CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors

Sponsor
Carisma Therapeutics Inc (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04660929
Collaborator
(none)
18
Enrollment
4
Locations
1
Arm
24
Anticipated Duration (Months)
4.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Detailed Description

A Phase 1, First in Human Study of Adenovirally Transduced Autologous Macrophages Engineered to Contain an Anti-HER2 Chimeric Antigen Receptor in Subjects with HER2 Overexpressing Solid Tumors

Study Design

Study Type:
Interventional
Anticipated Enrollment :
18 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1, First in Human Study of Adenovirally Transduced Autologous Macrophages Engineered to Contain an Anti-HER2 Chimeric Antigen Receptor in Subjects With HER2 Overexpressing Solid Tumors
Actual Study Start Date :
Feb 2, 2021
Anticipated Primary Completion Date :
Feb 1, 2022
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: Group 1 and Group 2

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.

Biological: CT-0508
anti-HER2 CAR macrophages

Outcome Measures

Primary Outcome Measures

  1. Assess the safety and tolerability of CT-0508 by estimating the frequency and severity of adverse events in subjects with HER2 overexpressing solid tumors. [14 months]

    Frequency and severity of adverse events including, but not limited to, estimating frequency and severity of Cytokine Release Syndrome (CRS)

  2. Assess the feasibility of manufacturing CT-0508 by describing the percentage of products passing release criteria. [12 months]

    Percentage of products that pass release criteria among all manufactured products.

Secondary Outcome Measures

  1. 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. [24 months]

    Proportion of subjects with an objective response (either a complete response [CR] or partial response [PR]) in subjects who received at least 1 dose of CT-0508 and at least the 8-week tumor evaluation as determined by the investigator using RECIST v1.1.

  2. Estimate progression-free survival (PFS). [24 months]

    Defined as the time between the date of first dose and the date of first documented disease progression as determined by the investigator using RECIST v1.1 or death due to any cause, whichever occurs first. Defined as the time between the date of first dose and the date of first documented disease progression as determined by the investigator using RECIST v1.1 or death due to any cause, whichever occurs first.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • HER2-positive recurrent or metastatic solid tumors for which there are no available curative treatment options.

  • Breast cancer and gastric/gastroesophageal junction cancers must have failed approved HER2-targeted agents.

  • Other HER2-positive tumor types must have failed standard of care therapies, while prior therapy with anti-HER2 drugs is not required.

  • Subject must be willing and able to undergo tumor tissue biopsy procedures

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

  • Subject has adequate bone marrow and organ function

Exclusion Criteria:
  • HIV, active hepatitis B or hepatitis C infection.

  • Diagnosis of immunodeficiency or chronic exposure to systemic corticosteroid therapy or any other form of immunosuppressive therapy

  • Untreated or symptomatic central nervous system (CNS) metastases or cytology proven carcinomatous meningitis.

o Subjects with small, asymptomatic CNS metastases that do not require treatment are permitted to enroll.

  • Left ventricular ejection fraction (LVEF) <50% as determined by ECHO or multiple gated acquisition scan (MUGA)

Other protocol-defined Inclusion/Exclusion may apply.

-

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1City of Hope National Medical CenterDuarteCaliforniaUnited States91010
2UNC Lineberger Comprehensive Cancer CenterChapel HillNorth CarolinaUnited States27599
3Abramson Cancer CenterPhiladelphiaPennsylvaniaUnited States19104
4M D Anderson Cancer CenterHoustonTexasUnited States77030

Sponsors and Collaborators

  • Carisma Therapeutics Inc

Investigators

  • Study Director: Debora Barton, MD, Carisma Therapeutics

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Carisma Therapeutics Inc
ClinicalTrials.gov Identifier:
NCT04660929
Other Study ID Numbers:
  • 101
First Posted:
Dec 9, 2020
Last Update Posted:
Nov 17, 2021
Last Verified:
Nov 1, 2021

Study Results

No Results Posted as of Nov 17, 2021