Phase 2b of RAPA-201 Cell Therapy in Post-PD-(L)-1 Melanoma

Part of paid clinical trials in Hackensack, New Jersey.

Sponsor
Rapa Therapeutics LLC
Study ID
NCT06708455
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Malignant Melanoma
  • Malignant Melanoma Stage IIIc
  • Malignant Melanoma Stage IV
  • Malignant Melanoma With Metastasis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The protocol is a Simon's 2-stage, non-randomized, open label, multi-site, phase 2 trial for patients with advanced metastatic, recurrent and unresectable malignant melanoma that has recurred or relapsed after prior anti-PD-(L)1 therapy.

Key Dates

Start date
Mar 1, 2027
Status verified
Mar 2026
Primary completion
Mar 1, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
65 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Administration of RAPA-201 cells
    RAPA-201 cells will be administered at a target flat dose between 80 and 400 x 10\^6 cells per infusion.

Primary Outcome Measure

Efficacy of RAPA-201 Cell Therapy [ Time Frame: 18 months (6 mo. of treatment; 12 mo of clinical follow-up) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hackensack University Medical CenterHackensackNew Jersey07601
Oncology Clinical Research Referral Office
[email protected]
551-996-1777
Martin Gutierrez, M.D (PRINCIPAL_INVESTIGATOR)

Find similar trials in Hackensack, NJ

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Hackensack University Medical Center· Hackensack, NJ

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