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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
TC-D101 CAR-T
Biological/VaccineTC-D101 CAR-T treatment follows a lymphodepletion Drug: Fludarabine and Cyclophosphamide.
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: TC-D101 CAR-T Cell TherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety of TC-D101 CAR-T cells
The incidence, type, and severity of all adverse events, serious adverse events, and abnormal laboratory findings.
Time frame
Up to 24 months2
Safety of TC-D101 CAR-T cells
Incidence of DLT
Time frame
Up to 1 monthSecondary outcomes
1
Efficacy of TC-D101 CAR-T cells
Optimal objective response rate (ORR)
Time frame
Up to 24 monthsOther outcomes
1
To investigate the Cmax of TC-D101 CAR-T cells in the peripheral blood after infusion
Time frame
Up to 24 months2
To assess TC-D101 CAR-T cell trafficking into tumor tissues after infusion
To detect TC-D101 CAR-T cell number in tumor tissues after infusion
Time frame
Up to 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
TCRCure Biopharma Ltd.
Lead sponsor
The Jinling Hospital
Collaborator
Source ClinicalTrials.gov