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P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors

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ClinicalTrials.gov Identifier: NCT05239143
Recruitment Status : Recruiting
First Posted : February 14, 2022
Last Update Posted : April 23, 2024
Sponsor:
Information provided by (Responsible Party):
Poseida Therapeutics, Inc.

Study Description
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Brief Summary:
A Phase 1, open label, dose escalation and expanded cohort study of P-MUC1C-ALLO1 in adult subjects with advanced or metastatic epithelial derived solid tumors, including but not limited to the tumor types listed below.

Condition or disease Intervention/treatment Phase
Breast Cancer Ovarian Cancer Non Small Cell Lung Cancer Colorectal Cancer Pancreatic Cancer Renal Cell Carcinoma Nasopharyngeal Cancer Head and Neck Squamous Cell Carcinoma Gastric Cancer Biological: P-MUC1C-ALLO1 CAR-T cells Drug: Rimiducid Phase 1

Detailed Description:

This is an open label, multi-center Phase 1 study that will follow a 3 + 3 design of dose-escalating cohorts of single and multiple doses of P-MUC1C-ALLO1 to determine a Recommended Phase 2 Dose (RP2D). P-MUC1C-ALLO1 is an allogeneic chimeric antigen receptor (CAR) T cell therapy designed to target cancer cells expressing Mucin1 cell surface associated C-Terminal (MUC1-C) antigen. Additional participants will be treated with P-MUC1C-ALLO1 at the determined RP2D.

Following enrollment, subjects will be treated with P-MUC1C-ALLO1 and will undergo serial measurements of safety, tolerability and response. Rimiducid may be administered as indicated.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Open label, 3 + 3 design of dose-escalating cohorts with open label, dose expansion at recommended phase 2 dose (RP2D)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Dose Escalation and Expanded Cohort Study of P-MUC1C-ALLO1 in Adult Subjects With Advanced or Metastatic Solid Tumors
Actual Study Start Date : February 15, 2022
Estimated Primary Completion Date : April 2026
Estimated Study Completion Date : April 2039

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: P-MUC1C-ALLO1 CAR-T cells (Single Dose - Arm A)
  • Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following conditioning chemotherapy regimen 1.
  • Rimiducid may be administered as indicated.
 Biological: P-MUC1C-ALLO1 CAR-T cells
P-MUC1C-ALLO1 is an allogeneic CAR-T cell therapy designed to target cancer cells expressing MUC1-C.

Drug: Rimiducid
Rimiducid (safety switch activator) may be administered as indicated.
Experimental: P-MUC1C-ALLO1 CAR-T cells (Multiple Dose - Arm B)
  • Cyclic administration of ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following conditioning chemotherapy regimen 1.
  • Rimiducid may be administered as indicated.
 Biological: P-MUC1C-ALLO1 CAR-T cells
P-MUC1C-ALLO1 is an allogeneic CAR-T cell therapy designed to target cancer cells expressing MUC1-C.

Drug: Rimiducid
Rimiducid (safety switch activator) may be administered as indicated.
Experimental: P-MUC1C-ALLO1 CAR-T cells (Single Dose - Arm C)
  • Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following conditioning chemotherapy regimen 2.
  • Rimiducid may be administered as indicated.
 Biological: P-MUC1C-ALLO1 CAR-T cells
P-MUC1C-ALLO1 is an allogeneic CAR-T cell therapy designed to target cancer cells expressing MUC1-C.

Drug: Rimiducid
Rimiducid (safety switch activator) may be administered as indicated.
Experimental: P-MUC1C-ALLO1 CAR-T cells (Multiple Dose - Arm D)
  • Cyclic administration of ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following conditioning chemotherapy regimen 2.
  • Rimiducid may be administered as indicated.
 Biological: P-MUC1C-ALLO1 CAR-T cells
P-MUC1C-ALLO1 is an allogeneic CAR-T cell therapy designed to target cancer cells expressing MUC1-C.

Drug: Rimiducid
Rimiducid (safety switch activator) may be administered as indicated.


Outcome Measures
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Primary Outcome Measures :
  1. Determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of P-MUC1C-ALLO1 [ Time Frame: Baseline through Day 28 ]
    Number of subjects with a dose limiting toxicity (DLT)

  2. Evaluate the overall safety and tolerability profile of P-MUC1C-ALLO1 [ Time Frame: Baseline through 15 years ]
    Frequency and severity of adverse events

  3. Evaluate the preliminary efficacy of P-MUC1C-ALLO1 [ Time Frame: Baseline through 15 years ]
    According to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, secondarily Immune Response Evaluation Criteria in Solid Tumors (iRECIST): Overall Response Rate (ORR)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females, Subjects ≥18 years with life expectancy >3 months
  • Must have a confirmed diagnosis of unresectable, locally advanced or metastatic epithelial-derived cancer, refractory to standard of care therapy or ineligible or refused other existing treatment options
  • Must have progressed during or after last therapy and have measurable disease
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 or Karnofsky performance status ≥70%
  • Must have adequate vital organ function within pre-determined parameters
  • Must have archived tumor tissue available or consent to a biopsy collection
  • Must be willing to practice birth control
  • Must have a negative pregnancy test at screening and prior to initiating lymphodepletion chemotherapy or study drug administration
  • Must have recovered from toxicities due to prior therapies

Exclusion Criteria:

  • Has inadequate venous access
  • Has an active second malignancy in addition to the studied malignancy, excluding low-risk neoplasms such as non-metastatic basal cell or squamous cell skin carcinoma
  • Is pregnant or lactating
  • Has a history of or active autoimmune disease
  • Has a history of significant central nervous system (CNS) disease, such as stroke, epilepsy
  • Has an active systemic (viral, bacterial, or fungal) infection
  • Has New York Heart Association (NYHA) Class III or IV heart failure, unstable angina, or a history of myocardial infarction or significant arrhythmia
  • Has any psychiatric or medical disorder that would preclude safe participation in and/or adherence to the protocol
  • Has received anticancer medications within 2 weeks of the time of initiating conditioning chemotherapy
  • Has received immunosuppressive medications within 2 weeks of administration of P-MUC1C-ALLO1, and/or expected to require them while enrolled in the study
  • Has received systemic corticosteroid therapy within 1 week of the administration of P-MUC1C-ALLO1 or is expected to require it during the course of the study
  • Has known CNS metastases or symptomatic CNS involvement
  • Has a history of significant liver disease or active liver disease
  • Has a history of known genetic predisposition to HLH/MAS
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05239143


Contacts
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Contact: Angie Schinkel 858-779-3103 clinicaltrials@poseida.com

Locations
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United States, California
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
University of California, San Diego Recruiting
San Diego, California, United States, 92037
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
United States, Colorado
Sarah Cannon Research Institute at HealthONE Recruiting
Denver, Colorado, United States, 80218
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
United States, Kansas
University of Kansas Cancer Center Recruiting
Westwood, Kansas, United States, 66205
Cancer Center of Kansas Recruiting
Wichita, Kansas, United States, 67214
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
NEXT Oncology Recruiting
San Antonio, Texas, United States, 78229
United States, Wisconsin
Froedtert Hospital and the Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Poseida Therapeutics, Inc.
Investigators
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Study Director: Rajesh Belani, M.D. Sponsor Executive Medical Director
More Information
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Responsible Party: Poseida Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05239143    
Other Study ID Numbers: P-MUC1C-ALLO1-001
First Posted: February 14, 2022    Key Record Dates
Last Update Posted: April 23, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Squamous Cell Carcinoma of Head and Neck
Nasopharyngeal Neoplasms
Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Carcinoma, Squamous Cell
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Urogenital Neoplasms
 Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Kidney Diseases
Urologic Diseases
Male Urogenital Diseases
Head and Neck Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases