Clinical trial · Interventional
Investigator Initiated Phase 1 Study of TBI-1201
Multi-center, Investigator Initiated Phase 1 Study of MAGE-A4 Specific TCR Gene Transferred T Lymphocytes With Solid Tumors
NCT02096614CI-TRIAL-00052319completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Following pre-treatment with cyclophosphamide and/or fludarabine, MAGE-A4-specific TCR gene transduced T lymphocytes are transferred to the patients with MAGE-A4-expressing solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| TBI-1201 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Low dose TBI-1201 with pre-treatment 1
- description
- TBI-1201(5\*10\^8) single-dose administration with pre-treatment of cyclophosphamide alone.
- interventionNames
- Drug: TBI-1201
- Drug: Cyclophosphamide
- type
- EXPERIMENTAL
- label
- High dose TBI-1201 with pre-treatment 1
- description
- TBI-1201(5\*10\^9) single-dose administration with pre-treatment of cyclophosphamide alone.
- interventionNames
- Drug: TBI-1201
- Drug: Cyclophosphamide
- type
- EXPERIMENTAL
- label
- High dose TBI-1201 with pre-treatment 2
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically or cytologically confirmed solid tumors 2. Solid tumor, which is unresectable , refractory to standard therapy (chemotherapy, radiotherapy, etc) , metastatic or recurrent 3. HLA-A\*24:02 positive 4. MAGE-A4-expression by PCR or immunohistochemistry 5. ECOG Performance Status, 0 or 1 6. Age \>20 years on consent 7. No treatment (surgery, chemotherapy, radiotherapy, etc.) and expected sufficient recovery from the treatment at the time of the lymphocytes collection for gene transfer. 8. Life expectancy \>= 16 weeks after consent 9. No severe damage on the major organs (bone marrow, heart, lung, liver, kidney, etc) and meet the following lab value criteria: * WBC \> 2,500/μL * Hemoglobin \> 8.0g/dL * Platelets \> 75,000/μL * T. bilirubin \< 1.5 x ULN * AST(GOT)、ALT(GPT) \< 3.0 x ULN * Creatinine \< 1.5 x ULN 10. Ability to understand the study contents and to give a written consent at his/her free will. Exclusion Criteria: 1. The following serious complications are excluded from the study; * Unstable angina, cardiac infarction, or heart failure * Uncontrolled diabetes or hypertension * Active infection * Obvious interstitial pneumonia or lung fibrosis by chest X-ray * Active autoimmune disease requiring steroids or immunosuppressive therapy 2. Serious hypersensitivity 3. Tumor cell invasion into CNS 4. Active multiple cancer 5. Positive for HBs antigen/antibody, HBc antibody, or HCV antibody, and virus DNA observed in serum, except for HBs antibody positive case who had vaccine injection before. 6. Positive for antibodies against HIV or HTLV-1 7. Left Ventricular Ejection Fraction (LVEF): =\< 50% 8. Percutaneous Oxygen saturation: \< 94% 9. History of hypersensitivity reactions to bovine or murine derived substances. 10. History of hypersensitivity reaction to drugs used in this study 11. Psychological disorder or drug dependency which may have impact on the consent. 12. Pregnant females, lactating females (except when they cease and don't resume lactation) or female and male patients who cannot agree to practice the adequate birth control after the consent during the study 13. Clinically significant systemic illness that in the judgment of the PI or sub-investigator would compromise the patient's ability to tolerate protocol therapy or significantly increase the risk of complications.
References
Publications (0)
Data not yet available
No reference posted for this study.