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HER2-positivePhase 1NCT06254807

CAR-monocytes for the Treatment of HER2 Overexpressing Solid Tumors

A Phase 1 study testing CT-0525 in people with HER2-positive, run by Carisma Therapeutics Inc at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a first-in-human open-label study to evaluate the safety and tolerability, and manufacturing feasibility of anti-HER2 CAR-monocytes (CT-0525) in participants with locally advanced (unresectable) or metastatic solid tumors overexpressing HER2 whose disease has progressed on standard approved therapies. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HER2-positive
What is being tested?
CT-0525
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
8 Jan 2024to 31 Mar 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Tumor tissue that is HER2-positive, following most recent therapy, by IHC using standard local assay resulting in 3+, or 2+ with confirmation by ISH testing. IHC and ISH assays and interpretation must follow the most recent ASCO/CAP guidelines and be performed in an accredited laboratory. Other tumor types (non-breast, non gastroesophageal) will be tested according to the breast cancer ASCO/CAP guidelines.
  • Histologically confirmed recurrent or metastatic solid HER2-positive tumor for which there are no available curative treatment options, AND after failure of the following systemic therapies used for the treatment of recurrent (unresectable) and/or metastatic disease:
  • Any participant with HER2-positive breast or gastroesophageal cancers who has previously been treated with at least 2 FDA approved anti-HER2 therapies in the advanced/metastatic setting, including, but not limited to checkpoint inhibitors (i.e., PD-1/L1 inhibitors) and/or other targeted therapies for actionable molecular alterations (e.g., EGFR, ALK, ROS-1, BRAF, RET, MET, KRAS);
  • Other HER2-positive tumor types must have progressed following treatment with at least 2 prior standard of care lines of therapy, including, but not limited to checkpoint inhibitors (i.e., PD-1/L1 inhibitors) and/or other targeted therapies for actionable molecular alterations (e.g., EGFR, ALK, ROS-1, BRAF, RET, MET, KRAS).
  • Participant must be willing and able to undergo on-study tumor tissue biopsy procedures to provide samples for biomarker analysis pre- and post-CT-0525 infusion:
  • A participant whose tumor is not amenable to perform a safe post-baseline biopsy for the post-baseline translational studies may be allowed on the trial by mutual agreement of the Principal Investigator and Sponsor;
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  • Archived tumor tissue biopsy taken after progression on the most recent therapy is acceptable to be used in lieu of a pre-treatment biopsy for translational studies.
  • At least one measurable lesion (that will not be biopsied for eligibility and/or translational protocol requirements) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the Investigator/site.
  • Eastern Cooperative Oncology Group (ECOG) Performance status 0-1 at screening.
  • Must have adequate hepatic function, as follows:
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels less than or equal to 3.0 x upper limit of normal (ULN) (less than or equal to 5 x ULN for participants with liver metastases) according to reference lab;
  • Total bilirubin < 1.5 x ULN or direct bilirubin < 1.5 x ULN if total bilirubin is > 1.5 x ULN according to reference lab; for participants with Gilbert's syndrome total bilirubin < 3.0 mg/dL and direct bilirubin < 1.5 mg/dL.
  • Must have adequate cardiac function as follows:
  • Class 0 or I/II cardiovascular disability according to the New York Heart Association Classification (Chavey, 2001);
  • No history of unstable angina and/or myocardial infarction within 6 months prior to screening;
  • Left ventricular ejection fraction (LVEF) less than or equal to 50% as determined by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA).
  • Must have an O2 saturation > 85%.
  • Pregnancy and Contraception/Barriers Female subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year, must be willing to use 1 highly effective method of birth control (as per Clinical Trial Facilitation Group [CTFG] guidance 2020), be surgically sterile, or abstain from heterosexual activity for the duration of the study through 120 days after the last dose of study medication. Refer to Appendix 4 for contraception guidance for female participants (Section 10.4).
  • Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Refer to Appendix 4 for contraception guidance for female participants (Section 10.4).
  • Male participants who are partnered with female participants of childbearing potential should be willing to use 1 highly effective method (as per Clinical Trial Facilitation Group [CTFG] guidance 2020) of birth control, be surgically sterile, or abstain from heterosexual activity for the duration of the study through 120 days after the last day of study medication.

Who cannot join

  • Medical Conditions
  • Pregnant or lactating women. The safety of this therapy on unborn children is not known. Female study subjects of reproductive potential must have a negative urine pregnancy test at enrollment. The urine pregnancy test will need to be repeated prior to treatment if greater than 4 weeks has lapsed between the enrollment pregnancy test and treatment.
  • Known and previously documented human immunodeficiency virus (HIV) infection. Screening HIV test is not required in the absence of history or clinical suspicion.
  • Active hepatitis B or hepatitis C infection.
  • Diagnosis of immunodeficiency or exposure to systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
  • Nasal or oral inhalers are permissible.
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  • Physiologic replacement doses of steroids (mineralocorticoid or less than or equal to a prednisone 10 mg daily dose) are permissible.
  • Any uncontrolled active medical disorder that would preclude participation as outlined.
  • Untreated or symptomatic central nervous system (CNS) metastases or cytology proven carcinomatous meningitis.
  • Participants with arrhythmias that are not stable on medical management, within 2 weeks of the Screening/Enrollment visit.
  • Known additional active and invasive malignancy within 5 years, other than the HER2 overexpressing malignancy being treated in this study.
  • Exceptions include surgically cured non-melanoma skin cancers, noninvasive bladder tumors, or in situ breast or cervical cancer.
  • Uncontrolled acute bacterial, viral, or fungal infection (eg, blood culture positive less than or equal to 72 hours prior to study treatment) or any other clinically significant disease that, in the opinion of the investigator, would pose a risk to participant safety or interfere with the study evaluation, procedures or completion.
  • Prior/Concomitant Therapy
  • Known history of allergy or hypersensitivity to human granulocyte colony-stimulating factors such as filgrastim or pegfilgrastim, or study product excipients including human serum albumin, Cryostor (DMSO or Dextran 40), or Plasma-Lyte.
  • Concurrent receipt of another anti-cancer therapy.
  • Note: To be considered for inclusion in this study the following washout periods prior to apheresis must be completed as follows:
  • Cytotoxic chemotherapy - 2 weeks;
  • Tyrosine kinase/small molecule inhibitor - 2 weeks;
  • Biologic therapy/monoclonal antibody - 4 weeks;
  • Radiation therapy - 2 weeks;
  • Prior investigational agent(s) - at least 5 half-lives of the agent in question, or 28 days, whichever is shorter prior to enrollment into the trial;
  • With the exception of alopecia and the above Inclusion Criteria, participants must have recovered from prior treatment related toxicities with residual toxicity no greater than Grade 1 per CTCAE v.5.
  • Prior/Concurrent Clinical Study Experience
  • Currently participating in or has participated in a study of an investigational agent or using an investigational device within 2 weeks of CT-0525 apheresis (4 weeks if investigational agent is a biologic/monoclonal antibody).
  • Participants with previous cell therapy exposure may be eligible after discussion with the Sponsor.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Cincinnati

    Cincinnati, Ohio, 45267

Other trials in United States

About this study

Official title: An Open-Label, Single-Arm Study of Autologous Anti-HER2 Chimeric Antigen Receptor Monocytes (CT-0525), in Participants With HER2 Over Expressing Solid Tumors

This is a first-in-human open-label study to evaluate the safety and tolerability, and manufacturing feasibility of anti-HER2 CAR-monocytes (CT-0525) in participants with locally advanced (unresectable) or metastatic solid tumors overexpressing HER2 whose disease has progressed on standard approved therapies.

Conditions
HER2-positive
Being tested
CT-0525

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CT-0525Drug

    Autologous monocyte engineered to contain an anti-HER2 chimeric antigen receptor

Study groups in NCT06254807
Study groupRoleWhat they receive
CT-0525ExperimentalCohort 1: 3 participants will be treated with a single IV administration of CT-0525 (3 billion CAR positive cells) on Day 1. Cohort 2: 3 participants will be treated with a single IV administration of CT-0525 (10 billion CAR positive cells) on Day 1.
Receives: Drug: CT-0525

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assess the safety and tolerability of CT-0525 by estimating the frequency and severity of adverse events in participants with HER2 overexpressing solid tumors.

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

    Measured: Day 28

  2. Assess the feasibility of manufacturing CT-0525.

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

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2024
  2. Study start8 Jan 2024
  3. Primary completion31 Mar 2025 (estimated)
  4. Study completion31 Mar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06254807
Sponsor's protocol ID
Study 102
Status last verified
Apr 2024
First submitted
2 Feb 2024
Last updated
19 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CT-0525 in people with HER2-positive, run by Carisma Therapeutics Inc at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assess the safety and tolerability of CT-0525 by estimating the frequency and severity of adverse events in participants with HER2 overexpressing solid tumors. (time frame: Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06254807.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2024.

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