Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Experimental cell therapy takes aim at Hard-to-Treat cancers

NCT ID NCT06001684

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 02, 2026 · Last updated Jul 02, 2026

Summary

This early-stage trial tests an experimental cell therapy called IBR854 in people with advanced solid tumors that cannot be surgically removed or have spread. The main goals are to check the treatment's safety and find the right dose. Participants receive the cells by infusion twice per treatment cycle. The study will also look for early signs that the therapy might shrink or control the cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
IBR854 cell injection
What this could lead to
If successful, this could point toward a new cell-based treatment option for people with advanced solid tumors that have limited alternatives.
What could go wrong
This is an early phase 1 trial with only 19 participants, so safety and effectiveness are not yet established. Cell therapies can cause serious side effects, and the treatment may not shrink tumors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

19 people

The number who actually took part.

Started

Sep 2023

Finished

Dec 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subjects volunteer to participate in this clinical study, are fully aware of the study and have signed the Informed Consent Form (ICF). Subjects are willing to follow and able to complete all trial procedures. 2. Age: adult at the age of 18-75 (both inclusive), female or male. 3. Subjects with histologically or cytologically confirmed, unresectable, locally advanced or metastatic solid tumors (which can be diagnosed with the use of tumor markers in combination with imaging for specific advanced tumors, such as liver cancer) who have no current standard of care. 4. Eastern Cooperative Oncology Group (ECOG) score ≤2 and expected survival time \>3 months. 5. According to the Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 criteria, the subjects have at least one target lesion (non-lymph node lesion with major diameter ≥ 1.0cm or lymph node lesion with minor diameter ≥ 1.5 cm). A lesion that is within the field of previous radiotherapy could not be considered a target unless there is radiographic evidence of progression. 6. Organ function during screening should meet the following criteria: * Absolute neutrophil count (ANC) ≥1.5×10\^9/L; Platelet (PLT) ≥75×10\^9/L; Hemoglobin (Hb)≥80g/L (no blood transfusion or hematopoietic stimulator treatment within 7 days). * Alanine aminotransferase (ALT)≤3×ULN (Patients with liver metastasis: ≤5×ULN); Aspartate aminotransferase (AST)≤3×ULN (Patients with liver metastasis: ≤5×ULN); * Creatinine (Cr) ≤2× ULN; Creatinine clearance (Ccr) (to be calculated only when Cr \> 2× ULN) \> 50ml/min (Cockcroft-Gault formula); * Activated partial thrombin time (APTT) ≤1.5×ULN, International normalized ratio (INR) ≤1.5×ULN (Patients with anticoagulants: ≤ 2.5×ULN). 7. Subjects of reproductive age and their partners should agree to have no family planning and to use effective contraceptive methods for 6 months from signing the ICF until the last dose of the study drug is administered. Exclusion Criteria: 1. Have received systemic antitumor therapy within 4 weeks or five half-lives of the drug (whichever is longer) before the first dose of the study drug: Systemic chemotherapy (2 weeks for oral fluorouracil, 6 weeks for mitomycin C and nitrosoureas), endocrine therapy, targeted therapy (2 weeks or 5 half-life for small molecule targeted therapy, whichever is longer), immunotherapy, radical radiotherapy, tumor embolization, Chinese herbal medicine for anti-tumor indications, etc. Or received palliative radiotherapy within 2 weeks before the first dose. 2. Toxic effects from previous antitumor therapy have not returned to grade 1 or less (other than alopecia or fatigue). 3. Any prior adoptive cellular immunotherapy. 4. Active brain metastases (one of the following criteria: clinical symptoms; A new diagnosis; Progression after previous local treatment). 5. Have undergone major organ surgery within 4 weeks prior to their first use of the study drug, or required elective surgery during the study period. 6. Long-term (≥ 3 days) treatment with a glucocorticoid (prednisone \> 10 mg per day or equivalent) or another immunosuppressive agent is anticipated to be required during the study. Inhaled or topical steroid hormones are allowed in subjects without active autoimmune disease 7. Have received a live or attenuated vaccine within 4 weeks before the first dose or plan to receive a live or attenuated vaccine during the study period. 8. Have severe infections that cannot be controlled. 9. Active hepatitis B, hepatitis C virus infection or HIV infection. 10. Have undergone an allogeneic bone marrow transplant or other organ transplant. 11. Have active autoimmune diseases or have had autoimmune diseases that are likely to recur (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, vasculitis, psoriasis, etc.). Except in the following cases: type 1 diabetes that was well controlled with hormone replacement therapy, hypothyroidism, skin conditions that did not require systemic therapy (e.g., vitiligo), and other conditions that were well controlled and that the investigator determined were less likely to recur (e.g., childhood asthma in remission). 12. Have a history of serious cardiovascular and cerebrovascular diseases, including but not limited to: * There are serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia, and Ⅱ-Ⅲ degree atrioventricular block, which need clinical intervention; * Prolonged QT interval corrected with Fridericia's method (QTcF) (\>450 ms in men; \>470 ms for women) * Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or above cardiovascular and cerebrovascular events occurring within 6 months before the first administration; * Patients with heart failure or left ventricular ejection fraction (LVEF) \< 50% in the New York Heart Association (NYHA) classification ≥II; * Hypertension beyond clinical control. 13. Clinically significant chronic obstructive pulmonary disease or other moderate to severe chronic respiratory disease developed within 6 months. 14. Have other malignant tumors in the past 3 years, excluding skin basal cell carcinoma, ductal carcinoma in situ and cervical carcinoma in situ with a radical surgery. 15. Pregnant or lactating women. 16. Have mental disorders or a history of alcohol, drug or drug abuse within one year. 17. Have participated in other clinical trials and received any unmarketed investigational drug or treatment within 4 weeks prior to first use of the study drug. 18. Allergic to the main components of the study drug. 19. The investigator considered that the subjects had a history of other serious systemic diseases or other reasons that made them unsuitable for the study. 20. Unsuitable for participation in this study considered by the investigators.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Solid tumor are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.