phase I study is ongoing. A phase I/II trial has been initiated to assess the safety and efficacy of DR-01 in previously treated LGLL patients."

Preclinical • Anemia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Neutropenia • Oncology • Thrombocytopenia • B3GAT1 • CD8 • FCGR3A • KLRC1 • LAMP1 • PTPRC

A Study of DR-01 in Subjects With Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas (clinicaltrials.gov) - P1/2 | N=69 | Recruiting | Sponsor: Dren Bio

New P1/2 trial • Cutaneous T-cell Lymphoma • Gastrointestinal Disorder • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma