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ACTengine® IMA203/IMA203CD8 as Monotherapy or in Combination With Nivolumab in Recurrent and/or Refractory Solid Tumors

NCT03686124 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 375

Last updated 2026-05-13

No results posted yet for this study

Summary

The study's purpose is to establish the safety and tolerability of IMA203/IMA203CD8 products with or without combination with nivolumab in patients with solid tumors that express preferentially expressed antigen in melanoma (PRAME).

Conditions

  • Refractory Cancer
  • Recurrent Cancer
  • Solid Tumor, Adult
  • Cancer

Interventions

BIOLOGICAL

IMA203 Product

The cell dose will be based on viable CD3+CD8+ HLA- Dextramer+ cells per body surface area (BSA) as defined by the Mosteller formula

BIOLOGICAL

IMA203 product- flat dose

The cell dose will be based on viable CD3+CD8+ HLA- Dextramer+ cells

BIOLOGICAL

IMA203CD8 Product

The cell dose will be based on viable CD3+CD8+ HLA- Dextramer+ cells per body surface area (BSA) as defined by the Mosteller formula

DRUG

Nivolumab

Nivolumab will be given post IMA203/IMA203CD8 infusion, after hematologic recovery is achieved. Clinical supply provided by Bristol Myers Squibb.

DEVICE

IMADetect®

IMADetect® is developed as a companion diagnostic to aid in selecting patients with relapsed and/or refractory solid cancers who might be eligible for enrollment in Immatics clinical trials.

Sponsors & Collaborators

  • Immatics US, Inc.

    lead INDUSTRY

Principal Investigators

  • Cedrik Britten, M.D. · Immatics US, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-14
Primary Completion
2028-12-31
Completion
2032-06-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Germany

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03686124 on ClinicalTrials.gov