P-CD19CD20-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With B Cell Malignancies
Open-Label, Multicenter, Phase 1 Study to Assess the Safety of P-CD19CD20-ALLO1 in Subjects With Selected Relapsed/Refractory B Cell Malignancies
1 other identifier
interventional
120
1 country
17
Brief Summary
Phase 1 study comprised of open-label, dose escalation and expansion cohort study of P-CD19CD20-ALLO1 allogeneic T stem cell memory (Tscm) CAR-T cells in subjects with relapsed/refractory B cell malignancies
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2024
Longer than P75 for phase_1
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2023
CompletedFirst Posted
Study publicly available on registry
August 28, 2023
CompletedStudy Start
First participant enrolled
April 16, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2041
February 27, 2026
February 1, 2026
4.9 years
August 17, 2023
February 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assess the safety and MTD or RDE of P-CD19CD20-ALLO1 based on dose limiting toxicities (DLT)
Rate of DLT's
Baseline through 28 days
Secondary Outcomes (6)
The safety of P-CD19CD20-ALLO1 (AEs)
Baseline through 36 months
The anti-B cell malignancy effect of P-CD19CD20-ALLO1 (ORR)
Baseline through 15 years
The anti-B cell malignancy effect of P-CD19CD20-ALLO1 (DOR)
Baseline through 15 years
The anti-B cell malignancy effect of P-CD19CD20-ALLO1 (PFS)
Baseline through 15 years
The anti-B cell malignancy effect of P-CD19CD20-ALLO1 (OS)
Baseline through 15 years
- +1 more secondary outcomes
Study Arms (3)
P-CD19CD20-ALLO1 CAR-T Cells (Arm S)
EXPERIMENTALP-CD19CD20-ALLO1 following conditioning chemotherapy regimen S. Rimiducid may be administered.
P-CD19CD20-ALLO1 CAR-T Cells (Arm LD 750)
EXPERIMENTALP-CD19CD20-ALLO1 following conditioning chemotherapy regimen LD 750. Rimiducid may be administered.
P-CD19CD20-ALLO1 CAR-T Cells (Arm LD 1000)
EXPERIMENTALP-CD19CD20-ALLO1 following conditioning chemotherapy regimen LD 1000. Rimiducid may be administered.
Interventions
Single weight-based IV administration
Single weight-based IV administration
Eligibility Criteria
You may qualify if:
- Must have signed written, informed consent.
- Males or females ≥ 18 years of age.
- Must have prior biopsy proven confirmed diagnosis of DLBCL NOS (including DLBCL arising from indolent lymphomas), HGBL, PMBCL,and tFL or follicular lymphoma Grade 3B.
- Diagnosis of the disease based on WHO 2016 (Swerdlow, 2016) criteria.
- Subjects must have measurable disease as defined by Lugano 2016 criteria (Cheson, 2016).
- Must have relapsed/refractory disease and have received adequate prior anti-cancer therapy, as defined below:
- a. Prior systemic chemotherapy must include a line of chemoimmunotherapy that includes an anti-CD20 antibody, an anthracycline, and 1 or more of the following: i. No response to first-line therapy (primary refractory disease). Refractory disease (defined as SD, PD, PR or CR with relapse before 3 months).
- ii. Progressive disease following two or more lines of therapy. However, SD as the best response after at least 2 cycles of the last line of therapy with SD duration no longer than 6 months from the last dose of therapy is also acceptable.
- iii. Refractory post-autologous stem cell transplant (ASCT). Disease progression or relapse occurring at less than or equal to 12 months of undergoing ASCT (must have biopsy proven recurrence in relapsed patients). If salvage therapy is given post-ASCT, the patient must have had no response to or relapsed after the last line of therapy.
- iv. Refractory disease (SD, PD, PR or CR with relapse before 3 months) or relapsed disease (defined as CR/PR with relapse on, or after lasting at least 3 months but no more than 12 months), to CD20 antibody and anthracycline containing first-line therapy.
- Must be willing to practice birth control from the time of Screening and throughout the first year of the study after P-CD19CD20-ALLO1 administration (both males and females of childbearing potential).
- Must have a negative serum pregnancy test at Screening and a negative urine pregnancy test within 3 days prior to initiating the lymphodepletion chemotherapy regimen (females of childbearing potential).
- Must be at least 90 days since ASCT, if performed.
- Treatment with prior CD19 targeted therapy is allowed, provided the last dose was administered at least 90 days before the start of P-CD19CD20-ALLO1 treatment in this study. Must be at least 3 months since autologous CAR-T therapy if such therapy was administered (medical monitor must approve prior CAR-T therapy or other prior T cell targeted therapy).
- Must have adequate vital organ function, defined as follows (or medical monitor approval):
- +6 more criteria
You may not qualify if:
- Is pregnant or lactating.
- Has inadequate venous access.
- Has active hemolytic anemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), disseminated intravascular coagulation, leukostasis, or amyloidosis.
- Concurrent or previous other malignancy within 2 years of study entry, except curatively treated malignancies including basal or squamous cell skin cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, breast, or Bowen's disease. Patients with other curatively treated malignancies with low risk of recurrence not listed may also be considered eligible after review and approval by the Sponsor medical monitor.
- Has active autoimmune disease, such as psoriasis, multiple sclerosis, lupus, rheumatoid arthritis, etc. (the medical monitor will determine if a disease is active and autoimmune).
- Has a history of significant central nervous system (CNS) disease, such as stroke, epilepsy, primary CNS lymphoma, etc. (the medical monitor will determine if significant).
- Has an active systemic infection (e.g., causing fevers or requiring antimicrobial treatment).
- Has a history of hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), or human T-lymphotropic virus (HTLV) infection, or any immunodeficiency syndrome. Subjects with a history of treated hepatitis C can be enrolled if negative by hepatitis C polymerase chain reaction (PCR) on multiple occasions and with medical monitor approval.
- Is positive for human herpes virus (HHV)-6 or HHV-7 infection by PCR at the Screening Visit (subjects may be included in the study if they are HHV-6 or HHV-7 IgG antibody-positive but PCR-negative).
- Has New York Heart Association (NYHA) Class III or IV heart failure, unstable angina, or a history of myocardial infarction or significant arrhythmia (e.g., atrial fibrillation, sustained \[\> 30 seconds\] ventricular tachyarrhythmias, etc.).
- Has any psychiatric or medical disorder (e.g., cardiovascular, endocrine, renal, gastrointestinal, genitourinary, immunodeficiency or pulmonary disorder not otherwise specified) that would, in the opinion of the Investigator or medical monitor, preclude safe participation in and/or adherence to the protocol (including medical conditions or laboratory findings that indicate a significant probability of not qualifying for or being unable to undergo, LD chemotherapy and/or CAR-T cell administration).
- Has received non-mAb anti-cancer medications within 2 weeks of the time of initiating LD chemotherapy.
- Has received mAb therapy within 4 weeks of initiating LD chemotherapy.
- Has received immunosuppressive medications within 2 weeks of the time of administration of P-CD19CD20-ALLO1, and/or expected to require them while on study (the medical monitor will determine if a medication is considered immunosuppressive.)
- Has received systemic corticosteroid therapy \> 5 mg/day of prednisone or equivalent dose of another corticosteroid within 1 week or 5 half-lives (whichever is shorter) of the administration of P-CD19CD20-ALLO1 or is expected to require it during the course of the study. (Topical and inhaled steroids are permitted. Systemic corticosteroids are contraindicated after receiving P-CD19CD20-ALLO1 cells outside of study-specific guidance or medical monitor approval).
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Poseida Therapeutics, Inc.lead
- Roche-Genentechcollaborator
Study Sites (17)
University of California San Diego
La Jolla, California, 92093, United States
Loma Linda University Cancer Center
Loma Linda, California, 92354, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Advent Health Orlando
Orlando, Florida, 32803, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Our Lady of the Lake Hospital
Baton Rouge, Louisiana, 70808, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Wayne State - Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
NYU Grossman School of Medicine
New York, New York, 10016, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
University of Cincinnati
Cincinnati, Ohio, 45206, United States
University of Oklahoma, Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Pennsylvania State University
Hershey, Pennsylvania, 17033, United States
Prisma Health - Upstate Cancer Institute
Greenville, South Carolina, 29605, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Baylor Scott & White Research Institute
Dallas, Texas, 75204, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Simon Heidegger, MD
Lead Medical Director, Oncology, Genentech Research Early Development
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2023
First Posted
August 28, 2023
Study Start
April 16, 2024
Primary Completion (Estimated)
March 1, 2029
Study Completion (Estimated)
March 1, 2041
Last Updated
February 27, 2026
Record last verified: 2026-02