Metastatic Breast CancerPhase 1NCT04020575
Autologous huMNC2-CAR44 or huMNC2-CAR22 T Cells for Breast Cancer Targeting Cleaved Form of MUC1 (MUC1*)
A Phase 1 study testing huMNC2-CAR44 CAR T cells or huMNC2-CAR22 CAR T cells and huMNC2-CAR44 CAR T cells or huMNC2-CAR22 CAR T cells @ RP2D in people with Metastatic Breast Cancer, run by Minerva Biotechnologies Corporation at 1 site in United States.
Trial summary
Phase I/II study of adoptive immunotherapy for advanced MUC1* positive breast cancer with autologous T cells engineered to express either a chimeric antigen receptor, huMNC2-CAR44 or huMNC2-CAR22, which are specific for a cleaved form of MUC1 (MUC1*). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- huMNC2-CAR44 CAR T cells or huMNC2-CAR22 CAR T cells and huMNC2-CAR44 CAR T cells or huMNC2-CAR22 CAR T cells @ RP2D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2020to 15 Jan 2035
- 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
- Confirmation of diagnosis of breast cancer by pathology review of initial or subsequent biopsy or other pathologic material at the City of Hope Pathology department. ER, PR, and HER2 status known and documented per ASCO/CAP guidelines.
- For dose expansion cohorts, tumors with ER and/or PR ≥1% will be considered hormone receptor positive. Tumors with ER and PR <1% will be considered hormone receptor negative. HER2 status will be determined by IHC or FISH per ASCO/CAP guidelines. Patients will be allocated to expansion cohorts according to guidelines in table below.
- Dose expansion cohorts
- Expansion Cohort Hormone Receptor status HER2 status Luminal ER and/or PR >/=1% positive Negative by IHC or FISH HER2 positive Any ER or PR status Positive by IHC or FISH Triple Negative ER and PR <1% Negative by IHC or FISH
- Patients must have received standard metastatic systemic therapy per NCCN guidelines or institutional practice which are known to confer benefit. No maximum on number of prior systemic treatment regimens.
- Patients with hormone receptor positive disease must have received at least 3 prior endocrine therapies and at least 2 prior lines of chemotherapy in the metastatic setting.
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- Patients with HER2 positive breast cancer must have received at least 3 prior HER2- directed therapies (trastuzumab, pertuzumab, TDM-1 or others) in the metastatic setting.
- Patients with triple negative disease must have received at least 2 prior lines of chemotherapy in the metastatic setting.
- MUC1* membrane expression ≥30% by immunohistochemistry on a tumor specimen obtained at screening or previous tumor specimen that is less than 6-months old (see Appendix I for examples of MUC1* expression patterns).
- Patients must be 18 years of age or older, of any gender, race or ethnicity.
- Patients must be capable of understanding and providing a written informed consent.
- Patients must have a Karnofsky performance status of ≥60%.
- Patients must have measurable disease by at least one of the criteria below:
- Extra skeletal disease that can be accurately measured by CT or MRI per RECIST 1.1,
- Skeletal or bone-only metastases measurable by FDG PET imaging.
- Negative serum pregnancy test within 14 days of planned leukapheresis and within 28 days of lymphodepleting chemotherapy for women of childbearing potential, defined as those who have not been surgically sterilized or who have not been free of menses for at least 1 year.
- Fertile male and female patients must be willing to use an effective contraceptive method before, during, and for at least 4 months after the huMNC2-CAR T cell infusion.
Who cannot join
- Patients requiring ongoing daily corticosteroid therapy at a dose of >15 mg of prednisone per day (or equivalent). Pulsed corticosteroid use for disease control is acceptable.
- Active autoimmune disease requiring immunosuppressive therapy is excluded unless discussed with the PI.
- Major organ dysfunction defined as:
- Serum creatinine > 2 mg/dL
- Bilirubin ≥ 1.5 mg/dL with the following exception: Patients with known Gilbert disease, serum bilirubin > 3 mg/dL
- AST or ALT ≥ 2.5 x upper institutional limit of normal with the following exception: Patients with known hepatic metastases, AST or ALT > 3x upper institutional limit of normal
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- Patients with clinically significant pulmonary dysfunction, as determined by medical history and physical exam should undergo pulmonary function testing. Those with an FEV1 of < 50 % of predicted or DLCO (corrected) < 40% will be excluded.
- Significant cardiovascular abnormalities as defined by any one of the following:
- NYHA class III or IV congestive heart failure, ii. clinically significant hypotension, iii. uncontrolled symptomatic coronary artery disease, or iv. a documented ejection fraction of <45%. Any patient with an EF of 45-49% must receive clearance by a cardiologist to be eligible for the trial.
- ANC <1000/mm^3.
- Hemoglobin <9 mg/dl (transfusion permitted to achieve this).
- Platelet count <75,000/mm^3.
- Treatment with investigational agent(s) within 30 days of planned lymphodepletion.
- HIV seropositive.
- Uncontrolled active infection.
- Anticipated survival of <3 months.
- Breast-feeding women.
- Patients who have a contraindication to cyclophosphamide chemotherapy.
- Known second malignancy that is progressing or requires active treatment.
- Untreated CNS metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate with documented stable disease as defined by no evidence of progression by imaging or symptoms for at least 4 weeks prior to enrollment.
- Have psychiatric illness, social situation, or other medical condition that would preclude informed consent to limit compliance with study requirements, as determined by the investigator.
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
City of Hope Medical Center
Duarte, California, 91010-3000
Joanne Mortimer, MD, 800-826-4673
Joanne Mortimer, MD
About this study
Official title: Adoptive Immunotherapy for Advanced MUC1* Positive Breast Cancer With Autologous T Cells Engineered to Express a Chimeric Antigen Receptor, huMNC2-CAR44 or huMNC2-CAR22, Specific for a Cleaved Form of MUC1 (MUC1*)
Phase I/II study of adoptive immunotherapy for advanced MUC1* positive breast cancer with autologous T cells engineered to express either a chimeric antigen receptor, huMNC2-CAR44 or huMNC2-CAR22, which are specific for a cleaved form of MUC1 (MUC1*).
Read the detailed description
Recent trials have demonstrated that chimeric antigen receptor (CAR)-modified T cells (CAR-T cells) specific for the CD19 molecule can mediate marked tumor regression in a subset of patients with advanced acute lymphoblastic leukemia (ALL) and non-Hodgkin's lymphoma (NHL). It would be ideal to extend CAR-T cell therapy to common epithelial cancers. However, this poses several challenges, including the identification of molecules expressed on tumor cells that can be targeted safely with CAR-T cells. Minerva Biotechnologies has developed a CAR T product (huMNC2-CAR44 or huMNC2-CAR22) that targets the extra cellular domain of the cleaved form of MUC1 (called MUC1*), which is the form of MUC1 that functions as a growth factor receptor and is present on large percentage of solid tumors, including breast tumors. The antibody targeting head of huMNC2-CAR44 or huMNC2-CAR22 specifically recognizes a cancerous form of MUC1* and does not bind to another form of cleaved MUC1 that is present on some normal tissues that also have a rapid turnover. To be clear, patients will receive either huMNC2-CAR44 or huMNC2-CAR22, but not a combined product.
The huMNC2-CAR44 product consists of autologous T cells that are isolated from cancer patients, transduced with a proprietary lentiviral vector backbone manufactured under cGMP and containing sequences for a human CD8 alpha leader sequence, humanized MNC2-scFv (MUC1* targeting head), portions of human CD8 hinge and transmembrane domains, and human 4-1BB and human CD3-zeta costimulatory domains. The huMNC2-CAR44 transduced T cells are antigen-stimulated in vitro, with a synthetic MUC1* extracellular domain peptide. The CAR T cells are then ready for administration to the patient. Alternatively, the CAR T cells can be cryopreserved, then administered to the patient after thaw at bedside.
The huMNC2-CAR22 product is comprised of a CD8-α leader sequence, the huMNC2 scFv, a CD28 hinge and transmembrane region, followed by a CD28 co-stimulatory domain and a CD3-ζ signaling domain bearing two Tyrosine to Phenylalanine mutations in each of ITAMs 2 and 3 to minimize CAR T cell exhaustion and increase in vivo persistence. The huMNC2-CAR22 transduced T cells are not antigen-stimulated. The CAR T cells can be cryopreserved, then administered to the patient after thaw at bedside.
The investigators propose to evaluate the safety and preliminary anti-tumor activity of adoptively transferred autologous T cells genetically modified to express a CAR that targets MUC1*, huMNC2-CAR44 or huMNC2-CAR22, in Phase I/II clinical trials in patients with metastatic MUC1* positive breast cancers.
- Conditions
- Metastatic Breast Cancer
- Being tested
- huMNC2-CAR44 CAR T cells or huMNC2-CAR22 CAR T cells, huMNC2-CAR44 CAR T cells or huMNC2-CAR22 CAR T cells @ RP2D
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
huMNC2-CAR44 CAR T cells or huMNC2-CAR22 CAR T cellsBiological
huMNC2-CAR44 T cells or huMNC2-CAR22 CAR T cells are an autologous T cell product transduced with a proprietary lentiviral vector backbone coding for humanized MNC2-scFv (the targeting head).
huMNC2-CAR44 CAR T cells or huMNC2-CAR22 CAR T cells @ RP2DBiological
huMNC2-CAR44 T cells or huMNC2-CAR22 CAR T cells are an autologous T cell product transduced with a proprietary lentiviral vector backbone coding for humanized MNC2-scFv (the targeting head) @ RP2D
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | Dose escalation or de-escalation is tested in cohorts of 3 patients each using standard "3+3" dose-finding. Receives: Biological: huMNC2-CAR44 CAR T cells or huMNC2-CAR22 CAR T cells |
| Luminal | Experimental | Dose Expansion - 15 patients will be enrolled with luminal (hormone receptor positive, HER2 negative) metastatic breast cancer. Receives: Biological: huMNC2-CAR44 CAR T cells or huMNC2-CAR22 CAR T cells @ RP2D |
| HER2+ | Experimental | Dose Expansion - 15 patients will be enrolled with HER2+ metastatic breast cancer. Receives: Biological: huMNC2-CAR44 CAR T cells or huMNC2-CAR22 CAR T cells @ RP2D |
| Triple Negative | Experimental | Dose Expansion - 15 patients will be enrolled with triple negative metastatic breast cancer. Receives: Biological: huMNC2-CAR44 CAR T cells or huMNC2-CAR22 CAR T cells @ RP2D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
To determine the safety and maximally tolerated cell dose (MTD) and recommended phase 2 cell dose (RP2D) of ex vivo expanded autologous huMNC2-CAR44 T cells or huMNC2-CAR22 CAR T cells for patients with advanced MUC1* positive breast cancer using CTCAE version 5.0 and Lee criteria.
Measured: Within 35 days after T cell infusion
Secondary outcomes (3)
In vivo persistence
Determine duration of in vivo persistence and phenotype of adoptively transferred huMNC2-CAR44 T cells or huMNC2-CAR22 CAR T cells.
Measured: Up to 365 days after the T cell infusion
Preliminary Antitumor Activity
Preliminary antitumor activity of the adoptive transfer of huMNC2-CAR44 T cells or huMNC2-CAR22 CAR T cells in all patients with measurable tumor prior to T cell transfer by RECIST 1.1
Measured: Up to 15 years
Antitumor Activity
Determine antitumor activity at MTD/RP2D of huMNC2-CAR44 T cells or huMNC2-CAR22 CAR T cells in patients with luminal breast cancer (hormone receptor positive, HER2 negative), HER2 positive breast cancer, and triple negative breast cancer (hormone receptor and HER2 negative) by RECIST 1.1 in expansion cohorts.
Measured: Up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start15 Jan 2020
- Primary completionJan 2025 (estimated)
- Study completion15 Jan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast CancerStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minerva Biotechnologies Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- City of Hope Medical Center
- Responsible party
- Sponsor
- Investigators
- Joanne Mortimer, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04020575
- Sponsor's protocol ID
- 10038
- Status last verified
- Jun 2023
- First submitted
- 12 Jul 2019
- Last updated
- 18 Jun 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gorodetska I, Samusieva A, Lahuta T, Ponomarova O, Socha O, Kozeretska I. Exploring New Frontiers: Alternative Breast Cancer Treatments Through Glycocalyx Research. Breast J. 2025 May 22;2025:9952727. doi: 10.1155/tbj/9952727. eCollection 2025.
PubMed 40443562
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adoptive Immunotherapy for Advanced MUC1* Positive Breast Cancer With Autologous T Cells Engineered to Express a Chimeric Antigen Receptor, huMNC2-CAR44 or huMNC2-CAR22, Specific for a Cleaved Form of MUC1 (MUC1*)
- ClinicalTrials.gov ID
- NCT04020575
- Acronym / sponsor ID
- 10038
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Minerva Biotechnologies CorporationIndustry (pharma, biotech, devices)
- Collaborators
- City of Hope Medical Center
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- 15 Jan 2035 (estimated)
- First posted
- 16 Jul 2019 (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.
Phase I/II study of adoptive immunotherapy for advanced MUC1* positive breast cancer with autologous T cells engineered to express either a chimeric antigen receptor, huMNC2-CAR44 or huMNC2-CAR22, which are specific for a cleaved form of MUC1 (MUC1*).
Detailed description
Recent trials have demonstrated that chimeric antigen receptor (CAR)-modified T cells (CAR-T cells) specific for the CD19 molecule can mediate marked tumor regression in a subset of patients with advanced acute lymphoblastic leukemia (ALL) and non-Hodgkin's lymphoma (NHL). It would be ideal to extend CAR-T cell therapy to common epithelial cancers. However, this poses several challenges, including the identification of molecules expressed on tumor cells that can be targeted safely with CAR-T cells. Minerva Biotechnologies has developed a CAR T product (huMNC2-CAR44 or huMNC2-CAR22) that targets the extra cellular domain of the cleaved form of MUC1 (called MUC1*), which is the form of MUC1 that functions as a growth factor receptor and is present on large percentage of solid tumors, including breast tumors. The antibody targeting head of huMNC2-CAR44 or huMNC2-CAR22 specifically recognizes a cancerous form of MUC1* and does not bind to another form of cleaved MUC1 that is present on some normal tissues that also have a rapid turnover. To be clear, patients will receive either huMNC2-CAR44 or huMNC2-CAR22, but not a combined product.
The huMNC2-CAR44 product consists of autologous T cells that are isolated from cancer patients, transduced with a proprietary lentiviral vector backbone manufactured under cGMP and containing sequences for a human CD8 alpha leader sequence, humanized MNC2-scFv (MUC1* targeting head), portions of human CD8 hinge and transmembrane domains, and human 4-1BB and human CD3-zeta costimulatory domains. The huMNC2-CAR44 transduced T cells are antigen-stimulated in vitro, with a synthetic MUC1* extracellular domain peptide. The CAR T cells are then ready for administration to the patient. Alternatively, the CAR T cells can be cryopreserved, then administered to the patient after thaw at bedside.
The huMNC2-CAR22 product is comprised of a CD8-α leader sequence, the huMNC2 scFv, a CD28 hinge and transmembrane region, followed by a CD28 co-stimulatory domain and a CD3-ζ signaling domain bearing two Tyrosine to Phenylalanine mutations in each of ITAMs 2 and 3 to minimize CAR T cell exhaustion and increase in vivo persistence. The huMNC2-CAR22 transduced T cells are not antigen-stimulated. The CAR T cells can be cryopreserved, then administered to the patient after thaw at bedside.
The investigators propose to evaluate the safety and preliminary anti-tumor activity of adoptively transferred autologous T cells genetically modified to express a CAR that targets MUC1*, huMNC2-CAR44 or huMNC2-CAR22, in Phase I/II clinical trials in patients with metastatic MUC1* positive breast cancers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Biological: huMNC2-CAR44 CAR T cells or huMNC2-CAR22 CAR T cellsDose escalation or de-escalation is tested in cohorts of 3 patients each using standard "3+3" dose-finding. |
| Luminal | Experimental | Biological: huMNC2-CAR44 CAR T cells or huMNC2-CAR22 CAR T cells @ RP2DDose Expansion - 15 patients will be enrolled with luminal (hormone receptor positive, HER2 negative) metastatic breast cancer. |
| HER2+ | Experimental | Biological: huMNC2-CAR44 CAR T cells or huMNC2-CAR22 CAR T cells @ RP2DDose Expansion - 15 patients will be enrolled with HER2+ metastatic breast cancer. |
| Triple Negative | Experimental | Biological: huMNC2-CAR44 CAR T cells or huMNC2-CAR22 CAR T cells @ RP2DDose Expansion - 15 patients will be enrolled with triple negative metastatic breast cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Confirmation of diagnosis of breast cancer by pathology review of initial or subsequent biopsy or other pathologic material at the City of Hope Pathology department. ER, PR, and HER2 status known and documented per ASCO/CAP guidelines.
- Expansion Cohort Hormone Receptor status HER2 status Luminal ER and/or PR >/=1% positive Negative by IHC or FISH HER2 positive Any ER or PR status Positive by IHC or FISH Triple Negative ER and PR <1% Negative by IHC or FISH
- Patients must have received standard metastatic systemic therapy per NCCN guidelines or institutional practice which are known to confer benefit. No maximum on number of prior systemic treatment regimens.
- MUC1* membrane expression ≥30% by immunohistochemistry on a tumor specimen obtained at screening or previous tumor specimen that is less than 6-months old (see Appendix I for examples of MUC1* expression patterns).
- Patients must be 18 years of age or older, of any gender, race or ethnicity.
Key exclusion criteria (21 listed)
- Patients requiring ongoing daily corticosteroid therapy at a dose of >15 mg of prednisone per day (or equivalent). Pulsed corticosteroid use for disease control is acceptable.
- Active autoimmune disease requiring immunosuppressive therapy is excluded unless discussed with the PI.
- Major organ dysfunction defined as:
- ANC <1000/mm^3.
- Hemoglobin <9 mg/dl (transfusion permitted to achieve this).
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 |
|---|---|---|
| huMNC2-CAR44 CAR T cells or huMNC2-CAR22 CAR T cellshuMNC2-CAR44 T cells or huMNC2-CAR22 CAR T cells are an autologous T cell product transduced with a proprietary lentiviral vector backbone coding for humanized MNC2-scFv (the targeting head). | Biological | Dose Escalation |
| huMNC2-CAR44 CAR T cells or huMNC2-CAR22 CAR T cells @ RP2DhuMNC2-CAR44 T cells or huMNC2-CAR22 CAR T cells are an autologous T cell product transduced with a proprietary lentiviral vector backbone coding for humanized MNC2-scFv (the targeting head) @ RP2D | Biological | HER2+, Luminal, Triple Negative |
Primary outcome
Incidence of Adverse Events
Time frame: Within 35 days after T cell infusion
To determine the safety and maximally tolerated cell dose (MTD) and recommended phase 2 cell dose (RP2D) of ex vivo expanded autologous huMNC2-CAR44 T cells or huMNC2-CAR22 CAR T cells for patients with advanced MUC1* positive breast cancer using CTCAE version 5.0 and Lee criteria.
3 secondary outcomes
In vivo persistence
Time frame: Up to 365 days after the T cell infusion
Preliminary Antitumor Activity
Time frame: Up to 15 years
Antitumor Activity
Time frame: Up to 15 years
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 18 Jun 2023.
- Derived from this study: PubMed 40443562Gorodetska I, Samusieva A, Lahuta T, Ponomarova O, Socha O, Kozeretska I. Exploring New Frontiers: Alternative Breast Cancer Treatments Through Glycocalyx Research. Breast J. 2025 May 22;2025:9952727. doi: 10.1155/tbj/9952727. eCollection 2025.
- 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.
Joanne Mortimer, MD principal investigator
City of Hope Medical 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 huMNC2-CAR44 CAR T cells or huMNC2-CAR22 CAR T cells and huMNC2-CAR44 CAR T cells or huMNC2-CAR22 CAR T cells @ RP2D in people with Metastatic Breast Cancer, run by Minerva Biotechnologies Corporation 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 17 inclusion and 21 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 18 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?
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 Joanne Mortimer, MD (1-800-826-4673, Minerva18625@coh.org), 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: Within 35 days after T cell infusion). 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 NCT04020575, which also lists 1 linked publication.
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 18 Jun 2023.