TC-D101 Cell Therapy for Patients With DLL3-Positive SCLC | NCT07246304

Studies
TC-D101 Cell Therapy for Patients With DLL3-Positive SCLC

NCT07246304

Sponsor

TCRCure Biopharma Ltd.

Status

Recruiting

Last Update Posted

Nov 24, 2025Actual

Enrollment

24Estimated

Phase

Early Phase 1

Conditions

Small Cell Lung Cancer ( SCLC )
CAR-T Cell Therapy

Interventions

TC-D101 CAR-T

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 30, 2025Estimated

Primary Completion Date

Nov 30, 2027Estimated

Completion Date

Nov 30, 2028Estimated

First Submitted Date

Nov 17, 2025

First Submission Date that Met QC Criteria

Nov 17, 2025

First Posted Date

Nov 24, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2025

Last Update Posted Date

Nov 24, 2025Actual

Name	Class
The Jinling Hospital	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

This study is designed as a single-arm, open-label, single-dose clinical trial to evaluate the safety and efficacy of TC-D101 CAR-T cell therapy in patients with r/r SCLC. The study protocol consists of five main stages: (1) patient screening, (2) collection of peripheral blood mononuclear cells (PBMCs), (3) lymphodepletion chemotherapy, (4) TC-D101 CAR-T cell infusion, and (5) post-infusion follow-up.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TC-D101 CAR-T Cell Therapy	Experimental	Following lymphodepletion chemotherapy, participants will receive Following lymphodepletion chemotherapy, participants will receive TC-D101 CAR-T Cell CAR-T	Biological: TC-D101 CAR-T

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TC-D101 CAR-T	Biological	TC-D101 CAR-T treatment follows a lymphodepletion Drug: Fludarabine and Cyclophosphamide.	TC-D101 CAR-T Cell Therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety of TC-D101 CAR-T cells	The incidence, type, and severity of all adverse events, serious adverse events, and abnormal laboratory findings.	Up to 24 months
Safety of TC-D101 CAR-T cells	Incidence of DLT	Up to 1 month

Secondary Outcomes

Measure	Description	Time Frame
Efficacy of TC-D101 CAR-T cells	Optimal objective response rate (ORR)	Up to 24 months

Other Outcomes

Measure	Description	Time Frame
To investigate the Cmax of TC-D101 CAR-T cells in the peripheral blood after infusion		Up to 24 months
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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.
Bleeding disorders (inherited or acquired).
Clinically significant cardiovascular disease.
Active infection (including tuberculosis, hepatitis B/C, syphilis).
Pregnant or breastfeeding women.
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Tangfeng LV	Contact	+862580863234		njzyjg80863256@163.com

Facility	Status	City	State	ZIP	Country	Contacts
The Jinling Hospital	Recruiting	Nanjing	Jiangsu		China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D055752	Small Cell Lung Carcinoma

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C024352	fludarabine
D003520	Cyclophosphamide

Ancestor Terms

ID	Term
D010752	Phosphoramide Mustards
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated

Browse Leaves

Not provided

Browse Branches

Not provided