CT-0508 for HER2-positive Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
HER2-positive Breast Cancer+33 MoreCT-0508 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

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).

Eligible Conditions
  • HER2-positive Breast Cancer
  • Ovarian Cancer
  • Small Cell Carcinoma
  • Squamous Cell Carcinoma
  • Endometrial Cancer
  • Biliary Tract Cancer
  • Breast Cancer
  • Inflammatory Breast Cancer
  • Small Cell Lung Cancer
  • Ovarian Tumors
  • Cholangiocarcinoma
  • Colorectal Cancer
  • Cancer
  • HER2 Positive
  • HER2 Positive Breast Cancer
  • Transitional Cell Carcinoma
  • Stomach Tumors
  • Head and Neck Cancer
  • Hepatocellular Carcinoma
  • Prostate Cancer
  • Adenocarcinoma
  • Bladder Cancer
  • Non-Small Cell Lung Cancer
  • Esophagogastric Junction Cancer
  • Ductal Carcinoma
  • Pancreatic Cancer
  • HER2 Positive Gastric Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 2 Secondary · Reporting Duration: 24 months

12 months
Assess the feasibility of manufacturing CT-0508 by describing the percentage of products passing release criteria.
14 months
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)
24 months
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.

Trial Safety

Safety Progress

1 of 3

Side Effects for

Pembrolizumab Second Course
100%Parkinsonism
100%Urinary tract infection
100%Inappropriate antidiuretic hormone secretion
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab Second Course ARM group. Side effects include: Parkinsonism with 100%, Urinary tract infection with 100%, Inappropriate antidiuretic hormone secretion with 100%.

Trial Design

4 Treatment Groups

89[Zr]radiolabeled CT-0508
1 of 4
Intraperitoneal Administration
1 of 4
CT-0508 in Combination with Pembrolizumab
1 of 4
Group 1 and Group 2
1 of 4

Experimental Treatment

48 Total Participants · 4 Treatment Groups

Primary Treatment: CT-0508 · No Placebo Group · Phase 1

89[Zr]radiolabeled CT-0508
Biological
Experimental Group · 1 Intervention: CT-0508 · Intervention Types: Biological
Intraperitoneal Administration
Biological
Experimental Group · 1 Intervention: CT-0508 · Intervention Types: Biological
CT-0508 in Combination with PembrolizumabExperimental Group · 2 Interventions: Pembrolizumab, CT-0508 · Intervention Types: Biological, Biological
Group 1 and Group 2
Biological
Experimental Group · 1 Intervention: CT-0508 · Intervention Types: Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2240

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months

Who is running the clinical trial?

Carisma Therapeutics IncLead Sponsor
Debora Barton, MDStudy DirectorCarisma Therapeutics
2 Previous Clinical Trials
1,075 Total Patients Enrolled
Ramona Swaby, MDStudy DirectorCarisma Therapeutics

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have HER2-positive recurrent or metastatic solid tumors for which there are no curative treatments currently available.
Your breast cancer or gastric/gastroesophageal junction cancers have not responded to HER2-targeted treatments.
Other HER2-positive tumor types must have had unsuccessful responses to conventional treatments, although prior usage of anti-HER2 medications is not mandatory.
You are willing and capable of undergoing a tumor biopsy.
Your ECOG performance status is 0 or 1.
You possess satisfactory bone marrow and organ functioning.