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Status unknownNCT03931720Updated Apr 30, 2019

Clinical Research of ROBO1 Specific BiCAR-NK/T Cells on Patients With Malignant Tumor

A Phase 1/2 interventional study of BiCAR-NK/T cells (ROBO1 CAR-NK/T cells) in Malignant Tumor, sponsored by Asclepius Technology Company Group (Suzhou) Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-04-30.

Sponsored by Asclepius Technology Company Group (Suzhou) Co., Ltd. · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
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Study summary

Immunotherapy has become the major breakthrough and the most promising treatment, with the host of development of tumor biology, molecular biology and immunology. ROBO1 is a potential target and spectacular paradigm in the diagnosis and treatment of solid tumors. This study is for evaluation of the safety and efficacy of ROBO1 CAR-NK/T cell immunotherapy for malignant tumors.

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Conditions studied

  • Malignant Tumor

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03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 20 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

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Lead sponsor

Asclepius Technology Company Group (Suzhou) Co., Ltd. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age 18\~75 years old, male or female
  2. Life expectancy ≥ 6 months
  3. ECOG score: 0-3
  4. ROBO1 expression in malignancy tissues detected by immuno-histochemistry (IHC)
  5. Advanced solid tumor was diagnosed by pathological or clinical physicians
  6. Laboratory examination: white blood cell≥3 x 10*9/L, blood platelet count≥70 x 10*9/L, hemoglobin≥80g/L, lymphocyte count≥15%, total bilirubin≤100 mol/L, ALT and AST less than five times of the normal level, serum creatinine less than 1.5 times of the normal level
  7. Signed informed consent
  8. Women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 2 weeks following the cell transfusion

Exclusion criteria

Exclusion Criteria:

  1. Expected overall survival \< 6 months
  2. Patients with uncontrolled hypertension, unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (> Class II, NYHA), or myocardial infarction within 6 months
  3. Abnormal lung function: FEV (forced expiratory volume) \< 30% prediction, DLCO (diffusing capacity of the lung for carbon monoxide) \< 30% prediction, blood oxygen saturation \< 90%
  4. Other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc.
  5. Unable or unwilling to provide informed consent, or fail to comply with the test requirements
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Study design

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

Study arms

  • Experimental
    anti-tumor response of BiCAR-NK/T cells (ROBO1 CAR-NK/T cells)

    Patients with relapsed and refractory cancer of ROBO1 expression will be treated with BiCAR-NK/T cells (ROBO1 CAR-NK/T cells).

    Biological: BiCAR-NK/T cells (ROBO1 CAR-NK/T cells)

Interventions

  • BiologicalBiCAR-NK/T cells (ROBO1 CAR-NK/T cells)

    The subject will be observed for any side effects during this time and all the adverse events will be recorded.

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What researchers measure

Primary outcomes

  1. Occurrence of treatment related adverse events as assessed by CTCAE v4.03

    Defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment.

    Time frame: 1 year

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Study locations

1 of 1 sites recruiting
  • Department of Oncology, Suzhou Kowloon Hospital, Shanghai Jiaotong University School of Medicine
    Suzhou, Jiangsu 215021, China
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03931720
Lead sponsor
Asclepius Technology Company Group (Suzhou) Co., Ltd.
Responsible party
Sponsor
First posted
Apr 30, 2019
Start date
May 2019 (estimated)
Primary completion
May 2021 (estimated)
Completion
May 2022 (estimated)
Last update
Apr 30, 2019

Study contacts

Guangfu Li
Contact
lgf@atcgcell.com
+86 13615181959
Xianfeng Feng
Contact
fxf@atcgcell.com
+86 15157190521

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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