CAR-Macrophages + Pembrolizumab for HER2 Positive Cancer

Recruiting at 6 trial locations

Overseen By Ramona Swaby, MD, Vice President - Clinical Development

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Carisma Therapeutics Inc

Must not be taking: Corticosteroids, Immunosuppressants

Disqualifiers: HIV, Hepatitis B/C, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 week

48 Participants Needed

Trial Summary

What is the purpose of this trial?

Phase 1, first-in-human, open label study of CAR macrophages in HER2 overexpressing solid tumors.

Research Team

Jeanett Wetzel

Principal Investigator

Carisma Therapeutics

Eligibility Criteria

This trial is for adults with HER2-positive solid tumors that have no curative treatments left. They must have tried all standard therapies, and if they have breast or gastric cancers, also failed HER2-targeted drugs. Participants need to be relatively healthy (ECOG 0-1) and able to undergo biopsies. Those with heart issues, active autoimmune diseases, organ transplants, certain infections or severe allergies to the study drug can't join.

Inclusion Criteria

My cancer is HER2-positive, has returned or spread, and cannot be cured with available treatments.

I am fully active or can carry out light work.

My HER2-positive cancer has not responded to standard treatments.

Exclusion Criteria

I have received an organ or tissue transplant from another person.

I have an immune system disorder or I'm on long-term steroids or other drugs that weaken my immune system.

You have a severe allergic reaction to pembrolizumab or any of its ingredients.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CT-0508, with or without pembrolizumab, through IV or IP administration with dose escalation over several days

1 week

Multiple visits for dose escalation on Days 1, 3, and 5

Follow-up

Participants are monitored for safety and effectiveness after treatment, including progression-free survival and objective response rate assessments

24 months

Safety Monitoring

Assess the safety and tolerability of CT-0508, including frequency and severity of adverse events

14 months

Treatment Details

Interventions

• CAR-macrophages

Trial Overview The trial is testing a new therapy called CT-0508 in combination with an existing cancer drug named Pembrolizumab on patients with various types of advanced cancer that overexpresses HER2 protein. It's a phase 1 study which means it's the first time this treatment is being used in humans to check its safety.

Participant Groups

Group I: Intraperitoneal Administration Experimental Treatment 1 Intervention

All cohorts will receive the full dose manufactured per patient. Cohorts 1-3 will undergo intrasubject dose escalations of IP administration as follows: Cohort 1 up to 500 million total cells on Day 1, up to 1 billion total cells on Day 3 and up to 1.5 billion total cells on Day 5. Cohort 2 up to 1.5 billion total cells on Day 1, up to 2 billion total cells on Day 3 and any remaining cells on Day 5. Cohort 3 up to 2.5 billion total cells on Day 1 and up to 2.5 billion total cells on Day 3. Cohort 4 will 1 dose on Day 1 of up to 5 billion total cells.

Group II: Group 1 and Group 2 Experimental Treatment 1 Intervention

Both groups will receive the full dose manufactured per patient. Group 1 will undergo intra subject dose escalation of IV administrations of up to 500 million total cells on Day 1, up to 1.5 billion total cells on Day 3, and up to 3.0 billion total cells on Day 5. Group 2 will receive the full dose IV on Day 1 of up to 5 billion cells total.

Group III: CT-0508 in Combination with Pembrolizumab Experimental Treatment 2 Interventions

All regimen levels will receive the full dose manufactured per patient up to 5 billion total cells. Regimen Levels 1 and 2 will undergo intrasubject dose escalations of IV administration as follows: Regimen Level 1: up to 500 million total cells on Day 1, up to 1.5 billion total cells on Day 3, and up to 3.0 billion total cells on Day 5 plus pembrolizumab 200 mg q3w starting on Day 8. Regimen Level 2: up to 500 million total cells on Day 1, up to 1.5 billion total cells on Day 3, and up to 3.0 billion total cells on Day 5 plus pembrolizumab 200 mg q3w starting on Day 1. Regimen Level 3 will receive the full dose IV on Day 1 of up to 5 billion total cells plus pembrolizumab 200 mg q3w starting on Day 1.

Group IV: 89[Zr]radiolabeled CT-0508 Experimental Treatment 1 Intervention

89\[Zr\] radiolabeled group will receive a full dose IV on Day 1 of up to 500 million total cells of 89\[Zr\] radiolabeled CT-0508 and non-radiolabeled CT-0508 of up to 4.5 billion total cells (Univ of Penn Abramson Cancer Center only).

Who Is Running the Clinical Trial?

Carisma Therapeutics Inc

Lead Sponsor

Trials

2

Recruited

50+