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NK Cell Therapy
Allogeneic NK Cell Therapy for Non-Hodgkin's Lymphoma
Phase 1 & 2
Recruiting
Research Sponsored by Gamida Cell ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must be at least 18 years of age
Patients must have relapsed/refractory FL or HGBCL/DLBCL that has failed conventional therapy defined as follows: Received at least 2 prior lines of therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trial will test an allogeneic cryopreserved NK cell therapy derived from donor peripheral blood, in combination with rituximab, for patients with relapsed or refractory B Cell non-Hodgkin lymphoma.
Who is the study for?
This trial is for adults with B Cell non-Hodgkin lymphoma that hasn't improved after at least two treatments. They must be in good health otherwise, not have had certain cell therapies or transplants recently, and can't join if they have cancer affecting the brain.Check my eligibility
What is being tested?
The study tests GDA-201 NK cells combined with rituximab in patients whose lymphoma has returned or didn't respond to treatment. It's an early-phase trial where everyone gets the same therapy to see how safe it is and if it works.See study design
What are the potential side effects?
Possible side effects include reactions related to immune cells from another person (like fever or chills), issues from rituximab like infusion reactions, and general risks such as fatigue, infection risk increase, and organ inflammation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My FL or DLBCL cancer has not responded to at least 2 previous treatments.
Select...
I had a stem cell transplant using my own cells less than 3 months ago.
Select...
I have received treatment after my follicular lymphoma changed to a more aggressive type.
Select...
I have not received CAR-T therapy within the last 2 months.
Select...
I had a stem cell transplant from a donor less than 6 months ago.
Select...
I have had CAR-T cell therapy or am not eligible for it according to my doctor.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1: Safety as determined by dose limiting toxicities (DLTs)
Phase 2: overall response rate
Trial Design
1Treatment groups
Experimental Treatment
Group I: GDA-201Experimental Treatment1 Intervention
Phase 1 dose escalation with up to 4 dose levels to reach MTD and determine recommended phase 2 dose (RP2D).
Phase 2 RP2D will be administered to all patients.
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Who is running the clinical trial?
Gamida Cell ltdLead Sponsor
8 Previous Clinical Trials
277 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My FL or DLBCL cancer has not responded to at least 2 previous treatments.I had a stem cell transplant using my own cells less than 3 months ago.My blood, liver, kidneys, heart, and lungs are all functioning well enough for treatment.I have received treatment after my follicular lymphoma changed to a more aggressive type.I have not received CAR-T therapy within the last 2 months.I have lymphoma in my central nervous system.I had a stem cell transplant from a donor less than 6 months ago.I have had CAR-T cell therapy or am not eligible for it according to my doctor.
Research Study Groups:
This trial has the following groups:- Group 1: GDA-201
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are engaged in this trial?
"To adequately conduct this research, Gamida Cell Ltd needs 99 participants who comply with the selection criteria. The trial will be run at Loyola University, Cardinal Bernardin Cancer Center in Maywood, Illinois and Dana-Farber/Mass General Brigham Cancer Care, Inc. in Boston, Massachusetts respectively."
Answered by AI
How many healthcare facilities are participating in this trial?
"At present, there are 4 trial sites hosting this medical study. Two of the locations are in Maywood and Boston while Detroit is another option. Additionally, there exist other centres nearby to reduce travelling if you choose to participate."
Answered by AI
Is enrollment for this trial still open to participants?
"As of the August 15th update, this clinical trial is still actively looking for participants. The original post was made to clinicaltrials.gov on July 5th 2022."
Answered by AI
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