Non-Hodgkin LymphomaPhase 1NCT06447376
Study of Cytokine Release Syndrome Prophylaxis and Treatment With Siltuximab Prior to Epcoritamab
A Phase 1 study testing Siltuximab, Epcoritamab and Gemcitabine and oxaliplatin in people with Non-Hodgkin Lymphoma and Cytokine Release Syndrome, run by Taylor Brooks at 1 site in United States.
Trial summary
The goal of this clinical trial is to is to determine the safety, feasibility and efficacy of siltuximab prophylaxis of cytokine release syndrome and neurotoxicity occurring after epcoritamab subcutaneous administration for participants with large b-cell lymphoma (DLBCL) or follicular lymphoma (FL). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-Hodgkin Lymphoma, Cytokine Release Syndrome
- What is being tested?
- Siltuximab, Epcoritamab and Gemcitabine and oxaliplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2025to 1 Sep 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18 years of age and older
- Diagnosis of non-Hodgkin lymphoma.
- DLBCL (including high grade B cell lymphoma and follicular lymphoma grade 3B and transformed follicular lymphoma) treated with at least 2 lines of systemic antineoplastic therapies, including at least 1 anti-CD20 monoclonal antibody - containing therapy
- FL grade 1-3A previously treated with at least 2 lines of systemic antineoplastic therapy, including at least 1 anti-CD20 monoclonal antibody - containing therapy.
- At least 1 risk factor for cytokine release syndrome, including:
- Age ≥ 65 years,
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- Elevated lactate dehydrogenase,
- White blood cell count pre-anti-CD20 treatment > 4.5x109 cells/L,
- Ann Arbor Stage III/IV,
- Sum of the product of the perpendicular diameters at study entry ≥3000mm2,
- Cardiac comorbidity, including prior coronary disease, heart failure and other conditions that in the opinion of the investigator would increase the risk of heightened toxicity from CRS
- Bone marrow infiltration,
- Circulating lymphoma cells in peripheral blood
- Adequate bone marrow function including:
- Hemoglobin ≥ 8g/dL (unless bone marrow involvement by lymphoma) (transfusion allowed for symptomatic participants),
- Absolute neutrophil count cell count ≥1000 / μL, with or without growth factor support
- Platelet counts ≥ 75,000 / μL (unless bone marrow involvement by lymphoma, in which case platelet counts ≥ 50,000 / µL are required)
- ECOG performance status 0 - 2
- Adequate renal function, defined as an estimated creatinine clearance ≥ 30 mL/min.
- NOTE: Participants who will receive the addition of GemOx in cycle 2 must continue to exhibit an estimated creatinine clearance of ≥ 30 mL/min prior to initiation of these agents in cycle 2.
- Adequate hepatic function:
- AST and/or ALT up to 3 times upper limit of normal (unless elevation is secondary to disease involvement of the liver, in which case up to 5 times upper limit is permitted after discussion with the principal investigator).
- Total bilirubin up to 1.5 times upper limit of normal (unless elevation is secondary to Gilbert syndrome or of non - hepatic origin).
- Subjects (or legal guardians) must have the ability to understand and the willingness to sign a written informed consent document.
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of < 1% per year during the treatment period. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (< 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below: With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of < 1% per year during the treatment period. Men must refrain from donating sperm during this same period. With pregnant female partners, men must remain abstinent or use a condom during the treatment period. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
Who cannot join
- Primary mediastinal B cell lymphoma
- Active central nervous system or meningeal involvement by lymphoma
- History of severe allergic or anaphylactic reactions to anti-CD20 monoclonal antibody therapy
- Active bacterial, viral, fungal, mycobacterial, parasitic or other infection requiring systemic therapy within 2 weeks prior to first dose of study drug. This includes participants with COVID-19 infection
- History of active chronic infection by hepatitis B or C or Cytomegalovirus (CMV) requiring treatment or prophylaxis. Resolved infections (either by treatment or immune response) are not exclusion criterion.
- Active malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast). History of prior malignancy is not excluded.
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- HIV seropositivity.
- Subjects with uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant or breastfeeding women are excluded from this study because siltuximab therapy may be associated with the potential for teratogenic or abortifacient effects. Women of childbearing potential must have a negative serum pregnancy test. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with siltuximab, breastfeeding should be continued and not restarted for 3 months after the last dose of siltuximab. These potential risks may also apply to other agents used in this study.
- Participants with history of clinically relevant and active CNS pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia and Parkinson's disease.
- Peripheral neuropathy assessed to be Grade >1 according to NCI CTCAE v5.0 at enrollment for participants anticipated to receive GemOx
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
Taylor Brooks, MD, 866-223-8100, TaussigResearch@ccf.org
About this study
Official title: Pilot Safety-feasibility Study of Cytokine Release Syndrome Prophylaxis and Treatment With Siltuximab Prior to Epcoritamab
The goal of this clinical trial is to is to determine the safety, feasibility and efficacy of siltuximab prophylaxis of cytokine release syndrome and neurotoxicity occurring after epcoritamab subcutaneous administration for participants with large b-cell lymphoma (DLBCL) or follicular lymphoma (FL).
Participants will receive siltuximab, prior to the injection of epcoritamab. Epcoritamab is administered in 28 day cycles for one year. After this injection, the physician will continue to watch participants for side effects and follow the condition for a minimum of 60 days.
Read the detailed description
Siltuximab is a monoclonal antibody that blocks interleukin-6 (IL-6) from binding to its receptor, preventing it from acting. IL-6 is a cytokine, a type of protein that is a cause of inflammatory reactions. Decreasing levels of IL-6 has been shown to reduce symptoms of cytokine release syndrome (CRS), a potential side effect of epcoritamab. Addition of siltuximab to the medications given before epcoritamab, may prevent, or reduce the severity, of CRS. Siltuximab is experimental because it is not approved by the Food and Drug Administration for treatment or prevention of CRS. Epcoritamab is a so-called bispecific antibody, which is a molecule that can bind simultaneously to two different receptors. Epcoritamab binds to a receptor called CD3 with one part of the antibody and to a receptor called CD20 with another part of the antibody. CD20 is expressed on the normal, healthy B cells but also on the cancerous lymphoma cells of B cell origin. CD3 is expressed on T cells, which are important cells of the immune system and help the body fight cancers, infections, etc. By simultaneous binding to CD3 and CD20, Epcoritamab brings T cells and B cells close together and activates the T cells to kill the B cells, including the cancerous ones.
- Conditions
- Non-Hodgkin Lymphoma, Cytokine Release Syndrome
- Being tested
- Siltuximab, Epcoritamab, Gemcitabine and oxaliplatin
- Keywords
- Siltuximab, Epcoritamab, Prophylactic siltuximab
- Medical subject headings
- Lymphoma, Non-Hodgkin, Cytokine Release Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SiltuximabDrug
Single dose of prophylactic siltuximab, 11mg/kg, started 1 hour prior (+/- 60 minutes) to the infusion of epcoritamab.
EpcoritamabDrug
Epcoritamab dosing for Diffuse Large B-cell Lymphoma Participants:
- Cycle 1, Day 1 = 0.16mg
- Cycle 1, Day 8 = 0.8mg
- Cycle 1, Day 15 = 48mg
- Cycle 1, Day 22 = 48mg
- Cycles 2 \& 3, Day 1 = 48mg
- Cycles 2 \& 3, Day 8 = 48mg
- Cycles 2 \& 3, Day 15 = 48mg
- Cycles 2 \& 3, Day 22 = 48mg
- Cycles 4-9, Day 1 = 48mg
- Cycles 4-9, Day 15 = 48mg
- Cycle 10+ , Day 1 = 48mg
Epcoritamab dosing for Follicular Lymphoma Participants:
- Cycle 1, Day 1 = 0.16mg
- Cycle 1, Day 8 = 0.8mg
- Cycle 1, Day 15 = 3mg
- Cycle 1, Day 22 = 48mg
- Cycle 2 \& 3, Day 1 = 48mg
- Cycle 2 \& 3, Day 8 = 48mg
- Cycle 2 \& 3, Day 15 = 48mg
- Cycle 2 \& 3, Day 22 = 48mg
- Cycle 4-9, Day 1 = 48mg
- Cycle 4-9, Day 15 = 48mg
- Cycle 10+ , Day 1 = 48mg
Gemcitabine and oxaliplatinDrug
Also called GemOx
Starting on Cycle 2, participants may receive the addition of GemOx. Participants receive 1,000 milligrams/meter^2 (mg/m^2) of GemOx on Days 1 and 15 of Cycle 2 and onwards.
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic siltuximab + epcoritamab | Experimental | Siltuximab Administration:
• Participants will receive a single dose of prophylactic siltuximab, 11mg/kg, started 1 hour prior (+/- 60 minutes) to the infusion of epcoritamab. There is no planned dose escalation of siltuximab and epcoritamab dosing will be done following the standard planned ramp-up over the course of the first 3 weeks
Epcoritamab Infusion:
• The treatment regimen of epcoritamab is done in 28-day cycles. Epcoritamab is to be administered by subcutaneous injection. Participants can be treated for up to 24 cycles. Participants who achieve complete remission at the time of their disease response assessment after 12 cycles may be considered for early discontinuation of treatment.
Option of gemcitabine and oxaliplatin (GemOx) Administration:
• Starting on Cycle 2, participants may receive the addition of GemOx Receives: Drug: Siltuximab; Drug: Epcoritamab; Drug: Gemcitabine and oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of all-grade cytokine release syndrome
The primary objective is to evaluate the feasibility and efficacy of prophylactic administration of siltuximab prior to infusion of the first dose of epcoritamab with the purpose of preventing all-grade CRS, as measured by incidence of all-grade cytokine release syndrome.
Measured: Up to 28 days after beginning treatment
Secondary outcomes (6)
Incidence of grade ≥ 2 cytokine release syndrome
A secondary objective is to determine the incidence of grade ≥ 2 CRS after siltuximab prophylaxis
Measured: Up to 28 days after beginning treatment
Incidence of all grade and grade ≥ 2 ICANS after siltuximab prophylaxis
A secondary objective is to determine the incidence of all grade and grade ≥ 2 ICANS after siltuximab prophylaxis
Measured: Up to 28 days beginning treatment
Incidence of adverse events during Cycle 1 (Day 1 - 28)
A secondary objective is to describe the adverse events after siltuximab prophylaxis.
Measured: Up to 28 days after beginning treatment
Best overall and complete response rates
A secondary objective is to describe the disease response rates (overall and complete response rates) to epcoritamab in participants treated with prophylactic siltuximab, based on Lugano response criteria for malignant lymphomas, which can include complete response (CR), partial response (PR), stable disease (SD), progression (PD) and relapse.
Measured: Up to 456 days after beginning treatment
Incidence of hospitalizations secondary to all causes
A secondary objective is to describe the rates of hospitalization for all causes and for cytokine release syndrome
Measured: Up to 456 days after beginning treatment
Incidence of hospitalizations secondary to cytokine release syndrome or neurologic complications
A secondary objective is to describe the rates of hospitalization for for cytokine release syndrome
Measured: Up to 456 days after beginning treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start14 Jan 2025
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
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
- Model description
- Single cohort study.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taylor Brooks
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Taylor Brooks, Case Comprehensive Cancer Center
- Investigators
- Taylor Brooks, MD, Principal investigator, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06447376
- Sponsor's protocol ID
- CASE1424
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2024
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be shared with the FDA and Recordati and Genmab who are the suppliers of the investigational products any participant data shared will be deidentified.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Safety-feasibility Study of Cytokine Release Syndrome Prophylaxis and Treatment With Siltuximab Prior to Epcoritamab
- ClinicalTrials.gov ID
- NCT06447376
- Acronym / sponsor ID
- CASE1424
- Conditions
- Non-Hodgkin Lymphoma, Cytokine Release Syndrome
- Keywords
- Siltuximab, Epcoritamab, Prophylactic siltuximab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Taylor BrooksUniversity, hospital or other
- Collaborators
- Genmab, AbbVie, RECORDATI GROUP
- Study start
- 14 Jan 2025 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to is to determine the safety, feasibility and efficacy of siltuximab prophylaxis of cytokine release syndrome and neurotoxicity occurring after epcoritamab subcutaneous administration for participants with large b-cell lymphoma (DLBCL) or follicular lymphoma (FL).
Participants will receive siltuximab, prior to the injection of epcoritamab. Epcoritamab is administered in 28 day cycles for one year. After this injection, the physician will continue to watch participants for side effects and follow the condition for a minimum of 60 days.
Detailed description
Siltuximab is a monoclonal antibody that blocks interleukin-6 (IL-6) from binding to its receptor, preventing it from acting. IL-6 is a cytokine, a type of protein that is a cause of inflammatory reactions. Decreasing levels of IL-6 has been shown to reduce symptoms of cytokine release syndrome (CRS), a potential side effect of epcoritamab. Addition of siltuximab to the medications given before epcoritamab, may prevent, or reduce the severity, of CRS. Siltuximab is experimental because it is not approved by the Food and Drug Administration for treatment or prevention of CRS. Epcoritamab is a so-called bispecific antibody, which is a molecule that can bind simultaneously to two different receptors. Epcoritamab binds to a receptor called CD3 with one part of the antibody and to a receptor called CD20 with another part of the antibody. CD20 is expressed on the normal, healthy B cells but also on the cancerous lymphoma cells of B cell origin. CD3 is expressed on T cells, which are important cells of the immune system and help the body fight cancers, infections, etc. By simultaneous binding to CD3 and CD20, Epcoritamab brings T cells and B cells close together and activates the T cells to kill the B cells, including the cancerous ones.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single cohort study.
| Arm | Type | Receives |
|---|---|---|
| Prophylactic siltuximab + epcoritamab | Experimental | Drug: Siltuximab, Drug: Epcoritamab, Drug: Gemcitabine and oxaliplatinSiltuximab Administration: • Participants will receive a single dose of prophylactic siltuximab, 11mg/kg, started 1 hour prior (+/- 60 minutes) to the infusion of epcoritamab. There is no planned dose escalation of siltuximab and epcoritamab dosing will be done following the standard planned ramp-up over the course of the first 3 weeks Epcoritamab Infusion: • The treatment regimen of epcoritamab is done in 28-day cycles. Epcoritamab is to be administered by subcutaneous injection. Participants can be treated for up to 24 cycles. Participants who achieve complete remission at the time of their disease response assessment after 12 cycles may be considered for early discontinuation of treatment. Option of gemcitabine and oxaliplatin (GemOx) Administration: • Starting on Cycle 2, participants may receive the addition of GemOx |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Adults 18 years of age and older
- Diagnosis of non-Hodgkin lymphoma.
- At least 1 risk factor for cytokine release syndrome, including:
- Adequate bone marrow function including:
- ECOG performance status 0 - 2
Key exclusion criteria (11 listed)
- Primary mediastinal B cell lymphoma
- Active central nervous system or meningeal involvement by lymphoma
- History of severe allergic or anaphylactic reactions to anti-CD20 monoclonal antibody therapy
- Active bacterial, viral, fungal, mycobacterial, parasitic or other infection requiring systemic therapy within 2 weeks prior to first dose of study drug. This includes participants with COVID-19 infection
- History of active chronic infection by hepatitis B or C or Cytomegalovirus (CMV) requiring treatment or prophylaxis. Resolved infections (either by treatment or immune response) are not exclusion criterion.
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 |
|---|---|---|
| SiltuximabSingle dose of prophylactic siltuximab, 11mg/kg, started 1 hour prior (+/- 60 minutes) to the infusion of epcoritamab. | Drug | Prophylactic siltuximab + epcoritamab |
| EpcoritamabEpcoritamab dosing for Diffuse Large B-cell Lymphoma Participants: * Cycle 1, Day 1 = 0.16mg * Cycle 1, Day 8 = 0.8mg * Cycle 1, Day 15 = 48mg * Cycle 1, Day 22 = 48mg * Cycles 2 \& 3, Day 1 = 48mg * Cycles 2 \& 3, Day 8 = 48mg * Cycles 2 \& 3, Day 15 = 48mg * Cycles 2 \& 3, Day 22 = 48mg * Cycles 4-9, Day 1 = 48mg * Cycles 4-9, Day 15 = 48mg * Cycle 10+ , Day 1 = 48mg Epcoritamab dosing for Follicular Lymphoma Participants: * Cycle 1, Day 1 = 0.16mg * Cycle 1, Day 8 = 0.8mg * Cycle 1, Day 15 = 3mg * Cycle 1, Day 22 = 48mg * Cycle 2 \& 3, Day 1 = 48mg * Cycle 2 \& 3, Day 8 = 48mg * Cycle 2 \& 3, Day 15 = 48mg * Cycle 2 \& 3, Day 22 = 48mg * Cycle 4-9, Day 1 = 48mg * Cycle 4-9, Day 15 = 48mg * Cycle 10+ , Day 1 = 48mg | Drug | Prophylactic siltuximab + epcoritamab |
| Gemcitabine and oxaliplatinAlso: GemOxStarting on Cycle 2, participants may receive the addition of GemOx. Participants receive 1,000 milligrams/meter^2 (mg/m^2) of GemOx on Days 1 and 15 of Cycle 2 and onwards. | Drug | Prophylactic siltuximab + epcoritamab |
Primary outcome
Incidence of all-grade cytokine release syndrome
Time frame: Up to 28 days after beginning treatment
The primary objective is to evaluate the feasibility and efficacy of prophylactic administration of siltuximab prior to infusion of the first dose of epcoritamab with the purpose of preventing all-grade CRS, as measured by incidence of all-grade cytokine release syndrome.
6 secondary outcomes
Incidence of grade ≥ 2 cytokine release syndrome
Time frame: Up to 28 days after beginning treatment
Incidence of all grade and grade ≥ 2 ICANS after siltuximab prophylaxis
Time frame: Up to 28 days beginning treatment
Incidence of adverse events during Cycle 1 (Day 1 - 28)
Time frame: Up to 28 days after beginning treatment
Best overall and complete response rates
Time frame: Up to 456 days after beginning treatment
Incidence of hospitalizations secondary to all causes
Time frame: Up to 456 days after beginning treatment
Incidence of hospitalizations secondary to cytokine release syndrome or neurologic complications
Time frame: Up to 456 days after beginning treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: Yes. The data will be shared with the FDA and Recordati and Genmab who are the suppliers of the investigational products any participant data shared will be deidentified.
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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.
Taylor Brooks, MD principal investigator
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Siltuximab, Epcoritamab and Gemcitabine and oxaliplatin in people with Non-Hodgkin Lymphoma and Cytokine Release Syndrome, run by Taylor Brooks 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 11 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 25 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Taylor Brooks, MD (1-866-223 8100, TaussigResearch@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of all-grade cytokine release syndrome (time frame: Up to 28 days after beginning treatment). 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 25 Jun 2026.