Treatment of Advanced Solid Tumors With TSA-CTL(Tumor Specific Antigen-Induced Cytotoxic T Lymphocytes)

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-22

Study Completion Date

2022-05-20

Brief Summary

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The primary objective of this study is to evaluate the safety of TSA-CTL in the treatment of advanced solid tumors.

The secondary objective of this study is to evaluate preliminarily the effect of TSA-CTL in the treatment of advanced solid tumors.

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Detailed Description

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This is a single arm, open label and non-randomized clinical study with two parts.

In Part 1, 9 subjects with advanced solid tumors will be enrolled into Groups A (no non-myeloablative lymphodepletion), B and C (non-myeloablative lymphodepletion with different chemotherapy intensities) to assess the safety and dose intensity of non-myeloablative lymphodepletion chemotherapy before cell infusion.

Depending on results in Part 1, the study may proceed to Part 2, where 15 subjects with advanced solid tumors will be enrolled to receive TSA-CTL cell infusions with or without non-myeloablative lymphodepletion.

Conditions

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Solid Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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medium-dose lymphodepletion regimen

Patients will receive medium-dose lymphodepletion regimen consisting of cyclophosphamide and fludarabine followed by TSA-CTL.

Group Type EXPERIMENTAL

TSA-CTL

Intervention Type BIOLOGICAL

Patients will receive TSA-CTL iv over 20-30 minutes on day 0.

Fludarabine

Intervention Type DRUG

Fludarabine 25 mg/m2/day iv over 30 minutes on day -5 and -4 for two days.

Cyclophosphamide

Intervention Type DRUG

Cyclophosphamide 500 mg/m2/day iv on day -5 and -4 for two days.

low-dose lymphodepletion regimen

Patients will receive low-dose lymphodepletion regimen consisting of cyclophosphamide and fludarabine followed by TSA-CTL.

Group Type EXPERIMENTAL

TSA-CTL

Intervention Type BIOLOGICAL

Patients will receive TSA-CTL iv over 20-30 minutes on day 0.

Cyclophosphamide

Intervention Type DRUG

Cyclophosphamide 500 mg/m2/day iv on day -5 for one day.

Fludarabine

Intervention Type DRUG

Fludarabine 25 mg/m2/day iv over 30 minutes on day -5 and -4 for two days.

No lymphodepletion regimen

Patients will only receive TSA-CTL.

Group Type EXPERIMENTAL

TSA-CTL

Intervention Type BIOLOGICAL

Patients will receive TSA-CTL iv over 20-30 minutes on day 0.

Interventions

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TSA-CTL

Patients will receive TSA-CTL iv over 20-30 minutes on day 0.

Intervention Type BIOLOGICAL

Cyclophosphamide

Cyclophosphamide 500 mg/m2/day iv on day -5 for one day.

Intervention Type DRUG

Fludarabine

Fludarabine 25 mg/m2/day iv over 30 minutes on day -5 and -4 for two days.

Intervention Type DRUG

Cyclophosphamide

Cyclophosphamide 500 mg/m2/day iv on day -5 and -4 for two days.

Intervention Type DRUG

Other Intervention Names

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Tumor Specific Antigen Induced Cytotoxic Lymphocyte Cytoxan Fludarabine Phosphate Cytoxan

Eligibility Criteria

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Inclusion Criteria

1. Greater than or equal to 18 years of age and less than or equal to 70 years of age; all genders.
2. Advanced solid tumors including but not limited to some high frequency somatic mutations, such as melanoma, colorectal cancer, gastric cancer, esophageal cancer, squamous cell carcinoma of the lung, triple-negative breast cancer, etc.
3. Advanced solid tumors patients who are HLA - A0201 /A1101/A2402 subtypes.
4. Measurable solid tumors with at least one lesion that is resectable or tumor biopsies for DNA extraction.
5. Patients who failed or were intolerant to standard treatment.
6. Patients (or their legal representatives) who are able to understand and sign the Informed Consent Form and willing to sign a durable power of attorney.
7. Clinical performance status of ECOG is 0 or 1 and expected lifetime is greater than six month and patients who are able to cooperate to observe adverse reactions and the effect of the treatment.
8. Patients of both genders must be willing to practice birth control from the time of enrollment to five months after treatment on this study.
9. Serology: HIV antibody(-), hepatitis B antigen(-), and hepatitis C antibody(-). A fertile woman must have a negative pregnancy test. Hematology: Absolute neutrophil count is greater than 1500/mm3 without the support of filgrastim; WBC is greater than or equal to 3000/mm3; lymphocyte count is greater than or equal to 800/mm3; Platelet count is greater than or equal to 100,000/mm3; Hemoglobin is greater than or equal to 9.0 g/dL ; Chemistry: Serum ALT/AST is less than or equal to 2.5 times the upper limit of normal; Serum Creatinine is less than or equal to 1.5 times the upper limit of normal ; Total bilirubin is less than or equal to 1.5 the upper limit of normal, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 3 times the upper limit of normal.
10. More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the lymphodepletion regimen, and toxicities must have recovered to grade 1 or less (except for toxicities such as alopecia or vitiligo).

Note: Patients may have undergone minor surgical procedures within the past 3 weeks, as long as all toxicities have recovered to grade 1 or less.

Exclusion Criteria

1. Pregnant or lactating women.
2. Any primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
3. Opportunistic infection.
4. History of autoimmune disease.
5. Active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system.
6. Systemic steroid therapy in the past 4 weeks.
7. History of severe immediate hypersensitivity reaction to any of the agents used in this study.
8. Patients with unstable brain metastases.
9. Choroidal melanoma and clear cell sarcoma patients.
10. Negative for expression of MHC molecules.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No