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CAR T-cell Therapy

SENTI-202 for Blood Cancers

Phase 1

Recruiting

Research Sponsored by Senti Biosciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance score of 0-1

Subjects with CD33 and/or FLT3 expressing malignancies, including relapsed refractory acute myeloid leukemia (AML) with morphologic relapse as defined by ≥5% bone marrow blasts who have received at least 1 prior line, but no more than 3 prior lines of standard anti-AML therapy. Subjects with FLT3-mutated or IDH ½-mutated disease must have received at least one prior targeted therapy

Must not have

Evidence of leukemic meningitis or known active central nervous system disease

Presence of extra-medullary disease or myeloid sarcoma alone with no morphologic hematologic relapse

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the safety and effectiveness of a new treatment called SENTI-202 in patients with certain types of blood cancers.

Who is the study for?

This trial is for adults with blood cancers like AML or MDS that have come back after treatment. They must have tried at least one, but no more than two or three treatments (depending on the condition), and their cancer cells need to show CD33 or FLT3 markers. Participants should be fairly active (ECOG score 0-1) and have decent organ function.

What is being tested?

SENTRI-202, a new type of cell therapy using modified natural killer (NK) cells designed to target cancer cells in patients with specific proteins on their leukemia or tumor cells, is being tested for safety and effectiveness.

What are the potential side effects?

While not specified here, CAR NK cell therapies like SENTRI-202 can cause immune reactions, infusion-related symptoms, fatigue, fever, bone marrow suppression leading to low blood counts which increases infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My leukemia has specific mutations and I've had 1-3 standard treatments.

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My MDS has returned or didn't respond to treatment, and I've had 1-2 prior treatments.

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I have a blood cancer and have received at least one standard treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have leukemia in my brain or active brain disease.

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My cancer involves organs outside the bone marrow without signs of returning in the blood.

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I have MDS with fibrosis or a genetic condition that responds to chemo for AML.

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I had a stem cell transplant less than 100 days ago.

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My leukemia is specifically diagnosed with a genetic abnormality in the APML-RARA gene.

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I have previously received NK or CAR T cell therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety and tolerability for dose determination of SENTI-202

Secondary study objectives

Anti-cancer activity of SENTI-202

Host immune response to SENTI-202

Pharmacokinetic (PK) and pharmacodynamic (PDn) profile of SENTI-202

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: SENTI-202 CAR NK cell therapyExperimental Treatment1 Intervention

Part 1 Dose Finding: Sequential cohorts will receive doses of SENTI-202 using a modified 3+3 study design to determine the recommended phase 2 dose (RP2D). The starting dose will be 1 billion cells. Other doses may be explored depending on study data. Part 2 Cohort Expansion: After determination of the RP2D, additional subjects will be enrolled in disease-specific expansion cohorts at that dose to further explore safety, biodynamics, and anti-cancer activity of SENTI-202

0 / 10Eligibility criteria met