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CAR T-cell Therapy

Engineered TILs + Acetazolamide for Melanoma

Phase 1
Waitlist Available
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
Must not have
The use of immune checkpoint inhibitors as bridging therapy is not allowed
Patients with active infection requiring systemic therapy or causing fever (temperature > 38.1oC) or patients with unexplained fever (temperature > 38.1oC) within 7 days prior to day of investigational product administration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not used immune checkpoint inhibitors as a temporary treatment.
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I do not have a fever or an active infection needing treatment.
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I have a history of interstitial lung disease.
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I can understand and agree to the study's procedures.
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My melanoma has spread to my brain or spinal cord.
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I regularly take medication for fluid build-up or eye pressure.
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I have had an organ or bone marrow transplant.
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I am currently receiving treatment for HIV, hepatitis B, or hepatitis C.
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I do not have serious heart problems like recent heart attacks or severe heart failure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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
Furosemide
2015
Completed Phase 4
~4240
Mesna
2003
Completed Phase 2
~1380
Cyclophosphamide
2010
Completed Phase 4
~2310
Fludarabine Phosphate
1997
Completed Phase 3
~2390
Acetazolamide
2011
Completed Phase 4
~3030

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,524 Total Patients Enrolled
9 Trials studying Tumors
8,540 Patients Enrolled for Tumors
Rodabe N Amaria, MDPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
234 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
~10 spots leftby Apr 2027
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