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CAR T-cell Therapy
ONCT-808 for Aggressive B-Cell Malignancies
Phase 1 & 2
Recruiting
Led By Michael Wang
Research Sponsored by Oncternal Therapeutics, Inc
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 up to 15 years
Awards & highlights
Study Summary
This trial tests a new cancer therapy to determine if it is safe and effective for people with hard-to-treat B cell cancers.
Who is the study for?
Adults over 18 with aggressive B-cell non-Hodgkin lymphoma (NHL) who've tried other treatments like chemotherapy, stem cell transplant, or CD19 CAR-T therapy without success. They should have at least one measurable tumor and be in good physical condition with well-functioning organs. People can't join if they've had certain brain disorders, significant heart issues within the last year, HIV/HBV/HCV infections, recent systemic fungal infections, COVID-19 lung complications, another cancer not in remission for 2+ years or autoimmune diseases requiring treatment recently.Check my eligibility
What is being tested?
The trial is testing ONCT-808, a new CAR-T therapy designed to target and kill cancer cells in patients with relapsed/refractory aggressive B-cell malignancies. It's an early-stage study to see how safe it is and how well it works. Some participants may receive bridging therapy before getting ONCT-808.See study design
What are the potential side effects?
Potential side effects of ONCT-808 could include immune system reactions leading to fever and flu-like symptoms; low blood cell counts causing increased infection risk; neurological events like confusion or tremors; as well as potential organ inflammation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 15 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To evaluate the incidence, severity, and relationship of Dose Limiting Toxicities (DLT)
To evaluate the incidence, severity, and relationship of Treatment Emergent Adverse Events (TEAE)
To select a RP2D of ONCT-808
Secondary outcome measures
Pharmacokinetics of ONCT-808
Safety and Tolerability of ONCT-808
To evaluate the Complete Response (CR) of ONCT-808
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Phase 2: Dose ExpansionExperimental Treatment2 Interventions
Patients with LBCL or MCL will receive ONCT-808 for each RP2D regimen determined in Phase 1.
Group II: Phase 1: Dose EscalationExperimental Treatment2 Interventions
Patients will receive a conditioning regimen of cyclophosphamide and fludarabine intravenously (IV) followed by ONCT-808 IV infusion escalated sequentially with a target dose consistent with the dose required by cohort being enrolled to determine Phase 2 dose (RP2d) regimen(s). Participants may receive bridging therapy that is appropriate to the subject's disease and treatment history if clinically indicated to maintain disease stability.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bridging Therapy
2019
Completed Phase 2
~40
Find a Location
Who is running the clinical trial?
Oncternal Therapeutics, IncLead Sponsor
6 Previous Clinical Trials
273 Total Patients Enrolled
Michael WangPrincipal InvestigatorMD Anderson
Matthew WeiPrincipal InvestigatorCity of Hope Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can provide previous biopsy samples or am willing to have a new biopsy.I have not taken medication for a fungal infection in the last year.I have waited the required time after my last cancer treatment before starting a new one.I have an autoimmune disease that has caused organ damage or needed strong medication in the last 2 years.I haven't had serious heart issues or needed heart rhythm medication in the last year.My aggressive B-cell NHL is confirmed with specific genetic markers.My lymphoma is an aggressive type, like DLBCL or follicular grade 3B.I cannot stop my blood thinner medication for 3 days before and 28 days after getting ONCT-808.I have not had a brain disorder in the last 6 months.I have previously received treatment targeting ROR1.I am over 18 years old.I am fully active or restricted in physically strenuous activity but can do light work.I have had a bone marrow or organ transplant.My cancer has spread to my brain or spinal cord in the last 6 months.I had COVID-19 and now have lung scarring.I have relapsed or refractory cancer with no treatment options left, and either can't undergo or have refused a stem cell transplant.I have been cancer-free for at least 2 years, except for non-melanoma skin cancer or carcinoma in situ.I have relapsed or refractory cancer with no treatment options left and have either received CD19 CAR T-cell therapy or am ineligible for/refused it.I am on or expect to be on immune-suppressing drugs.I've had treatments including an alkylating agent, anthracycline, and anti-CD20 but my condition hasn't improved.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1: Dose Escalation
- Group 2: Phase 2: Dose Expansion
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.
What is the precise number of participants currently being admitted to this research endeavor?
"Affirmative. The clinical trial is still recruiting patients, as indicated on the clinicaltrials.gov website. It was initially posted to this platform in May of 2023 and has since been updated for the last time in June of that same year. There are 57 participants needed between two sites."
Answered by AI
Is this research opportunity accessible to potential participants?
"Affirmative. Clinicaltrials.gov details suggest that this clinical trial is actively recruiting and was initially posted on May 9th, 2023 while being most recently updated on June 13th of the same year. The experiment requires 57 volunteers to be recruited from 2 different sites."
Answered by AI
What objectives is this research endeavor hoping to realize?
"This trial's primary end-point, measured over a 28 day period post ONCT-808 administration is to analyse the rate and severity of Treatment Emergent Adverse Events (TEAE). Additionally, this study seeks to assess Safety and Tolerability of ONCT-808 by further characterizing TEAEs. It will also work towards determining Duration of Response (DOR) according to Lugano 2014 Standards as well as an Overall Response Rate (ORR) based on Cheson Guidelines from 2014."
Answered by AI
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