Large B-cell LymphomaPhase 1NCT07052305
NT-I7 (Efineptakin Alfa), a Long-acting Human IL-7, Post-Axicabtagene Ciloleucel or Post-Lisocabtagene Maraleucel in Subjects With Relapsed/Refractory Large B-cell Lymphoma
A Phase 1 study testing NT-I7 and CAR T-cell therapy in people with Large B-cell Lymphoma, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Diffuse large B-cell lymphoma is the most commonly occurring subtype of non-Hodgkin lymphoma, but treatment is often not curative, with as many as 50% of patients with adverse risk factors developing relapsed/refractory disease. 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?
- NT-I7 and CAR T-cell therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2026to 31 Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), high grade B-cell lymphoma, DLBCL arising from an indolent lymphoma, grade 3B follicular lymphoma and primary mediastinal large B-cell lymphoma.
- Measurable disease by IWG response criteria for lymphoma.
- Baseline FDG-PET/CT scan must show FDG-avid lesions compatible with CT-defined anatomical tumor sites.
- A previously irradiated lesion can be considered a target lesion if it is well defined, measurable, and has clearly progressed following radiation.
- FDG-PET/CT scans done as SOC up to 60 days pre-lymphodepletion therapy will be allowed. NOTE: After eligibility is confirmed, restaging FDG-PET/CT scans will not be used to change eligibility.
- Eligible for treatment with an FDA-approved SOC CD19 CAR T-cell therapy respective to the current FDA-approved CAR T-cell label for axi-cel(Yescarta®) or liso-cel (Breyanzi®).
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- If the patient has previously received an autologous stem cell transplant, s/he must be at least 3 months post-transplant.
- At least 18 years of age.
- ECOG performance status ≤ 2
- Adequate bone marrow and organ function at the start of lymphodepleting chemotherapy as pre-conditioning for SOC CD19 CAR T-cell infusion as defined below:
- Absolute neutrophil count ≥ 1.0 K/cumm
- Platelets ≥ 50 K/cumm
- Hemoglobin ≥ 8.0 g/dL
- Total bilirubin ≤ 1.5 x IULN or direct bilirubin ≤ IULN for patients with total bilirubin levels > 1.5 x IULN (except for patients with Gilbert's syndrome, who must have a baseline total bilirubin ≤ 3.0 mg/dL)
- AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN (except for patients with documented liver involvement or bone metastases, who must have an AST and/or ALT ≤ 5.0 x IULN)
- Alkaline phosphatase ≤ 2.5 x IULN (except for patients with liver metastasis, who must have an alkaline phosphatase ≤ 5.0 x IULN)
- Creatinine clearance ≥ 30 mL/min by Cockcroft-Gault
- INR and aPTT ≤ 1.5 x IULN unless the patient is receiving anticoagulant therapy and the PT or aPTT is within the therapeutic range for the anticoagulant. Patients who are on anticoagulation should be able to hold the anticoagulant for 4-5 half-lives of the anticoagulant prior to IM NT-I7 injection to reduce risk of hematoma.
- ECG demonstrating Fridericia's corrected QT interval (QTcF) < 500 ms; patients with QTcF ≥ 500 ms will require clearance by a cardiologist.
- The effects of NT-I7 on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 90 days after the last NT-I7 injection. Should a woman become pregnant or suspect she is pregnant while participating in this study or should a man suspect he has fathered a child, s/he must inform her treating physician immediately.
- Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
Who cannot join
- Previous receipt of an allogeneic solid organ transplant or bone marrow transplant.
- Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial.
- Chemotherapy or biologic or hormonal therapy for prior or concurrent cancer treatment, within 14 days prior to the first NT-I7 injection.
- NOTE: Concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes, hormone replacement therapy) is acceptable.
- Currently receiving any other investigational agents, or received within 14 days prior to the first NT-I7 injection.
- Documented active central nervous system (CNS) involvement by lymphoma.
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- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to NT-I7 or other agents used in the study.
- Presence of clinically significant, unresolved toxicities from prior anticancer therapy, defined as having not received to grade ≤ 1 (with the exception of alopecia and laboratory values listed per the inclusion criteria). Patients with irreversible toxicity that is not reasonably expected to be exacerbated by NT-I7 may be included (e.g., hearing loss, peripheral neuropathy) after consultation with the PI.
- Uncontrolled intercurrent illness including, but not limited to:
- Ongoing or active infection (including active hepatitis A or mycobacterium tuberculosis (testing not required))
- Congestive heart failure with NYHA Class ≥ 2
- Uncontrolled atrial fibrillation
- Any of the following within 6 months prior to day of CAR T-cell administration:
- Unstable angina pectoris
- Myocardial infarction
- Coronary artery bypass grafting
- Coronary angioplasty
- Coronary stenting
- Clinically significant cardiac arrhythmia and/or conduction abnormality
- Other clinically significant cardiac disease that, in the opinion of the treating physician and/or PI, is a contraindication to study treatment
- History of autoimmune disease for the past 2 years prior to enrollment, including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.
- NOTE: The following are exceptions to this criterion: vitiligo, alopecia, type 1 diabetes mellitus, autoimmune hypothyroidism stable on hormone replacement, psoriasis not severe enough to require systemic treatment, diverticulitis not associated with inflammatory bowel disease.
- Contraindication to intramuscular therapy.
- Receipt of a live, attenuated vaccine within 30 days prior to NT-I7 injection.
- NOTE: Patients, if enrolled, should not receive live vaccines during the study period and through 30 days after the last NT-I7 injection. The administration of inactivated vaccines is permitted at any time per the discretion of the treating physician.
- Pregnant and/or breastfeeding and/or expecting to conceive or father children within the study duration (from enrollment through 90 days after last dose of NT-I7). Women of childbearing potential (including women who have had a tubal ligation) must have a negative serum or urine pregnancy test within 72 hours prior to CAR-T administration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible.
- Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible.
- History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible.
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
Washington University School of Medicine
St Louis, Missouri, 63110
Zachary D Crees, M.D., 314-273-1039, zcrees@wustl.edu
Zachary D Crees, M.D.
About this study
Official title: A Phase 1b Study Evaluating the Safety, Tolerability, and Preliminary Anti-tumor Activity of NT-I7 (Efineptakin Alfa), a Long-acting Human IL-7, Post-Axicabtagene Ciloleucel or Post-Lisocabtagene Maraleucel in Subjects With Relapsed/Refractory Large B-cell Lymphoma
Diffuse large B-cell lymphoma is the most commonly occurring subtype of non-Hodgkin lymphoma, but treatment is often not curative, with as many as 50% of patients with adverse risk factors developing relapsed/refractory disease. CAR T-cell therapy has revolutionized modern cancer therapy, with axicabtagene ciloleucel and lisocabtagene maraleucel (anti-CD19 CAR T-cell therapies) FDA approved for second- or later-line treatment of relapsed/refractory large B-cell lymphoma.
IL-7 plays a crucial role in T-cell homeostasis by inducing thymic differentiation, peripheral expansion, and extrathymic differentiation. It is the main regulator of T-cell hemostasis, inducing T-cell growth and proliferation in lymphopenic patients. There is data that suggests that exposure of T-cells to IL-7 may expand T-cells, prevent T-cell exhaustion, and improve effector functions.
Read more
NT-I7 is a long-acting human IL-7 cytokine which has been shown in nonclinical studies to increase peripheral T-cells, antitumor efficacy, and tumor infiltrating lymphocytes, either as a monotherapy or in combination with chemo/radiotherapy and/or immune checkpoint inhibitors and CAR T therapy.
This study is testing the hypothesis that the administration of NT-I7 following standard of care (SOC) approved CD19 CAR T-cell therapies for subjects with relapsed/refractory large B-cell lymphoma (LBCL) will be safe and tolerable and may increase the expansion and persistence of CAR T-cells in vivo, which may result in increased tumor response rate and improved clinical outcomes.
- Conditions
- Large B-cell Lymphoma
- Being tested
- NT-I7, CAR T-cell therapy
- Keywords
- Non-Hodgkins Lymphoma, Large B-cell Lymphoma, Yescarta, Axi-cel, Breyanzi, Liso-cel, Interleukin 7, NT-I7, CD19 CAR T-cell Therapy
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NT-I7Drug
Also called Efineptakin alfa
Provided by NeoImmune Tech
CAR T-cell therapyBiological
Also called Axicabtagene ciloleucel, Lisocabtagene maraleucel .
Standard of care: Will be given on day 0 and will be either axicabtagene ciloleucel or lisocabtagene maraleucel .
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Dose Level 1 Starting Dose: NT-I7 | Experimental | NT-I7 will be administered as an intramuscular injection at 600 μg/kg on Day 10 (-2/+5 days) and Day 31 (+/-3 days) post-CAR T-cell therapy infusion, with at least 2 weeks between the NT-I7 injections. |
| Dose Escalation Dose Level 2: NT-I7 | Experimental | NT-I7 will be administered as an intramuscular injection at 720 μg/kg on Day 10 (-2/+5 days) and Day 31 (+/-3 days) post-CAR T-cell therapy infusion, with at least 2 weeks between the NT-I7 injections. |
| Dose Expansion (RP2D): NT-I7 | Experimental | NT-I7 will be administered as an intramuscular injection at the recommended phase 2 dose on Day 10 (-2/+5 days) and Day 31 (+/-3 days) post-CAR T-cell therapy infusion, with at least 2 weeks between the NT-I7 injections. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Measured per CTCAE v 5.0. CRS and ICANS will be graded per ASTCT guidelines
Measured: From start of CAR T-cell infusion (day 0) through day 90 (post CAR T-cell infusion)
Maximum tolerated dose of NT-I7 (Dose Escalation only)
Determined by incidence and nature of dose-limiting toxicities (DLTs). DLTs are defined in the protocol.
Measured: From first dose of NT-I7 until 14 days after the second dose NT-I7 dose (estimated to be 35 days)
Recommended phase 2 dose of NT-I7 (Dose Escalation only)
Determined by the potential correlation of dose levels with safety and efficacy parameters.
Measured: Through 90 days after CAR T-cell infusion
Secondary outcomes (7)
Overall response rate (ORR)
Response will be assessed based on IWG response criteria for lymphoma
Measured: Through completion of follow-up (estimated to be 1 year)
Partial response (PR) rate
Response will be assessed based on IWG response criteria for lymphoma
Measured: Through completion of follow-up (estimated to be 1 year)
Complete response (CR) rate
Response will be assessed based on IWG response criteria for lymphoma
Measured: Through completion of follow-up (estimated to be 1 year)
Duration of response (DoR)
For responders only: defined as the time from the first occurrence of a documented objective response (PR or CR) to the time of the first documented disease progression or death from any cause, whichever occurs first, per IWG.
Response will be assessed based on IWG response criteria for lymphoma
Measured: Through completion of follow-up (estimated to be 1 year)
Progression-free survival (PFS)
Defined as the time from the CAR T-cell infusion (Day 0) to the first occurrence of progression or death from any cause, whichever occurs first, per IWG.
Measured: Through completion of follow-up (estimated to be 1 year)
Overall survival (OS)
Defined as the time from CAR T-cell infusion (Day 0) to death from any cause.
Measured: Through completion of follow-up (estimated to be 1 year)
Effect of NT-I7 on CAR T-cell expansion as measured by quantitative DNA PCR and/or flow cytometry
Measured: From day 0 to day 42 post CAR T-cell infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start12 Mar 2026
- Primary completion30 Nov 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Large B-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- NeoImmuneTech, The Foundation for Barnes-Jewish Hospital, Daniel E Corbin Lymphoma Research Fund, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Zachary D Crees, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07052305
- Sponsor's protocol ID
- 202512084
- Other IDs
- R01CA286488
- Status last verified
- Sep 2026
- First submitted
- 26 Jun 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study Evaluating the Safety, Tolerability, and Preliminary Anti-tumor Activity of NT-I7 (Efineptakin Alfa), a Long-acting Human IL-7, Post-Axicabtagene Ciloleucel or Post-Lisocabtagene Maraleucel in Subjects With Relapsed/Refractory Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT07052305
- Acronym / sponsor ID
- 202512084
- Conditions
- Large B-cell Lymphoma
- Keywords
- Non-Hodgkins Lymphoma, Large B-cell Lymphoma, Yescarta, Axi-cel, Breyanzi, Liso-cel, Interleukin 7, NT-I7
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- NeoImmuneTech, The Foundation for Barnes-Jewish Hospital, Daniel E Corbin Lymphoma Research Fund, National Cancer Institute (NCI)
- Study start
- 12 Mar 2026 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 4 Jul 2025 (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.
Diffuse large B-cell lymphoma is the most commonly occurring subtype of non-Hodgkin lymphoma, but treatment is often not curative, with as many as 50% of patients with adverse risk factors developing relapsed/refractory disease. CAR T-cell therapy has revolutionized modern cancer therapy, with axicabtagene ciloleucel and lisocabtagene maraleucel (anti-CD19 CAR T-cell therapies) FDA approved for second- or later-line treatment of relapsed/refractory large B-cell lymphoma.
IL-7 plays a crucial role in T-cell homeostasis by inducing thymic differentiation, peripheral expansion, and extrathymic differentiation. It is the main regulator of T-cell hemostasis, inducing T-cell growth and proliferation in lymphopenic patients. There is data that suggests that exposure of T-cells to IL-7 may expand T-cells, prevent T-cell exhaustion, and improve effector functions.
NT-I7 is a long-acting human IL-7 cytokine which has been shown in nonclinical studies to increase peripheral T-cells, antitumor efficacy, and tumor infiltrating lymphocytes, either as a monotherapy or in combination with chemo/radiotherapy and/or immune checkpoint inhibitors and CAR T therapy.
This study is testing the hypothesis that the administration of NT-I7 following standard of care (SOC) approved CD19 CAR T-cell therapies for subjects with relapsed/refractory large B-cell lymphoma (LBCL) will be safe and tolerable and may increase the expansion and persistence of CAR T-cells in vivo, which may result in increased tumor response rate and improved clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Dose Level 1 Starting Dose: NT-I7 | Experimental | –NT-I7 will be administered as an intramuscular injection at 600 μg/kg on Day 10 (-2/+5 days) and Day 31 (+/-3 days) post-CAR T-cell therapy infusion, with at least 2 weeks between the NT-I7 injections. |
| Dose Escalation Dose Level 2: NT-I7 | Experimental | –NT-I7 will be administered as an intramuscular injection at 720 μg/kg on Day 10 (-2/+5 days) and Day 31 (+/-3 days) post-CAR T-cell therapy infusion, with at least 2 weeks between the NT-I7 injections. |
| Dose Expansion (RP2D): NT-I7 | Experimental | –NT-I7 will be administered as an intramuscular injection at the recommended phase 2 dose on Day 10 (-2/+5 days) and Day 31 (+/-3 days) post-CAR T-cell therapy infusion, with at least 2 weeks between the NT-I7 injections. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Histologically confirmed relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), high grade B-cell lymphoma, DLBCL arising from an indolent lymphoma, grade 3B follicular lymphoma and primary mediastinal large B-cell lymphoma.
- Measurable disease by IWG response criteria for lymphoma.
- Eligible for treatment with an FDA-approved SOC CD19 CAR T-cell therapy respective to the current FDA-approved CAR T-cell label for axi-cel(Yescarta®) or liso-cel (Breyanzi®).
- If the patient has previously received an autologous stem cell transplant, s/he must be at least 3 months post-transplant.
- At least 18 years of age.
Key exclusion criteria (29 listed)
- Previous receipt of an allogeneic solid organ transplant or bone marrow transplant.
- Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial.
- Chemotherapy or biologic or hormonal therapy for prior or concurrent cancer treatment, within 14 days prior to the first NT-I7 injection.
- Currently receiving any other investigational agents, or received within 14 days prior to the first NT-I7 injection.
- Documented active central nervous system (CNS) involvement by lymphoma.
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 |
|---|---|---|
| NT-I7Also: Efineptakin alfaProvided by NeoImmune Tech | Drug | – |
| CAR T-cell therapyAlso: Axicabtagene ciloleucel, Lisocabtagene maraleucel .Standard of care: Will be given on day 0 and will be either axicabtagene ciloleucel or lisocabtagene maraleucel . | Biological | – |
Primary outcome
Incidence of adverse events
Time frame: From start of CAR T-cell infusion (day 0) through day 90 (post CAR T-cell infusion)
Measured per CTCAE v 5.0. CRS and ICANS will be graded per ASTCT guidelines
Maximum tolerated dose of NT-I7 (Dose Escalation only)
Time frame: From first dose of NT-I7 until 14 days after the second dose NT-I7 dose (estimated to be 35 days)
Determined by incidence and nature of dose-limiting toxicities (DLTs). DLTs are defined in the protocol.
Recommended phase 2 dose of NT-I7 (Dose Escalation only)
Time frame: Through 90 days after CAR T-cell infusion
Determined by the potential correlation of dose levels with safety and efficacy parameters.
7 secondary outcomes
Overall response rate (ORR)
Time frame: Through completion of follow-up (estimated to be 1 year)
Partial response (PR) rate
Time frame: Through completion of follow-up (estimated to be 1 year)
Complete response (CR) rate
Time frame: Through completion of follow-up (estimated to be 1 year)
Duration of response (DoR)
Time frame: Through completion of follow-up (estimated to be 1 year)
Progression-free survival (PFS)
Time frame: Through completion of follow-up (estimated to be 1 year)
Overall survival (OS)
Time frame: Through completion of follow-up (estimated to be 1 year)
Effect of NT-I7 on CAR T-cell expansion as measured by quantitative DNA PCR and/or flow cytometry
Time frame: From day 0 to day 42 post CAR T-cell infusion
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 29 Sep 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Zachary D Crees, M.D. principal investigator
Washington University School of Medicine
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 NT-I7 and CAR T-cell therapy in people with Large B-cell Lymphoma, run by Washington University School of Medicine 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 21 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 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 Zachary D Crees, M.D. (314-273-1039, zcrees@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: From start of CAR T-cell infusion (day 0) through day 90 (post CAR T-cell infusion)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.