TC-D101 Cell Therapy for Patients With DLL3-Positive SCLC
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTCRCure Biopharma Ltd.
About this trial
This is a single-arm, open-label, dose-escalation clinical trial designed to evaluate the safety, tolerability, expansion, and persistence of TC-D101 CAR-T cells in patients with DLL3-positive Relapsed/Refractory primary small cell lung cancer(r/r SCLC) who have progressed after prior therapies. The primary objective is to determine the maximum tolerated dose (MTD), with a secondary aim to assess preliminary clinical efficacy in SCLC.
Eligibility criteria
Qualifiers
Participants must voluntarily provide written informed consent.
Aged 18-75 years (inclusive).
Life expectancy ≥ 3 months.
ECOG performance status 0-1.
Disqualifiers
Primary CNS malignancy or uncontrolled CNS metastases.
Other malignancies within 5 years (except adequately treated non-melanoma skin cancer or carcinoma in situ).
Active autoimmune disease or history of autoimmune disease.
Immunodeficiency, including HIV positivity.
Trial design
Treatments tested in this trial
- TC-D101 CAR-T
Treatment groups
24 Participants
are divided into 1 treatment groupSponsors and collaborators
TCRCure Biopharma Ltd.
Lead sponsor
The Jinling Hospital
Collaborator
Source ClinicalTrials.gov