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New treatment option for Solid Tumor, Adult
Official title CD70 Targeted CAR-T Cells in CD70 Positive Advanced/Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT05947487
What this study is testing
What is CD70-targeting CAR-T cells?
CD70-targeting CAR-T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for solid tumor, adult.
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
- In this single-center, single-arm,prospective, open-label, phase 1/2 study, the safety and efficacy of autologous CD70 targeted chimeric antigen receptor modified T (CAR-T) cell therapy will be evaluated in patients with CD70 antigen positive advanced/metastatic solid tumors . In this clinical trial, at least 12 eligible patients in dose escalation period will be enrolled to receive 3 doses of CD70-CAR cell therapy according to the "3+3" principle.
- 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 18 to 75
You may be able to join if
- Age 18-75 (inclusive).
- ECOG performance status ≤2 and Estimated life expectancy of more than 3 months.
- Histopathological confirmed advanced or metastatic solid tumors failed to at least first-line treatment or initially diagnosed advanced/metastatic...
- At least one measurable lesion at baseline per RECIST version 1.1.
- Fresh solid tumor samples or formalin-fixed paraffin embedded tumor archival samples within 6 months are necessary; Fresh tumor samples are...
You likely can't join if
- people are being treated with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of...
- Received cytotoxic chemicals, monoclonal antibodies, or immunotherapy within 4 weeks or 5 half-lives before enrollment;
- Pregnant, lactating, or breastfeeding females;
- Known positive test result for human immunodeficiency virus (HIV) oracquired immune deficiency syndrome (AIDS);Active infection of hepatitis B virus...
- History of allergy or intolerance to study drug components;
- Prior organ allograft transplantations or allogeneic hematopoietic stem cell transplantation;
See the full eligibility criteria
- Age 18-75 (inclusive).
- ECOG performance status ≤2 and Estimated life expectancy of more than 3 months.
- Histopathological confirmed advanced or metastatic solid tumors failed to at least first-line treatment or initially diagnosed advanced/metastatic solid tumors that have no NCCN guideline recommended standard first-line...
- At least one measurable lesion at baseline per RECIST version 1.1.
- Fresh solid tumor samples or formalin-fixed paraffin embedded tumor archival samples within 6 months are necessary; Fresh tumor samples are preferred. people are willing to accept tumor rebiopsy in the process of this...
- Adequate organ function as defined by the following criteria: ANC≥1.5x10\^9/L; Platelet count ≥75x10\^9/L; Hemoglobin ≥90 g/L;Serum AST and serum ALT, ≤3.0 x ULN (≤5 x ULN for patients with liver cancer or metastases)...
- Pregnancy tests for women of childbearing age shall be negative; Both men and women agreed to use effective contraception during treatment and during the subsequent 1 year.
- Ability to understand and sign a written informed consent documen.
- people are being treated with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment.
- Received cytotoxic chemicals, monoclonal antibodies, or immunotherapy within 4 weeks or 5 half-lives before enrollment;
- Pregnant, lactating, or breastfeeding females;
- Known positive test result for human immunodeficiency virus (HIV) oracquired immune deficiency syndrome (AIDS);Active infection of hepatitis B virus (HBV), or hepatitis C virus (HCV);
- History of allergy or intolerance to study drug components;
- Prior organ allograft transplantations or allogeneic hematopoietic stem cell transplantation;
- Major surgery or trauma occurred within 28 days prior to enrollment, or major side effects have not been recovered.
- Known brain metastases or active central nervous system (CNS).people with CNS metastases who were treated with radiotherapy for at least 3 months prior to enrollment, have no central nervous symptoms and are off...
- Previous or concurrent cancer within 5 years prior to treatment start except for curatively treated cervical cancer in situ, non-melanoma skin cancer, superficial bladder tumors;
- Any serious underlying medical (eg, pulmonary, renal, hepatic,gastrointestinal, or neurological) or psychiatric condition or any issue that would limit compliance with study requirements;
- Vaccination within 30 days of study enrollment;
- Previously received CD70-CAR T cell therapy;
- Being participating any other trials or withdraw within 4 weeks;
- Researchers believe that other reasons are not suitable for clinical trials.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Iotherapeutic Department of Chinsese PLA Gereral Hospital, 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, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Iotherapeutic Department of Chinsese PLA Gereral Hospital, 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.