| Eligibility |
Inclusion Criteria:
- Patient = 18 years of age
- Pathologically confirmed advanced and/or metastatic solid tumor
- Patients may enter screening procedure before, during, or after the last available
indicated standard of care treatment. There is no limitation for prior anti cancer
treatments.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- HLA phenotype positive for the study
- Patients must have measurable disease according to RECIST 1.1
- Disease accessible to biopsy
- Adequate pulmonary function per protocol
- Adequate organ and bone marrow function per protocol
- Acceptable coagulation status per protocol
- Adequate hepatic function per protocol
- Adequate renal function per protocol
- Patient's tumor must express tumor antigen by qPCR using a fresh tumor biopsy specimen
- Life expectancy more than 3 months
- Confirmed availability of production capacities for IMA201 product
- Patients must have recurrent/progressing and/or refractory solid tumors and must have
received or not be eligible for all available indicated standard of care treatment.
- For hepatocellular carcinoma (HCC) patients only, Child-Pugh score of = 6
- IMA201 product must have passed all of the release tests
- Female patient of childbearing potential must use adequate contraception prior to
study entry until 12 months after the infusion of IMA201
- Male patient must agree to use effective contraception or be abstinent while on study
and for 6 months after the infusion of IMA201
- The patient must have recovered from any side effects of prior therapy to Grade 1 or
lower (except for non-clinically significant toxicities; e.g., alopecia, vitiligo)
prior to lymphodepletion. As determined by the investigator, the patient may still be
eligible if the patient has not fully recovered from Grade = 2 toxicities if these
toxicities are not anticipated to further improve (e.g., chronic neuropathy) and such
toxicities are not anticipated to worsen with the lymphodepletion therapy
Exclusion Criteria:
- History of other malignancies (except for adequately treated basal or squamous cell
carcinoma or carcinoma in situ) within the last 3 years
- Solid tumors with low likelihood of tumor biomarker expression per protocol
- Pregnant or breastfeeding
- Serious autoimmune disease Note: At the discretion of the investigator, these patients
may be included if their disease is well controlled without the use of
immunosuppressive agents.
- History of cardiac conditions as per protocol
- Prior stem cell transplantation or solid organ transplantation
- Concurrent severe and/or uncontrolled medical disease that could compromise
participation in the study
- History of hypersensitivity to cyclophosphamide (CY), fludarabine (FLU), or IL-2, or
to any of the rescue medications
- History of or current immunodeficiency disease or prior treatment compromising immune
function at the discretion of the treating physician
- HIV infection, active hepatitis B virus (HBV), active hepatitis C virus (HCV)
infection, ongoing active anti-HCV treatment or detectable HBV or HCV viral load at
the most recent laboratory report. Patients with both HBV and HCV infections will be
excluded from screening
1. Patients with a history of HCV infection and with an undetectable viral load per
the most recent laboratory report and/or completed anti-HCV treatment but are HCV
antibody positive are permitted.
2. History of treated HBV infection is permitted if the viral load is undetectable
per the most recent laboratory report. Note: HCC patients with controlled HBV
infection, as defined by resolved (anti-hepatitis B surface antigen [HBs-Ag]
antibody (Ab) negative, anti-core antigen [HBc Ag] Ab positive) or chronic stable
(anti HBs-Ag Ab positive) HBV infection will be eligible for screening. Patients
with active HBV infection who are not on anti-HBV treatment will be excluded.
- Any condition contraindicating leukapheresis, lymphodepletion, low-dose IL-2, and/or
IMA201 treatment
- Patients with any active viral infection
- Patients with active brain metastases
NOTE: Patients with a history of brain metastases may be eligible, if an imaging scan with
contrast enhancement not older than 4 weeks is able to exclude the existence of currently
active brain metastasis, and steroid therapy has been discontinued for =2 weeks.
- Treatment with protocol-defined excluded treatments, medical devices, and/or
procedures per protocol
- Concurrent participation in an interventional part of another clinical trial
|
