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Diffuse Large B-Cell Lymphoma, Not Otherwise SpecifiedPhase 1NCT06014762

P-CD19CD20-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With B Cell Malignancies

A Phase 1 study testing P-CD19CD20-ALLO1 and Rimiducid in people with Diffuse Large B-Cell Lymphoma, Not Otherwise Specified and High-grade B-cell Lymphoma, run by Poseida Therapeutics, Inc. at 16 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
P-CD19CD20-ALLO1 and Rimiducid
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
16 sitesUnited States
Study dates
16 Apr 2024to Mar 2041
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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).
  • 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.
  • 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.
  • 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):
  • Serum creatinine ≤ 1.5 mg/dL or estimated creatinine clearance ≥ 30 mL/min as calculated using the Cockcroft-Gault formula and not dialysis-dependent.
  • Adequate hematologic function, including:
  • Absolute neutrophil count (ANC) ≥ 1000/μL in the absence of growth factor support (granulocyte colony stimulating factor [G-CSF] within 7 days or peg-G-CSF within 14 days) ii. Platelet count ≥ 50,000/μL in the absence of transfusion support (platelet transfusion within 7 days) iii. Hemoglobin ≥ 8 g/dL in the absence of transfusion support (red blood cell count or whole blood within 7 days) c. Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤ 3 × the upper limit of normal (ULN), and total bilirubin ≤ 2.0 mg/dL (unless there is a history of Gilbert's Syndrome in which case bilirubin levels ≤ 3 mg/dL).
  • Left ventricular ejection fraction (LVEF) ≥ 45%. LVEF assessment must have been performed within 4 weeks of enrollment.
  • Must have recovered from toxicities due to prior therapies to Grade ≤ 2 according to the NCI CTCAE v5.0 criteria or to the subject's prior baseline.
  • Must have an ECOG performance status of 0 to 1.

Who cannot join

  • 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).
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  • 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).
  • Has CNS metastases or CNS involvement (including leptomeningeal carcinomatosis, cranial neuropathies or mass lesions, cauda equina syndrome, and spinal cord compression).
  • Has a history of severe immediate hypersensitivity reaction to any of the agents used in this study.
  • Has a history of having undergone allogeneic or xenogeneic transplant, or has undergone autologous transplantation within 90 days. Subjects with prior history of allogeneic stem cell transplant may be enrolled if they are not on immunosuppressive medications and with medical monitor approval.
  • Has received prior allogeneic genetically modified cellular therapy or was treated with experimental allogeneic cell therapy.
  • History or Grade ≥ 3 HLH/MAS or neurotoxicity with prior therapies (all symptoms of HLH/MAS, neurotoxicity, or CRS from prior therapies must be resolved at the time of enrollment).
  • Has positive DAT at Screening Visit (may be allowed with medical monitor approval).

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • Our Lady of the Lake Hospital

    Baton Rouge, Louisiana, 70808

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • University of Cincinnati

    Cincinnati, Ohio, 45206

  • Baylor Scott & White Research Institute

    Dallas, Texas, 75204

  • Wayne State - Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Prisma Health - Upstate Cancer Institute

    Greenville, South Carolina, 29605

  • Pennsylvania State University

    Hershey, Pennsylvania, 17033

  • Indiana University

    Indianapolis, Indiana, 46202

  • Loma Linda University Cancer Center

    Loma Linda, California, 92354

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • NYU Grossman School of Medicine

    New York, New York, 10016

  • University of Oklahoma, Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Advent Health Orlando

    Orlando, Florida, 32803

  • Oregon Health & Science University

    Portland, Oregon, 97239

Other trials in United States

About this study

Official title: Open-Label, Multicenter, Phase 1 Study to Assess the Safety of P-CD19CD20-ALLO1 in Subjects With Selected Relapsed/Refractory B Cell Malignancies

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

Read the detailed description

Phase 1 study consisting of two parts. Part 1 is a weight-based dose escalation following a 3+3 design of dose-escalating cohorts to define a maximum tolerated dose (MTD). Part 2 includes administration at a selected dose and LD regimen. After enrollment, subjects will receive a lymphodepletion therapy regimen before administration of allogeneic CAR-T cells, administered as a single dose. Treated subjects will undergo serial measurements of safety, tolerability and response. Rimiducid may be administered.

Being tested
P-CD19CD20-ALLO1, Rimiducid
Keywords
DLBCL, HGBCL, HGBL, PMBCL, tFL, FL Grade 3B, Diffuse Large B-Cell Lymphoma, DLBCL NOS
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Dendritic Cell Sarcoma, Interdigitating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • P-CD19CD20-ALLO1Biological

    Single weight-based IV administration

  • RimiducidDrug

    Single weight-based IV administration

Study groups in NCT06014762
Study groupRoleWhat they receive
P-CD19CD20-ALLO1 CAR-T Cells (Arm S)ExperimentalP-CD19CD20-ALLO1 following conditioning chemotherapy regimen S. Rimiducid may be administered.
Receives: Biological: P-CD19CD20-ALLO1; Drug: Rimiducid
P-CD19CD20-ALLO1 CAR-T Cells (Arm LD 750)ExperimentalP-CD19CD20-ALLO1 following conditioning chemotherapy regimen LD 750. Rimiducid may be administered.
Receives: Biological: P-CD19CD20-ALLO1; Drug: Rimiducid
P-CD19CD20-ALLO1 CAR-T Cells (Arm LD 1000)ExperimentalP-CD19CD20-ALLO1 following conditioning chemotherapy regimen LD 1000. Rimiducid may be administered.
Receives: Biological: P-CD19CD20-ALLO1; Drug: Rimiducid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assess the safety and MTD or RDE of P-CD19CD20-ALLO1 based on dose limiting toxicities (DLT)

    Rate of DLT's

    Measured: Baseline through 28 days

Secondary outcomes (6)

  1. The safety of P-CD19CD20-ALLO1 (AEs)

    Incidence and severity of adverse events (AEs)

    Measured: Baseline through 36 months

  2. The anti-B cell malignancy effect of P-CD19CD20-ALLO1 (ORR)

    Overall Response Rate (ORR) - Percentage of patients with complete response (CR) or partial response (PR)

    Measured: Baseline through 15 years

  3. The anti-B cell malignancy effect of P-CD19CD20-ALLO1 (DOR)

    Duration of Response - Time from complete response (CR) or partial response (PR) to progressive disease

    Measured: Baseline through 15 years

  4. The anti-B cell malignancy effect of P-CD19CD20-ALLO1 (PFS)

    Progression Free Survival (PFS) - Time from P-CD19CD20-ALLO1 treatment to progressive disease

    Measured: Baseline through 15 years

  5. The anti-B cell malignancy effect of P-CD19CD20-ALLO1 (OS)

    Overall Survival (OS) - Duration of survival from time of treatment with P-CD19CD20-ALLO1

    Measured: Baseline through 15 years

  6. The effect of cell dose and LD regimen to guide selection of specific cell dose and LD regimen for further assessment in Phase 2/3 studies

    Cytokine release syndrome (CRS) graded using American Society for Transplantation and Cellular Therapy (ASTCT) criteria

    Measured: Baseline through 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2023
  2. Study start16 Apr 2024
  3. Primary completionMar 2029 (estimated)
  4. Study completionMar 2041 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06014762
Sponsor's protocol ID
P-CD19CD20-ALLO1-001
Status last verified
May 2026
First submitted
17 Aug 2023
Last updated
7 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing P-CD19CD20-ALLO1 and Rimiducid in people with Diffuse Large B-Cell Lymphoma, Not Otherwise Specified and High-grade B-cell Lymphoma, run by Poseida Therapeutics, Inc. at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assess the safety and MTD or RDE of P-CD19CD20-ALLO1 based on dose limiting toxicities (DLT) (time frame: Baseline through 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06014762.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.

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