CD70 targeted CAR-T cell therapy for advanced solid tumors

Phase I/II Study of CD70 Targeted CAR-T Cell Treatment in CD70 Positive Advanced/Metastatic Solid Tumors

This study is testing a new type of CAR-T cell therapy that targets CD70 to see if it can help people with advanced solid tumors feel better and improve their treatment outcomes.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Chinese PLA General Hospital (other)
• Drugs / interventions: CAR T, immunotherapy, prednisone, CAR-T, chimeric antigen receptor
• Locations: 1 site (Beijing, Iotherapeutic Department of Chinsese PLA Gereral Hospital)
• Trial ID: NCT05947487 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of autologous CD70 targeted chimeric antigen receptor modified T (CAR-T) cell therapy in patients with CD70 positive advanced or metastatic solid tumors. It is a single-center, single-arm, prospective, open-label study that includes a dose escalation phase with at least 12 patients receiving three doses of CD70-CAR-T cells, followed by a dose expansion phase enrolling up to 21 additional patients at the recommended phase 2 dose. The trial aims to address the challenges of treating solid tumors by leveraging the unique properties of CD70 as a target for immunotherapy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with CD70 positive advanced or metastatic solid tumors that have failed at least first-line treatment.

Not a fit: Patients with solid tumors that do not express CD70 or those who have not failed prior treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a novel treatment option for patients with advanced solid tumors that currently have limited effective therapies.

How similar studies have performed: While CAR-T cell therapy has shown success in hematological malignancies, this approach targeting solid tumors is still novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Age 18-75 (inclusive).
2. ECOG performance status ≤2 and Estimated life expectancy of more than 3 months.
3. 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 therapy. CD70 antigen expression level ≥ 30%.
4. At least one measurable lesion at baseline per RECIST version 1.1.
5. Fresh solid tumor samples or formalin-fixed paraffin embedded tumor archival samples within 6 months are necessary; Fresh tumor samples are preferred. Subjects are willing to accept tumor rebiopsy in the process of this study.
6. 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); Total serum bilirubin ≤1.5 x ULN(≤3 x ULN for patients with liver cancer or metastases); Serum creatinine ≤1.5 xULN or creatinine clearance of ≥60 mL/min.
7. 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.
8. Ability to understand and sign a written informed consent documen.

Exclusion Criteria:

1. Subjects are being treated with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment.
2. Received cytotoxic chemicals, monoclonal antibodies, or immunotherapy within 4 weeks or 5 half-lives before enrollment;
3. Pregnant, lactating, or breastfeeding females;
4. 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);
5. History of allergy or intolerance to study drug components;
6. Prior organ allograft transplantations or allogeneic hematopoietic stem cell transplantation;
7. Major surgery or trauma occurred within 28 days prior to enrollment, or major side effects have not been recovered.
8. Known brain metastases or active central nervous system (CNS).Subjects with CNS metastases who were treated with radiotherapy for at least 3 months prior to enrollment, have no central nervous symptoms and are off corticosteroids, are eligible for enrollment, but require a brain MRI screening.
9. 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;
10. Any serious underlying medical (eg, pulmonary, renal, hepatic,gastrointestinal, or neurological) or psychiatric condition or any issue that would limit compliance with study requirements;
11. Vaccination within 30 days of study enrollment;
12. Previously received CD70-CAR T cell therapy;
13. Being participating any other trials or withdraw within 4 weeks;
14. Researchers believe that other reasons are not suitable for clinical trials.

Where this trial is running

Beijing, Iotherapeutic Department of Chinsese PLA Gereral Hospital

• China — Beijing, Iotherapeutic Department of Chinsese PLA Gereral Hospital, China (RECRUITING)

Study contacts

• Study coordinator: Weidong Han, Ph.D

Conditions: Solid Tumor, Adult, CD70, advanced or metastatic