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Cell Therapy

AB-101 + Immunotherapy for Non-Hodgkin's Lymphoma

Phase 1 & 2

Recruiting

Research Sponsored by Artiva Biotherapeutics, Inc.

Eligibility Criteria Checklist

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

Must have

Confirmed diagnosis of indolent or aggressive NHL of B-cell origin

Be older than 18 years old

Must not have

Inadequate pulmonary function

Prior allogeneic stem cell transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the icf signature through 13 weeks after last study drug dose.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer treatment made of "natural killer" cells, which are part of the immune system. The treatment will be given to patients with relapsed or refractory Non-Hodgkin lymphoma of B-cell origin, in order to determine if it is effective.

Who is the study for?

This trial is for adults with B-cell non-Hodgkin lymphoma that's come back or didn't respond to treatment. They must have tried at least two FDA-approved therapies, including one with anti-CD20 monoclonal antibody therapy. People can't join if they have heart, lung problems, uncontrolled infections, HIV, hepatitis B/C, are pregnant/breastfeeding or unwilling to use contraception.

What is being tested?

The trial tests AB-101 alone or combined with rituximab and/or bendamustine in patients whose lymphoma has returned after treatment. It aims to find the safest dose of AB-101 and see how well it works against cancer cells when given alone or with other drugs.

What are the potential side effects?

Possible side effects include reactions related to immune system activation by NK cells from AB-101 and typical chemotherapy-related issues like fatigue, nausea, risk of infection from rituximab and bendamustine.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with a type of non-Hodgkin lymphoma that comes from B-cells.

Exclusion Criteria

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

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My lung function is not normal.

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I have had a stem cell transplant from a donor.

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My heart's pumping ability is below 45%.

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I do not have any ongoing, uncontrolled infections.

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I have a serious heart condition.

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I have a history of organ transplant or diseases worsened by IL-2.

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I agree to use birth control during and up to 6 months after the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline disease assessment through end of study participation.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline disease assessment through end of study participation.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline disease assessment through end of study participation. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Phase 1, combination therapy: AB-101 clinical activity, determined by ORR

Phase 1, combination therapy: Identify the recommended Phase 2 dose (R2PD) for AB-101.

Phase 1: Safety and tolerability of AB-101 as monotherapy, and in combination with rituximab (including the DLBCL specific cohort) and in combination with bendamustine and rituximab.

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase 2: AB-101 given with rituximab or with BR to patients with B-cell NHL at the R2PDExperimental Treatment6 Interventions

Phase 2: AB-101 given with rituximab or with bendamustine and rituximab to patients with B-cell NHL at the R2PD

Group II: Phase 1: Dose confirmation of AB-101 as mono, ritux combo (including DLBCL specific) & BR comboExperimental Treatment6 Interventions

Phase 1: Dose confirmation of AB-101 as monotherapy, in combination with rituximab (including the DLBCL specific cohort) and in combination with bendamustine and rituximab

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rituximab

1999

Completed Phase 4

~2990

Cyclophosphamide

2010

Completed Phase 4

~2310