TC-D101 CAR-T therapy for DLL3-positive small cell lung cancer

A Preliminary Exploratory Clinical Study of TC-D101 in the Treatment of DLL3-Positive Relapsed/Refractory Primary Small Cell Lung Cancer

This trial will try a single infusion of TC-D101 CAR-T cells in adults with DLL3-positive relapsed or refractory small cell lung cancer who have progressed after prior treatments.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: TCRCure Biopharma Ltd. (Industry-sponsored)
• Drugs / interventions: CAR-T, chemotherapy
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT07246304 on ClinicalTrials.gov

What this trial studies

This single-arm, open-label, early phase 1 dose-escalation trial gives a single infusion of TC-D101 CAR-T cells to adults with DLL3-positive relapsed or refractory SCLC to determine safety and the maximum tolerated dose. The protocol includes screening, leukapheresis to collect peripheral blood mononuclear cells, lymphodepletion chemotherapy, TC-D101 infusion, and scheduled post-infusion follow-up. Investigators will monitor CAR-T cell expansion and persistence, record adverse events, and measure tumor response by RECIST 1.1. Secondary goals include preliminary signs of clinical activity and durability of any responses.

Who should consider this trial

Good fit: Adults aged 18–75 with DLL3-positive relapsed or refractory SCLC, ECOG 0–1, adequate organ and marrow function, measurable disease, and who have failed or are unsuitable for standard therapies and can undergo leukapheresis.

Not a fit: Patients who are DLL3-negative, have uncontrolled CNS metastases, active infections, significant autoimmune disease, serious cardiac conditions, or poor performance status are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, this targeted CAR-T approach could produce meaningful tumor shrinkage or disease control in patients with DLL3-positive r/r SCLC who have limited treatment options.

How similar studies have performed: CAR-T therapies have had limited success in solid tumors and DLL3-directed approaches remain experimental with only early-phase data and no established proof of clinical benefit for SCLC.

Eligibility criteria

Inclusion Criteria:

1. Participants must voluntarily provide written informed consent.
2. Aged 18-75 years (inclusive).
3. Life expectancy ≥ 3 months.
4. ECOG performance status 0-1.
5. Failed or unsuitable for standard therapy.
6. At least one measurable lesion per RECIST 1.1.
7. DLL3-positive r/r SCLC confirmed by immunohistochemistry.
8. Adequate organ and bone marrow function.
9. Effective contraception required for participants of childbearing potential.
10. Adequate venous access for leukapheresis.

Exclusion Criteria:

1. Primary CNS malignancy or uncontrolled CNS metastases.
2. Other malignancies within 5 years (except adequately treated non-melanoma skin cancer or carcinoma in situ).
3. Active autoimmune disease or history of autoimmune disease.
4. Immunodeficiency, including HIV positivity.
5. Bleeding disorders (inherited or acquired).
6. Clinically significant cardiovascular disease.
7. Active infection (including tuberculosis, hepatitis B/C, syphilis).
8. Pregnant or breastfeeding women.
9. Clinically significant ascites . 10 Uncontrolled pleural effusion or pericardial effusion.

11\. Prior cell or gene therapy. 12. Severe drug hypersensitivity history. 13. Investigator-assessed unsuitability for trial participation.

Where this trial is running

Nanjing, Jiangsu

• The Jinling Hospital — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Tangfeng LV

Conditions Small Cell Lung Cancer; CAR-T Cell Therapy; DLL3