Co-administration of CART22-65s and huCART19 for B-ALL

NCT05674175 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 22-02064022CT015
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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 Lineage Lymphoblastic Lymphoma; B-cell Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (2)

• Safety of CART22-65s and huCART19 co-administration

  The safety of the administering CART22-65s and huCART19 will be measured by the monitoring the frequency and severity of adverse events in patients with advanced or refractory B-Cell Acute Lymphoblastic Leukemia or B Cell Lymphoblastic Lymphoma (B-LLy), including those previously treated with cell therapy.

  1 year

• Efficacy of CART22-65s and huCART19 co-administration

  The efficacy of CART22-65s and huCART19 co-administration will be measured by the evaluating the overall response rate in patients with advanced or refractory B cell hematologic malignancies, including those previously treated with cell therapy.

  1 year

Secondary Outcomes (7)

• Manufacturing Feasibility

  5 years

• Anti-tumor response due to CART22-65s and huCART19 co-administration

  Day 28

• Event Free Survival

  1 year

• Relapse Free Survival

  1 year

• Overall Survival

  1 year

Study Arms (2)

Dose Finding Arm

EXPERIMENTAL

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

Biological: Autologous, humanized anti-CD22 CAR T cell therapy (CART22-65s); Biological: Autologous, humanized anti-CD19 CAR T cell therapy (huCART19)

Expansion Arm

EXPERIMENTAL

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).

Biological: Autologous, humanized anti-CD22 CAR T cell therapy (CART22-65s); Biological: Autologous, humanized anti-CD19 CAR T cell therapy (huCART19)

Interventions

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

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

Also known as: huCART19

Dose Finding Arm; Expansion Arm

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

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

Also known as: CART22-65s

Dose Finding Arm; Expansion Arm

Eligibility Criteria

• Age: Up to 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Signed informed consent form
• Patients with documented CD19+ and/or CD22+ ALL/LLy:
• Cohort A: Patients with relapsed or refractory ALL/LLy:
• Cohort B: Patients with poor response to prior B cell directed engineered cell therapy
• Patients with prior or current history of Central Nervous System 3 disease will be eligible if Central Nervous System disease is responsive to therapy
• 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.
• Age 0-29 years
• Adequate organ function
• Adequate performance status defined as Lanksy or Karnofsky performance score ≥50.
• Subjects of reproductive potential must agree to use acceptable birth control methods.

You may not qualify if:

• Active hepatitis B or active hepatitis C
• HIV infection
• Active acute or chronic Graft Vs. Host Disease requiring systemic therapy
• 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.
• 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.
• Pregnant or nursing (lactating) women
• Uncontrolled active infection

Sponsors & Collaborators

• Stephan Grupp MD PhD: lead
• University of Pennsylvania: collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Burkitt Lymphoma

Condition Hierarchy (Ancestors)

Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Regina Myers, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

CART Nurse Navigator

CONTACT

445-942-5891; CARTNurseNavigator@chop.edu

Melissa S. Varghese, M.S.

CONTACT

8455535358; varghesem@chop.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief, Cell Therapy and Transplant Section Director, Susan S. and Stephen P. Kelly Center for Cancer Immunotherapy Medical Director, Cell and Gene Therapy Lab

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: January 6, 2023
• Study Start: January 25, 2023
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)