Advanced Malignant Solid TumorsPhase 1NCT07657585
CIB In Vivo CAR-T Lentiviral Injection in Patients With Advanced Malignant Tumors
A Phase 1 study testing CIB in vivo CAR-T Lentiviral Injection in people with Advanced Malignant Solid Tumors, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This is an open-label, single-arm, phase 1 dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of CIB in vivo CAR-T lentiviral injection in patients with advanced malignant tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Malignant Solid Tumors
- What is being tested?
- CIB in vivo CAR-T Lentiviral Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 31 May 2028
- Phase
- 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
- Age ≥ 18 years and ≤ 75 years.
- At least one measurable target lesion according to RECIST version 1.1 at screening.
- Histologically or cytologically confirmed advanced or metastatic malignant tumor, with positive target expression confirmed by validated assay methods.
- Patients who have failed prior standard systemic therapy (including but not limited to VEGF-targeted tyrosine kinase inhibitors and/or immune checkpoint inhibitors), or are intolerant to standard therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Expected survival time ≥ 3 months as assessed by the investigator.
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- Adequate organ function at baseline (no growth factor support or transfusion within 14 days prior to screening):
- Bone marrow function: i. Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; ii. Hemoglobin (Hb) ≥ 90 g/L; iii. Platelet count (PLT) ≥ 75 × 10⁹/L. b. Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN); if liver metastases are present, ALT and AST ≤ 5 × ULN; total bilirubin (TBIL) ≤ 1.5 × ULN.
- Renal function: Serum creatinine ≤ ULN or creatinine clearance rate ≥ 80 mL/min.
- For female patients of childbearing potential, serum β-HCG test result must be negative within 7 days prior to enrollment.
- Patients must agree to use effective contraception from the signing of the informed consent form (ICF) until at least 90 days after the end of the study.
- Voluntarily sign the informed consent form (ICF) and be able to understand and comply with the requirements of the study protocol.
Who cannot join
- Asymptomatic untreated brain metastases; symptomatic central nervous system (CNS) metastases or carcinomatous meningitis; or other evidence of uncontrolled CNS/meningeal metastases that are considered unsuitable for enrollment by the investigator.
- Presence of clinically significant cardiovascular, pulmonary, neurological, or systemic disease at baseline that may increase study participation risk or interfere with safety assessments.
- Presence of severe chronic or active infection at baseline, including:
- Active hepatitis B (HBsAg positive with HBV DNA > ULN);
- Active hepatitis C (anti-HCV positive with detectable HCV RNA);
- Known history of or positive test for human immunodeficiency virus (HIV);
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- Systemic anti-infective therapy required within 4 weeks prior to first administration, including hospitalization for infectious complications, bacteremia, severe pneumonia, or active tuberculosis.
- History of active autoimmune disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, vasculitis) or receipt of long-term systemic corticosteroids (prednisone > 10 mg/day or equivalent) or other immunosuppressive agents within 4 weeks prior to first administration.
- Prior allogeneic tissue or solid organ transplantation.
- Evidence of severe immunodeficiency, such as primary immunodeficiency (e.g., severe combined immunodeficiency, SCID) or concurrent opportunistic infections.
- Prior gene therapy using lentiviral or retroviral vectors.
- Prior treatment with drugs targeting the same antigen.
- Requiring therapeutic anticoagulation that cannot be discontinued prior to administration.
- History of severe cardiovascular disease, including:
- NYHA class ≥ II congestive heart failure;
- Left ventricular ejection fraction (LVEF) < 50%;
- Corrected QT interval (QTcF) > 470 ms or long QT syndrome;
- Acute coronary syndrome, aortic dissection, severe arrhythmia, stroke, or other grade ≥ 3 cardiovascular events within 6 months prior to first administration;
- Uncontrolled hypertension.
- Prior anti-tumor therapy within 4 weeks or 5 half-lives (whichever is longer) prior to first administration, including chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy; prior oral small-molecule targeted therapy within 2 weeks or 5 half-lives (whichever is longer); prior palliative radiotherapy within 14 days; prior participation in other anti-tumor clinical trials within 4 weeks; prior use of any anti-tumor traditional Chinese medicine within 2 weeks.
- Pregnant or breastfeeding women, or women of childbearing potential who refuse to use effective contraception during the study period.
- Any other disease or laboratory abnormality that, in the investigator's opinion, makes the patient unsuitable for participation in this study.
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
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Ning Li, +8601087788165, lining@cicams.ac.cn
About this study
Official title: A Phase 1, Open-Label, Single-Arm, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CIB In Vivo CAR-T Lentiviral Injection in Patients With Advanced Malignant Tumors
This is an open-label, single-arm, phase 1 dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of CIB in vivo CAR-T lentiviral injection in patients with advanced malignant tumors.
The study will enroll patients with histologically or cytologically confirmed advanced solid tumors that have progressed on or are intolerant to standard therapies. A "3+3" dose-escalation design will be used, with planned dose levels including 1×10⁵ TU/kg, 3×10⁵ TU/kg, 1×10⁶ TU/kg, 3×10⁶ TU/kg, 1×10⁷ TU/kg, and 3×10⁷ TU/kg. The primary objective is to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) based on dose-limiting toxicities (DLTs) observed within 28 days after administration. Secondary objectives include evaluating adverse events, objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and pharmacokinetic parameters of the study drug.
Read the detailed description
This is a single-center, open-label, phase 1 dose-escalation study. Eligible patients will receive CIB in vivo CAR-T lentiviral injection at escalating dose levels. Safety assessments include adverse events, laboratory tests, vital signs, and physical examinations. Efficacy assessments include tumor response evaluation according to RECIST v1.1. Pharmacokinetic and immunogenicity assessments will also be performed.
- Conditions
- Advanced Malignant Solid Tumors
- Being tested
- CIB in vivo CAR-T Lentiviral Injection
- Keywords
- Advanced Solid Tumors, In Vivo CAR-T, Phase 1 Study, Dose Escalation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CIB in vivo CAR-T Lentiviral InjectionBiological
CIB in vivo CAR-T lentiviral vector administered via intravenous infusion at escalating dose levels.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: CIB in vivo CAR-T Lentiviral Injection | Experimental | Intravenous administration of CIB in vivo CAR-T lentiviral injection as a single agent. Planned dose levels include 1×10⁵ TU/kg, 3×10⁵ TU/kg, 1×10⁶ TU/kg, 3×10⁶ TU/kg, 1×10⁷ TU/kg, and 3×10⁷ TU/kg. Receives: Biological: CIB in vivo CAR-T Lentiviral Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-Limiting Toxicities (DLTs) and Determination of Maximum Tolerated Dose (MTD)
To evaluate the incidence of dose-limiting toxicities (DLTs) within 28 days after administration, and to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of CIB in vivo CAR-T lentiviral injection.
Measured: 28 days after administration
Secondary outcomes (8)
Incidence and Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs)
To evaluate the incidence, frequency, and severity of all adverse events (AEs) and serious adverse events (SAEs) throughout the study period.
Measured: From administration up to 24 months
Objective Response Rate (ORR)
Percentage of patients with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1.
Measured: Every 6 weeks after administration, up to 12 months
Disease Control Rate (DCR)
Description: Percentage of patients with confirmed CR, PR, or stable disease (SD) according to RECIST v1.1.
Measured: Every 6 weeks after administration, up to 12 months
Duration of Response (DoR)
Time from the first documented response (CR or PR) to disease progression or death.
Measured: Up to 24 months after administration
Progression-Free Survival (PFS)
Time from administration to the first documented disease progression or death due to any cause.
Measured: Up to 24 months after administration
Dynamic Changes in Peripheral Blood CAR-Positive T Cell Proportion
Serial changes in the proportion of CAR-positive T cells in peripheral blood.
Measured: Pre-dose, Days 7, 14, 28, 60, 90, and 180 after administration
Dynamic Changes in Peripheral Blood Lentiviral Vector Copy Number
Serial changes in the lentiviral vector copy number in peripheral blood.
Measured: Pre-dose, Days 7, 14, 28, 60, 90, and 180 after administration
Changes in Plasma Cytokine Levels
Changes in plasma core cytokines including IFN-γ, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, and TNF-α from baseline.
Measured: Within 2 hours pre-dose, Days 2, 8, 14, and 28 after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant Solid TumorsStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label, single-arm, dose-escalation design.
- Masking
- None (open label)
- Enrolment
- 91 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Cliniboosta Biotech
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07657585
- Sponsor's protocol ID
- NCC6263
- Status last verified
- Apr 2026
- First submitted
- 14 Jun 2026
- Last updated
- 18 Jun 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 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Single-Arm, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CIB In Vivo CAR-T Lentiviral Injection in Patients With Advanced Malignant Tumors
- ClinicalTrials.gov ID
- NCT07657585
- Acronym / sponsor ID
- NCC6263
- Conditions
- Advanced Malignant Solid Tumors
- Keywords
- Advanced Solid Tumors, In Vivo CAR-T, Phase 1 Study, Dose Escalation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 91 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Cliniboosta Biotech
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 18 Jun 2026 (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 an open-label, single-arm, phase 1 dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of CIB in vivo CAR-T lentiviral injection in patients with advanced malignant tumors.
The study will enroll patients with histologically or cytologically confirmed advanced solid tumors that have progressed on or are intolerant to standard therapies. A "3+3" dose-escalation design will be used, with planned dose levels including 1×10⁵ TU/kg, 3×10⁵ TU/kg, 1×10⁶ TU/kg, 3×10⁶ TU/kg, 1×10⁷ TU/kg, and 3×10⁷ TU/kg. The primary objective is to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) based on dose-limiting toxicities (DLTs) observed within 28 days after administration. Secondary objectives include evaluating adverse events, objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and pharmacokinetic parameters of the study drug.
Detailed description
This is a single-center, open-label, phase 1 dose-escalation study. Eligible patients will receive CIB in vivo CAR-T lentiviral injection at escalating dose levels. Safety assessments include adverse events, laboratory tests, vital signs, and physical examinations. Efficacy assessments include tumor response evaluation according to RECIST v1.1. Pharmacokinetic and immunogenicity assessments will also be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label, single-arm, dose-escalation design.
| Arm | Type | Receives |
|---|---|---|
| Experimental: CIB in vivo CAR-T Lentiviral Injection | Experimental | Biological: CIB in vivo CAR-T Lentiviral InjectionIntravenous administration of CIB in vivo CAR-T lentiviral injection as a single agent. Planned dose levels include 1×10⁵ TU/kg, 3×10⁵ TU/kg, 1×10⁶ TU/kg, 3×10⁶ TU/kg, 1×10⁷ TU/kg, and 3×10⁷ TU/kg. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 18 years and ≤ 75 years.
- At least one measurable target lesion according to RECIST version 1.1 at screening.
- Histologically or cytologically confirmed advanced or metastatic malignant tumor, with positive target expression confirmed by validated assay methods.
- Patients who have failed prior standard systemic therapy (including but not limited to VEGF-targeted tyrosine kinase inhibitors and/or immune checkpoint inhibitors), or are intolerant to standard therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (22 listed)
- Asymptomatic untreated brain metastases; symptomatic central nervous system (CNS) metastases or carcinomatous meningitis; or other evidence of uncontrolled CNS/meningeal metastases that are considered unsuitable for enrollment by the investigator.
- Presence of clinically significant cardiovascular, pulmonary, neurological, or systemic disease at baseline that may increase study participation risk or interfere with safety assessments.
- Presence of severe chronic or active infection at baseline, including:
- History of active autoimmune disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, vasculitis) or receipt of long-term systemic corticosteroids (prednisone > 10 mg/day or equivalent) or other immunosuppressive agents within 4 weeks prior to first administration.
- Prior allogeneic tissue or solid organ transplantation.
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 |
|---|---|---|
| CIB in vivo CAR-T Lentiviral InjectionCIB in vivo CAR-T lentiviral vector administered via intravenous infusion at escalating dose levels. | Biological | Experimental: CIB in vivo CAR-T Lentiviral Injection |
Primary outcome
Incidence of Dose-Limiting Toxicities (DLTs) and Determination of Maximum Tolerated Dose (MTD)
Time frame: 28 days after administration
To evaluate the incidence of dose-limiting toxicities (DLTs) within 28 days after administration, and to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of CIB in vivo CAR-T lentiviral injection.
8 secondary outcomes
Incidence and Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From administration up to 24 months
Objective Response Rate (ORR)
Time frame: Every 6 weeks after administration, up to 12 months
Disease Control Rate (DCR)
Time frame: Every 6 weeks after administration, up to 12 months
Duration of Response (DoR)
Time frame: Up to 24 months after administration
Progression-Free Survival (PFS)
Time frame: Up to 24 months after administration
Dynamic Changes in Peripheral Blood CAR-Positive T Cell Proportion
Time frame: Pre-dose, Days 7, 14, 28, 60, 90, and 180 after administration
Dynamic Changes in Peripheral Blood Lentiviral Vector Copy Number
Time frame: Pre-dose, Days 7, 14, 28, 60, 90, and 180 after administration
Changes in Plasma Cytokine Levels
Time frame: Within 2 hours pre-dose, Days 2, 8, 14, and 28 after administration
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 18 Jun 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 Phase 1 study testing CIB in vivo CAR-T Lentiviral Injection in people with Advanced Malignant Solid Tumors, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 12 inclusion and 22 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: opening soon, as of the sponsor's last update on 18 Jun 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?
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?
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 Ning Li (+8601087788165, lining@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-Limiting Toxicities (DLTs) and Determination of Maximum Tolerated Dose (MTD) (time frame: 28 days after administration). 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 18 Jun 2026.