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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
Patient must have progressed or demonstrated intolerance to at least two lines of FDA-approved therapies, one of which must have included anti-CD20 monoclonal antibody therapy. The following are permitted: Prior autologous hematopoietic stem cell transplantation, prior treatment with FDA-approved CAR-T therapy, and/or prior treatment with an investigational agent
Confirmed diagnosis of indolent or aggressive NHL of B-cell origin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline disease assessment through end of study participation.
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I have tried at least two treatments for my condition, including one with anti-CD20 therapy.
Select...
I have been diagnosed with a type of non-Hodgkin lymphoma that comes from B-cells.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the icf signature through 13 weeks after last study drug dose.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the icf signature through 13 weeks after last study drug dose. for reporting.

Treatment Details

Study Objectives

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

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
~1880
Bendamustine
2015
Completed Phase 3
~2950
Cyclophosphamide
1995
Completed Phase 3
~3780
Fludarabine
2012
Completed Phase 3
~1100
AB-101
2018
Completed Early Phase 1
~10
Interleukin-2
1994
Completed Phase 3
~700

Find a Location

Who is running the clinical trial?

Artiva Biotherapeutics, Inc.Lead Sponsor
3 Previous Clinical Trials
305 Total Patients Enrolled
Jason Litten, M.D.Study DirectorArtiva Biotherapeutics
Thorsten Graef, M.D., Ph.D.Study DirectorArtiva Biotherapeutics

Media Library

AB-101 (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04673617 — Phase 1 & 2
Non-Hodgkin's Lymphoma Research Study Groups: Phase 1: Dose confirmation of AB-101 as mono, ritux combo (including DLBCL specific) & BR combo, Phase 2: AB-101 given with rituximab or with BR to patients with B-cell NHL at the R2PD
Non-Hodgkin's Lymphoma Clinical Trial 2023: AB-101 Highlights & Side Effects. Trial Name: NCT04673617 — Phase 1 & 2
AB-101 (Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04673617 — Phase 1 & 2

Frequently Asked Questions

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

How many medical facilities are conducting this research project?

"The primary locations for this research are University of California, Irvine; Oregon Health Sciences Center; and University of Iowa Hospitals and Clinics. There are also 10 other sites across the country where this study is taking place."

Answered by AI

Is this research project still recruiting participants?

"The clinicaltrials.gov website indicates that this study is still recruiting patients. The initial posting was on 29 March 2021, with the most recent update taking place 31 May 2022."

Answered by AI

What are the most common indications for AB-101?

"AB-101 has been traditionally used to ameliorate symptoms for patients with lung cancer, however it can also be given as a treatment for b-cell lymphomas, multiple sclerosis and polyangium."

Answered by AI

Are there other similar experiments underway that include AB-101?

"There are 1215 ongoing studies and 227 in Phase 3 that are researching AB-101. Some of the trials for AB-101 are based out of Philadelphia, but there are a total of 36963 clinical trial locations for AB-101."

Answered by AI
~18 spots leftby Nov 2024