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CAR T-cell Therapy

CAR T-Cell Therapy for B-Cell Leukemia and Lymphoma (ANCHOR2 Trial)

Q: Are the results of Cohort A, in regards to non-ALL relapsed/refractory cases, federally approved?

<p>Cohort A, non-<a href="https://www.withpower.com/clinical-trials/all">ALL</a> relapsed/refractory was assigned a safety rating of 1 due to the lack of evidence and data surrounding its efficacy in Phase 1 trials.</p>

Phase 1

Recruiting

Led By Carlos Ramos, MD

Research Sponsored by Athenex, Inc.

Eligibility Criteria Checklist

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

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks post t cell infusion

Awards & highlights

ANCHOR2 Trial Summary

This trialwill test the safety of a potential new drug for people with certain types of leukemia or lymphoma.

Who is the study for?

This trial is for people aged 3-75 with certain types of B-cell lymphoma or leukemia (ALL or CLL) that have relapsed or are not responding to treatment. They must have tried at least two prior therapies and meet specific health criteria, like normal organ function. Pregnant women, those with severe graft-versus-host disease, HIV/HTLV, hepatitis B/C, uncontrolled infections, or recent other cellular therapies cannot join.Check my eligibility

What is being tested?

The study tests KUR-502's safety in patients with refractory/relapsed B-cell non-Hodgkin's lymphoma (NHL) or leukemia. It involves multiple centers where participants receive the investigational therapy to see how well they tolerate it and what effect it has on their cancer.See study design

What are the potential side effects?

While the trial primarily assesses safety and doesn't list specific side effects for KUR-502, similar treatments can cause immune reactions, infusion-related symptoms like fever/chills, fatigue, possible organ inflammation due to immune response and increased risk of infection.

ANCHOR2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks post t cell infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks post t cell infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks post t cell infusion for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Dose limiting toxicity (DLT) rate and grade of single dose of Kur-502

ANCHOR2 Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort B, ALL releapsed/refractoryExperimental Treatment1 Intervention

This cohort is for patients with relapsed or refractory B-cell ALL afer 2 or more lines of therapy. Patients will also receive lymphodepletion chemotherapy consisting of cyclophosphamide and fludarabine followed by the CD19.CAR-aNKT cell infusion. Genetic: CD19.CAR-aNKT cells Patients will be given the T-cell product by intravenous injection (into the vein through an IV line) at the assigned dose. Dose level 1: 1×107/m2. Dose level 2: 3×107/m2. Dose level 3: 1×108/m2). Drug: Cyclophosphamide: Lymphodepletion chemotherapy. Patients will receive 3 daily doses of cyclophosphamide (500mg/m2/day finishing at least 24 hours before T-cell infusion. The drug will be given intravenously (through an IV needle) Other name: Cytoxan Drug Fludarabine Lymphodepletion chemotherapy. Patient will receive 3 daily dose of fludarabine (30mg/m2/day) finishing at least 24 hours before T-cell infusion. the drug will be given intravenously (through an IV needle)

Group II: Cohort A, non-ALL relapsed/refractoryExperimental Treatment1 Intervention

These dose levels will be evaluated. Patients will also receive lymphodepletion chemotherapy consisting of cyclophosphamide and fludarabine followed by CD19.CAR-aNKT cell infusion. Genetic: CD19.CAR-aNKT cells Patients will be given the T-cell product by intravenous injection (into the vein through an IV line) at the assigned dose. Dose level 1: 1×107/m2. Dose level 2: 3×107/m2. Dose level 3: 1×108/m2). Drug: Cyclophosphamide: Lymphodepletion chemotherapy. Patients will receive 3 daily doses of cyclophosphamide (500mg/m2/day finishing at least 24 hours before T-cell infusion. The drug will be given intravenously (through an IV needle) Other name: Cytoxan Drug Fludarabine Lymphodepletion chemotherapy. Patient will receive 3 daily dose of fludarabine (30mg/m2/day) finishing at least 24 hours before T-cell infusion. the drug will be given intravenously (through an IV needle) Other name: Fludara

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Athenex, Inc.Lead Sponsor

26 Previous Clinical Trials

1,932 Total Patients Enrolled

Carlos Ramos, MDPrincipal InvestigatorBaylor College of Medicine

6 Previous Clinical Trials

169 Total Patients Enrolled

Media Library

KUR-502 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05487651 — Phase 1

$Non-Hodgkin's Lymphoma Research Study Groups: Cohort A, non-ALL relapsed/refractory, Cohort B, ALL releapsed/refractory$

Non-Hodgkin's Lymphoma Clinical Trial 2023: KUR-502 Highlights & Side Effects. Trial Name: NCT05487651 — Phase 1

KUR-502 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05487651 — Phase 1

Frequently Asked Questions

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

What is the current capacity of this clinical trial to include participants?

"Affirmative. Clinicaltrials.gov records suggest that this research has been ongoing since October 1st 2022 and is still in need of patient recruitment, specifically 36 individuals from 6 different sites."

Answered by AI

Could I potentially qualify for this clinical trial?

"This clinical trial is seeking 36 participants aged 3 to 75 bearing chronic lymphocytic leukemia. In addition, they must present with a signed informed consent and meet the criteria of having undergone two prior therapies, including ibrutinib or venetoclax (if CLL) or CD20 antibody plus anthracycline (for aggressive/highly aggressive lymphoma) or only CD20 antibody (for indolent lymphoma). Furthermore, those who are ineligible for autologous stem cell transplantation due to non-responsive disease after salvage therapy and failure to mobilize cells would also qualify. Lastly, measurable evidence of the condition by"

Answered by AI

Is enrollment open for this clinical trial currently?

"Affirmative. Clinicaltrials.gov attests that this medical experiment, first posted October 1st 2022, is presently enrolling participants. 36 individuals must be enrolled from 6 various sites."

Answered by AI

Are there various health centers conducting this research experiment in the city?

"At present, this medical study is welcoming enrolment from 6 sites: Seattle, Durham and Atlanta included. To minimize the burden of travel if chosen to participate in the trial, it is advised that patients select a location close to them."

Answered by AI

Are the results of Cohort A, in regards to non-ALL relapsed/refractory cases, federally approved?

"Cohort A, non-ALL relapsed/refractory was assigned a safety rating of 1 due to the lack of evidence and data surrounding its efficacy in Phase 1 trials."

Answered by AI

Is this medical experiment open to those aged under fifty-five?

"Patients aged between 3 and 75 are eligible for this trial, with 509 medical studies available to minors under 18 years old and 1942 trials catered towards persons over 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Allogeneic NK T-Cells Expressing CD19 Specific CAR in B-Cell Malignancies

2022. "Allogeneic NK T-Cells Expressing CD19 Specific CAR in B-Cell Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05487651.