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Recurrent Diffuse Large B-Cell LymphomaPhase 2NCT06905509

Epcoritamab Plus Standard of Care Platinum-Based Chemotherapy and Autologous Hematopoietic Cell Transplant for the Treatment of Relapsed or Refractory Large B-cell Lymphoma

A Phase 2 study testing Autologous Hematopoietic Stem Cell Transplantation, Carboplatin and Cytarabine in people with Recurrent Diffuse Large B-Cell Lymphoma and Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, run by University of California, Davis at 1 site in United States.

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

This phase II trial tests how well epcoritamab in combination with standard of care (SOC) platinum-based chemotherapy (rituximab, ifosfamide, carboplatin, etoposide [RICE], rituximab, cytarabine, dexamethasone, oxaliplatin or carboplatin RDHAP/X] or gemcitabine and oxaliplatin [Gem/Ox]) and autologous hematopoietic… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Autologous Hematopoietic Stem Cell Transplantation, Carboplatin and Cytarabine
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
31 Jul 2025to 1 Aug 2030
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

  • Participants must have histologically or cytologically confirmed R/R LBCL
  • Can include diffuse large B-cell lymphoma (DLBCL) (not otherwise specified [NOS] or with concurrent MYC and BCL2 rearrangements), high-grade B-cell lymphoma (HGBCL) (NOS or with MYC and BCL2 or BCL6 rearrangements) and transformed follicular lymphoma (FL) and nodal marginal zone lymphoma (MZL)
  • Histological confirmed CD20+ relapsed/ refractory large cell lymphoma
  • Must have had relapsed or refractory disease following standard frontline chemotherapy. Refractory disease is defined as large cell lymphoma not achieving complete remission, progressing, or relapsing within 6 months after first-line chemotherapy based on PET/CT per the Lugano criteria. Relapsed disease is defined as disease that recurs beyond 6 months after completion of initial chemotherapy based on PET/CT per the Lugano criteria
  • Have received 1 or more prior lines of systemic therapy for the treatment of large cell lymphoma. NOTE: Prior radiation therapy or systemic corticosteroids will not be considered a line of therapy
  • Candidate for platinum-containing chemotherapy (RICE, RDHAP/X, or R-Gem/Ox) pre-autologous hematopoietic cell transplantation (autoHCT) followed by autoHCT as per institutional guidelines
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  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
  • Measurable disease via diagnostic quality CT or PET/CT with at least 1 node having the longest diameter (LDi) greater than (>) 1.5 centimeter (cm) or 1 extranodal lesion with LDi > 1 cm (per the Lugano criteria 2014)
  • Aged ≥ 18 at the time of consent
  • Creatinine clearance (CrCl) ≥ 45 mL/min (Cockcroft-Gault)
  • Serum alanine aminotransferase (ALT) ≤ 3 x upper limit of normal (ULN)
  • Serum aspartate aminotransferase (AST) ≤ 3 x ULN
  • Bilirubin ≤ 1.5 x ULN unless due to Gilbert's syndrome or controlled autoimmune hemolytic anemia (not requiring immunosuppressive other than ≤ 20 mg of prednisolone daily)
  • Note: Patients with Gilbert's syndrome may be included if total bilirubin is ≤ 3 x ULN and direct bilirubin is ≤ 1.5 x ULN
  • Hemoglobin ≥ 8.0 g/dL
  • Note: Blood transfusion may be administered during Screening to meet this requirement only if anemia is due to marrow involvement of non-Hodgkin lymphoma (NHL)
  • Absolute neutrophil count ≥ 1000/uL
  • Note: Growth factor support is allowed to meet this requirement at Screening only if directly attributable to NHL infiltration of the bone marrow, proven by bone marrow biopsy
  • Platelet count ≥ 75,000/uL or ≥ 50,000/uL if bone marrow (BM) involvement or splenomegaly
  • Note: Transfusion may be administered during screening to meet this requirement
  • prothrombin time (PT)/international normalized ratio (INR)/activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN
  • Note: If any of the above-mentioned cytopenias are present, there should be no evidence of myelodysplastic syndrome (MDS) or hypoplastic bone marrow
  • HIV-infected patients on effective anti-retroviral therapy with stable viral load and CD4 count for 1 year prior to enrollment are eligible for this trial. Testing for HIV viral load and antibody at screening is mandatory
  • Patients with a history of chronic hepatitis B virus (HBV) infection, must have an undetectable HBV viral load on suppressive therapy, if indicated. Patients with evidence of prior HBV but who are polymerase chain reaction (PCR)-negative are permitted in the trial but should receive prophylactic antiviral therapy. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, the HCV viral load must be undetectable to be eligible for this trial. Patients who received treatment for HCV that was intended to eradicate the virus may participate if hepatitis C ribonucleic acid (RNA) levels are undetectable. Testing for HBV and HCV is mandatory at screening
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 12 months after the last dose of epcoritamab
  • Provision of signed and dated informed consent form

Who cannot join

  • Any adverse event (AE) related to the previous large cell lymphoma therapy which has not recovered to grade ≤ 1 (Common Terminology Criteria for Adverse Events [CTCAE] version [v.] 5.0) or baseline by cycle 1 day 1 (C1D1), except alopecia and non-clinically significant laboratory abnormalities
  • Uncontrolled intercurrent illness (including infection)
  • Known active central nervous system or meningeal (including leptomeningeal) involvement. Patients diagnosed with central nervous system (CNS) disease who achieved and maintained CNS complete response (CR) at the time of relapse are eligible. Lumbar puncture must be done in this case prior to study entry (within 90 days of enrollment) to demonstrate CNS CR status. Tests to investigate CNS involvement are required otherwise only if clinically indicated (i.e. disease suspected on basis of symptoms or other findings)
  • Receiving any other investigational treatments
  • Previous treatment with any bispecific T-cell engager with or without chemotherapy
  • Treatment with an investigational drug within 4 weeks or 5 half-lives, whichever is longer, prior to the first dose of epcoritamab
Show all 36Show fewer
  • Concurrent use of other anti-cancer agents or treatments except for certain therapeutics (e.g., prostate, breast hormonal-based therapy) per the treating physician's discretion
  • Standard agents within 2 weeks or 5 half-lives, whichever is shorter, prior to the first dose of epcoritamab (excluding anti-CD20 monoclonal antibodies [mAbs], which can be administered until first full dose of epcoritamab); or
  • CAR-T cell therapy within 30 days prior to the first dose of epcoritamab
  • Palliative radiation is permitted only if on non-target lesions
  • Motor and sensory neuropathy grade ≥ 2 (CTCAE v.5.0)
  • Patients with a history of other malignancies, except adequately treated non-melanoma skin cancer, non-invasive superficial bladder cancer, curatively treated in-situ cancer of the cervix, ductal carcinoma in situ (DCIS) of the breast, localized low grade prostate cancer (up to Gleason score 6), or other solid tumors curatively treated with no evidence of disease for at least 3 years
  • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at trial enrollment or significant infections within 2 weeks prior to the first dose of epcoritamab
  • Confirmed history or current autoimmune disease or other diseases requiring permanent immunosuppressive therapy. Low-dose (10 mg/day) prednisolone (or equivalent) for rheumatoid arthritis or similar conditions is allowed
  • Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study)
  • Participant received any prior allogeneic hematopoietic stem cell transplantation (HSCT) or solid organ transplantation
  • Autoimmune disease or other diseases that require continuous immunosuppressive therapy (except for prednisone doses of less than or equal to 10 mg, which is allowed)
  • Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia (requiring > 20 mg of prednisolone daily) or other concurrent uncontrolled medical conditions
  • Clinically significant cardiac disease including but not limited to:
  • Unstable or uncontrolled disease/condition related to or affecting cardiac function, e.g., unstable angina, congestive heart failure grade III or IV as classified by the New York Heart Association, uncontrolled clinically significant cardiac arrhythmia (CTCAE v 5.0 grade 2 or higher), or clinically significant electrocardiogram (ECG) abnormalities. Controlled New York Heart Association (NYHA) grade 1 or 2 are eligible
  • Myocardial infarction, intracranial bleed, or stroke within the past 6 months
  • Screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia's formula (QTcF) > 480 msec. NOTE: This criterion does not apply to participants with a left bundle branch block
  • In case of any history of cardiovascular disease, a cardiology consult is required within 60 days prior to enrollment
  • Age ≥ 75 and 2 or more active grade ≥ 2 cardiovascular conditions
  • Prior treatment with live, attenuated vaccines within 28 days prior to initiation of epcoritamab. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, bacillus Calmette-Guerin, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. Food and Drug Administration (FDA)-approved severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccinations allowed
  • Immune effector cell encephalopathy (ICE) score of less than 10 at study entry
  • Suspected allergies, hypersensitivity, or intolerance to epcoritamab or another anti-CD20 mAb or its excipients
  • Active HBV (DNA PCR-positive). Patients with evidence of prior HBV but who are PCR-negative are permitted in the trial but should receive prophylactic antiviral therapy
  • Active hepatitis C (RNA PCR-positive infection). Patients who received treatment for HCV that was intended to eradicate the virus may participate if hepatitis C RNA levels are undetectable
  • Known history of seropositivity for HIV infection
  • Active cytomegalovirus (CMV) infection (PCR positive)
  • Pregnant, breastfeeding, or planning to become pregnant while enrolled in this trial or within 12 months after the last dose of epcoritamab
  • Plans to donate sperm or conceive a child through intercourse while enrolled in this trial or within 12 months after the last dose of epcoritamab
  • Ongoing active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring systemic treatment (excluding prophylactic treatment) at the time of enrollment or within the previous 2 weeks prior to the first dose of epcoritamab
  • Known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. If a subject has signs/symptoms suggestive of SARS-CoV-2 infection or have had recent known exposure to someone with SARS-CoV-2 infection, the subject must have a negative molecular (e.g., PCR) test, or 2 negative antigen test results at least 24 hours apart, to rule out SARS-CoV-2 infection. Note: SARS-CoV-2 diagnostic tests should be applied following local requirements/recommendations. Subjects who do not meet SARS-CoV-2 infection eligibility criteria must be screen failed and may only rescreen per criteria
  • Suspected active or inadequately treated latent tuberculosis

Trial locations and contacts

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

Office of Clinical Research contact

916-382-6970

OCRReferral@health.ucdavis.edu

United States1 site, 1 recruiting

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

    Office of Clinical Research, 916-382-6970, OCRReferral@health.ucdavis.edu

    Joseph M. Tuscano

    Recruiting

Other trials in United States

About this study

Official title: A Phase 2 Study of Epcoritamab (Epco) Plus Physician's Choice of Platinum-Containing Chemotherapy Pre-Autologous Hematopoietic Cell Transplantation (AutoHCT) Followed by Post-AutoHCT Epco Consolidation/ Maintenance in Relapsed/ Refractory Large B-Cell Lymphoma (R/R LBCL)

This phase II trial tests how well epcoritamab in combination with standard of care (SOC) platinum-based chemotherapy (rituximab, ifosfamide, carboplatin, etoposide [RICE], rituximab, cytarabine, dexamethasone, oxaliplatin or carboplatin RDHAP/X] or gemcitabine and oxaliplatin [Gem/Ox]) and autologous hematopoietic cell transplant (HCT) works in treating patients with large B-cell lymphoma (LBCL) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Epcoritamab, a type of bispecific T-cell engager, binds to a protein called CD3, which is found on T cells (a type of white blood cell). It also binds to a protein called CD20, which is found on B cells (another type of white blood cell) and some lymphoma cells. This may help the immune system kill cancer cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells and some types of cancer cells. This may help the immune system kill cancer cells. Chemotherapy drugs, such as ifosfamide, etoposide phosphate, cytarabine, and gemcitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. An autologous HCT is a procedure in which blood-forming stem cells (cells from which all blood cells develop) are removed, stored, and later given back to the same person. Giving epcoritamab in combination with SOC platinum-based chemotherapy, such as RICE, RDHAP/X and Gem/Ox, and autologous HCT may kill more cancer cells in patients with relapsed or refractory LBCL.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To assess the anti-tumor activity of epcoritamab + platinum-containing chemotherapy + autologous HCT therapy in patients with relapsed or refractory (R/R) LBCL.

SECONDARY OBJECTIVES:

  1. To evaluate the toxicities of epcoritamab + platinum-containing chemotherapy with or without autologous HCT therapy in patients with R/R LBCL.

II. To further assess the anti-tumor activity of epcoritamab + platinum-containing chemotherapy + autologous HCT therapy in patients with R/R LBCL.

OUTLINE:

PRE-AUTOHCT: Patients receive epcoritamab subcutaneously (SC) on days 1, 8, 15, and 22 of each cycle. Cycles repeat every 28 days for up to 3 cycles without disease progression or unacceptable toxicity. Patients may also receive rituximab, cytarabine, dexamethasone, oxaliplatin, or carboplatin once every 21 days for cycles 1-3 or gemcitabine and oxaliplatin once every 2 weeks of each 28-day cycle for cycles 1-3 or rituximab, ifosfamide, carboplatin and etoposide phosphate once every 21 days of cycles 1-3 per SOC.

AUTOHCT: Patients undergo autoHCT on week 0 per SOC.

POST-AUTOHCT/CONSOLIDATION: Patients receive epcoritamab SC on days 1, 8, 15, and 22 of cycles 1-3, on days 1 and 15 of cycles 4-9, and on day 1 of the remaining cycles. Cycles repeat every 28 days for up to 12 cycles without disease progression or unacceptable toxicity.

Patients also undergo echocardiography (ECHO) or multigated acquisition scan (MUGA) at screening and as clinically indicated, and blood sample collection and computed tomography (CT) or positron emission tomography (PET)/CT throughout the study. Additionally, patients may undergo brain magnetic resonance imaging (MRI) or CT at screening.

After completion of study treatment, patients are followed up at 30 days then every 4 months for up to 2 years post autoHCT.

Being tested
Autologous Hematopoietic Stem Cell Transplantation, Carboplatin, Cytarabine, Dexamethasone, Epcoritamab
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Lymphoma, B-Cell, Marginal Zone

What participants receive

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

  • Autologous Hematopoietic Stem Cell TransplantationProcedure or surgery

    Also called AHSCT, Autologous, Autologous Hematopoietic Cell Transplantation, Autologous Stem Cell Transplant

    Undergo autoHCT

  • CarboplatinDrug

    Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino

    Given carboplatin

  • CytarabineDrug

    Also called .beta.-Cytosine arabinoside, 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-.beta.-D-Arabinofuranosylcytosine, 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone

    Given cytarabine

  • DexamethasoneDrug

    Also called Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex

    Given dexamethasone

  • EpcoritamabBiological

    Also called Anti-CD20/CD3 Bispecific Antibody GEN3013, DuoBody-CD3xCD20, Epcoritamab-bysp, Epkinly

    Given SC

  • Etoposide PhosphateDrug

    Also called Etopophos

    Given etoposide phosphate

  • GemcitabineDrug

    Also called dFdC, dFdCyd, Difluorodeoxycytidine

    Given gemcitabine

  • IfosfamideDrug

    Also called Asta Z 4942, Asta Z-4942, Cyfos, Holoxan

    Given ifosfamide

  • Multigated Acquisition ScanProcedure or surgery

    Also called Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan

    Undergo MUGA

  • OxaliplatinDrug

    Also called 1-OHP, Ai Heng, Aiheng, Dacotin

    Given oxaliplatin

  • RituximabBiological

    Also called ABP 798, ABP-798, ABP798, BI 695500

    Given rituximab

Study groups in NCT06905509
Study groupRoleWhat they receive
Treatment (epcoritamab, SOC chemotherapy, autoHCT)ExperimentalSee Detailed Description
Receives: Procedure: Autologous Hematopoietic Stem Cell Transplantation; Drug: Carboplatin; Drug: Cytarabine; Drug: Dexamethasone; Biological: Epcoritamab; Drug: Etoposide Phosphate; Drug: Gemcitabine; Drug: Ifosfamide; Procedure: Multigated Acquisition Scan; Drug: Oxaliplatin; Biological: Rituximab

What is being measured

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

  1. Complete response rate (CRR)

    Will be assessed by Lugano 2014. Will be calculated as the number of participants achieving complete response divided by the number of evaluable patients. CRR will be presented alongside the corresponding exact binomial 95% confidence interval.

    Measured: From first dose up to 2 years post-autologous hematopoietic cell transplantation (autoHCT) therapy

Secondary outcomes (6)

  1. Incidence of treatment-related adverse events (AEs)

    The proportion of participants experiencing AEs, serious AEs, and treatment delays will be summarized. All AEs will be listed, documenting the course, outcome, severity, and relationship to the study treatment. Incidence rates of AEs and the proportion of participants prematurely withdrawn from the study due to AEs will be reported. Will be classified by severity, and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.

    Measured: From first dose through 30 days post last epcoritamab dose

  2. Progression-free survival

    Will be summarized using the Kaplan-Meier method. Summary statistics will include median and event-free probabilities at pre-specified time points, along with their associated two-sided 95% confidence intervals (CIs).

    Measured: From the date of enrollment until the first occurrence of disease progression, or death from any cause, whichever occurs first, assessed up to 2 years post-autoHCT therapy

  3. Objective response

    Will be assessed by Lugano 2014. Will be presented using descriptive statistics. Tabulations will be produced for appropriate disposition, demographic, baseline, and efficacy parameters. For continuous variables, the number of participants, mean, median, standard deviation, minimum, and maximum values will be presented. For categorical variables, numbers and percentages of participants within each category (with a category for missing data) will be presented along with binomial exact 95% CIs, unless stated otherwise.

    Measured: From first dose up to 2 years post-autoHCT therapy

  4. Overall survival

    Will be summarized using the Kaplan-Meier method. Summary statistics will include median and event-free probabilities at pre-specified time points, along with their associated two-sided 95% confidence intervals.

    Measured: From first dose to death due to any causes, assessed up to 2 years post-autoHCT therapy

  5. Duration of minimal residual disease (MRD) negativity

    Will be presented using descriptive statistics. Tabulations will be produced for appropriate disposition, demographic, baseline, and efficacy parameters. For continuous variables, the number of participants, mean, median, standard deviation, minimum, and maximum values will be presented. For categorical variables, numbers and percentages of participants within each category (with a category for missing data) will be presented along with binomial exact 95% CIs, unless stated otherwise. Will be calculated by dividing the number of participants with at least one MRD-negative result within 3 cycles of consolidation therapy by the total number of participants who undergo circulating tumor derived deoxyribonucleic acid (ctDNA) MRD testing.

    Measured: Pre-autoHCT and 90 days post-autoHCT

  6. MRD negativity

    Will be presented using descriptive statistics. Tabulations will be produced for appropriate disposition, demographic, baseline, and efficacy parameters. For continuous variables, the number of participants, mean, median, standard deviation, minimum, and maximum values will be presented. For categorical variables, numbers and percentages of participants within each category (with a category for missing data) will be presented along with binomial exact 95% CIs, unless stated otherwise. Will be calculated by dividing the number of participants with at least one MRD-negative result within 3 cycles of consolidation therapy by the total number of participants who undergo ctDNA MRD testing.

    Measured: Pre-autoHCT and 90 days post-autoHCT

Timeline

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

  1. First posted1 Apr 2025
  2. Study start31 Jul 2025
  3. Primary completion1 Jul 2028 (estimated)
  4. Study completion1 Aug 2030 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06905509
Sponsor's protocol ID
UCDCC316
Other IDs
NCI-2025-01557, UCDCC316, P30CA093373
Status last verified
Jun 2026
First submitted
25 Mar 2025
Last updated
30 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Autologous Hematopoietic Stem Cell Transplantation, Carboplatin and Cytarabine in people with Recurrent Diffuse Large B-Cell Lymphoma and Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, run by University of California, Davis at 1 site 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 26 inclusion and 36 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 30 Jun 2026. 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 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?

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 Office of Clinical Research (916-382-6970, OCRReferral@health.ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete response rate (CRR) (time frame: From first dose up to 2 years post-autologous hematopoietic cell transplantation (autoHCT) therapy). 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 NCT06905509.

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 30 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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