NCT04029038

Modified Immune Cells (CD19-CD22 CAR T Cells) in Treating Patients With Recurrent or Refractory CD19 Positive, CD22 Positive Leukemia or Lymphoma

Withdrawn Phase 1, PHASE2 Last updated 21 August 2023

What this trial tests

Phase 1, PHASE2 trial testing Autologous CD19/CD22 Chimeric Antigen Receptor T-cells in CD19 Positive. Withdrawn.

Timeline

15 May 2019

Primary endpoint
16 November 2022

16 November 2022

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	Phase 1, PHASE2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Start date	15 May 2019
Primary completion	16 November 2022
Estimated completion	16 November 2022
Sites	1 location across United States

Drugs / interventions tested

• Autologous CD19/CD22 Chimeric Antigen Receptor T-cells — full drug profile →
• Cyclophosphamide (cyclophosphamide) — full drug profile →
• Fludarabine (FLUDARABINE) — full drug profile →

Conditions studied

• CD19 Positive — all drugs for CD19 Positive →
• CD22 Positive — all drugs for CD22 Positive →
• Minimal Residual Disease — all drugs for Minimal Residual Disease →
• Progressive Disease — all drugs for Progressive Disease →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

Adults 6 Months to 70, any sex, with CD19 Positive or CD22 Positive. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase I/II trial studies the side effects and best dose of modified immune cells called CD19-CD22 chimeric antigen receptor (CAR) T cells in treating patients with CD19 positive(+), CD22+ B-acute lymphoblastic leukemia, chronic lymphocytic leukemia, or non-Hodgkin's lymphoma that has come back (recurrent) or does not respond to treatment (refractory). T-cells are collected from the patient and genetic materials called "chimeric antigen receptors (CAR)" are transferred to the collected T-cells. The CAR T-cells are then infused back to the patient's body. Giving CD19- CD22 CAR T cells after chemotherapy may help to control the disease.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. CAR-T cell combination therapy: the next revolution in cancer treatment.
   Al-Haideri M, Tondok SB, Safa SH, Maleki AH, et al · · 2022 · cited 106× · PMID 36419058 · DOI 10.1186/s12935-022-02778-6
2. Administration of B7-H3 targeted chimeric antigen receptor-T cells induce regression of glioblastoma.
   Tang X, Wang Y, Huang J, Zhang Z, et al · · 2021 · cited 83× · PMID 33767145 · DOI 10.1038/s41392-021-00505-7
3. A deep insight into CRISPR/Cas9 application in CAR-T cell-based tumor immunotherapies.
   Razeghian E, Nasution MKM, Rahman HS, Gardanova ZR, et al · · 2021 · cited 80× · PMID 34321099 · DOI 10.1186/s13287-021-02510-7
4. Immune Dysfunctions and Immune-Based Therapeutic Interventions in Chronic Lymphocytic Leukemia.
   Griggio V, Perutelli F, Salvetti C, Boccellato E, et al · · 2020 · cited 54× · PMID 33312177 · DOI 10.3389/fimmu.2020.594556
5. Targeting CD22 for the Treatment of B-Cell Malignancies.
   Shah NN, Sokol L. · · 2021 · cited 42× · PMID 34262884 · DOI 10.2147/itt.s288546
6. Next-generation chimeric antigen receptors for T- and natural killer-cell therapies against cancer.
   Li Y, Rezvani K, Rafei H. · · 2023 · cited 29× · PMID 37548050 · DOI 10.1111/imr.13255
7. Development of CAR T Cell Therapy in Children-A Comprehensive Overview.
   Boettcher M, Joechner A, Li Z, Yang SF, et al · · 2022 · cited 23× · PMID 35456250 · DOI 10.3390/jcm11082158
8. Advances in immunotherapeutic targets for childhood cancers: A focus on glypican-2 and B7-H3.
   Li N, Spetz MR, Li D, Ho M. · · 2021 · cited 15× · PMID 33992682 · DOI 10.1016/j.pharmthera.2021.107892