← Back to Search

CAR T-cell Therapy

CAR-Macrophages + Pembrolizumab for HER2 Positive Cancer

Phase 1

Waitlist Available

Research Sponsored by Carisma Therapeutics Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

HER2-positive recurrent or metastatic solid tumors for which there are no available curative treatment options

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial is testing a new cancer treatment involving CAR macrophages (a type of white blood cell) and HER2 overexpressing solid tumors (a type of cancer).

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Possible side effects include immune system reactions leading to inflammation in different parts of the body, infusion-related reactions from receiving drugs through veins, fatigue, potential worsening of pre-existing autoimmune conditions and allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am fully active or can carry out light work.

Select...

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

Select...

My breast or stomach cancer did not respond to previous HER2 treatments.

Select...

I am willing and able to have a biopsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assess the feasibility of manufacturing CT-0508 by describing the percentage of products passing release criteria.

Assess the safety and tolerability of CT-0508 by estimating the frequency and severity of adverse events in subjects with HER2 overexpressing solid tumors.

Assess the safety and tolerability of CT-0508 in combination with pembrolizumab by estimating the frequency and severity of adverse events in subjects with HER2 overexpressing solid tumors (CT-0508 and pembrolizumab substudy only)

Secondary outcome measures

Estimate progression-free survival (PFS).

Estimate the objective response rate (ORR), according to RECIST v1.1, of at least 1 dose of CT-0508 among subjects with HER2 overexpressing solid tumors.

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

Trial Design

4Treatment groups

Experimental Treatment

Group I: Intraperitoneal AdministrationExperimental Treatment1 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 2Experimental Treatment1 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 PembrolizumabExperimental Treatment2 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-0508Experimental Treatment1 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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Carisma Therapeutics IncLead Sponsor

1 Previous Clinical Trials

6 Total Patients Enrolled

Jeanett WetzelStudy DirectorCarisma Therapeutics

Ramona Swaby, MDStudy DirectorCarisma Therapeutics

Media Library

CAR-macrophages (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04660929 — Phase 1

Breast Cancer Research Study Groups: CT-0508 in Combination with Pembrolizumab, 89[Zr]radiolabeled CT-0508, Group 1 and Group 2, Intraperitoneal Administration

Breast Cancer Clinical Trial 2023: CAR-macrophages Highlights & Side Effects. Trial Name: NCT04660929 — Phase 1

CAR-macrophages (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04660929 — Phase 1

Breast Cancer Patient Testimony for trial: Trial Name: NCT04660929 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is CT-0508 a viable option for risk mitigation?

"The safety of CT-0508 was largely unknown, so it received a score of 1. This is because this trial is in its early stages and there has been scant evidence to suggest efficacy or lack thereof."

Answered by AI

Is participation in this study currently available to potential subjects?

"Affirmative. Clinicaltrials.gov exhibits that the medical experiment, which was first put online on February 2nd 2021, is actively enrolling participants. A total of 18 individuals must be recruited from 5 sites to complete this research endeavour."

Answered by AI

How many sites are offering the trial administration?

"This clinical trial is enrolling patients at Abramson Cancer Center in Philadelphia, Tennessee Oncology/Sarah Cannon Research Institute in Nashville, and M D Anderson Cancer Center in Houston. Additionally, there are 5 other sites participating."

Answered by AI

How many participants are being observed during this experiment?

"To join this medical trial, 18 suitable candidates need to be recruited. These individuals can come from two separate locations: Abramson Cancer Center in Philadelphia and the Sarah Cannon Research Institute located in Nashville, Tennessee."

Answered by AI