93 Participants Needed

Dual CAR T Cell Therapy for Acute Lymphoblastic Leukemia

MV
LS
BL
CI
MS
Overseen ByMelissa S. Varghese, B.A.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will evaluate the safety and efficacy of administering two CAR T cell products, huCART19 and CART22-65s, in children with advanced B cell Acute Lymphoblastic Leukemia (B-ALL).

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use systemic steroids or immunosuppressants at the time of cell infusion or collection. It's best to discuss your specific medications with the trial team.

Is dual CAR T cell therapy for acute lymphoblastic leukemia safe?

Dual CAR T cell therapy targeting CD19 and CD22 has shown a favorable safety profile in clinical trials, with no severe side effects like cytokine release syndrome (a severe immune reaction) or neurotoxicity (nerve damage) reported. The treatment was generally well-tolerated in patients, indicating it is generally safe in humans.12345

What makes the dual CAR T cell therapy for acute lymphoblastic leukemia unique?

This treatment is unique because it targets both CD19 and CD22 on leukemia cells, which helps prevent the cancer from escaping treatment by losing one of these markers. This dual targeting approach aims to improve the durability of remission compared to therapies that target only one antigen.34567

What data supports the effectiveness of the dual CAR T cell treatment for acute lymphoblastic leukemia?

Research shows that CAR T cells targeting both CD19 and CD22 have been effective in treating B cell acute lymphoblastic leukemia, with a high remission rate of 86% in a trial. Dual targeting helps prevent treatment failure due to antigen loss, making it a promising approach for relapsed or refractory cases.34789

Who Is on the Research Team?

RM

Regina Myers, MD

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

This trial is for children and young adults (0-29 years) with advanced B cell Acute Lymphoblastic Leukemia who have either not responded well to previous CAR T cell therapy or have relapsed/refractory ALL/LLy. Participants must show CD19+ and/or CD22+ tumor expression, be in good enough health, agree to birth control if applicable, and cannot be pregnant or nursing.

Inclusion Criteria

Signed informed consent form
My leukemia cells test positive for CD19 or CD22.
My leukemia has returned or is not responding to treatment.
See 7 more

Exclusion Criteria

I do not have any ongoing infections that aren't responding to treatment.
I am currently receiving treatment for Graft Vs. Host Disease.
Active hepatitis B or active hepatitis C
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Finding

Phase 1 will evaluate the safety of co-administration of CART22-65s with huCART19 in patients who experienced a disease relapse after prior CAR T cell therapy.

4 weeks
Multiple visits for dose administration and monitoring

Dose Expansion

Phase 2 dose expansion phase where subjects receive the highest safe dose of CART22-65s and huCART19 cells.

4 weeks
Multiple visits for dose administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of anti-tumor response and CAR T cell persistence.

1 year
Regular follow-up visits for monitoring

What Are the Treatments Tested in This Trial?

Interventions

  • CART22-65s
  • huCART19
Trial Overview The study tests the safety and effectiveness of two CAR T cell therapies given together: huCART19 and CART22-65s. These are specialized treatments designed to target leukemia cells in patients whose disease has been difficult to treat with standard options.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Expansion ArmExperimental Treatment2 Interventions
Group II: Dose Finding ArmExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stephan Grupp MD PhD

Lead Sponsor

Trials
5
Recruited
370+

University of Pennsylvania

Collaborator

Trials
2,118
Recruited
45,270,000+

Published Research Related to This Trial

In a phase 1 trial involving 15 pediatric and young adult patients with relapsed or refractory B-ALL, the dual-targeting CAR T-cell therapy AUTO3 demonstrated a favorable safety profile with no severe toxicities reported and an impressive remission rate of 86% one month post-treatment.
Despite the high initial remission rate, the one-year overall survival rate was 60% and event-free survival rate was 32%, indicating that improvements in the persistence of AUTO3 CAR T-cells are necessary to enhance long-term outcomes and prevent relapses.
CAR T cells with dual targeting of CD19 and CD22 in pediatric and young adult patients with relapsed or refractory B cell acute lymphoblastic leukemia: a phase 1 trial.Cordoba, S., Onuoha, S., Thomas, S., et al.[2022]
A patient with relapsed and refractory B cell acute lymphoblastic leukemia (B-ALL) achieved over 14 months of minimal residual disease-negative remission after receiving CAR-T cell therapy targeting both CD19 and CD22.
This case suggests that dual-targeting CAR-T cell therapy may enhance the durability of remission in B-ALL patients, potentially addressing issues of antigen escape seen with single-target therapies.
Haploidentical CD19/CD22 bispecific CAR-T cells induced MRD-negative remission in a patient with relapsed and refractory adult B-ALL after haploidentical hematopoietic stem cell transplantation.Jia, H., Wang, Z., Wang, Y., et al.[2020]
Two adult patients with relapsed EP300-ZNF384-positive B cell acute lymphoblastic leukemia (B-ALL) achieved second remission after receiving tandem CD19/CD22 CAR T-cell therapy, indicating its potential efficacy for this specific leukemia subtype.
Both patients experienced manageable cytokine release syndrome but did not suffer from neurotoxicity, and they maintained remission for 14 and 13 months after undergoing hematopoietic stem cell transplantation, suggesting a promising treatment pathway.
MRD-Negative Remission Induced in EP300-ZNF384 Positive B-ALL Patients by Tandem CD19/CD22 CAR T-Cell Therapy Bridging to Allogeneic Stem Cell Transplantation.Zhang, XY., Dai, HP., Zhang, L., et al.[2021]

Citations

CAR T cells with dual targeting of CD19 and CD22 in pediatric and young adult patients with relapsed or refractory B cell acute lymphoblastic leukemia: a phase 1 trial. [2022]
Haploidentical CD19/CD22 bispecific CAR-T cells induced MRD-negative remission in a patient with relapsed and refractory adult B-ALL after haploidentical hematopoietic stem cell transplantation. [2020]
MRD-Negative Remission Induced in EP300-ZNF384 Positive B-ALL Patients by Tandem CD19/CD22 CAR T-Cell Therapy Bridging to Allogeneic Stem Cell Transplantation. [2021]
Effectiveness and safety of CD22 and CD19 dual-targeting chimeric antigen receptor T-cell therapy in patients with relapsed or refractory B-cell malignancies: A meta-analysis. [2023]
CAR T-cells that target acute B-lineage leukemia irrespective of CD19 expression. [2022]
Coadministration of CD19- and CD22-Directed Chimeric Antigen Receptor T-Cell Therapy in Childhood B-Cell Acute Lymphoblastic Leukemia: A Single-Arm, Multicenter, Phase II Trial. [2023]
Targeting CD19-CD22 Aids Younger Patients with ALL. [2021]
CAR-T Cell Therapy for Acute Lymphoblastic Leukemia: Transforming the Treatment of Relapsed and Refractory Disease. [2019]
CD19/BAFF-R dual-targeted CAR T cells for the treatment of mixed antigen-negative variants of acute lymphoblastic leukemia. [2023]
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