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NCT06150885 | RECRUITING | Solid Tumor

A Safety and Efficacy Study of Allogeneic CAR Gamma-Delta T Cells in Subjects with Relapsed/Refractory Solid Tumors
Sponsor:

Ever Supreme Bio Technology Co., Ltd.

Brief Summary:

This study is composed of phase I and IIa parts. The dose-escalation phase I part aims to find the maximum tolerated dose (MTD) and to identify the safety of CAR001 in subjects with relapsed/refractory solid tumor; the dose-expansion phase IIa part aims to evaluate the potential efficacy of CAR001 in subjects with relapsed/refractory non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), colorectal cancer (CRC) or Glioblastoma multiforme (GBM).

Condition or disease

Solid Tumor

Intervention/treatment

HLA-G-CAR.BiTE allogeneic γδ T cells

Phase

PHASE1

PHASE2

Detailed Description:

Primary Objective: Phase I: To evaluate the safety of CAR001 in subjects. Phase IIa: To provide potential evidence for the clinical efficacy of CAR001 in improving tumor response rate in subjects. Secondary Objectives: To evaluate the safety and potential efficacy of CAR001 in subjects. Exploratory: Level of CAR-positive γδT cells in peripheral blood from baseline to subsequent visits. (Time Frame: 12 months after the last infusion)

Study Type : INTERVENTIONAL
Estimated Enrollment : 60 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Single Arm, Open Label, Dose-escalation Phase I and Dose-expansion Phase IIa Clinical Study to Evaluate the Feasibility, Safety, and Efficacy of Allogeneic Chimeric Antigen Receptor (CAR) Gamma-Delta T Cells CAR001 in Subjects with Relapsed/refractory Solid Tumors
Actual Study Start Date : 2024-09-01
Estimated Primary Completion Date : 2027-06-30
Estimated Study Completion Date : 2027-09-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Male or female subjects aged ≥ 18 years
  • 2. For phase I part, subjects with histologically confirmed diagnosis of solid tumor with expression of PD-L1 ≥ 1% and are relapsed/refractory to at least two lines of standard-of-care therapy. For phase IIa part, subjects with histologically confirmed diagnosis of TNBC, NSCLC, CRC or GBM with expression of PD-L1 ≥ 1%, and are relapsed/refractory to at least two lines of standard-of-care therapy.
  • 3. With at least one measurable lesion as defined by RECIST1.1 (for TNBC, NSCLC or CRC) or RANO (for GBM)
  • 4. Able to understand and sign the ICF
  • 5. Have a life expectancy of \> 12 weeks
  • 6. ECOG performance status ≤ 1
  • 7. Recovered from any previous therapy related toxicity to ≤ grade 2 at screening
  • 8. With adequate renal function: serum creatinine ≤ 1.5 X ULN; eGFR \> 50 ml/min
  • 9. With adequate liver function: ALT, AST, and ALP ≤ 3X ULN or ≤ 5 X ULN if liver metastases; and total bilirubin ≤ 1.5X ULN or ≤ 3 X ULN if due to Gilbert's disease
  • 10. With PT and PTT ≤ 1.5X ULN
  • 11. With adequate hematopoietic function
    • * ANC ≥ 1,000 cells/μl
    • * Platelets ≥ 75,000 counts/μl
    • * Total WBC ≥ 2,000 cells/μl
    • * Hemoglobin ≥ 8 g/dL
    Exclusion Criteria
    • 1. Has received any allogeneic cell therapy before screening
    • 2. With known or suspected to be hypersensitivity to CAR001 or its excipients, such as DMSO or human serum albumin
    • 3. With more than one kind of active diagnosed primary cancer
    • 4. With active infection requiring systemic medication
    • 5. With medical conditions who are receiving systemic steroid therapy \>10 mg prednisone/day or equivalent dose, or other immune-suppressants in the past 2 weeks
    • 6. Has been diagnosed as HIV positive (confirmed by anti-HIV and nucleic acid test)
    • 7. With acute cardiovascular disease; NYHA classification ≥ 3; or history of myocardial infarction during the past 6 months; or has active uncontrolled arterial hypertension by medical history. Per investigator's judgment, would not make participation appropriate
    • 8. With historical or current auto-immune diseases, such as rheumatoid arthritis, type I diabetes, psoriasis or systemic lupus erythematosus
    • 9. Has uncontrolled psychiatric disorder by medical history
    • 10. Has CNS diseases except GBM or stroke
    • 11. Has received any investigational therapy from another clinical study within 4 weeks
    • 12. Inability to undergo radiological assessment, such as MRI or CT for any reason
    • 13. Has received radiotherapy or chemotherapy within 2 weeks (but palliative radiation therapy (R/T) for pain control are allowed)
    • 14. Not suitable to participate the trial as judged by the investigator
    • 15. Female subject of childbearing potential who
      • * Is lactating; or
      • * Has a positive pregnancy test result at eligibility checking; or
      • * Refuses to adopt at least two form of birth control from signing informed consent to 1 year after the last administration of CAR001.
      • 16. Male subject with a female spouse/partner who is of childbearing potential refuses to adopt at least two forms of birth control from signing informed consent to 1 year after the last administration of CAR001.
      • For exclusion criteria #15 and #16, acceptable forms of birth control include
        • * Established use of oral, injected, or implanted hormonal methods of contraception that have comparable efficacy (failure rate \< 1 %), for example hormone vaginal ring or transdermal hormone contraception
        • * Placement of an intrauterine device or intrauterine system
        • * Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps)
A Safety and Efficacy Study of Allogeneic CAR Gamma-Delta T Cells in Subjects with Relapsed/Refractory Solid Tumors

Location Details

NCT06150885

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Taiwan, Non-US

China Medical University Hospital

Taichung, Non-user, Taiwan, 404