New Immune-Cell cocktail takes on tough gut cancers
NCT ID NCT06251973
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial is testing a five-drug combination for people with advanced esophageal, stomach, or gastroesophageal junction cancer that has worsened after initial treatment. The combination includes immune cells from healthy donors, two immunotherapy drugs, and two standard chemotherapy drugs. The main goal is to see how many patients' tumors shrink or disappear.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A combination of immune cells (agenT-797), two immunotherapy drugs (botensilimab and balstilimab), and two chemotherapy drugs (ramucirumab and paclitaxel)
- What this could lead to
- If successful, this could offer a new treatment option for people with advanced esophageal, stomach, or gastroesophageal junction cancer that has stopped responding to initial therapy.
- What could go wrong
- This is a small, early-phase (phase 2) trial with only 20 participants, so results may not apply broadly. The combination of multiple drugs also increases the risk of side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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20 people
The number who actually took part.
- Started
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Feb 2024
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Metastatic or advanced unresectable adenocarcinoma of esophageal, gastric, or gastroesophageal junction * Disease progression on one prior line of therapy for metastatic disease. Patients with previously untreated advanced unresectable or metastatic disease may be included if disease progressed or recurred during neoadjuvant or adjuvant therapy or within 6 months of completion of those treatments. * Patients must have histologically or cytologically confirmed esophageal, gastric, or gastroesophageal junction adenocarcinoma * Patients must have measurable or evaluable disease as defined by RECIST v1.1 criteria. Patients with evaluable disease must be eligible to begin with an induction cycle * Age 18 years or older * ECOG performance status 0 to 1 * Adequate organ function as defined in Table 2 Table 2. Organ function requirements for eligibility Hematological Absolute neutrophil count: ≥1000/mcL Platelets: ≥90,000/mcL Hemoglobin: ≥8 g/dL Renal Serum creatinine: ≤1.5X ULN Hepatic Serum total bilirubin: ≤1.5X ULN OR Direct bilirubin ≤ULN for subjects with total bilirubin levels \>1.5X ULN, except patients with Gilbert's disease (≤3X ULN) AST and ALT: ≤2.5X ULN Albumin: ≥3 mg/dL Exclusion Criteria: * Received prior therapy with ramucirumab at any time * Received paclitaxel or docetaxel-based therapy within 6 month of study enrollment * Had a prior grade \>3 immune related adverse event due to anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA4 therapy at any time * Diagnosis of immunodeficiency or receipt of systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of trial treatment. Replacement therapy (ie physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic immunosuppressive therapy and is allowed. * History of gastrointestinal perforation or fistulae * A known history of active Bacillus tuberculosis * Known active central nervous system metastases and/or carcinomatous meningitis * History of or any evidence of active, non-infectious, immune-mediated pneumonitis. Patients with radiation-induced pneumonitis who are asymptomatic are permitted on study. * Peripheral neuropathy limiting ADLs * A known history of human immunodeficiency virus (HIV 1/2 antibodies) * Known active hepatitis B (e.g., HBsAg reactive) or hepatitis C (e.g., HCV RNA \[qualitative\] is detected). Patients with HBsAg reactive on entecavir may be eligible after consultation with hepatologist and study team. * Received a live vaccine within 30 days of planned start of study therapy * Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial * Pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the prescreening or screening visit through 5 months after the last dose of trial treatment * Unwilling to give written, informed consent, unwilling to participate, or unable to comply with the protocol for the duration of the study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
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Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553, United States
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Memorial Sloan Kettering Suffolk-Commack (Limited protocol activities)
Commack, New York, 11725, United States
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Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Experimental drug TJ037130 takes aim at advanced solid tumors
- Triple chemo cocktail aims to clear deadly bowel blockages in advanced stomach cancer
- Experimental drug combo targets Hard-to-Treat GI cancers
- Experimental cell therapy targets multiple cancers in early trial