Lymphoma Diffuse Large B-cellPhase 1/2QUADvanceNCT07284433
Study of Allo-QuadCAR01-T, an Allogeneic CAR-T Targeting CD19/CD20, in Patients With Relapsed or Refractory B-Cell Malignancies
A Phase 1/2 study testing Cyclophosphamide (Non-IMP, Lymphodepletion), Fludarabine (Non-IMP, Lymphodepletion) and Allo-QuadCAR01-T in people with Lymphoma Diffuse Large B-cell and Leukemia and Lymphoma, run by AvenCell Therapeutics, Inc. at 13 sites in 2 countries.
Trial summary
This study is testing Allo-QuadCAR01-T, a new off-the-shelf CAR-T therapy for people with hard-to-treat B-cell cancers. Unlike current CAR-T treatments that use a patient's own cells, this therapy uses donor cells that are ready to use, which can save time and reduce costs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma Diffuse Large B-cell, Leukemia and Lymphoma, Leukemia Relapse
- What is being tested?
- Cyclophosphamide (Non-IMP, Lymphodepletion), Fludarabine (Non-IMP, Lymphodepletion) and Allo-QuadCAR01-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 6 Jan 2026to 2 Nov 2029
- Phase
- Phase 1/2
- 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
- Adults 18 years or older.
- Diagnosed with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) or chronic lymphocytic leukemia (CLL).
- Must have received at least 2 prior lines of therapy.
- ECOG performance status 0-1 (able to carry out daily activities).
- Adequate organ function (heart, liver, kidneys).
- HLA B/C match with donor cells.
- No active uncontrolled infections.
Who cannot join
- Active CNS involvement (including PCNSL) in dose escalation cohorts; may be allowed in later cohorts with Sponsor approval.
- Prior CAR-T within 3 months of screening, or ≥Grade 3 ICAHT from prior CAR-T.
- Autologous stem cell transplant within 3 months.
- Prior allogeneic stem cell transplant or solid organ transplant.
- Prior therapy with dual CD19/CD20 CAR-T.
- Severe hypersensitivity to trial agents or similar compounds.
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- History of GvHD or post-transplant lymphoproliferative disorder.
- Presence of La/SS-B autoantibodies or related autoimmune diseases.
- Other malignancy that may interfere with trial, except:
- Curatively treated basal/squamous skin cancer or cervical carcinoma in situ
- Low-grade, early-stage prostate cancer (Gleason ≤6, Stage 1-2) with no therapy needed
- Adjuvant endocrine therapy for non-metastatic breast cancer (≥2 years)
- Any other curatively treated malignancy in remission ≥2 years
- Active viral infection within 1 week of screening, or serious bacterial/fungal infection.
- Hemorrhagic cystitis.
- Active neuro-autoimmune disease (e.g., MS, Guillain-Barré, ALS).
- Active or residual HBV, HCV, or syphilis.
- Active HIV. History of HIV may be eligible with Sponsor approval if:
- Neurological disorders within 6 months (e.g., stroke, dementia, Parkinson's, cerebellar disease, CNS autoimmune disease).
- Significant cardiac disease within 6 months (e.g., MI, stent, unstable angina).
- Primary immunodeficiency or autoimmune disease requiring systemic treatment within 1 year (unless stable and Sponsor-approved).
- Unresolved ≥Grade 2 non-hematologic toxicity from prior therapy (except neuropathy up to Grade 2).
- Systemic immunosuppression within 28 days.
- Last systemic lymphoma/CLL therapy (standard or investigational) within 28 days or 5 half-lives.
- Major surgery within 14 days.
- Local radiation within 28 days.
- Live vaccination within 28 days.
- Pregnant or breastfeeding.
Trial locations and contacts
13 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
13 sites in 2 countries
Germany8 sites, 8 recruiting
- Recruiting
Charité Universitätsmedizin Berlin
Berlin, 13353
Frederik Damm, Prof., frederik.damm@charite.de
- Recruiting
Universitätsklinikum Dresden
Dresden, Saxony, 01307
Martin Wermke, Prof., martin.wermke@ukdd.de
- Recruiting
Universitätsklinikum Erlangen
Erlangen, Bavaria, 91054
Fabian Müller, Prof., fabian.mueller@uk-erlangen.de
- Not yet recruiting
Uniklinikum Erlangen
Essen, North Rhine-Westphalia, 45147
Bastian von Tresckow, Prof., bastian.vontresckow@uk-essen.de
- Not yet recruiting
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
Francis Ayuketang Ayuk, Prof., ayuketang@uke.de
- Not yet recruiting
Universitätsklinikum Marburg
Marburg, Hesse, 35032
Stephan Metzelder, Prof., metzelde@med.uni-marburg.de
- Recruiting
Klinikum der Universität München
Munich, Bavaria, 81377
Veit Bücklein, MD, veit.buecklein@med.uni-muenchen.de
- Recruiting
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, 89081
Andreas Viardot, Prof., andreas.viardot@uniklinik-ulm.de
United States5 sites, 5 recruiting
- Not yet recruiting
University of Chicago
Chicago, Illinois, 60637
Peter Riedell, Ass. Prof., peter.riedell@uchicagomedicine.org
- Not yet recruiting
Northwestern University
Evanston, Illinois, 60208
Reem Karmali, Ass. Prof., reem.karmali@northwestern.edu
- Not yet recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Sairah Ahmed, Prof., sahmed3@mdanderson.org
- Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Krish Patel, MD, krish.patel@scri.com
- Not yet recruiting
Brown University Health
Providence, Rhode Island, 02903
Ari Pelcovits, MD, ari.pelcovits@brownhealth.org
About this study
Official title: A Single-arm, Multicenter, Open-label, Phase I/II Trial of Allo-QuadCAR01-T, an Allogeneic CAR-T-cell Therapy Targeting CD19 and CD20, for the Treatment of Relapsed or Refractory B-cell Malignancies
This study is testing Allo-QuadCAR01-T, a new off-the-shelf CAR-T therapy for people with hard-to-treat B-cell cancers. Unlike current CAR-T treatments that use a patient's own cells, this therapy uses donor cells that are ready to use, which can save time and reduce costs. It targets two proteins, CD19 and CD20, to lower the chance of relapse and uses gene editing to make it safer. The trial has three parts: first to find a safe dose, then to confirm it, and finally to test how well it works in patients with diffuse large B-cell lymphoma (DLBCL). Patients will get one infusion after chemotherapy to prepare their body. The main goal is to check safety and see how many patients have a complete response by Week 13. About 160 patients will take part, and researchers will follow them for up to 15 years.
- Conditions
- Lymphoma Diffuse Large B-cell, Leukemia and Lymphoma, Leukemia Relapse, Lymphoma Receiving CAR-T Therapy
- Being tested
- Cyclophosphamide (Non-IMP, Lymphodepletion), Fludarabine (Non-IMP, Lymphodepletion), Allo-QuadCAR01-T
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Leukemia, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclophosphamide (Non-IMP, Lymphodepletion)Other
Intravenous infusion over 3 days (d-5 to d-3)
Fludarabine (Non-IMP, Lymphodepletion)Other
Intravenous infusion over 3 days (d-5 to d-3)
Allo-QuadCAR01-TDrug
Single dose IV infusion on Day 1
| Study group | Role | What they receive |
|---|---|---|
| Allo-QuadCAR01-T | Experimental | Phase Ia (Escalation): Participants with relapsed or refractory B-cell malignancies will receive lymphodepleting chemotherapy followed by a single infusion of Allo-QuadCAR01-T.
Phase Ib (Expansion): After dose escalation, additional participants with relapsed or refractory B-cell lymphoma will receive lymphodepleting chemotherapy followed by a single infusion of Allo-QuadCAR01-T at one or more tolerable dose levels from Phase Ia.
Phase II: Participants with relapsed or refractory DLBCL will receive lymphodepleting chemotherapy, followed by a single infusion of Allo-QuadCAR01-T at the recommended Phase II dose. The primary endpoint is complete response rate at Week 13, with secondary endpoints including duration of response, progression-free survival, and overall survival. Receives: Other: Cyclophosphamide (Non-IMP, Lymphodepletion); Other: Fludarabine (Non-IMP, Lymphodepletion); Drug: Allo-QuadCAR01-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AEs defined as DLTs
Incidence and intensity of adverse events (AEs) graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for cytokine release syndrome (CRS), immune effector cell associated neurotoxicity syndrome (ICANS), tumor lysis syndrome, and graft versus host disease (GvHD), which will be graded according to widely accepted specialized criteria
Measured: At the end of cycle 1 (in total 28 days, given no treatment interruptions)
To determine the maximum tolerated dose (MTD)
MTD
Measured: At the End of Cycle 1 (in total 28 days, given no treatment interruptions)
To determine the incidence of dose-limiting toxicities (DLT)
Incidence of DLTs
Measured: At the end of cycle 1 (in total 28 days, given no treatment interruptions)
Phase 2: Complete response rate (CRR)
Complete remission rate is defined as the proportion of participants with complete remission, per international working group (IWG) Lugano classification, as assessed by the investigator.
Measured: Up to week 13
Secondary outcomes (9)
Pharmacokinetics of Allo-QuadCAR01-T in PB in patients after infusion of Allo-QuadCAR01-T
Detection of VCN in blood samples
Measured: Up to 24 months
To investigate the impact of Allo-QuadCAR01-T on MRD
MRD levels in responding CLL patients
Measured: Up to 24 months
To evaluate immunogenicity against Allo-QuadCAR01-T
Incidence of ADA1 formation against anti-CD19/CD20 ECD and ADA2 formation against the RevCAR ECD of Allo-QuadCAR01-T
Measured: Up to 24 months
To evaluate host immune cell depletion and reconstitution resulting from LD
Enumeration of host PB B-cell, T cell, and NK cell numbers
Measured: Up to 24 months
Overall Response Rate (ORR)
ORR is defined as the proportion of participants with best objective response of either a CR or a partial response (PR) during the trial prior to any new anti-lymphoma, anti-CLL therapy or local radiotherapy for lymphoma , per the Lugano Classification, as determined by the investigator.
Measured: Up to 24 months
Progression-Free Survival (PFS)
PFS is defined as the time from Allo-QuadCAR01-T infusion to disease progression per the Lugano Classification, as determined by investigator review or death from any cause.
Measured: Up to 24 months
Duration of Response (DOR)
DOR is defined as the time from first objective response to disease progression or death from any cause among participants who have achieved CR or PR per the Lugano Classification, as determined by the investigator.
Measured: Up to 24 months
Overall Survival (OS)
OS is defined as the time from Allo-QuadCAR01-T infusion to death from any cause.
Measured: Up to 24 months
Time to Next Treatment (TTNT)
TTNT is defined as time from Allo-QuadCAR01-T infusion to the start of subsequent new anti-lymphoma, anti-CLL therapy or local radiotherapy for lymphoma.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start6 Jan 2026
- Primary completion27 Apr 2029 (estimated)
- Study completion2 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma Diffuse Large B-cellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The trial is structured in three parts: Phase Ia uses a dose-escalation approach to find a safe starting dose of Allo-QuadCAR01-T. Phase Ib expands testing at the selected dose in patients with diffuse large B-cell lymphoma (DLBCL) and possibly other subtypes to confirm safety and early effectiveness. Phase II focuses on a larger group of DLBCL patients to measure how well the treatment works at the recommended dose. All participants receive a single infusion of the therapy after a short course of chemotherapy to prepare their immune system. Patients are closely monitored for 13 weeks, then every three months for two years, with an additional long-term follow-up lasting up to 15 years.
- Masking
- None (open label)
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AvenCell Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AvenCell Europe GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07284433
- Sponsor's protocol ID
- AVC-203-01
- Acronym
- QUADvance
- Status last verified
- Aug 2026
- First submitted
- 25 Nov 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Multicenter, Open-label, Phase I/II Trial of Allo-QuadCAR01-T, an Allogeneic CAR-T-cell Therapy Targeting CD19 and CD20, for the Treatment of Relapsed or Refractory B-cell Malignancies
- ClinicalTrials.gov ID
- NCT07284433
- Acronym / sponsor ID
- QUADvance / AVC-203-01
- Conditions
- Lymphoma Diffuse Large B-cell, Leukemia and Lymphoma, Leukemia Relapse, Lymphoma Receiving CAR-T Therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- AvenCell Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- AvenCell Europe GmbH
- Study start
- 6 Jan 2026 (actual)
- Primary completion
- 27 Apr 2029 (estimated)
- Study completion
- 2 Nov 2029 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is testing Allo-QuadCAR01-T, a new off-the-shelf CAR-T therapy for people with hard-to-treat B-cell cancers. Unlike current CAR-T treatments that use a patient's own cells, this therapy uses donor cells that are ready to use, which can save time and reduce costs. It targets two proteins, CD19 and CD20, to lower the chance of relapse and uses gene editing to make it safer. The trial has three parts: first to find a safe dose, then to confirm it, and finally to test how well it works in patients with diffuse large B-cell lymphoma (DLBCL). Patients will get one infusion after chemotherapy to prepare their body. The main goal is to check safety and see how many patients have a complete response by Week 13. About 160 patients will take part, and researchers will follow them for up to 15 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The trial is structured in three parts: Phase Ia uses a dose-escalation approach to find a safe starting dose of Allo-QuadCAR01-T. Phase Ib expands testing at the selected dose in patients with diffuse large B-cell lymphoma (DLBCL) and possibly other subtypes to confirm safety and early effectiveness. Phase II focuses on a larger group of DLBCL patients to measure how well the treatment works at the recommended dose. All participants receive a single infusion of the therapy after a short course of chemotherapy to prepare their immune system. Patients are closely monitored for 13 weeks, then every three months for two years, with an additional long-term follow-up lasting up to 15 years.
| Arm | Type | Receives |
|---|---|---|
| Allo-QuadCAR01-T | Experimental | Other: Cyclophosphamide (Non-IMP, Lymphodepletion), Other: Fludarabine (Non-IMP, Lymphodepletion), Drug: Allo-QuadCAR01-TPhase Ia (Escalation): Participants with relapsed or refractory B-cell malignancies will receive lymphodepleting chemotherapy followed by a single infusion of Allo-QuadCAR01-T. Phase Ib (Expansion): After dose escalation, additional participants with relapsed or refractory B-cell lymphoma will receive lymphodepleting chemotherapy followed by a single infusion of Allo-QuadCAR01-T at one or more tolerable dose levels from Phase Ia. Phase II: Participants with relapsed or refractory DLBCL will receive lymphodepleting chemotherapy, followed by a single infusion of Allo-QuadCAR01-T at the recommended Phase II dose. The primary endpoint is complete response rate at Week 13, with secondary endpoints including duration of response, progression-free survival, and overall survival. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults 18 years or older.
- Diagnosed with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) or chronic lymphocytic leukemia (CLL).
- Must have received at least 2 prior lines of therapy.
- ECOG performance status 0-1 (able to carry out daily activities).
- Adequate organ function (heart, liver, kidneys).
Key exclusion criteria (28 listed)
- Active CNS involvement (including PCNSL) in dose escalation cohorts; may be allowed in later cohorts with Sponsor approval.
- Prior CAR-T within 3 months of screening, or ≥Grade 3 ICAHT from prior CAR-T.
- Autologous stem cell transplant within 3 months.
- Prior allogeneic stem cell transplant or solid organ transplant.
- Prior therapy with dual CD19/CD20 CAR-T.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyclophosphamide (Non-IMP, Lymphodepletion)Intravenous infusion over 3 days (d-5 to d-3) | Other | Allo-QuadCAR01-T |
| Fludarabine (Non-IMP, Lymphodepletion)Intravenous infusion over 3 days (d-5 to d-3) | Other | Allo-QuadCAR01-T |
| Allo-QuadCAR01-TSingle dose IV infusion on Day 1 | Drug | Allo-QuadCAR01-T |
Primary outcome
Incidence of AEs defined as DLTs
Time frame: At the end of cycle 1 (in total 28 days, given no treatment interruptions)
Incidence and intensity of adverse events (AEs) graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for cytokine release syndrome (CRS), immune effector cell associated neurotoxicity syndrome (ICANS), tumor lysis syndrome, and graft versus host disease (GvHD), which will be graded according to widely accepted specialized criteria
To determine the maximum tolerated dose (MTD)
Time frame: At the End of Cycle 1 (in total 28 days, given no treatment interruptions)
MTD
To determine the incidence of dose-limiting toxicities (DLT)
Time frame: At the end of cycle 1 (in total 28 days, given no treatment interruptions)
Incidence of DLTs
Phase 2: Complete response rate (CRR)
Time frame: Up to week 13
Complete remission rate is defined as the proportion of participants with complete remission, per international working group (IWG) Lugano classification, as assessed by the investigator.
9 secondary outcomes
Pharmacokinetics of Allo-QuadCAR01-T in PB in patients after infusion of Allo-QuadCAR01-T
Time frame: Up to 24 months
To investigate the impact of Allo-QuadCAR01-T on MRD
Time frame: Up to 24 months
To evaluate immunogenicity against Allo-QuadCAR01-T
Time frame: Up to 24 months
To evaluate host immune cell depletion and reconstitution resulting from LD
Time frame: Up to 24 months
Overall Response Rate (ORR)
Time frame: Up to 24 months
Progression-Free Survival (PFS)
Time frame: Up to 24 months
Duration of Response (DOR)
Time frame: Up to 24 months
Overall Survival (OS)
Time frame: Up to 24 months
Time to Next Treatment (TTNT)
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cyclophosphamide (Non-IMP, Lymphodepletion), Fludarabine (Non-IMP, Lymphodepletion) and Allo-QuadCAR01-T in people with Lymphoma Diffuse Large B-cell and Leukemia and Lymphoma, run by AvenCell Therapeutics, Inc. at 13 sites in 2 countries.
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 7 inclusion and 28 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: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Germany, 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Antje Warth, Dr. (0493514466450 ext. 0, avc-203-01@avencell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of AEs defined as DLTs (time frame: At the end of cycle 1 (in total 28 days, given no treatment interruptions)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2026.