Multiple MyelomaPhase 1NCT03399448

NY-ESO-1-redirected CRISPR (TCRendo and PD1) Edited T Cells (NYCE T Cells)

A Phase 1 study testing NY-ESO-1 redirected autologous T cells with CRISPR edited endogenous TCR and PD-1, Cyclophosphamide and Fludarabine in people with Multiple Myeloma and Melanoma, run by University of Pennsylvania at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

This is a first-in-human trial proposed to test HLA-A*0201 restricted NY-ESO-1 redirected T cells with edited endogenous T cell receptor and PD-1. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Multiple Myeloma, Melanoma, Synovial Sarcoma
What is being tested?: NY-ESO-1 redirected autologous T cells with CRISPR edited endogenous TCR and PD-1, Cyclophosphamide and Fludarabine
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3 participants
Where: 1 siteUnited States
Study dates: 5 Sep 2018to 9 Oct 2020
Phase: Phase 1
Are there results?: None posted in the registry

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

1. Subjects with a confirmed diagnosis of relapsed refractory multiple myeloma (MM), melanoma, synovial sarcoma, or myxoid/round cell liposarcoma (MRCL) as follows:
Multiple Myeloma i. Subjects must have a confirmed prior diagnosis of active MM as defined by the International Myeloma Working Group (IMWG) criteria.
Subjects must have relapsed or refractory disease after either one of the following:
At least 3 prior regimens, which must have contained an alkylating agent, proteasome inhibitor, and immunomodulatory agent (IMiD) OR
At least 2 prior regimens if "double-refractory" to a proteasome inhibitor and IMiD, defined as progression on or within 60 days of treatment with these agents.
Note: Induction therapy, stem cell transplant, and maintenance therapy, if given sequentially without intervening progression, should be considered as 1 "regimen".

Show all 24Show fewer

Subjects must be at least 90 days since autologous stem cell transplant, if performed.
Toxicities from prior therapies, with the exception of alopecia or peripheral neuropathy attributable to bortezomib, must have recovered to grade ≤ 2 according to the Common Toxicity Criteria (CTCAE) 4.0 criteria or to the subject's prior baseline.
Subjects must have measurable disease per IMWG criteria on study entry, which must include at least 1 of the following:
Serum M-spike ≥ 0.5 g/dL*
24 hour (hr) urine M-spike ≥ 200mg
Involved serum free light chain (FLC) ≥ 50 mg/L with abnormal ratio
Measurable plasmacytoma on exam or imaging
Bone marrow plasma cells ≥ 20%
Note: Patients with IgA myeloma in whom serum protein electrophoresis is deemed unreliable, due to co-migration of normal serum proteins with the paraprotein in the beta region, may be considered eligible as long as total serum IgA level is elevated above normal range.
Melanoma i. Subjects must have a confirmed prior diagnosis of melanoma. ii. Progressed after at least 2 therapy lines. iii. Subjects with BRAF mutant tumors should have received and progressed through, or are intolerant to, BRAF/MEK inhibitor therapy prior to enrollment iv. Patients must have measurable disease per RECIST 1.1 in order to allow assessment of an anti-tumor response.
Synovial Sarcoma or Myxoid/Round Cell Liposarcoma (MRCL) i. Subjects must have a confirmed prior diagnosis of synovial sarcoma or MRCL. ii. Patients with proven metastatic disease or surgically inoperable local recurrence that have failed first line treatment.
Patients must have measurable disease per RECIST 1.1 in order to allow assessment of an anti-tumor response.
2. Provides written, informed consent. 3. Subjects ≥ 18 years of age. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 5. Documented NY-ESO-1 and/or LAGE-1 expression on tumor tissue. 6. HLA-A201 positive 7. Subjects of reproductive potential must agree to use acceptable birth control methods.
8. Adequate vital organ function as defined by:
Serum creatinine ≤ 2.5 or estimated creatinine clearance ≥30 ml/min and not dialysis-dependent.
Absolute neutrophil count ≥1000/μl and platelet count ≥50,000/μl (≥30,000/μl if bone marrow plasma cells are ≥50% of cellularity for MM patients).
Serum glutamic oxaloacetic transaminase (SGOT) ≤ 3x the upper limit of normal and total bilirubin ≤ 2.0 mg/dl (except for patients in whom hyperbilirubinemia is attributed to Gilbert's syndrome).
Left ventricular ejection fraction (LVEF) ≥ 45%. LVEF assessment must have been performed within 8 weeks of eligibility confirmation by physician-investigator.

Who cannot join

1. Pregnant or nursing (lactating) women.
2. Have inadequate venous access for or contraindications to leukapheresis.
3. Have any active and uncontrolled infection.
4. Active hepatitis B or hepatitis C
5. Human immunodeficiency virus (HIV) infection.
6. Any uncontrolled medical or psychiatric disorder that would preclude participation as outlined.

Show all 11Show fewer

7. New York Heart Association (NYHA) Class III or IV heart failure, unstable angina, or a history of recent (within 6 months) myocardial infarction or sustained (>30 seconds) ventricular tachyarrhythmias.
8. Received prior gene therapy or gene-modified cellular immunotherapy. Subject may have received, however, non-gene-modified autologous T-cells in association with an anti-myeloma vaccine (e.g., hTERT or MAGEA3) or vaccination against infectious agents (e.g., influenza or pneumococcus) as was performed on our previous studies.
9. Active auto-immune disease, including connective tissue disease, uveitis, sarcoidosis, inflammatory bowel disease, or multiple sclerosis, or have a history of severe (as judged by the principal investigator) autoimmune disease requiring prolonged immunosuppressive therapy.
10. Prior allogeneic stem cell transplant.
11. Prior or active central nervous system (CNS) involvement (e.g. leptomeningeal disease, parenchymal masses) with myeloma. Screening for this (e.g. with lumbar puncture) is not required unless suspicious symptoms or radiographic findings are present. Subjects with calvarial disease that extends intracranially and involves the dura will be excluded, even if cerebrospinal fluid (CSF) is negative for myeloma.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pennsylvania
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Phase 1 Trial of Autologous T Cells Engineered to Express NY-ESO-1 TCR and CRISPR Gene Edited to Eliminate Endogenous TCR and PD-1 (NYCE T Cells)

This is a first-in-human trial proposed to test HLA-A*0201 restricted NY-ESO-1 redirected T cells with edited endogenous T cell receptor and PD-1.

Conditions: Multiple Myeloma, Melanoma, Synovial Sarcoma, Myxoid/Round Cell Liposarcoma
Being tested: NY-ESO-1 redirected autologous T cells with CRISPR edited endogenous TCR and PD-1, Cyclophosphamide, Fludarabine, NY-ESO-1 expression testing
Medical subject headings: Multiple Myeloma, Melanoma, Sarcoma, Synovial, Liposarcoma, Myxoid

What participants receive

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

NY-ESO-1 redirected autologous T cells with CRISPR edited endogenous TCR and PD-1Biological
Autologous T cells transduced with a lentiviral vector to express NY-ESO-1 and electroporated with CRISPR guide RNA to disrupt expression of endogenous TCRα, TCRβ and PD-1 (NYCE T Cells).
CyclophosphamideDrug
a cytotoxic chemotherapy agent used for lymphodepletion prior to NYCE T cells.
FludarabineDrug
a chemotherapy agent used for lymphodepletion prior to NYCE T cells.
NY-ESO-1 expression testingDevice
Testing to determine if NY-ESO-1 is expressed on tumor tissue.

Study groups in NCT03399448
Study group	Role	What they receive
Multiple Myeloma (MM)	Experimental	Not described Receives: Biological: NY-ESO-1 redirected autologous T cells with CRISPR edited endogenous TCR and PD-1; Drug: Cyclophosphamide; Drug: Fludarabine; Device: NY-ESO-1 expression testing
Synovial Sarcoma (SS) and Myxoid/Round Cell Liposarcoma (MRCL)	Experimental	Not described Receives: Biological: NY-ESO-1 redirected autologous T cells with CRISPR edited endogenous TCR and PD-1; Drug: Cyclophosphamide; Drug: Fludarabine; Device: NY-ESO-1 expression testing
Melanoma	Experimental	Not Recruiting at the UPenn Site Receives: Biological: NY-ESO-1 redirected autologous T cells with CRISPR edited endogenous TCR and PD-1; Drug: Cyclophosphamide; Drug: Fludarabine; Device: NY-ESO-1 expression testing

What is being measured

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

Determine safety profile of a single infusion of NYCE T cells by monitoring the frequency and severity of adverse events assessed by the National Cancer Institute (NCI) - Common Toxicity Criteria (v4.03)
Measured: 5 years
Evaluate Manufacturing Feasibility of NYCE T Cells.
Evaluate the percentage of manufacturing products that do not meet release criteria for vector transduction efficiency, gene disruption T cell product purity, viability, sterility or due to tumor contamination.
Measured: 5 years

Secondary outcomes (5)

Percentage of patients achieving complete response (CR) before or at Month 6
Measured: 6 months
Overall survival (OS)
Measured: 5 years
Duration of remission (DOR)
Measured: 5 years
Progression- free survival (PFS)
Measured: 5 years
Cause of death (COD) when appropriate
Measured: 5 years

Timeline

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

5 Sep 20189 Oct 2020

First posted16 Jan 2018
Study start5 Sep 2018
Primary completion29 Feb 2020
Study completion9 Oct 2020

Why it stopped: Sponsor has terminated trial to pursue other targets.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Multiple MyelomaStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe 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: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 3 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03399448
Sponsor's protocol ID: UPCC# 25416; IRB #826672
Status last verified: Oct 2020
First submitted: 20 Dec 2017
Last updated: 22 Jun 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: Undecided

Publications

Stadtmauer EA, Fraietta JA, Davis MM, Cohen AD, Weber KL, Lancaster E, Mangan PA, Kulikovskaya I, Gupta M, Chen F, Tian L, Gonzalez VE, Xu J, Jung IY, Melenhorst JJ, Plesa G, Shea J, Matlawski T, Cervini A, Gaymon AL, Desjardins S, Lamontagne A, Salas-Mckee J, Fesnak A, Siegel DL, Levine BL, Jadlowsky JK, Young RM, Chew A, Hwang WT, Hexner EO, Carreno BM, Nobles CL, Bushman FD, Parker KR, Qi Y, Satpathy AT, Chang HY, Zhao Y, Lacey SF, June CH. CRISPR-engineered T cells in patients with refractory cancer. Science. 2020 Feb 28;367(6481):eaba7365. doi: 10.1126/science.aba7365. Epub 2020 Feb 6.
PubMed 32029687
Tsuchida CA, Brandes N, Bueno R, Trinidad M, Mazumder T, Yu B, Hwang B, Chang C, Liu J, Sun Y, Hopkins CR, Parker KR, Qi Y, Hofman L, Satpathy AT, Stadtmauer EA, Cate JHD, Eyquem J, Fraietta JA, June CH, Chang HY, Ye CJ, Doudna JA. Mitigation of chromosome loss in clinical CRISPR-Cas9-engineered T cells. Cell. 2023 Oct 12;186(21):4567-4582.e20. doi: 10.1016/j.cell.2023.08.041. Epub 2023 Oct 3.
PubMed 37794590
Miah KM, Hyde SC, Gill DR. Emerging gene therapies for cystic fibrosis. Expert Rev Respir Med. 2019 Aug;13(8):709-725. doi: 10.1080/17476348.2019.1634547. Epub 2019 Jun 27.
PubMed 31215818

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm

All Multiple Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1 Trial of Autologous T Cells Engineered to Express NY-ESO-1 TCR and CRISPR Gene Edited to Eliminate Endogenous TCR and PD-1 (NYCE T Cells)
ClinicalTrials.gov ID: NCT03399448
Acronym / sponsor ID: UPCC# 25416; IRB #826672
Conditions: Multiple Myeloma, Melanoma, Synovial Sarcoma, Myxoid/Round Cell Liposarcoma
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor has terminated trial to pursue other targets.
Enrolment: 3 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Collaborators: Parker Institute for Cancer Immunotherapy, Gilead Sciences
Study start: 5 Sep 2018 (actual)
Primary completion: 29 Feb 2020 (actual)
Study completion: 9 Oct 2020 (actual)
First posted: 16 Jan 2018 (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.

This is a first-in-human trial proposed to test HLA-A*0201 restricted NY-ESO-1 redirected T cells with edited endogenous T cell receptor and PD-1.

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Multiple Myeloma (MM)	Experimental	Biological: NY-ESO-1 redirected autologous T cells with CRISPR edited endogenous TCR and PD-1, Drug: Cyclophosphamide, Drug: Fludarabine, Device: NY-ESO-1 expression testing
Synovial Sarcoma (SS) and Myxoid/Round Cell Liposarcoma (MRCL)	Experimental	Biological: NY-ESO-1 redirected autologous T cells with CRISPR edited endogenous TCR and PD-1, Drug: Cyclophosphamide, Drug: Fludarabine, Device: NY-ESO-1 expression testing
Melanoma	Experimental	Biological: NY-ESO-1 redirected autologous T cells with CRISPR edited endogenous TCR and PD-1, Drug: Cyclophosphamide, Drug: Fludarabine, Device: NY-ESO-1 expression testingNot Recruiting at the UPenn Site

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (24 listed)

1. Subjects with a confirmed diagnosis of relapsed refractory multiple myeloma (MM), melanoma, synovial sarcoma, or myxoid/round cell liposarcoma (MRCL) as follows:
Multiple Myeloma i. Subjects must have a confirmed prior diagnosis of active MM as defined by the International Myeloma Working Group (IMWG) criteria.
Subjects must have relapsed or refractory disease after either one of the following:
At least 3 prior regimens, which must have contained an alkylating agent, proteasome inhibitor, and immunomodulatory agent (IMiD) OR
At least 2 prior regimens if "double-refractory" to a proteasome inhibitor and IMiD, defined as progression on or within 60 days of treatment with these agents.

Key exclusion criteria (11 listed)

1. Pregnant or nursing (lactating) women.
2. Have inadequate venous access for or contraindications to leukapheresis.
3. Have any active and uncontrolled infection.
4. Active hepatitis B or hepatitis C
5. Human immunodeficiency virus (HIV) infection.

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
NY-ESO-1 redirected autologous T cells with CRISPR edited endogenous TCR and PD-1Autologous T cells transduced with a lentiviral vector to express NY-ESO-1 and electroporated with CRISPR guide RNA to disrupt expression of endogenous TCRα, TCRβ and PD-1 (NYCE T Cells).	Biological	Melanoma, Multiple Myeloma (MM), Synovial Sarcoma (SS) and Myxoid/Round Cell Liposarcoma (MRCL)
Cyclophosphamidea cytotoxic chemotherapy agent used for lymphodepletion prior to NYCE T cells.	Drug	Melanoma, Multiple Myeloma (MM), Synovial Sarcoma (SS) and Myxoid/Round Cell Liposarcoma (MRCL)
Fludarabinea chemotherapy agent used for lymphodepletion prior to NYCE T cells.	Drug	Melanoma, Multiple Myeloma (MM), Synovial Sarcoma (SS) and Myxoid/Round Cell Liposarcoma (MRCL)
NY-ESO-1 expression testingTesting to determine if NY-ESO-1 is expressed on tumor tissue.	Device	Melanoma, Multiple Myeloma (MM), Synovial Sarcoma (SS) and Myxoid/Round Cell Liposarcoma (MRCL)

Primary outcome

Determine safety profile of a single infusion of NYCE T cells by monitoring the frequency and severity of adverse events assessed by the National Cancer Institute (NCI) - Common Toxicity Criteria (v4.03)
Time frame: 5 years
Evaluate Manufacturing Feasibility of NYCE T Cells.
Time frame: 5 years
Evaluate the percentage of manufacturing products that do not meet release criteria for vector transduction efficiency, gene disruption T cell product purity, viability, sterility or due to tumor contamination.

5 secondary outcomes

Percentage of patients achieving complete response (CR) before or at Month 6
Time frame: 6 months
Overall survival (OS)
Time frame: 5 years
Duration of remission (DOR)
Time frame: 5 years
Progression- free survival (PFS)
Time frame: 5 years
Cause of death (COD) when appropriate
Time frame: 5 years

Results and safety

The study was stopped early (reason given: Sponsor has terminated trial to pursue other targets.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
Results publication: PubMed 32029687Stadtmauer EA, Fraietta JA, Davis MM, Cohen AD, Weber KL, Lancaster E, Mangan PA, Kulikovskaya I, Gupta M, Chen F, Tian L, Gonzalez VE, Xu J, Jung IY, Melenhorst JJ, Plesa G, Shea J, Matlawski T, Cervini A, Gaymon AL, Desjardins S, Lamontagne A, Salas-Mckee J, Fesnak A, Siegel DL, Levine BL, Jadlowsky JK, Young RM, Chew A, Hwang WT, Hexner EO, Carreno BM, Nobles CL, Bushman FD, Parker KR, Qi Y, Satpathy AT, Chang HY, Zhao Y, Lacey SF, June CH. CRISPR-engineered T cells in patients with refractory cancer. Science. 2020 Feb 28;367(6481):eaba7365. doi: 10.1126/science.aba7365. Epub 2020 Feb 6.
Derived from this study: PubMed 37794590Tsuchida CA, Brandes N, Bueno R, Trinidad M, Mazumder T, Yu B, Hwang B, Chang C, Liu J, Sun Y, Hopkins CR, Parker KR, Qi Y, Hofman L, Satpathy AT, Stadtmauer EA, Cate JHD, Eyquem J, Fraietta JA, June CH, Chang HY, Ye CJ, Doudna JA. Mitigation of chromosome loss in clinical CRISPR-Cas9-engineered T cells. Cell. 2023 Oct 12;186(21):4567-4582.e20. doi: 10.1016/j.cell.2023.08.041. Epub 2023 Oct 3.
Derived from this study: PubMed 31215818Miah KM, Hyde SC, Gill DR. Emerging gene therapies for cystic fibrosis. Expert Rev Respir Med. 2019 Aug;13(8):709-725. doi: 10.1080/17476348.2019.1634547. Epub 2019 Jun 27.
Individual participant dataSharing planned: Undecided

Related trials for Multiple Myeloma

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Edward Stadtmauer, MD principal investigator

University of Pennsylvania

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 24 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: stopped early, as of the sponsor's last update on 22 Jun 2023. 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?

The study was stopped early (reason given: Sponsor has terminated trial to pursue other targets.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine safety profile of a single infusion of NYCE T cells by monitoring the frequency and severity of adverse events assessed by the National Cancer Institute (NCI) - Common Toxicity Criteria (v4.03) (time frame: 5 years). The study lists 2 primary outcomes in all. 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 NCT03399448, which also lists 3 linked publications.

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 22 Jun 2023.