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CAR T-cell Therapy

Engineered TILs + Acetazolamide for Melanoma

Phase 1
Recruiting
Led By Rodabe N Amaria, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female patients age ≥ 18 at the time of signing ICF
Patient has a pathologically confirmed diagnosis of metastatic melanoma that is unresectable stage III or stage IV and has lesion(s) amenable to resection for the generation of TILs and at least one separate lesion for RECIST v1.1 response assessment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through completion of study, an average of 1 year
Awards & highlights
No Placebo-Only Group

Study Summary

This trial is testing a new combination drug therapy for melanoma that has spread to other parts of the body and has not responded to other treatments.

Who is the study for?
Adults over 18 with stage III or IV metastatic melanoma that's not removable by surgery and have failed immune checkpoint inhibitor therapy can join. They need a tumor for TIL generation, another for response assessment, proper organ function tests, no severe heart issues, and must use birth control. Excluded are those with uncontrolled illnesses, recent chemotherapy or live vaccines, certain infections like HIV/HCV requiring treatment, brain metastases of melanoma, serious cardiac conditions within the last 6 months, other cancers in the last 2 years (with exceptions), significant allergies to sulfa drugs or on chronic acetazolamide.Check my eligibility
What is being tested?
This Phase I trial is testing OBX-115 combined with acetazolamide to find a safe dose for patients with metastatic melanoma who've already tried immune checkpoint inhibitors. It also includes pre-treatment drugs like cyclophosphamide and fludarabine phosphate to prepare the body ('lymphodepletion') before introducing OBX-115.See study design
What are the potential side effects?
Possible side effects include reactions related to infusion such as fever or chills; blood count changes leading to increased infection risk; fatigue; liver enzyme elevations indicating potential liver damage; nausea and vomiting from digestive system irritation; kidney function changes due to creatinine clearance alterations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have advanced melanoma with tumors that can be used to generate TILs and at least one tumor for tracking treatment response.
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I have cancer that didn't respond to specific immune treatments and followed standard care.
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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion of study, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of study, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence and nature of dose-limiting toxicities (DLTs) during the first 28 days after OBX-115 + acetazolamide administration as assessed by CTCAE version 5.0. Incidence and severity of AEs and SAEs after OBX-115 + acetazolamide administration.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: OBX-115 plus AcetazolamideExperimental Treatment6 Interventions
Participants will receive chemotherapy to prepare your body for the study drug combination, then you will receive OBX-115 and acetazolamide.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acetazolamide
2011
Completed Phase 4
~2910
Cyclophosphamide
1995
Completed Phase 3
~3780
Furosemide
2015
Completed Phase 4
~4240
Mesna
2003
Completed Phase 2
~1350
Fludarabine Phosphate
1997
Completed Phase 3
~2390

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,945 Previous Clinical Trials
1,803,351 Total Patients Enrolled
9 Trials studying Tumors
8,541 Patients Enrolled for Tumors
Rodabe N Amaria, MDPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
93 Total Patients Enrolled

Media Library

OBX-115 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05470283 — Phase 1
Tumors Research Study Groups: OBX-115 plus Acetazolamide
Tumors Clinical Trial 2023: OBX-115 Highlights & Side Effects. Trial Name: NCT05470283 — Phase 1
OBX-115 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05470283 — Phase 1

Frequently Asked Questions

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

How many individuals have been enrolled for this experiment?

"Affirmative. Clinicaltrials.gov provides information that this clinical trial is currently recruiting participants, with a first posting date of September 7th 2022 and last update on the same day. The research will require 30 individuals from one study centre to enrol in total."

Answered by AI

Are people still being accepted to join this investigation?

"Correct. According to the information hosted on clinicaltrials.gov, this medical trial is actively seeking enrolment of participants and was recently updated as of September 7th 2022. Currently, 30 patients are required in a single location for the study's completion."

Answered by AI

What health risks are potentially posed by OBX-115?

"Our team at Power has assessed the safety of OBX-115 to be a 1, as this is currently only in Phase 1 clinical trial with limited data on efficacy and security."

Answered by AI
~20 spots leftby Apr 2027