Status:
COMPLETED
TAA-Specific CTLS for Solid Tumors (TACTASOM)
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
The Methodist Hospital Research Institute
Center for Cell and Gene Therapy, Baylor College of Medicine
Conditions:
Rhabdomyosarcoma
Eligibility:
All Genders
2-80 years
Phase:
PHASE1
Brief Summary
This is a clinical trial for patients with a solid tumor which has come back, or may come back, or has not gone away after treatment, including the standard treatment we know for these diseases. This ...
Detailed Description
Blood will be collected from the patient and TAA-specific CTLs will be made. The cells will be injected by IV into the patient over 1 - 10 minutes. The patient may be pre-treated with acetaminophen (...
Eligibility Criteria
Inclusion
- THIS PROTOCOL IS CURRENTLY NOT RECRUITING ADULTS.
- Procurement
- Any patient regardless of sex with a solid tumor expressing any of the following antigens (PRAME, SSX2, MAGEA4, NY-ESO1-1 and/or Survivin) with:
- Active disease after first line therapy;
- Refractory disease;
- As adjuvant therapy for high risk disease (high risk disease is a disease that has a \>50% risk of progression within 5 years)
- Patients with life expectancy at least 6 weeks.
- Age greater than or equal to 2 and less than or equal to 80 years old.
- Hgb \>8.0
- Informed Consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.
- Procurement
Exclusion
- Diagnosis of primary CNS tumor.
- Patients with severe intercurrent infection.
- Patients with active HIV infection at time of procurement (can be pending at the time of blood draw).
- Patients in remission who are enrolled on another study where time to progression or disease-free survival is a primary endpoint.
- Treatment Inclusion Criteria:
- Any patient regardless of sex with a solid tumor expressing any of the following antigens (PRAME, SSX2, MAGEA4, NY-ESO1-1 and/or Survivin) with:
- Active disease after first line therapy;
- Refractory disease;
- As adjuvant therapy for high risk disease (high risk disease is a disease that has a \>50% risk of progression within 5 years)
- Patients with life expectancy at least 6 weeks.
- Age greater than or equal to 2 and less than or equal to 80 years old.
- Pulse oximetry of \>95% on room air in patients who previously received radiation therapy.
- Patients with a Karnofsky/Lansky score of greater than or equal to 50.
- Patients with bilirubin less than or equal to 2x upper limit of normal, AST less than or equal to 3x upper limit of normal, and Hgb \>8.0
- Patients with a creatinine less than or equal to 2x upper limit of normal for age.
- Patients should have been off other investigational therapy for one month prior to entry in this study.
- Patients should have been off conventional therapy for at least 1 week prior to entry in this study. PD1/PDL1 inhibitors will be allowed if medically indicated.
- Informed Consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.
- Due to unknown effects of this therapy on a fetus, pregnant women are excluded from this research. The male partner should use a condom Females of child-bearing potential must be willing to utilize one of the more effective birth control methods during the study unless female has had a hysterectomy or tubal ligation.
- Treatment
Key Trial Info
Start Date :
April 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 7 2022
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT02239861
Start Date
April 1 2015
End Date
April 7 2022
Last Update
April 12 2022
Active Locations (2)
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1
Houston Methodist Hospital
Houston, Texas, United States, 77030
2
Texas Children's Hospital
Houston, Texas, United States, 77030