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CompletedNCT02541370Updated Dec 17, 2019

Treatment of Relapsed and/or Chemotherapy Refractory Advanced Malignancies by CART133

A Phase 1/2 interventional study of anti-CD133-CAR vector-transduced T cells in Liver Cancer, Pancreatic Cancer and Brain Tumor, sponsored by Chinese PLA General Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-12-17.

Sponsored by Chinese PLA General Hospital · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
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Study summary

RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory into patient autologous or donor-derived T cells may make the body build immune response to kill cancer cells.

PURPOSE: This clinical trial is studying genetically engineered lymphocyte therapy in treating patients with Relapsed and/or Chemotherapy Refractory Advanced Malignancies.

Read the detailed description

I. Determine the safety and feasibility of the chimeric antigen receptor T cells transduced with the anti-CD133 (cluster of differentiation antigen 133 ) vector (referred to as CART-133 cells).

II. Determine duration of in vivo survival of CART-133 cells. RT-PCR (reverse transcription polymerase chain reaction) analysis of whole blood will be used to detect and quantify survival of CART-133 TCR (T-cell receptor) zeta:CD137 and TCR zeta cells over time.

SECONDARY OBJECTIVES:

I. For patients with detectable disease, measure anti-tumor response due to CART-133 cell infusions.

II. To determine if the CD137 transgene is superior to the TCR zeta only transgene as measured by the relative engraftment levels of CART-133 TCR zeta:CD137 and TCR zeta cells over time.

III. Estimate relative trafficking of CART-133 cells to tumor in bone marrow and lymph nodes.

IV. For patients with stored or accessible tumor cells determine tumor cell killing by CART-133 cells in vitro.

V. Determine if cellular or humoral host immunity develops against the murine anti-CD133, and assess correlation with loss of detectable CART-133 (loss of engraftment).

VI. Determine the relative subsets of CART-133 T cells (Tcm, Tem, and Treg).

02

Conditions studied

  • Liver Cancer
  • Pancreatic Cancer
  • Brain Tumor
  • Breast Cancer
  • Ovarian Tumor
  • Colorectal Cancer
  • Acute Myeloid and Lymphoid Leukemias
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In context

Leukemia, Lymphoid

1,780 studies on the registry are indexed under Leukemia, Lymphoid; 176 are open to participants now.

This study's planned enrollment of 20 is below the median of 36 across 1,416 interventional studies indexed under Leukemia, Lymphoid.

Browse Leukemia, Lymphoid studies →

Lead sponsor

Chinese PLA General Hospital is the lead sponsor of 558 studies on the registry; 202 are open to participants now.

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

04

Who can participate

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

Inclusion criteria

  1. Chemotherapy refractory or relapsed CD133-positive liver cancer, pancreatic cancer, brain tumor ,breast cancer, ovarian tumors, colorectal cancer and acute leukemia.
  2. Patients must be 18 years of age or older.
  3. Patients must have an ECOG (Eastern Cooperative Oncology Group )performance status of 0-2.

  4. Patients must have evidence of adequate bone marrow reserve, hepatic and renal function as evidenced by the following laboratory parameters:

    Absolute neutrophil count greater than 1500/mm3. Platelet count greater than 100,000/mm3. Hemoglobin greater than 10g/dl (patients may receive transfusions to meet this parameter).

    Total bilirubin \< 1.5 times upper limits of normal. Serum creatinine less than or equal to 1.6 mg/ml or the creatinine clearance must be greater than 70 ml/min/1.73m.

  5. Seronegative for HIV antibody.
  6. Seronegative for active hepatitis B, and seronegative for hepatitis C antibody.
  7. Patients must be willing to practice birth control during and for four months following treatment. NOTE: women of child-bearing age must have evidence of negative pregnancy test.
  8. Patients must be willing to sign an informed consent.

Exclusion criteria

Exclusion Criteria:

    1. Patients with life expectancy less than 12 months will be excluded. 2. Patients with uncontrolled hypertension (> 160/95), unstable coronary disease evidenced by uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (> New York Heart Association Class II), or myocardial infarction within 6 months of study will be excluded.

      1. Patients with any of the following pulmonary function abnormalities will be excluded: FEV(forced expiratory volume), \< 30% predicted; DLCO (diffusing capacity of lung for carbon monoxide) \< 30% predicted (post-bronchodilator); Oxygen Saturation less than 90% on room air.
      1. Patients with severe liver and kidney dysfunction or consciousness disorders will be excluded.
      1. Pregnant and/or lactating women will be excluded. 6. Patients with active infections, including HIV, will be excluded, due to unknown effects of the vaccine on lymphoid precursors.
      1. Patients with any type of primary immunodeficiencies will be excluded from the study.
      1. Patients requiring corticosteroids (other than inhaled) will be excluded. 9. Patients with history of T cell tumors will be excluded. 10. Patients who are participating or participated any other clinical trials in latest 30 days will be excluded.
      1. Patients with relapsed acute leukemia after allogeneic stem cell transplantation
05

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-CD133 CAR T cells

    Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation. Patients receive anti-CD133-CAR retroviral vector-transduced autologous-derived T cells on days 0, 1, 2 in the absence of disease progression or unacceptable toxicity.

    Biological: anti-CD133-CAR vector-transduced T cells

Interventions

  • Biologicalanti-CD133-CAR vector-transduced T cells

    genetically engineered lymphocyte therapy

    Also known as: genetically engineered lymphocyte therapy

06

What researchers measure

Primary outcomes

  1. Occurrence of study related adverse events

    defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical

    Time frame: Until week 24

Secondary outcomes

  1. Anti-tumor responses to CART-133 cell infusions

    Time frame: up to 24 weeks

Other outcomes

  1. in vivo existence of CART133

    Time frame: 1 year

07

Study locations

1 site
  • Biotherapeutic Department and Pediatrics Department of Chinese PLA General Hospital
    Beijing, Beijing 100853, China
08

References and documents

Publications

  • Dai H, Tong C, Shi D, Chen M, Guo Y, Chen D, Han X, Wang H, Wang Y, Shen P. Efficacy and biomarker analysis of CD133-directed CAR T cells in advanced hepatocellular carcinoma: a single-arm, open-label, phase II trial. Oncoimmunology. 2020 Nov 25;9(1):1846926. doi: 10.1080/2162402X.2020.1846926. PubMed 33312759 ↗
  • Feng KC, Guo YL, Liu Y, Dai HR, Wang Y, Lv HY, Huang JH, Yang QM, Han WD. Cocktail treatment with EGFR-specific and CD133-specific chimeric antigen receptor-modified T cells in a patient with advanced cholangiocarcinoma. J Hematol Oncol. 2017 Jan 5;10(1):4. doi: 10.1186/s13045-016-0378-7. PubMed 28057014 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02541370
Lead sponsor
Chinese PLA General Hospital
Responsible party
Han weidong (PI, Chinese PLA General Hospital) — Principal investigator
First posted
Sep 4, 2015
Start date
Jun 2015
Primary completion
Jun 2019
Completion
Jun 2019
Last update
Dec 17, 2019

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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