A Phase II Trial of T Cell Receptor Gene Therapy Targeting HPV-16 E7 for HPV-Associated Cancers.
The primary objective of this trial is to determine the objective tumor response rate (CR+PR) and duration of response for treatment of recurrent/refractory or metastatic HPV-associated cancers with E7 TCR-T cells.
Larynx
Other Female Genital
Cervix
Anus
Lip, Oral Cavity and Pharynx
- Rutgers Cancer Institute of New Jersey
Inclusion Criteria
1. Histologically or cytologically confirmed metastatic or refractory/recurrent HPV-16+
cancer.
2. Tumor with HPV16 genotype as determined by testing performed in a CLIA certified
laboratory.
3. HLA-A*02:01 allele as determined by testing performed in a Clinical Laboratory
Improvement Amendments (CLIA) certified laboratory. Participants may be enrolled
based on low resolution typing (i.e., HLA-A*02) but the HLA-A*02:01 allele type must
be confirmed prior to apheresis.
4. Measurable disease as assessed by RECIST Criteria Version 1.114.
5. Age ≥ 18 years.
6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at screening.
7. Must have received prior first line standard therapy or have declined standard
therapy.
8. Standard treatment options for first and second-line therapy must be presented and
formally declined (Appendix VII).
9. Patients with three or fewer brain metastases that have been treated with surgery or
stereotactic radiosurgery are eligible. Lesions that have been treated with
stereotactic radiosurgery must be clinically stable for one month before protocol
treatment. Patients must be fully recovered from surgery.
10. Negative pregnancy test for women under 55 and all women who have had a menstrual
period in the last 12 months. A pregnancy tests is not required for women who have
had a bilateral oophorectomy or hysterectomy.
11. Men and women of child-bearing potential must agree to use adequate contraception
(i.e., intrauterine device, hormonal barrier method of birth control; abstinence;
tubal ligation or vasectomy) prior to study entry and for four months after
treatment. Should a women become pregnant or suspect she is pregnant while she is
participating in this study, she should inform her treating physician immediately.
12. Seronegative for HIV antibody, hepatitis B antigen, and hepatitis C antibody. If a
hepatitis C antibody test is positive, then testing for antigen by RT-PCR for
Hepatitis C (HCV) RNA must be negative.
13. Participants must have organ and marrow function as defined below:
1. Leukocytes > 3,000/microliter (mcL)
2. Absolute neutrophil count > 1,500/mcL
3. Platelets > 100,000/mcL
4. Hemoglobin > 8.0 g/dL
5. Total bilirubin within normal institutional limits except in participants with
Gilbert's Syndrome who must have a total bilirubin < 3.0 mg/dL.
6. Serum aspartate transferase (AST) (SGOT)/alanine transaminase (ALT) (SGPT) <
2.5 x upper limit of normal (ULN)
7. Calculated creatinine clearance (CrCl) >50 mL/min/1.73 m2for participants with
creatinine levels above institutional normal (by the Chronic Kidney Disease
Epidemiology Collaboration (CKD-EPI) equation).
8. international normalized ratio (INR) or activated partial thromboplastin time (
aPTT) ≤1.5 X ULN unless the subject is receiving anticoagulant therapy.
Subjects on anticoagulant therapy must have a PT or aPTT within therapeutic
range and no history of severe hemorrhage.
14. More than four weeks must have elapsed since any prior systemic therapy at the time
the patient receives the E7 TCR cells.
15. Participants must be able to understand and be willing to sign the written informed
consent document.
16. Participants must agree to participate in protocol Cancer Institute of New Jersey
(CINJ) 192103 (Pro2021002307) for gene therapy long term follow up and in protocol
CINJ 192002 (Pro2021000281) for biospecimen collection study.
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.