CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT05442515
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Acute Lymphoblastic Leukemia
  • Acute Lymphocytic Leukemia
  • Acute Lymphoid Leukemia
  • B-All
  • B-Cell Leukemia
  • B-Cell Lymphoma
  • B-NHL
  • B-Non Hodgkin Lymphoma
  • B-precursor ALL
  • Leukemia, Lymphocytic, B Cell
  • Lymphoma, Non-Hodgkin

Eligibility Criteria

Sex
ALL
Age
3 Years - 39 Years
Healthy Volunteers
Not accepted

Interventions

  • CD19/CD22-CAR-transduced T cells — BIOLOGICAL
    CD19/CD22-CAR-transduced T cells on D0 after lymphodepleting preparative regimen
  • cyclophosphamide — DRUG
    Cyclophosphamide will be diluted in an appropriate solution and infused over one hour. The dose will be based on the patient s body weight, at 900 mg/m2/dose after fludarabine infusion.
  • fludarabine — DRUG
    Fludarabine is administered as an IV infusion in an appropriate solution over 30 minutes. To prevent undue toxicity the dose will be based on BSA (25 mg/m2/dose).

Study Details

Background: Acute lymphoblastic leukemia (ALL) is the most common cancer in children. About 90% of children and young adults who are treated for ALL can now be cured. But if the disease comes back, the survival rate drops to less than 50%. Better treatments are needed for ALL relapses. Objective: To test chimeric antigen receptor (CAR) therapy. CARs are genetically modified cells created from each patient s own blood cells. his trial will use a new type of CAR T-cell that is targeting both CD19 and CD22 at the same time. CD19 and CD22 are proteins found on the surface of most types of ALL. Eligibility: People aged 3 to 39 with ALL or related B-cell lymphoma that has not been cured by standard therapy. Design: Participants will be screened. This will include: Physical exam Blood and urine tests Tests of their lung and heart function Imaging scans Bone marrow biopsy. A large needle will be inserted into the body to draw some tissues from the interior of a bone. Lumbar puncture. A needle will be inserted into the lower back to draw fluid from the area around the spinal cord. Participants will undergo apheresis. Their blood will circulate through a machine that separates blood into different parts. The portion containing T cells will be collected; the remaining cells and fluids will be returned to the body. The T cells will be changed in a laboratory to make them better at fighting cancer cells. Participants will receive chemotherapy starting 4 or 5 days before the CAR treatment. Participants will be admitted to the hospital. Their own modified T cells will be returned to their body. Participants will visit the clinic 2 times a week for 28 days after treatment. Follow-up will continue for 15 years....

Key Dates

Start date
Dec 28, 2022
Status verified
May 2026
Primary completion
Jul 1, 2027
Completion
Jul 1, 2029

Study Design

Enrollment
130 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1/Phase I Dose Escalation-with standard LD - CLOSED
    CD19/CD22-CAR-transduced T cells at escalating dose + standard LD (75 mg/mg2 Flu+ 900 mg/m2 Cy)
  • Experimental: 1b/Phase 1 Dose Escalation - low disease burden
    CD19/CD22-CAR-transduced T cells
  • Experimental: 2/Phase I Dose Escalation- with intensified LD - CLOSED
    CD19/CD22-CAR-transduced T cells + standard LD (120 mg/m2 Flu + 1200 mg/m2 Cy)
  • Experimental: 2b/Phase 1 Dose Escalation - high disease burden
    CD19/CD22-CAR-transduced T cells
  • Experimental: 3/Phase II Dose Expansion- with low disease burden - CLOSED
    CD19/CD22-CAR-transduced T cells at MTD/or highest dose administered with LD
  • Experimental: 3b Phase I Dose Escalation: Either CD19 or CD22 positivity
    CD19/CD22-CAR-transduced T cells
  • Experimental: 4/Phase II Dose Expansion- with high disease burden - CLOSED
    CD19/CD22-CAR-transduced T cells at MTD/or highest dose administered with LD regimen #2
  • Experimental: 4b Phase II Dose Expansion in B-ALL/B-LBL
    CD19/CD22-CAR-transduced T cells at RP2D
  • No Intervention: A/Pre-treatment
    All participants enrolled on the study prior to treatment initiation.

Primary Outcome Measure

Safety [ Time Frame: 30 days post CAR T infusion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office
888-624-1937

Find similar trials in Bethesda, MD

By condition
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By research site
National Institutes of Health Clinical Center· Bethesda, MD

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