BridgeMD
New treatment option for Cancer
Official title Biomarker-Guided Allogeneic Single-Target or Dual-Target CAR-NK Cell Therapy for Advanced Solid Tumors
ClinicalTrials.gov ID: NCT07410494
What this study is testing
What is EB-SELECT Single-Target CAR-NK Cells?
EB-SELECT Single-Target CAR-NK Cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cancer.
Also referred to as Lymphodepleting Chemotherapy, Fludarabine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This Phase 1/2 study evaluates the safety, feasibility, and preliminary anti-tumor activity of allogeneic donor-derived CAR-NK cells in participants with advanced solid tumors. The CAR target antigen is selected for each participant after tumor profiling using a tissue biopsy and/or liquid biopsy.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 85
You may be able to join if
- Age 18-75 years.
- Histologically or cytologically confirmed advanced/unresectable or metastatic solid tumor that is relapsed/refractory after standard therapy, or no...
- Targetable antigen positivity from the protocol target menu based on: tissue biopsy and/or liquid biopsy platform (as defined in the lab manual).
- Arm assignment rules :
- Arm A: ≥1 antigen meets "positive" threshold
You likely can't join if
- Prior treatment with gene-modified cellular therapy (e.g., CAR-T, CAR-NK) within a defined washout period .
- Active, uncontrolled infection requiring IV antibiotics; known uncontrolled HIV; active HBV/HCV with detectable viral load (per local policy).
- Active CNS metastases requiring escalating steroids or urgent intervention (stable treated CNS disease may be allowed ).
- Active autoimmune disease requiring systemic immunosuppression, or chronic systemic steroids above protocol threshold.
- Clinically significant cardiovascular disease (e.g., recent MI, unstable arrhythmia), uncontrolled pulmonary disease, or other serious comorbidity...
- Major surgery or anticancer therapy too close to lymphodepletion (protocol-defined washout).
See the full eligibility criteria
- Age 18-75 years.
- Histologically or cytologically confirmed advanced/unresectable or metastatic solid tumor that is relapsed/refractory after standard therapy, or no standard therapy available.
- Targetable antigen positivity from the protocol target menu based on: tissue biopsy and/or liquid biopsy platform (as defined in the lab manual).
- Arm assignment rules :
- Arm A: ≥1 antigen meets "positive" threshold
- Arm B: ≥2 antigens meet "positive" threshold
- ECOG performance status 0-1 (or 0-2 ).
- At least one measurable lesion by RECIST 1.1.
- Adequate organ function (hematologic, renal, hepatic, cardiac) within protocol-defined limits.
- Willingness to undergo blood draws and required biopsies (when medically feasible).
- Negative pregnancy test for participants of childbearing potential; agreement to effective contraception during and after study treatment.
- Prior treatment with gene-modified cellular therapy (e.g., CAR-T, CAR-NK) within a defined washout period .
- Active, uncontrolled infection requiring IV antibiotics; known uncontrolled HIV; active HBV/HCV with detectable viral load (per local policy).
- Active CNS metastases requiring escalating steroids or urgent intervention (stable treated CNS disease may be allowed ).
- Active autoimmune disease requiring systemic immunosuppression, or chronic systemic steroids above protocol threshold.
- Clinically significant cardiovascular disease (e.g., recent MI, unstable arrhythmia), uncontrolled pulmonary disease, or other serious comorbidity that increases risk.
- Major surgery or anticancer therapy too close to lymphodepletion (protocol-defined washout).
- Pregnant or breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.