CAR-T for Claudin18.2 Positive Solid Tumors
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChengdu Ucello Biotechnology Co., Ltd.
About this trial
The purpose of this clinical trial is to learn if autologous claudin18.2-directed chimeric antigen receptor T-cell (CAR-T) therapy works to treat claudin18.2 positive solid tumors in adults. It will also learn about the safety and efficacy of the autologous claudin18.2 CAR-T cell product.
The main questions it aims to answer are:
1. What CAR-T-related adverse events (AEs) occur within 3 months after the autologous CAR-T cell infusion? 2. What is the Objective Response Rate (ORR), Progression-free survival (PFS), duration of response (DOR), and overall survival (OS)?
Participants will:
1. Undergo leukapheresis for collection of autologous T cells for CAR-T cell manufacturing. 2. May receive lymphodepletion chemotherapy (fludarabine plus cyclophosphamide) for 3 consecutive days if clinically needed. 3. If lymphodepletion chemotherapy is administered, rest for 2 days on Day -2 and Day -1. 4. Receive autologous CAR-T cells infusion on Day 0. 5. Be hospitalized for at least 7 days post-infusion for close safety monitoring and remain within 2 hours of the treatment facility for at least 28 days. 6. Visit the clinic at Day 14, Day 28, then monthly for up to 12 months after CAR-T cells infusion, with continued long-term follow-up for safety and persistence.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 to 75 years at the time of signing the the informed consent form (ICF).
Pathologically confirmed advanced solid tumor and patients have failed at least 2 prior lines of systemic therapy; or patients with advanced pancreatic cancer who have failed at least 1 prior line of systemic therapy.
Tumor tissue testing meets the requirement: Positive for Claudin 18.2 (CLDN18.2) by immunohistochemistry (IHC) staining.
Estimated life expectancy ≥ 12 weeks from the time of screening.
Disqualifiers
Pregnant or lactating women.
Serologically positive for human immunodeficiency virus (HIV), Treponema pallidum, or hepatitis C virus (HCV); or positive for Epstein-Barr virus (EBV)-DNA, cytomegalovirus (CMV)-DNA, or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acid.
Presence of any uncontrolled active infection, including but not limited to active tuberculosis and active hepatitis B virus (HBV) infection (defined as HBsAg positive with detectable HBV-DNA).
Persistent toxicities from prior anti-tumor therapy that have not resolved to Common Terminology Criteria for Adverse Events (CTCAE) grade ≤ 1, except for tolerable events such as alopecia as determined by the investigator.
Trial design
Design model
Single group
Treatments tested in this trial
claudin18.2 CAR-T
Druginjection of CAR T cells
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: CAR-T cells treatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
the incidence rate of CAR-T-related adverse events
Time frame
up to 3 months after CAR-T injectionSecondary outcomes
1
objective response rate (ORR)
The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1.
Time frame
up to 18 months2
Progression-free survival (PFS)
Time frame
up to 18 months3
Duration of response (DOR)
Time frame
up to 18 months4
Overall Survival (OS)
Time frame
up to 18 monthsOther outcomes
1
AUC of CAR-T cells
AUCS is defined as the area under the curve in 2 months
Time frame
up to 2 months after CAR-T injectionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Chengdu Ucello Biotechnology Co., Ltd.
Lead sponsor
The General Hospital of Western Theater Command
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: