Phase 1/2 Study of Autologous SCG142 TCR T Cells in Patients With HPV16/52-positive Carcinoma
NCT ID: NCT06505551
Last Updated: 2024-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1/PHASE2
66 participants
INTERVENTIONAL
2024-10-31
2028-12-31
Brief Summary
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Detailed Description
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The Phase 1 part of the trial consists of a dose-escalation portion designed to evaluate the safety and tolerability of SCG142, and to identify the RP2D.
The Phase 2 part of the trial is designed to evaluate the preliminary efficacy of SCG142 in the same patient populations.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SCG142 T cells
This is a single arm study.
SCG142
Autologous SCG142 cells infused on Day 0 after completion of lymphedepletion chemotherapy
Cyclophosphamide
for 3 consecutive days
Fludarabine
for 3 consecutive days
Interventions
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SCG142
Autologous SCG142 cells infused on Day 0 after completion of lymphedepletion chemotherapy
Cyclophosphamide
for 3 consecutive days
Fludarabine
for 3 consecutive days
Eligibility Criteria
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Inclusion Criteria
2. Tumor tissue positive for HPV16 or HPV52.
3. Advanced or metastatic carcinoma with progression after at least 1 line of standard of care systemic therapies, including but not limited to combination chemotherapy and/or combination chemo-immunotherapy.
4. Human leukocyte antigen (HLA)-A\*02:01 genotype.
5. Measurable disease as defined by RECIST v1.1.
6. Eastern Cooperative Group (ECOG) Performance Status of 0 or 1.
7. Anticipated life expectancy ≥3 months.
8. Adequate laboratory parameters including hematologic, renal, hepatic and coagulation function.
Exclusion Criteria
2. Active brain metastasis or leptomeningeal metastases.
3. History of other malignancy within 2 years prior to Screening.
4. History of organ transplant.
5. Positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
6. History of active cardiac disease.
7. History of active pulmonary disease.
8. Active, known, or suspected autoimmune disease.
9. Lack of peripheral venous or central venous access, or any condition that may prevent trial sample collection and administration of SCG142.
10. Prior exposure to any cell therapy including, but not limited to natural killer (NK) cells, cytokine-induced killer (CIK) cells, dendritic cells (DCs), cytotoxic T lymphocytes (CTLs), stem cell therapy, and CAR/TCR-T cell therapy.
11. Allergy to LD chemotherapy (cyclophosphamide or fludarabine) and/or any component of SCG142.
12. Any serious medical condition or abnormality in clinical laboratory tests.
18 Years
ALL
No
Sponsors
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SCG Cell Therapy Pte. Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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SCG Cell Therapy
Role: STUDY_DIRECTOR
SCG Cell Therapy Pte. Ltd.
Central Contacts
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Other Identifiers
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SCG142-UR-102
Identifier Type: -
Identifier Source: org_study_id
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