TCR-engineered T Cells in Solid Tumors: IMA202-101

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The study purpose is to establish the safety and tolerability of IMA202 product in patients with solid tumors that express melanoma-associated antigen 1 (MAGEA1).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Immatics US, Inc.
• Collaborator: M.D. Anderson Cancer Center

Criteria

Inclusion Criteria:

• 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

• Measurable disease and accessible to biopsy

• Adequate pulmonary function per protocol

• Acceptable 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 IMA202 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

• IMA202 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 IMA202

• Male patient must agree to use effective contraception or be abstinent while on study and for 6 months after the infusion of IMA202

• Hepatocellular carcinoma (HCC) patients with liver cirrhosis only - upper endoscopy is required within 6 months of study entry

• 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), IL-2, or 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 IMA202 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.