RecruitingPhase 1

FT836 With or Without Chemotherapy and/or Monoclonal Antibodies, in Participants With Advanced Solid Tumors

A Phase 1, Open-Label Study of FT836, an Off-the-Shelf CAR T-Cell Therapy, With or Without Chemotherapy and/or Monoclonal Antibodies, in Participants With Advanced Solid Tumors

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This early-stage study tests FT836 alone or with chemotherapy, trastuzumab, cetuximab, or a mix of these drugs. It checks safety, side effects, and the best dose for the next study phase. It is for people with advanced solid tumors that cannot be cured and have returned or grown after treatment.

This is a Phase 1 study of FT836 administered in participants with advanced solid tumors. The primary objectives of the study are to evaluate the safety and tolerability of FT836 with or without chemotherapy and/or trastuzumab or cetuximab, and to determine the recommended phase 2 dose (RP2D) of FT836 with or without chemotherapy and/or trastuzumab or cetuximab

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Cancer cannot be treated with a cure and has returned or grown after at least one treatment that works throughout the body.
  • Blood counts, kidney and liver tests, and oxygen levels meet the study's safety limits.
  • Able to do all usual activities, or able to walk and do light work despite some limits on hard physical activity.
  • Cancer can be measured on scans done within 28 days before study treatment starts.
  • Have a tumor that can be safely sampled during treatment and agree to these biopsies (removal of small tissue samples). The tumor must meet size rules unless an exception is approved.

Who can't join

  • Serious heart disease, such as uncontrolled heart rhythm problems, a heart attack in the past 6 months, unstable chest pain, heart failure that meets the study's limits, or heart pumping strength below 50%.
  • Recent cancer treatment, radiation, or an experimental treatment: within 2 weeks before study treatment, or a shorter time based on how long the drug stays in the body.
  • Active cancer in the brain or spinal cord. Past cancer there may be allowed if treated, with no symptoms without steroids, stable scans, and no cancer in the surrounding lining for at least 4 weeks.
  • A brain or spinal cord condition not caused by cancer, such as stroke, epilepsy, inflamed blood vessels, or a disease that damages nerves, or medicine for these conditions within the past 6 months.
  • Need medicines that weaken the immune system from the start of study treatment through Day 29, such as prednisone at 5 mg or more daily. Some steroids used before chemotherapy or required by the study are allowed.
  • Past severe immune-related side effects or moderate or worse eye damage from cancer immunotherapy. Exceptions include hormone problems controlled with replacement hormones and raised levels of certain pancreas enzymes without symptoms.
  • Moderate or worse nerve damage outside the brain and spinal cord that limits daily tasks, such as shopping or housework.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * For all regimens, disease that is not amenable to curative therapy and that has relapsed or progressed following at least one line of prior systemic therapy. * Evidence of adequate organ function as determined by all of the following: * Absolute neutrophil count (ANC) \>1000/µL without growth factor support within 7 days prior to start of first study intervention * Platelet count ≥75,000/µL without transfusion support within 14 days prior to start of first study intervention * Estimated creatinine clearance ≥50 mL/minute by Cockcroft-Gault method or other standard institutional method * Total bilirubin ≤1.5 × upper limit of normal (ULN); for participants with documented Gilbert syndrome, total bilirubin must be ≤3 ×ULN * Aspartate transaminase (AST) ≤3 × ULN or alanine transaminase (ALT) ≤3 × ULN; in participants with documented liver metastases, AST or ALT ≤5 × ULN * Alkaline phosphatase (ALP) ≤2.5 × ULN; in participants with documented liver or bone metastases, ALP ≤5 × ULN * Oxygen saturation \>90% on room air * Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1. * Presence of measurable disease by RECIST, v1.1 assessed within 28 days prior to start of first study intervention. * Presence of baseline safely accessible lesions of adequate size for on-treatment biopsies (exceptions for lesion size may be granted with medical monitor approval) and participant willingness to undergo protocol prescribed on-treatment biopsies. Exclusion Criteria: * Clinically significant cardiovascular disease including any of the following: uncontrolled/ unstable cardiac arrhythmias, myocardial infarction within 6 months prior to start of first study intervention, unstable angina or congestive heart failure of New York Heart Association (NYHA) Grade 2 or higher, or cardiac ejection fraction \<50%. * Receipt of any biological therapy, chemotherapy, investigational therapy, or radiation therapy within 2 weeks or five half-lives prior to start of first study intervention, whichever is shorter. * Known active central nervous system (CNS) involvement by malignancy. Participants with prior CNS involvement from their malignancy must have completed effective treatment of their CNS disease with no symptoms of disease in the absence of steroid treatment and at least stable findings on relevant CNS imaging and no evidence of leptomeningeal disease for at least 4 weeks prior to study enrollment. * Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease or receipt of medications for these conditions within 6 months prior to study enrollment. * Currently receiving or likely to require systemic immunosuppressive therapy (e.g., prednisone ≥5 mg daily) for any reason from start of first study intervention to Day 29 with the exception of corticosteroids as a premedication for chemotherapy side effects per institutional standard of care or as mandated by the protocol. * Any history of Grade ≥3 immune-related AE or Grade ≥2 eye toxicity attributed to prior cancer immunotherapy, other than endocrinopathy managed with replacement therapy or asymptomatic elevation of serum amylase or lipase. * Grade ≥2 peripheral neuropathy limiting instrumental activities of daily living.

Study sites (5)

CA

MN

  • University of Minnesota Masonic Cancer Center · Minneapolis, MN 55455Principle Investigator · Study contactMore trials in Minneapolis

PA

  • Thomas Jefferson University, Sidney Kimmel Cancer Center · Philadelphia, PA 19107Principle Investigator · Study contactMore trials in Philadelphia

TX

  • M. D. Anderson Cancer Center · Houston, TX 77030Principle Investigator · Study contactMore trials in Houston