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Large B Cell LymphomaPhase 2REPIFIRNCT07126236

Response-adaptive to Epcoritamab In First Relapse: Study to Evaluate the Efficacy of Eptoritamab in Patients With Relapse/Refractory Large B Cell Lymphoma

A Phase 2 study testing Epcoritamab and Epcoritamab, tafasitamab and lenalidomide in people with Large B Cell Lymphoma, run by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea at 19 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

phase II, response-adaptive, open-label, multicenter study aiming to include 80 patients in 78 months. Patients will receive 3 cycles of epcoritamab monotherapy and, since cycle 4, they can continue with epcoritamab monotherapy until cycle 12 or change to combination therapy (epcoritamab + tafasitamab + lenalidomide)… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Large B Cell Lymphoma
What is being tested?
Epcoritamab and Epcoritamab, tafasitamab and lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
19 sitesSpain
Study dates
4 Aug 2025to 27 Dec 2031
Phase
Phase 2
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

  • Written informed consent must be obtained before any study-specific assessment is performed.
  • Age >18 years
  • Patients with Relapse/Refractory histologically confirmed LBCL, including, Diffuse Large B Cell Lymphoma (DLBCL); Primary Mediastinal Large B Cell Lymphoma (PMBCL), High-grade B-cell lymphoma (HGBCL); and grade 3B Follicular Lymphoma.
  • Relapsed disease is defined as complete remission to first line therapy followed by a recurrence of the disease after a minimum of 6 months of completion of first-line therapy. A biopsy at the time of relapse is recommended but not mandatory.
  • Refractory disease is defined as no objective response to first line therapy (biopsy not mandatory if diagnostic sample available). Four groups of patients are eligible:
  • PD as best response to first line therapy.
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  • SD as best response after at least 4 cycles of first line therapy.
  • PR as best response after at least 6 cycles of first line therapy.
  • CR and disease recurrence within < 6 months from the completion of first-line therapy.
  • Patients must have received adequate first-line therapy including at a minimum: an anti-CD20 monoclonal antibody (rituximab or obinutuzumab), and CHOP (cyclophosphamide, hydroxydaunomycin, oncovin, and prednisone) or CHOP-like chemotherapy.
  • At the investigator's discretion, the patient should not be a candidate for 1st relapse CAR-T therapy or unwilling to receive CAR-T therapy.
  • Patients must be autologous stem cell transplantation (ASCT)-ineligible: Age ≥65 and/or HTC-CI ≥3 or or unwilling to receive transplant.
  • PET positive disease.
  • Performance status according to Eastern Cooperative Oncology Group (ECOG) 0 to 2.
  • Patients meeting with the following hematology values:
  • Hemoglobin ≥8 g/dl (transfusion support permitted but not within 7 days of screening lab collection)
  • Absolute neutrophil count (ANC) ≥ 1/109/L (growth factor support allowed in case of bone marrow involvement).
  • Absolute lymphocyte count ≥ 0.1/109/L,
  • Platelet count ≥ 70/109/L (unless secondary to bone marrow involvement, OR ≥50x/109/L if documented bone marrow involvement). Platelet transfusions permitted but not within 7 days of screening lab collection.
  • Female patients of child-bearing potential must have a negative urine or serum pregnancy test at screening and agree to use highly effective methods of contraception (e.g., established use of oral, injected or implanted combined (estradiol and progesterone containing) hormonal contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS) upon enrollment according to the recommendations provided by Clinical Trial Facilitation Group (CTFG), during the treatment period and for 4 months after the last dose of study medication. Moreover, the patient must agree to ongoing pregnancy testing during the course of the study, and after study therapy has ended. This applies even if the patient practices complete and continued sexual abstinence.
  • Women not of childbearing potential are defined as: premenarchal; postmenopausal (greater than 50 years of age with amenorrhea for at least 12 months or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone (FSH) level greater than 40 IU per L or milli-International unit (mIU) per mL); permanently sterilized (e.g., bilateral tubal occlusion [which includes tubal ligation procedures as consistent with local regulations], hysterectomy, bilateral salpingectomy, bilateral oophorectomy); or otherwise be incapable of pregnancy.
  • Male patients must use a reliable method of contraception (if sexually active with a female of child-bearing potential) upon enrollment according to the recommendations provided by CTFG, during the treatment period, and for 4 months following the last dose of investigational drug or agreement to remain abstinent. Agreement to refrain from donating blood or sperm during the study participation and for 4 months after the last dose of study medication.
  • Women must agree not to donate blood or oocytes during the course of the study and for 4 months after the last dose of study medication. Restrictions concerning blood donation apply as well to females who are not of childbearing potential. Men must also not donate sperm during the trial and for 4 months after receiving the last dose of study drug.
  • Females of childbearing potential must refrain from breastfeeding during the course of the study and for 4 months after the last dose of study medication.
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
  • Not included in other clinical trial or treated with an experimental drug.

Who cannot join

  • Patients who received more than one prior line of systemic therapy
  • Patients with detectable Central Nervous System (CNS) lymphoma
  • Significant organ function impairment:
  • creatinine clearance calculated by Cockcroft-Gault ≤ 45 ml/min
  • direct bilirubin level < 2 x ULN (except in patients with Gilbert's syndrome),
  • alanine transaminase (ALT) and aspartate aminotransferase (AST) >3 × ULN or >5 × ULN in cases of documented liver involvement.
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  • clinically relevant pleural effusion,
  • left ventricular ejection fraction (LVEF) ≤ 45%
  • Serious accompanying disorder leading to impaired organ function causing significant clinical problems and reduced life expectancy of less than 3 months.
  • Have a history of deep venous thrombosis/embolism, threatening thromboembolism or known thrombophilia or are at a high risk for a thromboembolic event in the opinion of the investigator and who are not willing/able to take venous thromboembolic event prophylaxis during the entire treatment period
  • Known clinically significant cardiac disease, including:
  • Onset of unstable angina pectoris within 6 months of signing the patient informed consent form.
  • Acute myocardial infarction within 6 months of signing the patient informed consent form.
  • Congestive heart failure (grade III or IV as classified by the New York Heart Association.
  • Left ventricular ejection fraction ≤45%.
  • Known past or current malignancy other than inclusion diagnosis, except for: Cervical carcinoma of Stage 1B or less; Non-invasive basal cell or squamous cell skin carcinoma; Non-invasive, superficial bladder cancer; Localized low grade prostate cancer (up to Gleason score 6); DCIS of the breast; Other malignancy that has been treated with curative intent and has remained in remission for 3 years.
  • Previous ASCT.
  • Prior anti-CD3 and CD20 bispecific antibodies therapy or prior treatment with tafasitamab.
  • Presence of severe infection that is uncontrolled or requiring IV antimicrobials for management.
  • History of HIV infection or acute or chronic active hepatitis B or C infection.
  • Individuals with positive HIV serology may be included if negative viral load and CD4 >200/mm3. For being included, patients should have controlled disease and been on treatment for at least 1 year
  • Individuals with history of hepatitis infection with positive antibodies (anti-HB and anti-HV) might be included if negative viral load (negative hepatitis B PCR). Patients who are HBcAb positive must receive HBV prophylaxis while on treatment. Patients with positive HbsAg are excluded. Patients who are hepatitis B PCR positive will be excluded. Patients who are hepatitis C RNA positive will be excluded.
  • Females who are pregnant or breastfeeding.
  • Richter's transformation or prior chronic lymphocytic leukemia (CLL).
  • Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 4 weeks prior to Cycle 1 Day 1.
  • Recent major surgery (within 4 weeks before the start of Cycle 1 Day 1) other than for diagnosis.
  • Vaccination with a live vaccine or COVID-19 vaccination within 4 weeks prior to treatment.
  • History of hypersensitivity to any of the study drugs or their ingredients or to drugs with similar structure. History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies.
  • Close affiliation with the investigator (e.g. a close relative) or persons working at the study site.

Trial locations and contacts

19 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Auxi Moreno contact

+34 683 636 850

amoreno@geltamo.com

Ana María Méndez contact

+34 942 203 450

administracion@geltamo.com

19 sites in 1 country

Spain19 sites, 19 recruiting

  • ICO Badalona

    Badalona, Catalonia, 08916

    Juan Manuel Sancho, +34 934 651 200, jsancho@iconcologia.net

    Recruiting

  • Hospital Universitari Vall d'Hebrón

    Barcelona, Catalonia, 08035

    Pau Abrisqueta, +34 932 746 100 ext. 4976 or 2697, pau.abrisqueta9@gmail.com

    Recruiting

  • Hospital Universitario de Basurto

    Bilbao, Vizcaya, 48013

    Cristina Barrenetxea, +34 944 006 000, cristina.barrene@gmail.com

    Recruiting

  • Hospital Universitario de Burgos

    Burgos, Castille and León, 09006

    Francisco Javier Díaz, +34 947 281 800 ext. 36071, fcdiaz@saludcastillayleon.es

    Recruiting

  • Hospital San Pedro de Alcántara

    Cáceres, Extremadura, 10003

    Juan Miguel Bergua, +34 927 621 540, jmberguaburg@gmail.com

    Recruiting

  • Hospital Virgen de la Arrixaca

    El Palmar, Murcia, 30120

    Almudena Cascales, +34 968 369 532, almudena.cascales@gmail.com

    Recruiting

  • Hospital General Universitario Gregorio Marañón

    Madrid, Madrid, 28007

    Mariana Bastos-Oreiro, +34 914 269 826, bastosmariana@yahoo.com

    Recruiting

  • Hospital Universitario Infanta Leonor

    Madrid, Madrid, 28031

    María Stefania Infante, +34 911 919 114, mariastefania.infante@salud.madrid.org

    Recruiting

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, Madrid, 28040

    Raúl Córdoba, +34 915 504 880, raul.cordoba@fjd.es

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, 28041

    Ana Jiménez Ubieto, MD, +34 917 792 809, anitiju@hotmail.com

    Recruiting

  • Hospital Universitario Costa del Sol

    Marbella, Málaga, 29603

    María Casanova, +34 951 976 542, mariacasanova@yahoo.com

    Recruiting

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011

    Angel Ramírez, +34 985 652 489, apayer.angel@gmail.com

    Recruiting

  • Hospital Universitario Son Espases

    Palma de Mallorca, Balearic Islands, 07120

    Antonio Gutiérrez, MD, +34 871 205 000 ext. 65115, antoniom.gutierrez@ssib.es

    Recruiting

  • Hospital Universitario de Salamanca

    Salamanca, Castille and León, 37007

    Alejandro Martín García-Sancho, MD, +34 923 291 100, amartingar@usal.es

    Recruiting

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, Tenerife, 38320

    María José Rodríguez, +34 922 678 000, rodriguezsalazarmariajose@gmail.com

    Recruiting

  • Hospital Universitario Virgen del Rocío

    Seville, Andalusia, 41013

    Fátima de la Cruz Vicente, MD, +34 955 0132 61, fatimadelacruzv@gmail.com

    Recruiting

  • Hospital Universitario Dr. Peset

    Valencia, Valencia, 46017

    Eva María Donato, +34 963 189 168, donato_eva@gva.es

    Recruiting

  • Hospital Universitario y Politécnico La Fe

    Valencia, Valencia, 46024

    Rafael Andreu, +34 961 244 868, andreu_raflap@gva.es

    Recruiting

  • Hospital Universitario Miguel Servet

    Zaragoza, Aragon, 50009

    Araceli Rubio, +34 976 765 690, arubiom@salud.aragon.es

    Recruiting

Other trials in Spain

About this study

Official title: Response-adaptive to Epcoritamab In First Relapse: A Phase II, Response-adaptive, Open-Label, Multicenter Study to Evaluate the Efficacy of Eptoritamab in Patients With Relapse/Refractory Large B Cell Lymphoma

phase II, response-adaptive, open-label, multicenter study aiming to include 80 patients in 78 months. Patients will receive 3 cycles of epcoritamab monotherapy and, since cycle 4, they can continue with epcoritamab monotherapy until cycle 12 or change to combination therapy (epcoritamab + tafasitamab + lenalidomide) until cycle 15. Patients will be followed up to 5 years.

Read the detailed description

Epcoritamab is a full-length bispecific IgG1 antibody directed against two proteins, CD3 on the T lymphocyte and CD20 on the lymphoma cell. This antibody redirects and activates T cells, generating an immune synapse that eventually eliminates malignant cells expressing CD20.

Previous studies have demonstrated that Epcoritamab has potent antitumor activity as a monotherapy agent, with a favorable and manageable safety profile.

Since its efficacy is so favorable it is reasonable to think that it could be an excellent option for first-relapse patients. However, to date, there is no data on this therapy's usefulness as second-line treatment. Therefore we intend to evaluate the efficacy of Epcoritamab as a treatment option for patients with first-relapse LBCL.

The purpose of this study is to determine the efficacy of Epcoritamab as second line treatment for LBCL patients. On the basis of the clinical experience, it is hypothesized that Epcoritamab would provide a better complete response rate (CRR) in comparison to Platinum-based immunochemotherapy (CRR=25%), Polatuzumab-Bendamustin Rituximab (CRR=40%) and Tafasitamab-Lenalidomide (CRR=43%).

Being tested
Epcoritamab, Epcoritamab, tafasitamab and lenalidomide
Keywords
lymphoma, geltamo, DIFFUSE LARGE B-CELL LYMPHOMA, DLBCL, RELAPSE, epcoritamab, tafasitamab, lenalidomide
Medical subject headings
Lymphoma, Lymphoma, Large B-Cell, Diffuse, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EpcoritamabDrug

    Patients will receive 12 cycles of Epcoritamab monotherapy.

  • Epcoritamab, tafasitamab and lenalidomideDrug

    Patients will receive 3 cycles of Epcoritamab monotherapy and then 12 cycles of Epcoritamab, Tafasitamab and Lenalidomide.

Study groups in NCT07126236
Study groupRoleWhat they receive
EPCO monotherapyExperimentalEpcoritamab in monotherapy will be administred until cycle 12.
Receives: Drug: Epcoritamab
Combination therapyExperimental3 cycles of Epcoritamab in monotherapy will be administred and then Epcoritamab will be administred with Tafasitamab and Lenalidomide from cycle 4 until cycle 15.
Receives: Drug: Epcoritamab, tafasitamab and lenalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of Epcoritamab monotherapy

    The efficacy of Epcoritamab monotherapy will be centrally evaluated by the best CRR at any moment since initiation. The CRR will be assessed by PET-CT according to Lugano Classification and is defined as the proportion of patients who achieve a best response of complete response (CR) at any moment since initiation of Epcoritamab first administration.

    Measured: Cycle 3, cycle 4, cycle 7, cycle 10, cycle 13 (for combination therapy) and EoT (28 days after last administration of investigational product) visits. Each cycle is 28 days.

Secondary outcomes (13)

  1. Efficacy of Epcoritamab monotherapy after 3 cycles

    The efficacy of Epcoritamab monotherapy will be centrally evaluated by the best CRR, defined as the proportion of patients who achieve a best response of CR after 3 cycles of Epcoritamab administration.

    Measured: At the end of cycle 3 (each cycle is 28 days)

  2. Efficacy of Epcoritamab monotherapy and combination therapy by CRR

    The efficacy of Epcoritamab monotherapy and combination therapy with tafasitamab-lenalidomide will be evaluated by local investigators and central evaluation as per CRR (locally evaluated for Epcoritamab monotherapy; local and central evaluation for combination therapy).

    Measured: Cycle 3, cycle 4, cycle 7, cycle 10, cycle 13 (for combination therapy) and EoT (28 days after last administration of investigational product) visits. Each cycle is 28 days.

  3. Evaluation of MRD

    The efficacy of Epcoritamab monotherapy and combination therapy will be evaluated by MRD (positive or negative) from ctDNA samples immediately before initiation of C3, C4, C7, C10, C12, C13, C15, End of Treatment (EoT) and cycles 18/24 (epcoritamab monotherapy) or cycles 21/27 (combination therapy).

    Measured: Cycles 3, 4, 7, 10, 12, 13, 15 (each cycle is 28 days), EoT (28 days after last administration of Study drug) and cycles 18 and 24 (epcoritamab monotherapy) or cycles 21 and 27 (combination therapy) visits (each cycle is 28 days).

  4. Evaluation of patients with negative MRD by PFS

    The PFS of patients with negative MRD at Visit 3 (V3) (immediately before administrating C3 of Epcoritamab monotherapy).

    Measured: At cycle 3 visit (each cycle is 28 days).

  5. Safety and tolerability

    The safety and tolerability of Epcoritamab monotherapy and combination therapy are evaluated as follows:

    • Type, frequency, and severity of adverse events (AEs).
    • Type, frequency, and severity of Adverse events of special interest (AESIs): Cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), clinical tumor lysis syndrome (CTLS) and other safety topics of interest (tumour flare reaction, prolonged cytopenia, serious infections and second primary malignancies).
    • Incidence, severity, and treatment.

    Measured: Baseline, during all the cycles day 1 visit (each cycle is 28 days) and at EoT (28 days afert las administration of Study drug).

  6. Efficacy of Epcoritamab Monotherapy and Combination therapy by ORR

    The efficacy of Epcoritamab monotherapy and combination therapy with tafasitamab-lenalidomide will be evaluated by local investigators and central evaluation as per ORR at any time.

    Measured: Cycle 3, cycle 4, cycle 7, cycle 10, cycle 13 (for combination therapy) and EoT (28 days after last administration of investigational product) visits. Each cycle is 28 days

  7. Efficacy of Epcoritamab Monotherapy and combination therapy by DoR

    The efficacy of Epcoritamab monotherapy and combination therapy with tafasitamab-lenalidomide will be evaluated by local investigators and central evaluation as per DoR at any time.

    Measured: Cycle 3, cycle 4, cycle 7, cycle 10, cycle 13 (for combination therapy) and EoT (28 days after last administration of investigational product) visits. Each cycle is 28 days

  8. Efficacy of Epcoritamab monotherapy and combination therapy by DoCR

    The efficacy of Epcoritamab monotherapy and combination therapy with tafasitamab-lenalidomide will be evaluated by local investigators and central evaluation as per DoCR at any time.

    Measured: Cycle 3, cycle 4, cycle 7, cycle 10, cycle 13 (for combination therapy) and EoT (28 days after last administration of investigational product) visits. Each cycle is 28 days

  9. Efficacy of Epcoritamab monotherapy and combination therapy by EFS

    The efficacy of Epcoritamab monotherapy and combination therapy with tafasitamab-lenalidomide will be evaluated by local investigators and central evaluation as per Event-free survival (EFS) at any time.

    Measured: Cycle 3, cycle 4, cycle 7, cycle 10, cycle 13 (for combination therapy) and EoT (28 days after last administration of investigational product) visits. Each cycle is 28 days

  10. Efficacy of Epcoritamab monotherapy and combination therapy by PFS

    The efficacy of Epcoritamab monotherapy and combination therapy with tafasitamab-lenalidomide will be evaluated by local investigators and central evaluation as per PFS at any time.

    Measured: Cycle 3, cycle 4, cycle 7, cycle 10, cycle 13 (for combination therapy) and EoT (28 days after last administration of investigational product) visits. Each cycle is 28 days

  11. Efficacy of Epcoritamab montherapy and combination therapy by OS

    The efficacy of Epcoritamab monotherapy and combination therapy with tafasitamab-lenalidomide will be evaluated by local investigators and central evaluation as per OS at any time.

    Measured: Cycle 3, cycle 4, cycle 7, cycle 10, cycle 13 (for combination therapy) and EoT (28 days after last administration of investigational product) visits. Each cycle is 28 days

  12. Evaluation of patients with negative MRD by OS

    The OS of patients with negative MRD at Visit 3 (V3) (immediately before administrating C3 of Epcoritamab monotherapy).

    Measured: At cycle 3 visit (each cycle is 28 days).

  13. Evaluation of patients with negative MRD by DoR

    The DoR of patients with negative MRD at Visit 3 (V3) (immediately before administrating C3 of Epcoritamab monotherapy).

    Measured: At cycle 3 visit (each cycle is 28 days).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2025
  2. Study start4 Aug 2025
  3. Primary completion27 Dec 2031 (estimated)
  4. Study completion27 Dec 2031 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07126236
Sponsor's protocol ID
REPIFIR-AGR-GEL-23
Other IDs
2024-514440-86-00
Acronym
REPIFIR
Status last verified
Sep 2026
First submitted
10 Jul 2025
Last updated
29 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data obtained through this study may be provided to qualified researchers with academic interest in hematology diseases. All individual data collected during the trial will be available. Data shared will be coded, with no PHI included. Study protocol, statistical analysis plan, informed consent form and clinical study report will be also available. Information will be available beginning 6 months after final publication with no end date established. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party. Data requests can be submitted starting 6 months after article publication. Access to trial IPD can be requested by qualified researchers and will be provided following review and approval of a research and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact to GELTAMO though the web page: https://www.geltamo.com/contacto

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Epcoritamab and Epcoritamab, tafasitamab and lenalidomide in people with Large B Cell Lymphoma, run by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea at 19 sites in Spain.

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 26 inclusion and 29 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 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Spain. 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?

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 Auxi Moreno (+34 683 636 850, amoreno@geltamo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of Epcoritamab monotherapy (time frame: Cycle 3, cycle 4, cycle 7, cycle 10, cycle 13 (for combination therapy) and EoT (28 days after last administration of investigational product) visits. Each cycle is 28 days.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07126236.

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 Sep 2026; AzTrials last refreshed its copy on 30 Oct 2026.

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