Treatment of solid tumors with genetically modified patients' own T-cells recognizing a particular tumor marker

Phase 1

• Conditions: Recurrent and / or refractory solid tumors; Therapeutic area: Diseases [C] - Cancer [C04]; MedDRA version: 21.1Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2019-002370-31-DE
• Lead Sponsor: Immatics US InC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-22
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 476

Inclusion Criteria

Eligibility Criteria: Initial Screening (HLA Screening, Biomarker Screening, and Leukapheresis):
1. Patient must have voluntarily signed a written ICF1
2.Patient must have pathologically confirmed advanced and/or metastatic solid tumor.
3.Patients = 18 years of age
4.ECOG PS 0 to 1
5.HLA phenotype: HLA-A*02:01 positive
6.The patient has adequate pulmonary function.
7.The patient has adequate organ and marrow function
8.Acceptable coagulation status
9.The patient has adequate hepatic and renal function
10.For leukapheresis eligibility, patient’s tumor must express IMA203/IMA203CD8-specific tumor biomarker
11. For HCC patients: an upper endoscopy is required

Eligibility Criteria: Treatment Screening (Prior to Lymphodepletion and IMA202 Infusion):
1.Patient must have voluntarily signed a written ICF2
2.Life expectancy > 3 months
3.ECOG PS 0 to 1
4.The patient has adequate hepatic function
5.The patient must have adequate renal function
6.Patients must have measurable disease according to RECIST 1.1
7. Confirmed and adequate production timelines and capacities
8.Patients must have recurrent and/or refractory solid tumors and must have received or not be eligible for all available indicated standard of care treatments.
9. For HCC patients only: Child Pugh score = 6
10.Female patients of childbearing potential must use adequate contraception
11.Male patients must agree to use effective contraception
12.The patient must have recovered from any side effects of prior therapy

Extension cohort B Eligibility Criteria: Nivolumab Treatment:
1. Patients have adequately recovered organ and marrow function
Note: Eligibility for combination treatment may be assessed at Day 14 or Day 21.
2. Patients must have recovered from infections to Grade 1 or lower
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 314
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 162

Exclusion Criteria

Eligibility Criteria: Initial Screening (HLA Screening, Biomarker Screening, and Leukapheresis):
1.History of other malignancies
2. Solid tumors indications with low target prevalence as indicated by the sponsor
3.The patient is pregnant or is breastfeeding
4.Patients with prior allogenic stem cell transplantation or solid organ transplantation
5.History of hypersensitivity to CY, FLU or IL-2 and Rescue medication
6.The patient has received systemic corticosteroids within 2 weeks prior to leukapheresis. The patient has received other anti-tumor therapies.
7.The patient has concurrent severe and/or uncontrolled medical disease
8.Any other condition that would, in the investigator’s or sponsor’s judgment, contraindicate the patient’s participation in the clinical study
9. Patient with any active infection (e.g., COVID-19, influenza, SARS)

Eligibility Criteria: Treatment Screening (Prior to Lymphodepletion and IMA203 Infusion):
1.Patients with active brain metastases
2.The patient has received any anti-tumor therapy chemotherapy, radiotherapy, or investigational therapies within 1 week prior to
lymphodepletion; Patients must have completed any major surgery at least 4 weeks prior to lymphodepletion
3.Patient, in the judgment of the investigator, is not able to tolerate lymphodepletion, low dose IL-2, and/or IMA203/IMA203CD8 treatment
4.The patient is pregnant or is breastfeeding
5.The patient has concurrent severe and/or uncontrolled medical disease
6.Patient with any active infection (e.g., COVID-19, influenza, SARS)
7.Concurrent treatment in an another clinical trial or a device study that could interfere with the IMA203/IMA203CD8 treatment after signature of ICF2.
8. Any condition that would, in the investigator’s or sponsor’s judgment, contraindicate the patient’s participation in the clinical study because of safety concerns or compliance with clinical study procedures

Extension cohort B Eligibility Criteria: Nivolumab Treatment:
1. Patients with a history of severe immune-related toxicities, defined as any Grade 3 or 4 toxicities related to prior PD1/PD-L1 inhibitor therapy (e.g., atezolizumab, pembrolizumab or nivolumab etc.).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified