Small Cell Lung Cancer ( SCLC )Early Phase 1NCT07246304
TC-D101 Cell Therapy for Patients With DLL3-Positive SCLC
A Early Phase 1 study testing TC-D101 CAR-T in people with Small Cell Lung Cancer ( SCLC ) and CAR-T Cell Therapy, run by TCRCure Biopharma Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Small Cell Lung Cancer ( SCLC ), CAR-T Cell Therapy
- What is being tested?
- TC-D101 CAR-T
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2026to 30 Nov 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Jinling Hospital
Nanjing, Jiangsu
Tangfeng Hospital, +862580863234, njzyjg80863256@163.com
About this study
Official title: A Preliminary Exploratory Clinical Study of TC-D101 in the Treatment of DLL3-Positive Relapsed/Refractory Primary Small Cell Lung Cancer
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.
Read the 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.
- Being tested
- TC-D101 CAR-T
- Keywords
- Small Cell Lung Cancer ( SCLC ), CAR-T Cell Therapy, DLL3
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TC-D101 CAR-TBiological
Also called Fludarabine, Cyclophosphamide
TC-D101 CAR-T treatment follows a lymphodepletion Drug: Fludarabine and Cyclophosphamide.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: TC-D101 CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of TC-D101 CAR-T cells
The incidence, type, and severity of all adverse events, serious adverse events, and abnormal laboratory findings.
Measured: Up to 24 months
Safety of TC-D101 CAR-T cells
Incidence of DLT
Measured: Up to 1 month
Secondary outcomes (1)
Efficacy of TC-D101 CAR-T cells
Optimal objective response rate (ORR)
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start10 Jun 2026
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung Cancer ( SCLC )Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TCRCure Biopharma Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jinling Hospital, China
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246304
- Sponsor's protocol ID
- D101-IIT-01
- Status last verified
- Oct 2026
- First submitted
- 17 Nov 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Exploratory Clinical Study of TC-D101 in the Treatment of DLL3-Positive Relapsed/Refractory Primary Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07246304
- Acronym / sponsor ID
- D101-IIT-01
- Keywords
- Small Cell Lung Cancer ( SCLC ), CAR-T Cell Therapy, DLL3
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- TCRCure Biopharma Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Jinling Hospital, China
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TC-D101 CAR-T Cell Therapy | Experimental | Biological: TC-D101 CAR-TFollowing lymphodepletion chemotherapy, participants will receive Following lymphodepletion chemotherapy, participants will receive TC-D101 CAR-T Cell CAR-T |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TC-D101 CAR-TAlso: Fludarabine, CyclophosphamideTC-D101 CAR-T treatment follows a lymphodepletion Drug: Fludarabine and Cyclophosphamide. | Biological | TC-D101 CAR-T Cell Therapy |
Primary outcome
Safety of TC-D101 CAR-T cells
Time frame: Up to 24 months
The incidence, type, and severity of all adverse events, serious adverse events, and abnormal laboratory findings.
Safety of TC-D101 CAR-T cells
Time frame: Up to 1 month
Incidence of DLT
1 secondary outcome
Efficacy of TC-D101 CAR-T cells
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing TC-D101 CAR-T in people with Small Cell Lung Cancer ( SCLC ) and CAR-T Cell Therapy, run by TCRCure Biopharma Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tangfeng LV (+862580863234, njzyjg80863256@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of TC-D101 CAR-T cells (time frame: Up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.