RecruitingPhase 1

This Study is an Open-lable, Early Study to Evaluate the Safety, Feasibility, Cytokinetics, and Preliminary Efficacy of GC511B in DLL3+ Relapsed/Refractory Small Cell Lung Cancer.

China55 participantsStarted 2026-03-03

Plain-language summary

This is a First-in-Human, open-label, early dose-escalation clinical study to evaluate the safety and preliminary efficacy of GC511B CAR T cell injection in Adult with DLL3+ r/r SCLC trial participants.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. A lesion can be considered TL if the lesion previously subjected to radiotherapy has a clear boundary, is measurable as per RECIST v1.1, and has clear progression during or after the latest treatment;
✓. If a fresh biopsy sample is selected at screening from a tumor lesion, the tumor lesion should not be selected as a TL unless imaging is performed at least approximately 2 weeks after the biopsy to allow time for healing. In a case where there is only one measurable TL, caution should be taken when obtaining biopsy tissues during the treatment period.

Exclusion criteria

✕. The trial participant has vitiligo or autoimmune alopecia;
✕. The trial participant has autoimmune hypothyroidism (e.g., following Hashimoto's thyroiditis) and is stable on hormone replacement;
✕. Any chronic inflammatory or autoimmune skin disease that does not require systemic therapy;
✕. Trial participants without active disease in the past 5 years may be enrolled in the study, but must first consult with the investigator;
✕. Trial participants whose celiac disease is controlled by dietary management alone.
✕. HBV infection, defined as HBsAg positive or hepatitis B core antibody positive and HBV-DNA detectable;
✕. HCV infection, defined as HCV antibody positive and HCV-RNA detectable;
✕. HIV infection, defined as anti-HIV (1/2) positive;

What they're measuring

Dose-Limiting Toxicity (DLT) Rate

Timeframe: 28 days

Adverse Events （AEs）

Timeframe: Up to 15 years from treatment discontinuation

Changes in vital signs to baseline

Timeframe: Up to 24 months from treatment discontinuation

Changes in Electrocardiogram(ECG) to baseline

Timeframe: Up to 24 months from treatment discontinuation

Changes in vital signs to baseline

Timeframe: Up to 24 months from treatment discontinuation

Changes in vital signs to baseline

Timeframe: Up to 24 months from treatment discontinuation

Changes in vital signs to baseline

Timeframe: Up to 24 months from treatment discontinuation

Trial details

NCT IDNCT07249879

SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11-10

Contact for this trial

Ning Li, Ph.D.

+86 15601395554 lining@cicams.ac.cn

View on ClinicalTrials.gov More Relapsed/Refractory Small Cell Lung Cancer trials

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. A lesion can be considered TL if the lesion previously subjected to radiotherapy has a clear boundary, is measurable as per RECIST v1.1, and has clear progression during or after the latest treatment;
✓. If a fresh biopsy sample is selected at screening from a tumor lesion, the tumor lesion should not be selected as a TL unless imaging is performed at least approximately 2 weeks after the biopsy to allow time for healing. In a case where there is only one measurable TL, caution should be taken when obtaining biopsy tissues during the treatment period.

Exclusion criteria

✕. The trial participant has vitiligo or autoimmune alopecia;
✕. The trial participant has autoimmune hypothyroidism (e.g., following Hashimoto's thyroiditis) and is stable on hormone replacement;
✕. Any chronic inflammatory or autoimmune skin disease that does not require systemic therapy;
✕. Trial participants without active disease in the past 5 years may be enrolled in the study, but must first consult with the investigator;
✕. Trial participants whose celiac disease is controlled by dietary management alone.
✕. HBV infection, defined as HBsAg positive or hepatitis B core antibody positive and HBV-DNA detectable;
✕. HCV infection, defined as HCV antibody positive and HCV-RNA detectable;
✕. HIV infection, defined as anti-HIV (1/2) positive;

What they're measuring

Dose-Limiting Toxicity (DLT) Rate

Timeframe: 28 days

Adverse Events （AEs）

Timeframe: Up to 15 years from treatment discontinuation

Changes in vital signs to baseline

Timeframe: Up to 24 months from treatment discontinuation

Changes in Electrocardiogram(ECG) to baseline

Timeframe: Up to 24 months from treatment discontinuation

Changes in vital signs to baseline

Timeframe: Up to 24 months from treatment discontinuation

Changes in vital signs to baseline

Timeframe: Up to 24 months from treatment discontinuation

Changes in vital signs to baseline

Timeframe: Up to 24 months from treatment discontinuation