CD22 CAR T-cells for Acute Lymphoblastic Leukemia

Overseen By Sara K Silbert, M.D.

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: Investigational agents

Disqualifiers: CNS involvement, Active GVHD, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for acute lymphoblastic leukemia (ALL), a type of blood cancer. The researchers aim to determine if a modified immune cell therapy, called CD22 CAR T-cell therapy, can prevent cancer recurrence after initial treatment. This is crucial because many patients experience a relapse after the first CAR T-cell therapy targeting a different marker, CD19. The trial seeks participants who have had ALL, are currently cancer-free after CD19 CAR T-cell treatment, and have not received a stem cell transplant. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to potentially groundbreaking advancements in ALL treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but if you are on maintenance therapy like vincristine or a tyrosine kinase inhibitor, you will need to stop it at least one week before certain procedures. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that CD22 CAR T-cell therapy is likely to be safe for humans?

Research has shown that CD22 CAR T-cell therapy has been tested in children and adults with B-cell acute lymphoblastic leukemia (ALL) who relapsed after CD19-targeted treatment. In these studies, CD22 CAR T-cells have shown promise in extending remission periods. However, like many treatments, they can cause side effects.

Previous studies have found that CD22 CAR T-cells are generally well-tolerated. Some patients experienced mild to moderate side effects, such as fever or tiredness. More serious side effects, though rare, have been reported, including cytokine release syndrome (a strong immune reaction) and neurotoxicity (nerve damage). Most side effects were manageable with medical care.

The safety of CD22 CAR T-cells remains under study, but trials have used the treatment with careful monitoring for adverse effects. This ongoing research helps ensure that doctors can manage side effects effectively. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for acute lymphoblastic leukemia (ALL) involve chemotherapy and bone marrow transplants. But CD22 CAR T-cells work differently, targeting the CD22 protein on the surface of leukemia cells. This approach is unique because it uses the patient's own T-cells, which are genetically modified to better recognize and attack cancer cells. Researchers are excited about this treatment because it could offer a more personalized and potentially more effective option for patients, especially those who have not responded well to standard therapies. Additionally, CAR T-cell therapy has shown promise in rapidly reducing cancer cells, which could lead to quicker improvements for patients.

What evidence suggests that CD22 CAR T-cell therapy might be an effective treatment for acute lymphoblastic leukemia?

Research has shown that CD22 CAR T-cell therapy might be a promising option for people with acute lymphoblastic leukemia (ALL) who have relapsed after CD19 CAR T-cell treatment. This trial will investigate CD22 CAR T-cells, administered to participants following lymphodepleting chemotherapy. Studies suggest that targeting the CD22 marker, instead of CD19, may help delay leukemia's return. Some patients have responded well to CD22 CAR T-cells, experiencing fewer cancer cells and longer periods without the disease. Early results indicate that this approach could offer new hope for those whose cancer has returned. The therapy is still under study to confirm these findings, but the initial results are encouraging. ^{1 2 3 4 5}

Who Is on the Research Team?

Sara K Silbert, M.D.

Principal Investigator

National Cancer Institute (NCI)

Are You a Good Fit for This Trial?

This trial is for people aged 3 to 65 with B-cell Acute Lymphoblastic Leukemia (ALL) who've had CD19 CAR T-cell treatment and are currently cancer-free. They shouldn't be planning a stem cell transplant, must have good organ function, and no ongoing complications from previous treatments.

Inclusion Criteria

I am between 3 and 65 years old.

My cancer cells showed CD19 and CD22 at diagnosis or relapse.

My cancer is in remission and tests show no minimal residual disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Leukapheresis and Cell Preparation

Participants undergo leukapheresis to collect T cells, which are then modified in a lab to create CD22 CAR T-cell therapy

1 week

1 visit (in-person)

Lymphodepleting Chemotherapy

Participants receive a 4-day lymphodepleting preparative regimen including fludarabine and cyclophosphamide

1 week

4 visits (in-person)

CD22 CAR T-cell Infusion

Participants receive their modified T cells through a tube inserted into a vein

1 day

1 visit (in-person)

Short-term Safety Monitoring

Participants are monitored for short-term safety, including CRS and ICANS incidence and severity

4 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including long-term safety and RFS

2 years

Regular visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• CD22 CAR-transduced T cells

Trial Overview

The study tests if CD22 CAR T-cells can extend remission in ALL patients post-CD19 CAR therapy. It involves leukapheresis to collect T cells, lab modification of these cells, drug preparation, then infusion of the modified T cells back into the patient.

How Is the Trial Designed?

Group I: 1 Experimental Treatment 3 Interventions

Lymphodepleting chemotherapy followed by CD22 CAR T-cells

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07328503

NCT07328503 | CD22 CAR T-cells to Extend Remission ...

Despite impressive cure rates in children and young adults with B-cell acute lymphoblastic leukemia (B-ALL) generally, patients with relapsed/ ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12007026/

CD22-targeted chimeric antigen receptor-modified T cells for ...

CD22-targeted chimeric antigen receptor-modified T cells for children and adults with relapse of B-cell acute lymphoblastic leukemia after CD19-directed ...

3.

isct-cytotherapy.org

isct-cytotherapy.org/article/S1465-3249(25)00850-3/fulltext

Outcomes following CD22 CAR T-cells in B-ALL: a tale of ...

In summary, while efficacy across both platforms was comparable, lower inflammatory markers in those who received Prodigy manufactured CAR T- ...

4.

ashpublications.org

ashpublications.org/blood/article/143/2/118/497728/CD19-CD22-targeting-with-cotransduced-CAR-T-cells

CD19/CD22 targeting with cotransduced CAR T cells to ...

CD19 chimeric antigen receptor (CAR) T-cell therapy has transformed relapsed/refractory B-cell acute lymphoblastic leukemia (ALL) outcomes.

5.

thelancet.com

thelancet.com/journals/ebiom/article/PIIS2352-3964(25)00316-0/fulltext

Tandem CD19/CD22 CAR T-cells as potential therapy for ...

Chimeric antigen receptor (CAR) T-cells targeting CD19 have shown impressive outcomes in refractory/relapsed B-cell acute lymphoblastic ...