Allo-QuadCAR01-T for Blood Cancers
(QUADvance Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called Allo-QuadCAR01-T for individuals with difficult-to-treat B-cell cancers, including certain lymphomas and leukemias. Unlike traditional CAR-T therapies that use a patient's own cells, this treatment uses ready-to-go donor cells, potentially speeding up and reducing the cost of treatment. The study will evaluate the treatment's safety and effectiveness, particularly in preventing relapses. Ideal participants have tried at least two other cancer treatments and can manage daily activities. The trial provides one infusion after chemotherapy to prepare the body and monitors responses over time. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this innovative therapy.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that you should not have had systemic immunosuppression or certain therapies within 28 days before starting the trial. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that Allo-QuadCAR01-T is likely to be safe for humans?
Research has shown that Allo-QuadCAR01-T, a new ready-to-use CAR-T therapy, targets two proteins, CD19 and CD20, in B-cell cancers to enhance safety. Early results suggest this method reduces the chances of cancer returning and improves safety through gene editing. Previous studies on similar CAR-T therapies have demonstrated long-term remission in some patients but also carry risks like severe side effects. Since this trial is in its early stages (Phase 1/2), the main goal is to determine a safe dose and assess patient tolerance. Detailed safety information is still being collected as researchers work to ensure the treatment is well-tolerated.12345
Why do researchers think this study treatment might be promising for blood cancers?
Most treatments for blood cancers like B-cell malignancies involve traditional chemotherapy or targeted therapies like rituximab. But Allo-QuadCAR01-T works differently, using a novel type of immunotherapy called CAR-T cell therapy. This treatment involves engineering T-cells to specifically recognize and attack cancer cells, offering a potentially more precise and powerful approach. Researchers are excited because it targets multiple cancer markers simultaneously, which may improve effectiveness and reduce the chance of cancer evading treatment. Additionally, being an allogeneic therapy, it could be more readily available compared to traditional autologous CAR-T therapies, potentially speeding up the time to treatment.
What evidence suggests that Allo-QuadCAR01-T might be an effective treatment for B-cell cancers?
Research has shown that CAR-T therapies, which use modified immune cells, have helped 30%–40% of patients with difficult-to-treat large B-cell lymphomas. In this trial, participants will receive Allo-QuadCAR01-T, a new CAR-T therapy targeting two proteins, CD19 and CD20, to reduce the chances of cancer recurrence. This treatment uses donor cells, making it more readily available and potentially less expensive. Gene editing enhances safety by lowering the risk of side effects. Early results suggest that targeting both proteins could improve outcomes for patients with challenging B-cell cancers.12467
Are You a Good Fit for This Trial?
This trial is for adults (18+) with hard-to-treat B-cell blood cancers like non-Hodgkin lymphoma or chronic lymphocytic leukemia who have tried at least two previous treatments. Participants must be able to do daily activities, have healthy organs, and no serious infections or recent transplants.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Chemotherapy
Participants receive lymphodepleting chemotherapy to prepare their body for CAR-T infusion
Treatment
Participants receive a single infusion of Allo-QuadCAR01-T after chemotherapy
Follow-up
Participants are monitored for safety and effectiveness, with primary endpoint assessment at Week 13
Long-term Follow-up
Participants are followed for safety and survival outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Allo-QuadCAR01-T
Trial Overview
The study tests Allo-QuadCAR01-T, a new off-the-shelf CAR-T cell therapy made from donor cells targeting CD19 and CD20 proteins in cancer cells. Patients receive chemotherapy first to prepare their body before getting one infusion of the CAR-T therapy. The main goals are safety and effectiveness.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
AvenCell Therapeutics, Inc.
Lead Sponsor
AvenCell Europe GmbH
Industry Sponsor
Citations
NCT07284433 | Study of Allo-QuadCAR01-T, an ...
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 ...
2.
clinicaltrials.eu
clinicaltrials.eu/trial/a-study-of-allo-quadcar01-t-cell-therapy-for-patients-with-relapsed-or-refractory-b-cell-non-hodgkin-lymphoma-or-chronic-lymphocytic-leukemia/A Study of Allo-QuadCAR01-T Cell Therapy for Patients ...
This study is looking at people who have relapsed or refractory B-cell non-Hodgkin lymphoma or chronic lymphocytic leukaemia.
Treatment outcomes in patients with large B‐cell lymphoma ...
Chimeric antigen receptor (CAR) T‐cell therapy targeting CD19 has shown durable responses in 30%–40% of patients with relapsed/refractory (R/R) ...
Study of Allo-QuadCAR01-T, an Allogeneic CAR-T Targeting ...
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 ...
AVC-203 - Drug Targets, Indications, Patents
AVC-203 is a dual-targeted CD19/CD20 therapy designed to treat B cell malignancies and autoimmune diseases. The therapy incorporates AvenCell's ...
Outcomes of CAR T-cell therapy in high-grade B ... - PMC - NIH
Anti-CD19 chimeric antigen receptor (CAR) T-cell therapy for third-line aggressive large B-cell lymphomas (LBCL) resulted in long-term remission in ≤40% of ...
A single-arm, multicenter, open-label, Phase I/II trial of Allo ...
Phase Ia: To assess the safety and tolerability of different dose levels of Allo-QuadCAR01-T Phase Ib: To assess the safety and tolerability ...
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