Non-hodgkin LymphomaPhase 1NCT05994157
Phase 1, Open-label, Dose-escalation Trial With CD38-SADA:177 Lu-DOTA Drug Complex in Subjects With Relapsed or Refractory Non-Hodgkin Lymphoma
A Phase 1 study testing CD38-SADA:177Lu-DOTA Complex in people with Non-hodgkin Lymphoma, run by Y-mAbs Therapeutics at 6 sites in United States.
Trial summary
Patients with non-Hodgkin Lymphoma will be treated with CD38-SADA:177Lu-DOTA complex (The IMP is a two-step radioimmunotherapy, delivered as two separate products CD38-SADA and 177Lu-DOTA) to establish optimal and safe therapeutic doses and dosing schedule of CD38-SADA, and 177Lu-DOTA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-hodgkin Lymphoma
- What is being tested?
- CD38-SADA:177Lu-DOTA Complex
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 6 sitesUnited States
- Study dates
- 21 Apr 2025to 15 Oct 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Target population must have relapsed, progressive or refractory non-hodgkin lymphoma and be ineligible for or have exhausted standard therapeutic options that may prolong survival
- The subject must have fluoro-deoxyglucose (FDG)-avid lymphoma with measurable disease
- CD38 positive tumor at most recent biopsy (new or archival) documented at central laboratory
- Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
- Each subject must sign an ICF indicating that he or she understands the purpose of, and procedures required for the trial and is willing to participate in the trial.
Who cannot join
- Primary central nervous system lymphoma or known central nervous system involvement with lymphoma
- Systemic chemotherapy, radiotherapy, immunotherapy, or major surgery administered within 3 weeks (for nitrosoureas within 6 weeks) prior to the first dose of CD38-SADA
- Radioimmunotherapy within 100 days prior to the first dose of CD38-SADA
- Autologous stem cell transplantation within 42 days prior to the first dose of CD38-SADA
- Treatment with approved CAR-T within 100 days prior to the first dose of CD38-SADA
- >40% lymphoma bone marrow involvement
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
City of Hope
Duarte, California, 91010
Corewell Health-BAMF Health
Grand Rapids, Michigan, 49503
East Carolina University Leo W. Jenkins Cancer Center
Greenville, North Carolina, 27834
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
HonorHealth
Scottsdale, Arizona, 85258
Stony Brook Cancer Center
Stony Brook, New York, 11794
About this study
Patients with non-Hodgkin Lymphoma will be treated with CD38-SADA:177Lu-DOTA complex (The IMP is a two-step radioimmunotherapy, delivered as two separate products CD38-SADA and 177Lu-DOTA) to establish optimal and safe therapeutic doses and dosing schedule of CD38-SADA, and 177Lu-DOTA.
- Conditions
- Non-hodgkin Lymphoma
- Being tested
- CD38-SADA:177Lu-DOTA Complex
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD38-SADA:177Lu-DOTA ComplexDrug
The IMP is a two-step radioimmunotherapy, delivered as two separate products CD38-SADA and 177Lu-DOTA. Both will be administered as an IV infusions.
| Study group | Role | What they receive |
|---|---|---|
| CD38-SADA:177Lu-DOTA Complex | Experimental | Not described Receives: Drug: CD38-SADA:177Lu-DOTA Complex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor imaging and occurrence of dose limiting toxicities (DLT) during the DLT evaluation period (Part A)
Measured: 4 weeks
Occurrence of dose limiting toxicities during the DLT evaluation period (Part B)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start21 Apr 2025
- Primary completion15 Oct 2025
- Study completion15 Oct 2025
Why it stopped: Study is terminated by Sponsor decision due to recruitment challenges.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-hodgkin LymphomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Y-mAbs Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05994157
- Sponsor's protocol ID
- 1201
- Status last verified
- Mar 2026
- First submitted
- 8 Aug 2023
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Open-label, Dose-escalation Trial With CD38-SADA:177 Lu-DOTA Drug Complex in Subjects With Relapsed or Refractory Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT05994157
- Acronym / sponsor ID
- 1201
- Conditions
- Non-hodgkin Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study is terminated by Sponsor decision due to recruitment challenges.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Y-mAbs TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 21 Apr 2025 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 16 Aug 2023 (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.
Patients with non-Hodgkin Lymphoma will be treated with CD38-SADA:177Lu-DOTA complex (The IMP is a two-step radioimmunotherapy, delivered as two separate products CD38-SADA and 177Lu-DOTA) to establish optimal and safe therapeutic doses and dosing schedule of CD38-SADA, and 177Lu-DOTA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD38-SADA:177Lu-DOTA Complex | Experimental | Drug: CD38-SADA:177Lu-DOTA Complex |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Target population must have relapsed, progressive or refractory non-hodgkin lymphoma and be ineligible for or have exhausted standard therapeutic options that may prolong survival
- The subject must have fluoro-deoxyglucose (FDG)-avid lymphoma with measurable disease
- CD38 positive tumor at most recent biopsy (new or archival) documented at central laboratory
- Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
- Each subject must sign an ICF indicating that he or she understands the purpose of, and procedures required for the trial and is willing to participate in the trial.
Key exclusion criteria (6 listed)
- Primary central nervous system lymphoma or known central nervous system involvement with lymphoma
- Systemic chemotherapy, radiotherapy, immunotherapy, or major surgery administered within 3 weeks (for nitrosoureas within 6 weeks) prior to the first dose of CD38-SADA
- Radioimmunotherapy within 100 days prior to the first dose of CD38-SADA
- Autologous stem cell transplantation within 42 days prior to the first dose of CD38-SADA
- Treatment with approved CAR-T within 100 days prior to the first dose of CD38-SADA
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 |
|---|---|---|
| CD38-SADA:177Lu-DOTA ComplexThe IMP is a two-step radioimmunotherapy, delivered as two separate products CD38-SADA and 177Lu-DOTA. Both will be administered as an IV infusions. | Drug | CD38-SADA:177Lu-DOTA Complex |
Primary outcome
Tumor imaging and occurrence of dose limiting toxicities (DLT) during the DLT evaluation period (Part A)
Time frame: 4 weeks
Occurrence of dose limiting toxicities during the DLT evaluation period (Part B)
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: Study is terminated by Sponsor decision due to recruitment challenges.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CD38-SADA:177Lu-DOTA Complex in people with Non-hodgkin Lymphoma, run by Y-mAbs Therapeutics at 6 sites in United States.
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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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?
The study was stopped early (reason given: Study is terminated by Sponsor decision due to recruitment challenges.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor imaging and occurrence of dose limiting toxicities (DLT) during the DLT evaluation period (Part A) (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 12 Mar 2026.