ClinicalTrials.gg
Not yet recruitingNCT07180927Updated Nov 2, 2026

DLL3 CAR-T Therapy Targeting Brain Tumors

A Phase 1/2 interventional study of 4SCAR DLL3 T cells in Glioblastoma of Cerebellum, sponsored by Shenzhen Geno-Immune Medical Institute. Not yet recruiting at 1 site in China. Open to participants aged 2 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by Shenzhen Geno-Immune Medical Institute · Phase 1/2, Interventional, and Treatment

Updated Nov 2, 2026Study contact changedGo to Updates ↓

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Phase
Phase 1/2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
2 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 142 studies in Glioblastoma with a site in China — 73 open to participants now, 80 under way, 7 of them phase 3. Glioblastoma · China.

Planned enrollment
71st of 127
30 · median 36
Started
2027
the only one that year
Phase 1/2
21 of 142
14 open now
Primary completion
2028-05
later than 63 of 79 live
Registered
113th of 142
by date

Among the 142 studies in Glioblastoma with a site in China, this one is the 71st largest by planned enrollment of the 127 interventional ones that give a count, is the only one that started in 2027, is one of 21 in phase 1/2, reaches primary completion later than 63 of the 79 other live ones, and was the 113th registered.

Glioblastoma

2,134 studies on the registry are indexed under Glioblastoma; 466 are open to participants now.

Browse Glioblastoma studies →

Open to participants now

73 of the 142 studies in Glioblastoma with a site in China are open now. Recruiting first, the newest first:

68 more — sign in →

All 73 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 339 Glioblastoma studies recruiting now, 234 (69%) set no upper age limit and 65 (19%) stop at 75 or younger; 27 take children under 18; 13 take healthy volunteers.

This study: 2 Years to 70 Years · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study summary

The purpose of this study is to assess the feasibility, safety and efficacy of Delta-like ligand 3 (DLL3)-specific CAR-T cell therapy in patients with DLL3 positive brain tumors including glioblastomas and diffused intrinsic pontine or midline gliomas (DIPG or DMG). Another goal of the study is to learn more about the function of the anti-DLL3 CAR-T cells and their persistency in patients.

Read the detailed description

Important Regulatory Notice:

This trial record is only for global academic information registration on ClinicalTrials.gov. Neither the sponsor Beijing Meikang Jimian Biotechnology Co., Ltd. nor collaborator Shenzhen Geno-Immune Medical Institute has obtained NMPA clinical trial approval or clinical technology filing permission to carry out interventional cell therapy trials in mainland China.

ClinicalTrials.gov registration alone does not represent legal approval by Chinese health and drug regulatory authorities.

Glioblastoma (GBM) and other aggressive brain tumors remain among the most challenging cancers to treat, with limited therapeutic options and poor survival rates. GBM is known to express increased levels of certain antigens that can be targeted by T cells including chimeric antigen receptor-modified T (CAR-T) cells.

One promising target in this effort is DLL3, a protein highly expressed on the surface of certain tumor cells including GBM/DIPG/DMG and other central nervous system malignancies but with minimal presence in normal tissues. This expression pattern makes DLL3 an attractive target for precision CAR-T therapy treating brain tumors, which involves engineering a patient's own T cells to recognize and eliminate cancer cells expressing this specific marker.

This study aims to evaluate the safety, feasibility, and preliminary efficacy of DLL3-directed CAR-T cells in patients with recurrent or refractory brain tumors. These studies represent a critical step toward harnessing the immune system to fight traditionally treatment-resistant cancers, offering new hope for patients with few other options.

03

Conditions studied

  • Glioblastoma of Cerebellum

Browse trials for

Keywords

  • CAR-T
  • Glioblastoma
  • DLL3
04

Who can participate

Ages eligible
2 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. abilities to understand and the willingness to provide written ;
  2. patients are ≥ 2 and ≤ 70 years old;
  3. recurrent or brain tumor patients with . Patients have received standard care of medication, such as gross total resection with concurrent radio-chemotherapy (\~54 - 60 Gy, TMZ). Patients must either not be receiving dexamethasone or receiving ≤ 4 mg/day at the time of leukopheresis;
  4. performance score (KPS) ≥ 60;
  5. >3 months;
  6. satisfactory bone marrow, liver and kidney functions as defined by the following: absolute neutrophile count ≥ 1500/mm\^3; > 10 g/dL; > 100000 /mm\^3; \< 1.5×; (ALT) or aspartate aminotransferase (AST) \< 2.5×ULN; creatinine \< 1.5×ULN;
  7. peripheral blood absolute lymphocyte count must be above 0.8×10\^9/L;
  8. satisfactory heart functions;
  9. patients must be willing to follow the instructions of doctors;
  10. women of (between 15 and 49 years old) must have a negative pregnancy test within 7 days of study start. Male and female patients of reproductive potential must agree to use during the study and 3 months post study.

Exclusion criteria

Exclusion Criteria:

  1. a prior history of gliadel implantation 4 weeks before this study start or currently receiving antibody based therapies;
  2. positive;
  3. tuberculosis infection not under control;
  4. history of disease, or other diseases require long-term administration of or therapies;
  5. history of allergic disease, or allergy to immune cells or study product ;
  6. patients already actively enrolled in other immune cell clinical study; patients, in the opinion of investigators, may not be eligible or not able to comply with the study.
Terms in these criteria, in plain language(17)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Reproductive potential

Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.

Criteria about it usually ask for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    4SCAR-DLL3 T Cell Therapy treating DLL3 positive glioblastoma

    Infusion of 4SCAR-DLL3 T cells at 10\^6 cells/kg body weight via intravenous route

    Biological: 4SCAR DLL3 T cells

Interventions

  • Biological4SCAR DLL3 T cells

    Infusion of 4SCAR DLL3 T cells at 10\^6 cells/kg body weight via intravenous route

06

What researchers measure

Primary outcomes

  1. Number of patients with adverse events.

    Determine the toxicity profile the 4SCAR DLL3 cells with Common Toxicity Criteria for Adverse Effects version 4.0

    Time frame: 6 months

Secondary outcomes

  1. Anti-tumor effects

    Objective responses (complete response (CR) are assessed by the Response Evaluation Criteria in Glioblastoma (RECIST) v1.1 criteria.

    Time frame: 1 year

  2. Anti-tumor effects

    Objective responses partial response (PR)) are assessed by the Response Evaluation Criteria in Glioblastoma (RECIST) v1.1 criteria.

    Time frame: 1 year

  3. The expansion of 4SCAR DLL3 T cells

    Scale of CAR copies for efficacy

    Time frame: 1 year

  4. The persistence of 4SCAR DLL3 T cells

    Scale of tumor burden for efficacy

    Time frame: 1 year

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2027; primary completion for May 2028, 11 months later.

Of 84 non-industry phase 1/2 interventional studies under Glioblastoma, half reached primary completion within 73 months of starting (the median), counting those still running; a quarter within 50 and three quarters within 102. This study's planned 11 months is below that.

Counting every sponsor, half of 137 studies reached it within 66 months; a quarter within 45 and three quarters within 100.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 12, 2025
First posted
Sep 18, 2025
StartEst.
Jun 1, 2027
Primary completionEst.
May 31, 2028
CompletionEst.
Dec 31, 2028
Last update
Nov 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Contact
Study contact's phone or email changed: c•••@szgimi.org→c•••@mkgimi.com. See the current contact
Nov 2, 2026
Site contacts
Changed at 1 site. See the sites
Show the site
  • Shenzhen Geno-immuno Medical Institute · Shenzhen, ChinaContact c•••@szgimi.org→c•••@mkgimi.com
Nov 2, 2026
Show all 1 update
  1. Nov 2, 2026
    Contact Study contact's phone or email changed: c•••@szgimi.org→c•••@mkgimi.com. See the current contact
    Site contacts Changed at 1 site. See the sites
    Show the site
    • Shenzhen Geno-immuno Medical Institute · Shenzhen, ChinaContact c•••@szgimi.org→c•••@mkgimi.com
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07180927
Lead sponsor
Shenzhen Geno-Immune Medical Institute
Responsible party
Sponsor
First posted
Sep 18, 2025
Start date
Jun 1, 2027 (estimated)
Primary completion
May 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Nov 2, 2026

Study contacts

Lung-Ji Chang, PhD
Contact
c@mkgimi.com
+86 0755-86573763

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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