Diffuse Large B-cell Lymphoma With no Other SpecificationPhase 1NCT07044050
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
A Phase 1 study testing allogenic natural killer cells in people with Diffuse Large B-cell Lymphoma With no Other Specification, run by Emercell SAS at 1 site in France.
Trial summary
The goal of this clinical trial is to learn the safety of OT-C001 and decide a good dose in treating relapsed or refractory diffuse large B-cell lymphoma patients. It will also learn about the preliminary activity of OT-C001. Participants will: Receive a short course of chemotherapy before OT-C001 treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B-cell Lymphoma With no Other Specification
- What is being tested?
- allogenic natural killer cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jun 2025to 31 Dec 2026
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age
- histologically confirmed diagnosis of R/R DLBCL-NOS without further standard treatment options including those relapsing after or ineligible for CAR T-cell therapy
- with evaluable disease
- with adequate biological parameters at baseline
- ECOG performance status ≤1
- life expectancy >3 months as assessed by the investigator
Who cannot join
- Receive concomitantly any antitumor-directed drug therapy
- Any vaccination with live virus vaccines before or during treatment
- With severe atopic predisposition who need a treatment with monoclonal antibodies, allergen immunotherapy, or long-term systemic corticosteroids
- Major surgery within 3 weeks
- With rapidly progressing disease that includes massive uncontrolled pleural, pericardial, or peritoneal effusions, pulmonary lymphangitis, and over 50% liver involvement
- Ongoing immune-related tocivities or adverse events grade >1 not resolved from previous therapies except vitiligo, stable neuropathy up to grade 2, hair loss, and stable endocrinopathies with substitutive hormone therapy
Show all 13Show fewer
- Documented history of active autoimmune disorders requiring systemic immunosuppressive therapy within the last 12 months
- Primary or secondary immune deficiency
- Active and uncontrolled infections requiring intravenous antibiotic or antiviral treatment
- Seropositive (except after vaccination or confirmed cure for hepatitis) for HIV, HBV, or HCV
- Clinically significant cardiac disease including heart failure, uncontrolled hypertension, pre-existing arrhythmia, uncontrolled angina pectoris, or myocardial infarction within 12 months
- Dementia or altered mental status that would prohibit informed consent
- Other malignancy within the last 3 years except adequately treated nonmelanoma skin cancer, in situ carcinoma of the uterine cervix, or myelodysplastic syndromes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Saint-Eloi Hospital
Montpellier, 34090
Cécile LONONGO (POPKO), +33 4 67 33 24 13, c-popko@chu-montpellier.fr
Guillaume Cartron, MD, PhD
About this study
Official title: A First-in-human, Open-label, Clinical Study to Assess the Safety, Tolerability, and Activity of OT-C001 (Amplified/Activated Allogenic Natural Killer Cells) in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma
The goal of this clinical trial is to learn the safety of OT-C001 and decide a good dose in treating relapsed or refractory diffuse large B-cell lymphoma patients. It will also learn about the preliminary activity of OT-C001.
Participants will:
Receive a short course of chemotherapy before OT-C001 treatment. During the study treatment, participants will recieve weekly dose of OT-C001 for 3 or 6 weeks. During the study period, participants will also receive another two drugs, rituximab and IL-2, to support OT-C001 treatment.
Participants need to visit the clinic or may be hospitalized according to the study plan.
- Being tested
- allogenic natural killer cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allogenic natural killer cellsBiological
Also called OT-C001, NK-001
OT-C001 will be administered by IV infusion weekly for at least 3 doses.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (Dose Level 1) | Experimental | OT-C001 1 vial, weekly dosing Receives: Biological: allogenic natural killer cells |
| Cohort 2 (Dose Level 2) | Experimental | OT-C001 3 vials, weekly dosing Receives: Biological: allogenic natural killer cells |
| Cohort -1 (Sub Dose Level) | Experimental | OT-C001 1/3 vial (100M) Receives: Biological: allogenic natural killer cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment-emergent adverse events and clinically significant findings on clinical laboratory tests, performance status, vital signs, ECGs, and physical examinations.
Measured: All assessments will be conducted from first study treatment administration through the End of Treatment or Early Termination Visit (scheduled within 14 days after the last dose).
Secondary outcomes (1)
Antitumor activity characterized by objective response rate per Lugano criteria.
Measured: Tumor will be assessed at the end treatment cycles (3 and 6 weeks after the first dose), and every 12 weeks afterwards for up to of 2 years until progression of disease or starting new anti-cancer treatments.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start10 Jun 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-cell Lymphoma With no Other SpecificationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emercell SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alain Herrera, Study chair, Emercell SAS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044050
- Sponsor's protocol ID
- C00101
- Status last verified
- Jun 2025
- First submitted
- 12 Jun 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-human, Open-label, Clinical Study to Assess the Safety, Tolerability, and Activity of OT-C001 (Amplified/Activated Allogenic Natural Killer Cells) in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma
- ClinicalTrials.gov ID
- NCT07044050
- Acronym / sponsor ID
- C00101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Emercell SASIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Jun 2025 (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.
The goal of this clinical trial is to learn the safety of OT-C001 and decide a good dose in treating relapsed or refractory diffuse large B-cell lymphoma patients. It will also learn about the preliminary activity of OT-C001.
Participants will:
Receive a short course of chemotherapy before OT-C001 treatment. During the study treatment, participants will recieve weekly dose of OT-C001 for 3 or 6 weeks. During the study period, participants will also receive another two drugs, rituximab and IL-2, to support OT-C001 treatment.
Participants need to visit the clinic or may be hospitalized according to the study plan.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (Dose Level 1) | Experimental | Biological: allogenic natural killer cellsOT-C001 1 vial, weekly dosing |
| Cohort 2 (Dose Level 2) | Experimental | Biological: allogenic natural killer cellsOT-C001 3 vials, weekly dosing |
| Cohort -1 (Sub Dose Level) | Experimental | Biological: allogenic natural killer cellsOT-C001 1/3 vial (100M) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥18 years of age
- histologically confirmed diagnosis of R/R DLBCL-NOS without further standard treatment options including those relapsing after or ineligible for CAR T-cell therapy
- with evaluable disease
- with adequate biological parameters at baseline
- ECOG performance status ≤1
Key exclusion criteria (13 listed)
- Receive concomitantly any antitumor-directed drug therapy
- Any vaccination with live virus vaccines before or during treatment
- With severe atopic predisposition who need a treatment with monoclonal antibodies, allergen immunotherapy, or long-term systemic corticosteroids
- Major surgery within 3 weeks
- With rapidly progressing disease that includes massive uncontrolled pleural, pericardial, or peritoneal effusions, pulmonary lymphangitis, and over 50% liver involvement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| allogenic natural killer cellsAlso: OT-C001, NK-001OT-C001 will be administered by IV infusion weekly for at least 3 doses. | Biological | Cohort -1 (Sub Dose Level), Cohort 1 (Dose Level 1), Cohort 2 (Dose Level 2) |
Primary outcome
Incidence and severity of treatment-emergent adverse events and clinically significant findings on clinical laboratory tests, performance status, vital signs, ECGs, and physical examinations.
Time frame: All assessments will be conducted from first study treatment administration through the End of Treatment or Early Termination Visit (scheduled within 14 days after the last dose).
1 secondary outcome
Antitumor activity characterized by objective response rate per Lugano criteria.
Time frame: Tumor will be assessed at the end treatment cycles (3 and 6 weeks after the first dose), and every 12 weeks afterwards for up to of 2 years until progression of disease or starting new anti-cancer treatments.
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 29 Jun 2025.
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.
Alain Herrera study chair
Emercell SAS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing allogenic natural killer cells in people with Diffuse Large B-cell Lymphoma With no Other Specification, run by Emercell SAS at 1 site in France.
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 6 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Erica Wang (886 921 865 855, e.wang@emercell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment-emergent adverse events and clinically significant findings on clinical laboratory tests, performance status, vital signs, ECGs, and physical examinations. (time frame: All assessments will be conducted from first study treatment administration through the End of Treatment or Early Termination Visit (scheduled within 14 days after the last dose).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2025.