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New treatment option for Metastatic Breast Cancer
Official title Autologous huMNC2-CAR44 or huMNC2-CAR22 T Cells for Breast Cancer Targeting Cleaved Form of MUC1 (MUC1*)
ClinicalTrials.gov ID: NCT04020575
What this study is testing
What is huMNC2-CAR44 CAR T cells or huMNC2-CAR22 CAR T cells?
huMNC2-CAR44 CAR T cells or huMNC2-CAR22 CAR T cells is an investigational medicine, being studied as a potential treatment for metastatic breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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\ ).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Please note that results of tests and/or procedures conducted as per standard of care purposes may be used for research purposes if conducted within...
- Confirmation of diagnosis of breast cancer by pathology review of initial or subsequent biopsy or other pathologic material at the City of Hope...
- 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...
- Dose expansion cohorts Expansion Cohort Hormone Receptor status HER2 status Luminal ER and/or PR \>/=1% positive Negative by IHC or FISH HER2...
- Patients must have received standard metastatic systemic therapy per NCCN guidelines or institutional practice which are known to confer benefit. No...
You likely can't join if
- Patients requiring ongoing daily corticosteroid therapy at a dose of \>15 mg of prednisone per day (or equivalent). Pulsed corticosteroid use for...
- 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...
See the full eligibility criteria
Who can join
- Please note that results of tests and/or procedures conducted as per standard of care purposes may be used for research purposes if conducted within the protocol-defined window prior to screening/leukapheresis and/or...
- 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...
- 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...
- 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...
- 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.
- 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...
- 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.
What rules you out
- 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
- 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) \<...
- Significant cardiovascular abnormalities as defined by any one of the following: i. NYHA class III or IV congestive heart failure, ii. clinically significant hypotension, iii. uncontrolled symptomatic coronary artery...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.