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CAR T-cell Therapy

AZD0486 for Non-Hodgkin's Lymphoma

Phase 1
Recruiting
Research Sponsored by Teneobio, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Biopsy proven B-NHL, including DLBCL, HGBL, or FL
Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 months
Awards & highlights

Study Summary

This trial is testing a new cancer drug, TNB-486, to see if it is safe and effective in people with B-cell non-Hodgkin lymphoma who have had two or more prior lines of therapy.

Who is the study for?
This trial is for adults with B-cell non-Hodgkin lymphoma that's come back or didn't respond after at least two treatments. They should be fairly active (ECOG ≤ 2), have good liver, bone marrow, and kidney function, and not be suitable for other effective therapies. Pregnant or breastfeeding women can't join.Check my eligibility
What is being tested?
The study tests AZD0486 IV, a new type of drug aiming to engage immune T-cells against cancer cells in patients with specific types of relapsed or refractory B-cell lymphomas who've tried multiple previous therapies.See study design
What are the potential side effects?
Potential side effects may include severe immune reactions like cytokine release syndrome (CRS) and neurotoxicity similar to those seen in other T-cell engaging therapies. The exact side effects of AZD0486 are being studied.

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.
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I can take care of myself and am up and about more than half of my waking hours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Apparent terminal half-life (t1/2) of AZD0486
Area under the concentration versus time curve from time zero to the last quantifiable time point prior to the next dose (AUClast)
Incidence of subjects with Dose-limiting toxicities (DLT)
+2 more
Secondary outcome measures
Anti-Lymphoma Activity by Clinical Benefit Rate
Anti-Lymphoma Activity by Duration of Objective Response (DOR)
Anti-Lymphoma Activity by Objective Response Rate (ORR)
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Part 2, Arm C: Monotherapy Dose Expansion in Subjects with RR FLExperimental Treatment1 Intervention
An expansion cohort in subjects with FL will be enrolled after RP2D is established.
Group II: Part 2, Arm B: Monotherapy Dose Expansion in Subjects with RR DLBCL/HGBLExperimental Treatment1 Intervention
An expansion cohort in subjects with DLBCL or HGBL will be enrolled after RP2D is established.
Group III: Part 1, Arm A: AZD0486 Monotherapy Dose Escalation in Subjects with RR B-NHLExperimental Treatment1 Intervention
AZD0486 monotherapy will be administered intravenously on day 1 and 15 of 28 day cycles for a maximum of 24 cycles or until disease progression. Depending on cohort, subjects may receive priming or step-up dosing during cycle 1 before reaching the target dose. While on study, subjects will be monitored for safety and efficacy with periodic disease assessment with PET/CT. If subject achieves two consecutive CRs after completing C6, then they may be eligible for monthly dosing

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Who is running the clinical trial?

Teneobio, Inc.Lead Sponsor
3 Previous Clinical Trials
320 Total Patients Enrolled
AstraZenecaLead Sponsor
4,267 Previous Clinical Trials
288,612,082 Total Patients Enrolled
TeneoTwo Inc.Lead Sponsor

Media Library

TNB-486 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04594642 — Phase 1
Non-Hodgkin's Lymphoma Research Study Groups: Part 2, Arm C: Monotherapy Dose Expansion in Subjects with RR FL, Part 2, Arm B: Monotherapy Dose Expansion in Subjects with RR DLBCL/HGBL, Part 1, Arm A: AZD0486 Monotherapy Dose Escalation in Subjects with RR B-NHL
Non-Hodgkin's Lymphoma Clinical Trial 2023: TNB-486 Highlights & Side Effects. Trial Name: NCT04594642 — Phase 1
TNB-486 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04594642 — 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 desired outcome of this investigation?

"The primary metric of success for this trial, monitored over 28 days, is the Maximum Observed Plasma Concentration (Cmax) of TNB-486. Other objectives include measuring Clinical Benefit Rate (defined as a sustained positive response to treatment), Objective Response Rate (the proportion of participants with partial or full responses) and Duration of Objective Responses (the time between an initial successful outcome and disease progression)."

Answered by AI

What is the aggregate number of participants enrolled in this trial?

"Teneobio, Inc. needs 116 individuals to meet the eligibility criteria of this trial in order for it to proceed as planned. The research is taking place at Medical College of Wisconsin in Milwaukee and UPMC Hillman Cancer Center located in Pittsburgh, Pennsylvania."

Answered by AI

Has TNB-486 obtained the regulatory approval of the Food and Drug Administration?

"Our team at Power assigned TNB-486 a score of 1 on their safety assessment scale, due to the fact that this is still in Phase 1 trials with limited evidence of effectiveness and protection."

Answered by AI

Are enrollments currently being accepted for this clinical trial?

"Per clinicaltrials.gov, this medical experiment is recruiting participants at the current moment. It was inaugurated on March 2nd 2021 and most recently modified on October 17th 2022."

Answered by AI

Are there any eligibility requirements for participating in this research?

"This trial has capacity for 116 participants who have lymphoma and are between ages 18-80. In order to qualify, they must meet a set of criteria: Arm B requires biopsy proven DLBCL or HGBL with refractory treatment history; Arm C necessitates confirmed FL diagnosis plus ECOG Performance Status ≤2 and adequate kidney, liver, and bone marrow function (eGFR ≥ 50 mL/min)."

Answered by AI

How many hospitals in this city are administering the experiment?

"This medical study is presently taking in patients at 6 sites, located throughout Milwaukee, Pittsburgh and Tampa. To minimize the need for travel, it's important to choose a trial site closest to you if enrolling."

Answered by AI

Does this research involve participants aged 25 or above?

"This medical study has a minimum age of 18 and maximum age of 80 for potential enrollees in line with its inclusion criteria."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of AZD0486 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
2021. "A Study of AZD0486 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04594642.
~53 spots leftby Jan 2027
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