Recruiting
Phase 1
Phase 2

CART22-65s & huCART19

Sponsor:

Stephan Grupp MD PhD

Code:

NCT05674175

Conditions

B-cell Acute Lymphoblastic Leukemia

B Lineage Lymphoblastic Lymphoma

Eligibility Criteria

Sex: All

Age: 0 - 29

Healthy Volunteers: Not accepted

Interventions

Autologous, humanized anti-CD22 CAR T cell therapy (CART22-65s)

Autologous, humanized anti-CD19 CAR T cell therapy (huCART19)

Study Details

Brief summary:

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).

Conditions

B-cell Acute Lymphoblastic Leukemia

B Lineage Lymphoblastic Lymphoma

Study ID

NCT05674175

Start date

Jan 25, 2023

Status verified date

Mar, 2026

Completion date

Jul 1, 2029

Anticipated

Primary completion date

Jul 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 29

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Signed informed consent form
2. Patients with documented CD19+ and/or CD22+ ALL/LLy:

1. Cohort A: Patients with relapsed or refractory ALL/LLy:
2. Cohort B: Patients with poor response to prior B cell directed engineered cell therapy
3. Patients with prior or current history of Central Nervous System 3 disease will be eligible if Central Nervous System disease is responsive to therapy
4. Documentation of CD19 and/or CD22 tumor expression in bone marrow, peripheral blood, Cerebrospinal fluid, or tumor tissue by flow cytometry at the time of last detectable disease. If the patient has experienced a relapse after CD19-directed and/or CD22-directed therapy, flow cytometry should be evaluated after this therapy to demonstrate CD19 and/or CD22 expression.
5. Age 0-29 years
6. Adequate organ function
7. Adequate performance status defined as Lanksy or Karnofsky performance score ≥50.
8. Subjects of reproductive potential must agree to use acceptable birth control methods.

Exclusion Criteria:

1. Active hepatitis B or active hepatitis C
2. HIV infection
3. Active acute or chronic Graft Vs. Host Disease requiring systemic therapy
4. Concurrent use of systemic steroids or immunosuppression at the time of cell infusion or cell collection, or a condition, in the treating physician's opinion, that is likely to require steroid therapy or immunosuppression during collection or after infusion. Steroids for disease treatment at times other than cell collection or at the time of infusion are permitted. Use of physiologic replacement hydrocortisone or inhaled steroids is permitted as well.
5. Central nervous system disease that is progressive on therapy, or with Central nervous system parenchymal lesions that might increase the risk of central nervous system toxicity.
6. Pregnant or nursing (lactating) women
7. Uncontrolled active infection

Study Design

Enrollment

93 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Finding Arm

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. There is no planned dose escalation but a dose-deescalation will be made based on the incidence of Dose Limiting Toxicities

experimental: Expansion Arm

If at least one dose level of phase 1 is determined to be safe, the phase 2 dose expansion phase of the trial will be opened to enrollment. Subjects will receive the highest dose of CART 22-65s and huCART19 cells that were determined to be safe. 2 cohorts are planned: Cohort A (relapsed/refractory, CAR T cell naïve) \& Cohort B (prior treatment with a prior CAR T cell product).

Interventions

Autologous, humanized anti-CD22 CAR T cell therapy (CART22-65s)

CART22-65s are autologous T cells that have been engineered to express an extracellular single chain antibody (scFv) with specificity for CD22 linked to an intracellular signaling molecule consisting of a tandem signaling domain comprised of the TCRζ signaling module linked to the 4-1BB costimulatory domain

Autologous, humanized anti-CD19 CAR T cell therapy (huCART19)

HuCART19 cells are autologous T cells that have been engineered to express an extracellular single chain antibody (scFv) with specificity for CD19 linked to an intracellular signaling molecule consisting of a tandem signaling domain comprised of the TCRζ signaling module linked to the 4-1BB costimulatory domain

Primary outcome measure

  • Safety of CART22-65s and huCART19 co-administration [ Time Frame: 1 year ]
  • Efficacy of CART22-65s and huCART19 co-administration [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Locations

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

More Information

Sponsor

Stephan Grupp MD PhD

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Stephan Grupp MD PhD on 2026-03-27.