Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
Intervention1: Gamma Delta T cells: Multicohort 10 cohorts, non comparative, open label, prospective, phase 2 study
Cohort 1 Glioblastoma
Cohort 2 Head and neck squamous cell carcinoma
Cohort 3 Non
Sponsors
Sunact Cancer Institute Private Limited
CytoMed Therapeutics
Eligibility
Inclusion criteria
Inclusion criteria: Participants must have recurrent residual solid tumor or lymphoma after at least one line of systemic treatment, and potentially planned for palliative intent systemic therapy fitting in one of the ten cohorts Cohort 1: Glioblastoma Cohort 2: Head & neck squamous cell carcinoma Cohort 3: Non small cell lung cancer Cohort 4 : Cervical Cancer Cohort 5 : Breast Cancer Cohort 6: Colon Cancer Cohort 7: Hepatocellular Cancer Cohort 8 : Non Hodgkin Lymphoma Cohort 9 : Renal Cell Carcinoma Cohort 10: Prostate Age: Male or female subjects aged more than 18 years Eastern Cooperative Oncology Group ECOG performance status PS 0-1 Participants must have normal organ and marrow function. Presence of at least one measurable lesion as defined by RECIST version 1.1 Pregnancy test: Negative serum or urine pregnancy test at screening for women of childbearing potential. Contraception: Highly effective contraception for both male and female subjects throughout the study and for at least 30 days after the last gamma delta T cells treatment administration, if the risk of conception exists. The effects of gamma delta T cells on the developing human fetus are unknown. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Both men and women of all races and ethnic groups are eligible for this trial. Willing and able to comply with all study requirements, including treatment, assessments and able to follow up at regular intervals Ability to understand and the willingness to sign a written informed consent document
Exclusion criteria
Exclusion criteria: Participants who are receiving any other investigational agents Within 3 weeks of administration of a chemotherapeutic agent IMMUNOSUPPRESSANTS Current use of immunosuppressive medication EXCEPT for the following a intranasal inhaled topical steroids or local steroid injection eg intra articular injection b Systemic corticosteroids at physiologic doses 10 mgday of prednisone or equivalent c Steroids as premedication for hypersensitivity reactions eg CT scan premedication AUTOIMMUNE DISEASE Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent Patients with diabetes type I vitiligo psoriasis or hypo or hyperthyroid diseases not requiring immunosuppressive treatment are eligible ORGAN TRANSPLANTATION Prior organ transplantation including allogeneic stemcell transplantation INFECTIONS Active infection requiring systemic therapy HIVAIDS Known history of testing positive for HIV or known acquired immunodeficiency syndrome HEPATITIS Hepatitis B virus HBV or hepatitis C virus HCV infection at screening positive HBV surface antigen or HCV RNA if antiHCV antibody screening test positive except in case of hepatocellular cancer HCC VACCINATION Vaccination within 4 weeks of the first dose of gamma delta T cells and while on trials i prohibited except for administration of inactivated vaccines HYPERSENSITIVITY TO STUDY DRUG Known prior severe hypersensitivity to investigational product or any component in its formulations including known severe hypersensitivity reactions to monoclonal antibodies CARDIOVASCULAR DISEASE Clinically significant ie active cardiovascular disease cerebrovascular accident or stroke 6 months prior to enrollment myocardial infarction 6 months prior to enrollment unstable angina congestive heart failure New York Heart Association Classification Class II or serious cardiac arrhythmia requiring medication OTHER PERSISTING TOXICITIES Persisting toxicity related to prior therapy however alopecia sensory neuropathy Grade 2 or other Grade 2 toxicities not constituting a safety risk based on investigators judgment are acceptable Other severe acute or chronic medical conditions including immune colitis inflammatory bowel disease immune pneumonitis pulmonary fibrosis or psychiatric conditions including recent within the past year or active suicidal ideation or behavior or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and in the judgment of the investigator would make the patient inappropriate for entry into this study Pregnant women and breastfeeding women are excluded from this study because gamma delta T cells have the potential for teratogenic or abortifacient effects and an unknown but potential risk for adverse events in nursing infants These potential risks may also apply to other agents used in this study In keeping with ICH E8 the pregnancy of a female subject will be reported to the IRB or IEC The female subject will receive counseling about the risks to the fetus and would be given an option of termination of pregnancy If the female subject chooses to continue the pregnancy then the investigator will follow her pregnancy to term or longer if possible for developmental sequelae so that any important safety information could be obtained
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rates ORRTimepoint: To evaluate the response rate according to Response Evaluation Criteria In Solid Tumors RECIST version 1.1 in each of 10 cohorts every 4 weeks till treatment completion. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Progression free survival 2.Overall SurvivalTimepoint: 1.Time from treatment initiation to disease progression or death, indicating how long the disease is controlled. 2.Time from treatment initiation to death from any cause, indicating the treatments impact on patient survival. | — |
Countries
India
Contacts
Public ContactZoya
Sunact Cancer Institute Pvt Ltd
Outcome results
None listed