First-in-human Study of OT-A201 in Patients With Selected Hematological Malignancies and Solid Tumors
NCT ID: NCT05828459
Last Updated: 2025-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
150 participants
INTERVENTIONAL
2023-07-10
2027-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A First-in-human Study to Assess OT-C001 (Amplified/Activated Allogenic Natural Killer Cells) in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma
NCT07044050
A Trial of Obinutuzumab,GDC-0199 Plus Ibrutinib in Relapsed/Refractory Mantle Cell Lymphoma Patients
NCT02558816
A First-in-Human, Phase 1 Dose-Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BJ-005 in Patients With Advanced Solid Tumor or Lymphoma
NCT05115292
A Study of NX-5948 in Adults With Relapsed/Refractory B-cell Malignancies
NCT05131022
A Study of MT-101 in Subjects With CD5+ Relapsed/Refractory TCL
NCT05138458
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
Further expansion of each groups.
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
OT-A201 monotherapy
OT-A201 administered by IV infusion on a weekly (qw) basis. An alternative dosing schedule of every 2 weeks (q2w) may be implemented based on the clinical safety and laboratory data.
OT-A201
OT-A201 IV infusion qw or q2w
OT-A201 in combination with iMiD
OT-A201 in combination with lenalidomide or pomalidomide at the approved dose
OT-A201
OT-A201 IV infusion qw or q2w
IMids
Combination regimen for hematological malignancy Lenalidomide: 25 mg on Days 1 to 21 of each 28-day cycle; or Pomalidomide: 4 mg on Days 1 to 21 of each 28-day cycle
OT-A201 in combination with a specific agent
OT-A201 in combination with late stage approved treatment (combination to be defined by a protocol amendment)
OT-A201
OT-A201 IV infusion qw or q2w
TBD Compound
Combination regimen for hematological malignancy
OT-A201 in combination with bevacizumab
OT-A201 in combination with bevacizumab at the approved dose
OT-A201
OT-A201 IV infusion qw or q2w
Bevacizumab
Combination regimen for solid tumor Bevacizumab: 10 mg/m² q2w
OT-A201 in combination with paclitaxel
OT-A201 in combination with paclitaxel at the approved dose
OT-A201
OT-A201 IV infusion qw or q2w
Paclitaxel
Combination regimen for solid tumor Paclitaxel: 175 mg/m² q3w
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
OT-A201
OT-A201 IV infusion qw or q2w
IMids
Combination regimen for hematological malignancy Lenalidomide: 25 mg on Days 1 to 21 of each 28-day cycle; or Pomalidomide: 4 mg on Days 1 to 21 of each 28-day cycle
Bevacizumab
Combination regimen for solid tumor Bevacizumab: 10 mg/m² q2w
Paclitaxel
Combination regimen for solid tumor Paclitaxel: 175 mg/m² q3w
TBD Compound
Combination regimen for hematological malignancy
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Measurable disease
* Have had all available therapeutic standards for their disease
* Willingness to undergo baseline biopsy/bone marrow aspiration in case biopsy was not collected after completion of the most recent prior therapy
* ECOG performance status ≤ 1
* Life expectancy \> 3 months as assessed by the investigator
* Acceptable clinical lab results
Exclusion Criteria
* Ongoing immune-related adverse events irAEs and or AEs ≥ grade 2 from previous therapies not resolved except vitiligo, stable neuropathy up to grade 2, hair loss, and stable endocrinopathies with substitutive hormone therapy
* Within 4 weeks of major surgery
* Documented history of active autoimmune disorder requiring systemic immunosuppressive therapy within the last 12 months
* Prior solid organ transplant
* Primary or secondary immune deficiency
* Active and uncontrolled infection requiring intravenous antibiotic or antiviral treatment
* Seropositive (except after vaccination or confirmed cure for hepatitis) for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
* Clinically significant disease
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Onward Therapeutics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Eric Raymond, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Saint-Joseph Hospital - Paris
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
ICM - Montpellier
Montpellier, , France
Saint-Eloi Hospital - Montpellier (CHU)
Montpellier, , France
Saint-Joseph Hospital - Paris
Paris, , France
Centre Eugène Marquis
Rennes, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
A20101
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.