Relapsed or Refractory Hodgkin LymphomaPhase 2LuminICE-203NCT05883449
Phase 2 Study of AFM13 in Combination With AB-101 in Subjects With R/R HL and CD30+ PTCL
A Phase 2 study testing AFM13, AB-101 and Cyclophosphamide in people with Relapsed or Refractory Hodgkin Lymphoma and Peripheral T Cell Lymphoma, run by Affimed GmbH at 15 sites in United States.
Trial summary
AFM13-203 is a phase 2, open-label, multi-center, multi-cohort study with a safety run-in followed by expansion cohorts. The study is evaluating the safety and efficacy of AFM13 in combination with AB-101 in subjects with R/R classical HL and CD30-positive PTCL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory Hodgkin Lymphoma, Peripheral T Cell Lymphoma
- What is being tested?
- AFM13, AB-101 and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 15 sitesUnited States
- Study dates
- 10 Oct 2023to 13 Jun 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subjects with a diagnosis of FDG-avid relapsed or refractory classical HL OR select subtypes of FDG-avid CD30-positive relapsed or refractory PTCL
- For subjects with R/R PTCL a pre-enrollment tumor biopsy positive for CD30 locally assessed by Ber-H2 targeted immunohistochemistry at ≥1% is mandatory (PTCL subtypes: PTCL-NOS, Angioimmunoblastic T-cell lymphoma, ALCL, anaplastic lymphoma kinase (ALK)-positive, ALCL, ALK-negative)
- Subjects with R/R classical HL must have received at least two lines of therapy including one prior line of combination chemotherapy. Prior therapy must also have included brentuximab vedotin and a PD1 check point inhibitor.
- Subjects with R/R PTCL must have received at least one prior line of combination chemotherapy. Subjects with ALCL subtype of PTCL must have received or been intolerant to brentuximab vedotin.
- Subjects with R/R classical HL AND R/R PTCL: Prior ASCT is permitted if completed at least 3 months prior to the first dose of study treatment. Prior allogeneic stem cell transplantation will be permitted if completed at least 1 year from study enrollment and there are no signs or symptoms of GVHD. Prior CAR-T therapy is permitted if last CAR-T dose completed at least 6 months prior to the first dose of study treatment.
- Ability to understand and sign the ICF
Who cannot join
- Active central nervous system (CNS) involvement (untreated or uncontrolled parenchymal brain metastasis or positive cytology of cerebrospinal fluid)
- Previous treatment with AFM13 or CBNK cells
- History of a solid organ allograft, or an inflammatory or autoimmune disease likely to be exacerbated by IL-2 (including subjects requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease that may require systemic steroids or immunosuppressive agents
- Treatment with any therapeutic mAb or immunosuppressive medications
- Known active Hepatitis B or C defined per protocol
- Active HIV Infection
- History of any other systemic malignancy, unless previously treated with curative intent and the subject has been disease free for 2 years or longer
- Active acute or chronic graft vs. host disease (GVHD) or GVHD requiring immunosuppressive treatment, clinically significant central nervous system (CNS) dysfunction
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
O'Neal Comprehensive Cancer Center at UAB
Birmingham, Alabama, 35294
Beth Israel Deaconess Medical
Boston, Massachusetts, 02215
UNC Immunotherapy Team, University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Cleveland Clinic
Cleveland, Ohio, 44195
Sarah Cannon Research Institute
Denver, Colorado, 80218
Karmanos Cancer Institute
Detroit, Michigan, 48201
City of Hope National Medical Center
Duarte, California, 91010
John Theurer Cancer Center
Hackensack, New Jersey, 07601
Norton Cancer Institute
Louisville, Kentucky, 40207
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
UC Irvine Health
Orange, California, 92868
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Phase 2, Open-Label, Multi-Center Study of Innate Cell Engager AFM13 in Combination With Allogeneic Natural Killer Cells (AB-101) in Subjects With Recurrent or Refractory Hodgkin Lymphoma and CD-30 Positive Peripheral T-Cell Lymphoma
AFM13-203 is a phase 2, open-label, multi-center, multi-cohort study with a safety run-in followed by expansion cohorts. The study is evaluating the safety and efficacy of AFM13 in combination with AB-101 in subjects with R/R classical HL and CD30-positive PTCL.
Read the detailed description
The study will start with a safety run-in exploring AFM13/AB-101 combination treatment in subjects with classical HL. Two dose levels of AFM13 and AB-101, respectively, will be tested in 4 cohorts. Cohort 1 and 2 will enroll in parallel. Enrolment into Cohort 3 and 4 will start only if the combination treatment has been well tolerated.
Following the safety run-in observation period, a thorough risk-benefit analysis will be performed to determine 2 of the 4 cohorts/dose levels that will be further evaluated in the main part of the study which will also include subjects with classical HL and will follow a Simon two-stage design.
An additional exploratory cohort (Cohort 5) will enroll subjects with select CD30-positive PTCL subtypes after completion of the safety run-in.
All subjects will be treated with AFM13/AB-101 for a maximum of 3 cycles (cycle length is 48-days).
- Being tested
- AFM13, AB-101, Cyclophosphamide, Fludarabine, Interleukin-2
- Medical subject headings
- Recurrence, Hodgkin Disease, Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AFM13Drug
anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101Drug
NK cell therapy, intravenous infusion
CyclophosphamideDrug
Lymphodepleting chemotherapy, intravenous infusion
FludarabineDrug
Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2Drug
Immune cytokine, subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Safety run-in in Hodgkin Lymphoma | Experimental | 4 safety run-in cohorts:
* Cohort 1: 200 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15)
* Cohort 2: 300 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15)
* Cohort 3: 200 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15)
* Cohort 4: 300 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15) Receives: Drug: AFM13; Drug: AB-101; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Interleukin-2 |
| Dose Level A in Hodgkin Lymphoma | Experimental | Randomized Simon 2-stage design in Hodgkin Lymphoma Dose Level A (selected from cohort 1-4 of Safety run-in) Receives: Drug: AFM13; Drug: AB-101; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Interleukin-2 |
| Dose Level B in Hodgkin Lymphoma | Experimental | Randomized Simon 2-stage design in Hodgkin Lymphoma Dose Level B (selected from cohort 1-4 of Safety run-in) Receives: Drug: AFM13; Drug: AB-101; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Interleukin-2 |
| Exploratory: AFM13 + AB-101 on CD30-positive PTCL | Experimental | AFM13 + AB-101 on select CD30-positive PTCL subtypes (Dose Level A or B) Receives: Drug: AFM13; Drug: AB-101; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Interleukin-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) by Independent Radiology Committee
Best ORR (complete response (CR) + partial response [PR]) by Independent Radiology Committee (IRC) based on positron emission tomography-computed tomography (PET-CT) as assessed by the Lugano classification. A participant will be assumed as a responder if he/she achieves complete or partial response at any postbaseline visit.
Measured: Disease assessments were conducted on Day 43 (+- 3 days) of each cycle. All subjects were treated for a maximum of 3 cycles.
Secondary outcomes (10)
Duration of Response by Independent Radiology Committee
Duration of response (DOR) defined as time from first assessment of PR or CR to the first assessment of progressive disease/death. Response based on positron emission tomography-computed tomography (PET-CT) as assessed by the Lugano classification assessed by Independent Radiology Committee.
Measured: Tumor assessment performed every 6 weeks for 3 cycles, if no disease progression on completion of treatment, then every 3 months for the first 12 months and then every 6 months (up to 20 months)
Complete Response Rate (CRR) by Independent Radiology Committee
Complete Response Rate based on positron emission tomography-computed tomography (PET-CT) as assessed by the Lugano classification.
Measured: Tumor assessment performed every 6 weeks for 3 cycles, if no disease progression on completion of treatment, then every 3 months for the first 12 months and then every 6 months (up to 20 months)
ORR by Investigator Based on PET-CT as Assessed by the Lugano Classification
ORR (CR + PR) by Investigator based on positron emission tomography-computed tomography (PET-CT) as assessed by the Lugano classification
Measured: Tumor assessment performed every 6 weeks for 3 cycles, if no disease progression on completion of treatment, then every 3 months for the first 12 months and then every 6 months (up to 20 months)
Duration of Response by Investigator
Duration of response (DOR) defined as time from first assessment of PR or CR to the first assessment of progressive disease/death. Response based on positron emission tomography-computed tomography (PET-CT) as assessed by the Lugano classification assessed locally by the Investigator.
Measured: Tumor assessment performed every 6 weeks for 3 cycles, if no disease progression on completion of treatment, then every 3 months for the first 12 months and then every 6 months (up to 20 months)
Incidence of Subjects Receiving Subsequent Transplant
The number of subjects receiving subsequent transplant will be assessed and summarized by percentage rates
Measured: Throughout study completion (up to 20 months)
Frequency of Subjects With Study Drug Related TEAEs
The number of subjects with study-drug related (AFM13 or AB-101) treatment-emergent adverse events (TEAEs)
Measured: From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
Frequency of Subjects With Serious Treatment Emergent Adverse Events
The number of subjects who had serious treatment emergent adverse events.
Measured: From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
Frequency of Subjects Developing Anti-drug Antibodies (ADAs) Against AFM13
The number of subjects developing anti-drug antibodies (ADAs) against AFM13
Measured: During treatment cycles (up to 6 months)
Progression-free Survival (PFS) by Independent Radiology Committee
Progression-free survival (PFS) defined as time from first treatment (AFM13/AB-101) received until progressive disease (PD). Subjects who started a new anti-lymphoma therapy prior to a documented progressive disease were censored at the last disease assessment prior to initiation of new anti-lymphoma therapy. Subjects who discontinued the study before the first assessment of progressive disease or death were censored at their last disease assessment.
Measured: From the first treatment received until the first progression disease assessed by IRC or death.
Overall Survival
Overall Survival (OS) was defined as (date of death - date of first dose)/30.4375. Patients alive at the end of study will be censored on the last date of observation.
Measured: From the first treatment received until the death.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start10 Oct 2023
- Primary completion7 Nov 2024
- Study completion13 Jun 2025
Why it stopped: Due to sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Relapsed or Refractory 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affimed GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Artiva Biotherapeutics, Inc.
- Responsible party
- Sponsor
- Investigators
- Wunderle Lydia, MD, Study director, Affimed Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05883449
- Sponsor's protocol ID
- AFM13-203
- Acronym
- LuminICE-203
- Status last verified
- Aug 2025
- First submitted
- 19 May 2023
- Last updated
- 20 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-Label, Multi-Center Study of Innate Cell Engager AFM13 in Combination With Allogeneic Natural Killer Cells (AB-101) in Subjects With Recurrent or Refractory Hodgkin Lymphoma and CD-30 Positive Peripheral T-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT05883449
- Acronym / sponsor ID
- LuminICE-203 / AFM13-203
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to sponsor decision
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Affimed GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Artiva Biotherapeutics, Inc.
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 7 Nov 2024 (actual)
- Study completion
- 13 Jun 2025 (actual)
- First posted
- 1 Jun 2023 (actual)
- Results
- Posted 20 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
AFM13-203 is a phase 2, open-label, multi-center, multi-cohort study with a safety run-in followed by expansion cohorts. The study is evaluating the safety and efficacy of AFM13 in combination with AB-101 in subjects with R/R classical HL and CD30-positive PTCL.
Detailed description
The study will start with a safety run-in exploring AFM13/AB-101 combination treatment in subjects with classical HL. Two dose levels of AFM13 and AB-101, respectively, will be tested in 4 cohorts. Cohort 1 and 2 will enroll in parallel. Enrolment into Cohort 3 and 4 will start only if the combination treatment has been well tolerated.
Following the safety run-in observation period, a thorough risk-benefit analysis will be performed to determine 2 of the 4 cohorts/dose levels that will be further evaluated in the main part of the study which will also include subjects with classical HL and will follow a Simon two-stage design.
An additional exploratory cohort (Cohort 5) will enroll subjects with select CD30-positive PTCL subtypes after completion of the safety run-in.
All subjects will be treated with AFM13/AB-101 for a maximum of 3 cycles (cycle length is 48-days).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Safety run-in in Hodgkin Lymphoma | Experimental | Drug: AFM13, Drug: AB-101, Drug: Cyclophosphamide, Drug: Fludarabine, Drug: Interleukin-24 safety run-in cohorts: * Cohort 1: 200 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15) * Cohort 2: 300 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15) * Cohort 3: 200 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15) * Cohort 4: 300 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15) |
| Dose Level A in Hodgkin Lymphoma | Experimental | Drug: AFM13, Drug: AB-101, Drug: Cyclophosphamide, Drug: Fludarabine, Drug: Interleukin-2Randomized Simon 2-stage design in Hodgkin Lymphoma Dose Level A (selected from cohort 1-4 of Safety run-in) |
| Dose Level B in Hodgkin Lymphoma | Experimental | Drug: AFM13, Drug: AB-101, Drug: Cyclophosphamide, Drug: Fludarabine, Drug: Interleukin-2Randomized Simon 2-stage design in Hodgkin Lymphoma Dose Level B (selected from cohort 1-4 of Safety run-in) |
| Exploratory: AFM13 + AB-101 on CD30-positive PTCL | Experimental | Drug: AFM13, Drug: AB-101, Drug: Cyclophosphamide, Drug: Fludarabine, Drug: Interleukin-2AFM13 + AB-101 on select CD30-positive PTCL subtypes (Dose Level A or B) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects with a diagnosis of FDG-avid relapsed or refractory classical HL OR select subtypes of FDG-avid CD30-positive relapsed or refractory PTCL
- For subjects with R/R PTCL a pre-enrollment tumor biopsy positive for CD30 locally assessed by Ber-H2 targeted immunohistochemistry at ≥1% is mandatory (PTCL subtypes: PTCL-NOS, Angioimmunoblastic T-cell lymphoma, ALCL, anaplastic lymphoma kinase (ALK)-positive, ALCL, ALK-negative)
- Subjects with R/R classical HL must have received at least two lines of therapy including one prior line of combination chemotherapy. Prior therapy must also have included brentuximab vedotin and a PD1 check point inhibitor.
- Subjects with R/R PTCL must have received at least one prior line of combination chemotherapy. Subjects with ALCL subtype of PTCL must have received or been intolerant to brentuximab vedotin.
- Subjects with R/R classical HL AND R/R PTCL: Prior ASCT is permitted if completed at least 3 months prior to the first dose of study treatment. Prior allogeneic stem cell transplantation will be permitted if completed at least 1 year from study enrollment and there are no signs or symptoms of GVHD. Prior CAR-T therapy is permitted if last CAR-T dose completed at least 6 months prior to the first dose of study treatment.
Key exclusion criteria (8 listed)
- Active central nervous system (CNS) involvement (untreated or uncontrolled parenchymal brain metastasis or positive cytology of cerebrospinal fluid)
- Previous treatment with AFM13 or CBNK cells
- History of a solid organ allograft, or an inflammatory or autoimmune disease likely to be exacerbated by IL-2 (including subjects requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease that may require systemic steroids or immunosuppressive agents
- Treatment with any therapeutic mAb or immunosuppressive medications
- Known active Hepatitis B or C defined per protocol
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 |
|---|---|---|
| AFM13anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion | Drug | Dose Level A in Hodgkin Lymphoma, Dose Level B in Hodgkin Lymphoma, Exploratory: AFM13 + AB-101 on CD30-positive PTCL, Safety run-in in Hodgkin Lymphoma |
| AB-101NK cell therapy, intravenous infusion | Drug | Dose Level A in Hodgkin Lymphoma, Dose Level B in Hodgkin Lymphoma, Exploratory: AFM13 + AB-101 on CD30-positive PTCL, Safety run-in in Hodgkin Lymphoma |
| CyclophosphamideLymphodepleting chemotherapy, intravenous infusion | Drug | Dose Level A in Hodgkin Lymphoma, Dose Level B in Hodgkin Lymphoma, Exploratory: AFM13 + AB-101 on CD30-positive PTCL, Safety run-in in Hodgkin Lymphoma |
| FludarabineLymphodepleting chemotherapy, intravenous infusion | Drug | Dose Level A in Hodgkin Lymphoma, Dose Level B in Hodgkin Lymphoma, Exploratory: AFM13 + AB-101 on CD30-positive PTCL, Safety run-in in Hodgkin Lymphoma |
| Interleukin-2Immune cytokine, subcutaneously | Drug | Dose Level A in Hodgkin Lymphoma, Dose Level B in Hodgkin Lymphoma, Exploratory: AFM13 + AB-101 on CD30-positive PTCL, Safety run-in in Hodgkin Lymphoma |
Primary outcome
Objective Response Rate (ORR) by Independent Radiology Committee
Time frame: Disease assessments were conducted on Day 43 (+- 3 days) of each cycle. All subjects were treated for a maximum of 3 cycles.
Best ORR (complete response (CR) + partial response [PR]) by Independent Radiology Committee (IRC) based on positron emission tomography-computed tomography (PET-CT) as assessed by the Lugano classification. A participant will be assumed as a responder if he/she achieves complete or partial response at any postbaseline visit.
10 secondary outcomes
Duration of Response by Independent Radiology Committee
Time frame: Tumor assessment performed every 6 weeks for 3 cycles, if no disease progression on completion of treatment, then every 3 months for the first 12 months and then every 6 months (up to 20 months)
Complete Response Rate (CRR) by Independent Radiology Committee
Time frame: Tumor assessment performed every 6 weeks for 3 cycles, if no disease progression on completion of treatment, then every 3 months for the first 12 months and then every 6 months (up to 20 months)
ORR by Investigator Based on PET-CT as Assessed by the Lugano Classification
Time frame: Tumor assessment performed every 6 weeks for 3 cycles, if no disease progression on completion of treatment, then every 3 months for the first 12 months and then every 6 months (up to 20 months)
Duration of Response by Investigator
Time frame: Tumor assessment performed every 6 weeks for 3 cycles, if no disease progression on completion of treatment, then every 3 months for the first 12 months and then every 6 months (up to 20 months)
Incidence of Subjects Receiving Subsequent Transplant
Time frame: Throughout study completion (up to 20 months)
Frequency of Subjects With Study Drug Related TEAEs
Time frame: From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
Frequency of Subjects With Serious Treatment Emergent Adverse Events
Time frame: From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
Frequency of Subjects Developing Anti-drug Antibodies (ADAs) Against AFM13
Time frame: During treatment cycles (up to 6 months)
Progression-free Survival (PFS) by Independent Radiology Committee
Time frame: From the first treatment received until the first progression disease assessed by IRC or death.
Overall Survival
Time frame: From the first treatment received until the death.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Wunderle Lydia, MD study director
Affimed Inc.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AFM13, AB-101 and Cyclophosphamide in people with Relapsed or Refractory Hodgkin Lymphoma and Peripheral T Cell Lymphoma, run by Affimed GmbH at 15 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 6 inclusion and 8 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 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Objective Response Rate (ORR) by Independent Radiology Committee (time frame: Disease assessments were conducted on Day 43 (+- 3 days) of each cycle. All subjects were treated for a maximum of 3 cycles.). 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 20 Aug 2025.