NCT03579927

CAR.CD19-CD28-zeta-2A-iCasp9-IL15-Transduced Cord Blood NK Cells, High-Dose Chemotherapy, and Stem Cell Transplant in Treating Participants With B-cell Lymphoma

Withdrawn Phase 1, PHASE2 Last updated 29 January 2020

What this trial tests

Phase 1, PHASE2 trial testing Autologous Hematopoietic Stem Cell Transplantation in CD19 Positive. Withdrawn.

Timeline

3 October 2019

Primary endpoint
3 October 2019

3 October 2019

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Status	Withdrawn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	3 October 2019
Primary completion	3 October 2019
Estimated completion	3 October 2019
Sites	1 location across United States

Drugs / interventions tested

• Autologous Hematopoietic Stem Cell Transplantation
• Carmustine (CARMUSTINE) — full drug profile →
• Cytarabine — full drug profile →
• Etoposide (etoposide) — full drug profile →
• Filgrastim
• Melphalan
• Rituximab — full drug profile →
• Umbilical Cord Blood-derived Natural Killer Cells — full drug profile →

Conditions studied

• CD19 Positive — all drugs for CD19 Positive →
• Mantle Cell Lymphoma — all drugs for Mantle Cell Lymphoma →
• Recurrent Diffuse Large B-Cell Lymphoma — all drugs for Recurrent Diffuse Large B-Cell Lymphoma →
• Recurrent Follicular Lymphoma — all drugs for Recurrent Follicular Lymphoma →

Sponsor

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

Who can join

Adults 18 to 70, any sex, with CD19 Positive or Mantle Cell Lymphoma. 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 chimeric antigen receptor (CAR).CD19-CD28-zeta-2A-iCasp9-IL15-transduced cord blood NK cells when given together with high-dose chemotherapy and stem cell transplant and to see how well they work in treating participants with B-cell lymphoma. Cord blood-derived CAR-NK cells may react against the B-cell lymphoma cells in the body, which may help to control the disease. Giving chemotherapy before a stem cell transplant may help kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.

Publications & conference data

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

1. NK cell-based cancer immunotherapy: from basic biology to clinical development.
   Liu S, Galat V, Galat Y, Lee YKA, et al · · 2021 · cited 504× · PMID 33407739 · DOI 10.1186/s13045-020-01014-w
2. Cancer Immunotherapy Based on Natural Killer Cells: Current Progress and New Opportunities.
   Hu W, Wang G, Huang D, Sui M, et al · · 2019 · cited 279× · PMID 31214177 · DOI 10.3389/fimmu.2019.01205
3. Natural killer cell homing and trafficking in tissues and tumors: from biology to application.
   Ran GH, Lin YQ, Tian L, Zhang T, et al · · 2022 · cited 207× · PMID 35768424 · DOI 10.1038/s41392-022-01058-z
4. Natural Killer Cells as Allogeneic Effectors in Adoptive Cancer Immunotherapy.
   Lupo KB, Matosevic S. · · 2019 · cited 146× · PMID 31163679 · DOI 10.3390/cancers11060769
5. CAR-NK cells for cancer immunotherapy: from bench to bedside.
   Zhang L, Meng Y, Feng X, Han Z. · · 2022 · cited 144× · PMID 35303962 · DOI 10.1186/s40364-022-00364-6
6. Natural killer cells: a promising immunotherapy for cancer.
   Chu J, Gao F, Yan M, Zhao S, et al · · 2022 · cited 140× · PMID 35606854 · DOI 10.1186/s12967-022-03437-0
7. Chimeric antigen receptor-engineered natural killer cells for cancer immunotherapy.
   Yilmaz A, Cui H, Caligiuri MA, Yu J. · · 2020 · cited 139× · PMID 33287875 · DOI 10.1186/s13045-020-00998-9
8. Natural killer cells in clinical development as non-engineered, engineered, and combination therapies.
   Lamers-Kok N, Panella D, Georgoudaki AM, Liu H, et al · · 2022 · cited 125× · PMID 36348457 · DOI 10.1186/s13045-022-01382-5