SCLC, Extensive StagePhase 1NCT05507593
Study of DLL3-CAR-NK Cells in the Treatment of Extensive Stage Small Cell Lung Cancer
A Phase 1 study testing DLL3-CAR-NK cells in people with SCLC, Extensive Stage, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This is a multicenter, open-label, phase I clinical trial aimed to evaluate the safety and efficacy of DLL3-CAR-NK cells treatment for relapsed and refractory extensive small cell lung cancer (ES-SCLC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- SCLC, Extensive Stage
- What is being tested?
- DLL3-CAR-NK cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 1 Jul 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Only patient who meet all the following conditions can be selected for this trial:
- Patients voluntarily sign informed consent;
- The age was 18-75 years old, and the gender was not limited;
- Patients who meet the following diagnosis and treatment : 1) small cell lung cancer diagnosed by tissue / cytology; 2) extensive small cell lung cancer diagnosed by imaging according to VALG and AJCC-8; 3) disease progression after receiving at least one line treatment, and disease progression within 6 months after the last line treatment;
- The expected survival time was more than 3 months;
- There are measurable target lesions on imaging during screening: the maximum diameter is greater than 1.0 cm;
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- The Eastern Cooperative Oncology Group (ECOG) scored 0 or 1 for physical fitness;
- Sufficient bone marrow reserve at screening, defined as:
- Neutrophil absolute value (ANC) > 1.5 × 10^9/L；
- Lymphocyte absolute value (ALC) ≥ 0.3 × 10^9/L；
- Platelet (PLT) ≥ 100 × 10^9/L；
- Hemoglobin (HGB) ≥ 100g / L;
- The screening has appropriate organ function and meets the following criteria:
- Aspartate aminotransferase (AST) ≤ 2.5 times ULN (due to tumor infiltration ≤ 5 times ULN);
- Alanine aminotransferase (ALT) ≤ 2.5 times ULN (due to tumor infiltration ≤ 5 times ULN);
- Total serum bilirubin ≤ 1.5 times ULN (due to tumor infiltration ≤ 3 times ULN);
- Serum creatinine (SCR) ≤ 1.5 times ULN, or creatinine clearance rate ≥ 60ml / min;
- Have the lowest level of lung reserve, defined as ≤ grade 1 dyspnea and oxygen saturation > 91% in non oxygen breathing state;
- International normalized ratio (INR) ≤ 1.5 times ULN, and activated partial prothrombin time (APTT) ≤ 1.5 times ULN;
- Blood vessel conditions for collection of mononuclear cells are available during screening;
- The urine pregnancy test of women of childbearing age is negative. Any male and female patient with fertility must agree to use effective contraceptive methods during the whole study and at least 1 year after the study treatment.
Who cannot join
- Patient who meet any of the following conditions well excluded in this trial:
- At the time of screening, patients with symptomatic central nervous system (CNS) metastases (asymptomatic CNS metastases, or asymptomatic after local treatment and stable condition for 4 weeks can be enrolled);
- Those with a history of central nervous system before screening, such as epilepsy, cerebral ischemia / hemorrhage, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, cerebral organic syndrome, mental disease or any autoimmune disease involving the central nervous system;
- Those who had received immunotherapy, targeted therapy, chemotherapy, or radiotherapy within 4 weeks before screening and were assessed by the investigator as unsuitable for inclusion;
- Those who stopped systemic hormone therapy for less than 72 hours before cell transfusion; But it is allowed to use a physiological substitute amount of hormone (such as prednisone < 10mg / D or equivalent);
- Those who have used any adoptive cell therapy before screening;
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- Those who have received organ / tissue transplantation before screening;
- Active systemic autoimmune disease is known before screening and is under treatment;
- Those who meet any of the following conditions during screening:
- positive for hepatitis B surface antigen (HBsAg) and / or hepatitis B e antigen (HBeAg);
- hepatitis B e antibody (HBE AB) and / or hepatitis B core antibody (HBC AB) are positive, and the copy number of HBV-DNA is greater than the lower measurable limit;
- positive for hepatitis C antibody (HCV AB);
- positive anti Treponema pallidum antibody (TP AB);
- HIV antibody test positive;
- the copy number of EBV-DNA and cmv-dna is greater than the lower measurable limit;
- Those who had undergone major surgery within 4 weeks before screening and were assessed by the investigator as unsuitable for inclusion;
- Those who had or were suffering from other malignant tumors within 2 years before screening;
- The heart meets any of the following conditions during screening:
- left ventricular ejection fraction (LVEF) ≤ 50% (echo);
- New York Heart Association (NYHA) class III or IV congestive heart failure;
- hypertension (systolic blood pressure ≥ 140mmHg and / or diastolic blood pressure ≥ 90mmHg) or pulmonary hypertension that has not been controlled by standard treatment;
- have had myocardial infarction or cardiac surgery within 12 months before cell transfusion;
- clinically significant valvular disease.
- The tumors involved atrium or ventricle during screening;
- Patients with history of pulmonary interstitial fibrosis or severe COPD;
- There are clinical emergencies (such as intestinal obstruction or vascular compression) requiring urgent treatment due to tumor body obstruction or compression during screening;
- Patients with active bleeding during screening;
- Patients with deep venous thrombosis or pulmonary embolism within 6 months before screening;
- Those who received live vaccine within 6 weeks before screening;
- Patients with active infection and need treatment during screening;
- Participated in other intervention clinical studies within 4 weeks before screening;
- Poor compliance.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Liang Liu, MD., 86-22-23340123 ext. 3172, liangcoh@163.com
Xiubao Ren, MD. PhD., 86-22-23340123 ext. 3173, renxiubao@tjmuch.com
About this study
Official title: A Multicenter Phase I Trial on the Safety and Preliminary Efficacy of DLL3-CAR-NK Cells in the Treatment of Relapsed / Refractory Extensive Stage Small Cell Lung Cancer
This is a multicenter, open-label, phase I clinical trial aimed to evaluate the safety and efficacy of DLL3-CAR-NK cells treatment for relapsed and refractory extensive small cell lung cancer (ES-SCLC).
Read the detailed description
This study is a multicenter, single arm, open-label, non randomized, single dose, dose escalation, phase I clinical trial on relapsed and refractory ES-SCLC. The phase I clinical trial will be conducted according to the principle of "3 + 3". Three dose groups will be set up, namely group A: 1.0 × 10^7, group B: 1.0 × 10^8, and group C: 1.0 × 10^9 DLL3-CAR-NK cells. 9-18 subjects will be enrolled in the groups and given a single infusion of DLL3-CAR-NK cells injection in order to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD), evaluate the safety and efficacy of the cell infusion. It well be recommend dose for phase II clinical study (recommended phase II dose, RP2D).
- Conditions
- SCLC, Extensive Stage
- Being tested
- DLL3-CAR-NK cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DLL3-CAR-NK cellsBiological
Patients of Group A will be received 1x10^7 DLL3-CAR-NK cells infusion treatment，of group B will be received 1x10^8 DLL3-CAR-NK cells infusion treatment，and of group C will be received 1x10^9 DLL3-CAR-NK cells infusion treatment.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients of group A will be received 1x10^7 DLL3-CAR-NK cells infusion treatment. Receives: Biological: DLL3-CAR-NK cells |
| Group B | Experimental | Patients of group B will be received 1x10^8 DLL3-CAR-NK cells infusion treatment. Receives: Biological: DLL3-CAR-NK cells |
| Group C | Experimental | Patients of group C will be received 1x10^9 DLL3-CAR-NK cells infusion treatment. Receives: Biological: DLL3-CAR-NK cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
The dose-limiting toxicity (DLT)
Measured: 1 year
Maximum tolerated dose (MTD)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start1 Sep 2022 (estimated)
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCLC, Extensive StageStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dingzhi Huang, M.D, Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05507593
- Sponsor's protocol ID
- E20220808
- Status last verified
- Aug 2022
- First submitted
- 15 Aug 2022
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase I Trial on the Safety and Preliminary Efficacy of DLL3-CAR-NK Cells in the Treatment of Relapsed / Refractory Extensive Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05507593
- Acronym / sponsor ID
- E20220808
- Conditions
- SCLC, Extensive Stage
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 19 Aug 2022 (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 multicenter, open-label, phase I clinical trial aimed to evaluate the safety and efficacy of DLL3-CAR-NK cells treatment for relapsed and refractory extensive small cell lung cancer (ES-SCLC).
Detailed description
This study is a multicenter, single arm, open-label, non randomized, single dose, dose escalation, phase I clinical trial on relapsed and refractory ES-SCLC. The phase I clinical trial will be conducted according to the principle of "3 + 3". Three dose groups will be set up, namely group A: 1.0 × 10^7, group B: 1.0 × 10^8, and group C: 1.0 × 10^9 DLL3-CAR-NK cells. 9-18 subjects will be enrolled in the groups and given a single infusion of DLL3-CAR-NK cells injection in order to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD), evaluate the safety and efficacy of the cell infusion. It well be recommend dose for phase II clinical study (recommended phase II dose, RP2D).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: DLL3-CAR-NK cellsPatients of group A will be received 1x10^7 DLL3-CAR-NK cells infusion treatment. |
| Group B | Experimental | Biological: DLL3-CAR-NK cellsPatients of group B will be received 1x10^8 DLL3-CAR-NK cells infusion treatment. |
| Group C | Experimental | Biological: DLL3-CAR-NK cellsPatients of group C will be received 1x10^9 DLL3-CAR-NK cells infusion treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Patients voluntarily sign informed consent;
- The age was 18-75 years old, and the gender was not limited;
- Patients who meet the following diagnosis and treatment : 1) small cell lung cancer diagnosed by tissue / cytology; 2) extensive small cell lung cancer diagnosed by imaging according to VALG and AJCC-8; 3) disease progression after receiving at least one line treatment, and disease progression within 6 months after the last line treatment;
- The expected survival time was more than 3 months;
- There are measurable target lesions on imaging during screening: the maximum diameter is greater than 1.0 cm;
Key exclusion criteria (32 listed)
- At the time of screening, patients with symptomatic central nervous system (CNS) metastases (asymptomatic CNS metastases, or asymptomatic after local treatment and stable condition for 4 weeks can be enrolled);
- Those with a history of central nervous system before screening, such as epilepsy, cerebral ischemia / hemorrhage, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, cerebral organic syndrome, mental disease or any autoimmune disease involving the central nervous system;
- Those who had received immunotherapy, targeted therapy, chemotherapy, or radiotherapy within 4 weeks before screening and were assessed by the investigator as unsuitable for inclusion;
- Those who stopped systemic hormone therapy for less than 72 hours before cell transfusion; But it is allowed to use a physiological substitute amount of hormone (such as prednisone < 10mg / D or equivalent);
- Those who have used any adoptive cell therapy before screening;
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 |
|---|---|---|
| DLL3-CAR-NK cellsPatients of Group A will be received 1x10^7 DLL3-CAR-NK cells infusion treatment，of group B will be received 1x10^8 DLL3-CAR-NK cells infusion treatment，and of group C will be received 1x10^9 DLL3-CAR-NK cells infusion treatment. | Biological | Group A, Group B, Group C |
Primary outcome
The dose-limiting toxicity (DLT)
Time frame: 1 year
Maximum tolerated dose (MTD)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.
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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. This study is not recruiting at the moment.
Dingzhi Huang, M.D principal investigator
Tianjin Medical University Cancer Institute and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DLL3-CAR-NK cells in people with SCLC, Extensive Stage, run by Tianjin Medical University Cancer Institute and Hospital 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 21 inclusion and 32 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: status not confirmed, as of the sponsor's last update on 19 Aug 2022. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liang Liu, M.D (86-22-23340123 ext. 3172, liuliang@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The dose-limiting toxicity (DLT) (time frame: 1 year). 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 19 Aug 2022.