Acute Lymphoblastic LeukemiaPhase 1NCT06777979
CD19-CD22-Bispecific Chimeric Antigen Receptor (CAR) T Cell Therapy for Pediatric Patients With Acute Lymphoblastic Leukemia
A Phase 1 study testing Fludarabine, Cyclophosphamide and Mesna in people with Acute Lymphoblastic Leukemia and Recurrent Acute Lymphoblastic Leukemia, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
This study is a phase I study designed to evaluate the safety of CD19-CD22-CAR T cells. Primary Objective: To determine the safety profile and propose the recommended phase 2 dose (RP2D) of autologous CD19-CD22-CAR T cells in patients ≤ 21 years of age with recurrent/refractory CD19- and/or CD22-positive leukemia. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Recurrent Acute Lymphoblastic Leukemia, Recurrent B Acute Lymphoblastic Leukemia
- What is being tested?
- Fludarabine, Cyclophosphamide and Mesna
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2025to Jan 2031
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age <21 years old
- Relapsed/refractory CD19- and/or CD22-positive acute leukemia defined as:
- CD19 and/or CD22-positivity confirmed within 2 months and after receipt of any CD19 or CD22-directed therapy
- Second or greater relapse
- Any relapse after allogeneic HCT
- Refractory disease (primary or in relapse) despite therapy designed to induce remission
Show all 27Show fewer
- Estimated life expectancy of > 12 weeks
- Karnofsky or Lansky (age-dependent) performance score ≥50 (Appendix A)
- For females of childbearing age:
- Not lactating with intent to breastfeed
- Not pregnant with negative serum or urine pregnancy test within 7 days prior to enrollment
- Age < 21 years old
- Detectable disease in the bone marrow
- Estimated life expectancy of > 8 weeks
- Karnofsky or Lansky (age-dependent) performance score > 50 (Appendix A)
- Adequate cardiac function defined as left ventricular ejection fraction >40%, or shortening fraction > 25%
- EKG without evidence of clinically significant arrhythmia
- Adequate renal function defined as creatinine clearance or radioisotope GFR >50 mL/min/1.73m2 (GFR >40 mL/min/1.73m2 if <2 years of age)
- Adequate pulmonary function defined as forced vital capacity (FVC) >50% of predicted value; or pulse oximetry >92% on room air
- Total bilirubin < 3 times the upper limit of normal for age, except in subjects with Gilbert's syndrome
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 5 times the upper limit of normal for age
- Has recovered from all NCI CTAE grade III-IV, non-hematologic acute toxicities from prior therapy
- Prior to planned CAR T cell infusion, patients with a history of prior allogeneicHCT must be at least 3 months from HCT, have no evidence of acute GVHD, and have not received a donor lymphocyte infusion (DLI) within the 28 daysprior to planned infusion
- For females of childbearing age:
- Not lactating with intent to breastfeed
- Not pregnant with negative serum or urine pregnancy test within 7 days prior to enrollment
- If sexually active, agreement to use birth control until 3 months after T cell infusion. Male partners should use a condom.
Who cannot join
- Known primary immunodeficiency
- Known HIV positivity
- Known contraindication to receiving protocol defined lymphodepleting
- chemotherapy regimen
- History of hypersensitivity reaction to murine protein-containing products
- Treatment Eligibility
Show all 14Show fewer
- Known primary immunodeficiency
- Known HIV positivity
- Known contraindication to receiving protocol defined lymphodepleting
- chemotherapy regimen
- History of hypersensitivity reactions to murine protein-containing products
- Severe, uncontrolled bacterial, viral or fungal infection
- Active CNS-3 disease
- Evidence of active, uncontrolled neurologic disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Rebecca Epperly, MD, 888-226-4343, referralinfo@stjude.org
About this study
Official title: CD19-CD22-Bispecific Chimeric Antigen Receptor (CAR) T Cell Therapy for Pediatric Patients With Acute Lymphoblastic Leukemia (1922CAR)
This study is a phase I study designed to evaluate the safety of CD19-CD22-CAR T cells.
Primary Objective:
To determine the safety profile and propose the recommended phase 2 dose (RP2D) of autologous CD19-CD22-CAR T cells in patients ≤ 21 years of age with recurrent/refractory CD19- and/or CD22-positive leukemia.
Secondary Objective:
To evaluate the anti-leukemic activity of CD19-CD22-CAR T cells.
Read the detailed description
Treatment will include a single course of lymphodepleting chemotherapy (fludarabine/cyclophosphamide) followed by CAR T cell infusion. CAR T cell dose will be determined by the protocol-defined dose escalation scheme, based on the number of CAR+ T cells and participant weight.
- Conditions
- Acute Lymphoblastic Leukemia, Recurrent Acute Lymphoblastic Leukemia, Recurrent B Acute Lymphoblastic Leukemia
- Being tested
- Fludarabine, Cyclophosphamide, Mesna, CD19-CD22 CAR T cell infusion
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FludarabineDrug
IV
CyclophosphamideDrug
IV
MesnaDrug
IV
CD19-CD22 CAR T cell infusionDevice
CAR T cell infusion will be given intravenously, either centrally or peripherally.
| Study group | Role | What they receive |
|---|---|---|
| CD19-CD22-CAR T cell therapy | Experimental | This study has two parts:
Collection and Manufacturing Phase - Patients will have white blood cells collected in the St. Jude Blood Donor Center through a procedure called apheresis, or your doctors may use a previously collected frozen product. The collected cells will be engineered to improve their ability to recognize and kill cancer cells. The final cell product is referred to as the CD19-CD22 CAR T cells.
Treatment Phase - Eligible patients will receive chemotherapy before receiving the CAR T cells. Receives: Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Mesna; Device: CD19-CD22 CAR T cell infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended phase 2 dose (RP2D) of CD19-CD22-CAR T cells
Phase I design to determine the RP2D of CD19-CD22-CAR T cells. Two (2) dose levels will be evaluated (1x106 and 3x106cells/kg).
Measured: up to 4 weeks after CD19-CD22-CAR T-cell infusion
Incidence of adverse events
Will be assessed and graded using the CTCAE v5.0, with the exception of CRS and ICANS, which will be graded according to ASTCT Consensus Guidelines. Adverse events will be summarized descriptively and dose limiting toxicity (DLT) rate will be reported.
Measured: up to 4 weeks after CD19-CD22-CAR T-cell infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start28 Apr 2025
- Primary completionJan 2030 (estimated)
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca Epperly, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777979
- Sponsor's protocol ID
- 1922CAR
- Other IDs
- NCI-2024-10103
- Status last verified
- May 2026
- First submitted
- 10 Jan 2025
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No