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CAR T-cell Therapy
Gene Therapy for Non-Hodgkin's Lymphoma (NatHaLi-01 Trial)
Phase 1 & 2
Recruiting
Led By Jeremy Abramson, MD
Research Sponsored by Cellectis S.A.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from initiation of any study treatment to death from any cause, assessed up to year 15
Awards & highlights
NatHaLi-01 Trial Summary
This trial studies the safety and effectiveness of gene therapy to treat B-Cell Non-Hodgkin Lymphoma. They'll look for the best dose to use.
Who is the study for?
This trial is for adults with B-Cell Non-Hodgkin Lymphoma that has come back or hasn't responded to treatment. They must have tried at least two prior treatments, including a specific type of cell therapy if available. People can't join if they've had certain other recent treatments, infections, hypersensitivity reactions, uncontrolled diseases, or another cancer within the last 2 years.Check my eligibility
What is being tested?
The study tests UCART20x22 (a new therapy) in people with relapsed/refractory B-NHL to find out how safe it is and what dose works best. It's an early-stage trial where everyone gets the experimental treatment intravenously and doctors closely monitor their response.See study design
What are the potential side effects?
Potential side effects aren't listed but may include typical reactions to immunotherapies such as fever, fatigue, infusion-related reactions and increased risk of infection due to immune system modification.
NatHaLi-01 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from initiation of any study treatment to death from any cause, assessed up to year 15
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from initiation of any study treatment to death from any cause, assessed up to year 15
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose finding and expansion parts: Incidence of adverse events/serious adverse events/dose limiting toxicity [Safety and Tolerability]
Dose finding part: Occurrence of Dose Limiting Toxicities (DLTs)
Secondary outcome measures
Duration of Response
Lymphoma
Overall survival
+1 moreNatHaLi-01 Trial Design
1Treatment groups
Experimental Treatment
Group I: Dose finding partExperimental Treatment2 Interventions
UCART20x22 tested at several dose levels until the Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RP2D) is identified.
Dose expansion part: UCART20x22 administered at the RP2D determined during the dose finding part
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Who is running the clinical trial?
Cellectis S.A.Lead Sponsor
5 Previous Clinical Trials
117 Total Patients Enrolled
Jeremy Abramson, MDPrincipal InvestigatorMassachusetts General Hospital
6 Previous Clinical Trials
175 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have another active cancer.I take more than 20 mg of prednisone or its equivalent daily.I am on medication that suppresses my immune system.I have received approved therapy within the required time before starting the LD regimen.I haven't had cell or gene therapy recently.I had a stem cell transplant or donor lymphocyte infusion recently.My lymphoma has affected or is affecting my brain.My condition relapsed or didn't respond after 2 prior treatments.My condition is a type of non-Hodgkin lymphoma as defined by WHO.I currently have an active infection or a previously inactive infection that has become active again.I haven't taken any immune-boosting drugs recently.I have not had monoclonal antibody therapy recently.I have not had major surgery recently.I have my own stem cells stored for a treatment if I'm at high risk of long-lasting blood toxicity.I have received radiotherapy within the required time before starting the LD regimen.I have had a reaction to the drug alemtuzumab.I have a current brain or nerve condition that affects my health.I am fully active or restricted in physically strenuous activity but can do light work.I have heart problems that are not well-managed.I had a stem cell transplant using my own cells within the required time before starting LD.My B-cell NHL has returned or didn't respond to treatment and tests positive for CD20 or CD22.
Research Study Groups:
This trial has the following groups:- Group 1: Dose finding part
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 is the clinical trial recruiting?
"Affirmative. According to clinicaltrials.gov, this trial is currently seeking participants with an original post date of November 1st 2022 and most recent update on December 8th 2022. The study aims to recruit 80 individuals from a single medical centre."
Answered by AI
Does this clinical trial allow for individuals aged 55 and older to participate?
"The minimum age for participation in this trial is 18, while the upper limit of eligibility is 80 years old."
Answered by AI
Is enrollment for this experiment still open?
"Affirmative. Information on clinicaltrials.gov confirms that the recruiting process for this medical trial commenced November 1st 2022 and was most recently modified December 8th 2022. 80 patients from a single location are needed to complete it."
Answered by AI
For whom is this clinical trial appropriate?
"This clinical trial is enrolling 80 patients between the ages of 18-80 with a b-lymphocyte diagnosis. To be eligible, participants must meet the following conditions: Relapsed or refractory (R/R) mature B-NHL per 2016 WHO criteria and positive for CD20 and/or CD22; R/R LBCL such as DLBCL, high grade B cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements; transformed follicular lymphoma Grade 3B; an anti-CD20 antibody plus anthracycline to treat certain forms of non"
Answered by AI
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