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CAR T-cell Therapy

Dose Escalation of CB-012 for Acute Myeloid Leukemia (AMpLify Trial)

Phase 1

Recruiting

Research Sponsored by Caribou Biosciences, Inc.

Eligibility Criteria Checklist

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

Must have

No available therapy with reasonable survival benefit

Documented diagnosis of AML with either refractory or relapsed disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

AMpLify Trial Summary

This trial is testing a new type of cell therapy called CB-012. It is being studied in adults with a type of blood cancer called acute myeloid leukemia (AML) that has come back

Who is the study for?

This trial is for adults with acute myeloid leukemia (AML) that's returned after treatment or isn't responding to current treatments. They should be fit for a stem cell transplant, have an ECOG score of 0-1, and can't have had more than three prior AML treatments. Participants need good kidney, liver, lung, and heart function and must use effective birth control if they can have children.Check my eligibility

What is being tested?

The study tests CB-012, a CRISPR-edited CAR-T therapy targeting CLL-1 in AML patients. It's a Phase 1 trial focusing on safety, how well it works (efficacy), and how the body processes the drug (pharmacokinetics).See study design

What are the potential side effects?

Potential side effects may include immune system reactions against normal cells leading to symptoms like fever or fatigue; organ inflammation; infusion-related reactions; increased risk of infections due to weakened immunity.

AMpLify Trial Eligibility Criteria

Inclusion Criteria

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

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There are no treatments left that doctors think could significantly extend my life.

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My AML cancer has come back or is not responding to treatment.

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I have had 3 or fewer previous cancer treatments.

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My kidney, liver, lung, and heart functions meet the required health standards.

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I am mostly active and considered fit for a stem cell transplant.

AMpLify Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

(Part A) Number of patients with dose limiting toxicities (DLT)

(Part B) Overall Response Rate (ORR)

AMpLify Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose Expansion of CB-012Experimental Treatment1 Intervention

Part B (Dose Expansion) - participants will be enrolled to receive CB-012 at the RDE and/or MTD determined in Part A in order to the determine the RP2D.

Group II: Dose Escalation of CB-012Experimental Treatment1 Intervention

Part A (Dose Escalation) of CB-012 with increasing doses using a 3+3 design, during which the MTD and/or RDE will be identified.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Caribou Biosciences, Inc.Lead Sponsor

3 Previous Clinical Trials

222 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the potential risks associated with increasing the dosage of CB-012 in individuals?

"Given that this trial is classified as Phase 1, our team at Power rates the safety of Dose Escalation of CB-012 with a score of 1. This indicates that there is limited data available to support both safety and efficacy at this stage."

Answered by AI

What is the current number of participants being enrolled in this research investigation?

"Indeed, the details provided on clinicaltrials.gov affirm that this investigation is actively seeking suitable candidates. The trial was initially posted on December 20th, 2023 and most recently revised on January 4th, 2024. For successful completion, a total of 70 individuals are being sought from two distinct locations."

Answered by AI

Are there any available vacancies for potential participants in this research study?

"According to the information provided on clinicaltrials.gov, this ongoing medical trial is actively seeking eligible participants. The study was initially posted for recruitment on December 20th, 2023 and has been recently updated as of January 4th, 2024."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CRISPR-Edited Allogeneic Anti-CLL-1 CAR-T Cell Therapy in Patients With Relapsed/Refractory Acute Myeloid Leukemia

2024. "CRISPR-Edited Allogeneic Anti-CLL-1 CAR-T Cell Therapy in Patients With Relapsed/Refractory Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06128044.

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