NCT01217203: KIRIMID

Multicenter Phase I Study on the Safety, Anti-tumor Activity and Pharmacology of IPH2101, a Human Monoclonal Anti-KIR, Combined With Lenalidomide in Patients With Multiple Myeloma Experiencing a First or Second Relapse

Completed Phase 1 Last updated 27 February 2014

What this trial tests

Phase 1 trial testing IPH2101 combined to lenalidomide in Patients With Multiple Myeloma Experiencing a in 15 participants. Completed in 1 February 2014.

Timeline

1 September 2010

Primary endpoint
1 December 2013

1 February 2014

Quick facts

Lead sponsor	Innate Pharma
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	1 September 2010
Primary completion	1 December 2013
Estimated completion	1 February 2014
Sites	6 locations across United States

Drugs / interventions tested

• IPH2101 combined to lenalidomide — full drug profile →

Conditions studied

• Patients With Multiple Myeloma Experiencing a — all drugs for Patients With Multiple Myeloma Experiencing a →
• First or Second Relapse — all drugs for First or Second Relapse →

Sponsor

Innate Pharma — full company profile →

Who can join

Adults 18 to 80, any sex, with Patients With Multiple Myeloma Experiencing a or First or Second Relapse. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• number of patients with Dose Limiting Toxicity (DLT) at each dose level
  Time frame: 1 year
  safety of IPH2101 combined with lenalidomide at different dose levels.

Sponsor's own description

The primary objective of the clinical study is to evaluate, in patients who experience a first or second relapse of their multiple myeloma, the safety of escalating doses of IPH2101 combined with lenalidomide

Publications & conference data

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

1. Natural killer cells in cancer biology and therapy.
   Wu SY, Fu T, Jiang YZ, Shao ZM. · · 2020 · cited 640× · PMID 32762681 · DOI 10.1186/s12943-020-01238-x
2. NK Cell-Based Immune Checkpoint Inhibition.
   Khan M, Arooj S, Wang H. · · 2020 · cited 296× · PMID 32117298 · DOI 10.3389/fimmu.2020.00167
3. Anti-KIR antibody enhancement of anti-lymphoma activity of natural killer cells as monotherapy and in combination with anti-CD20 antibodies.
   Kohrt HE, Thielens A, Marabelle A, Sagiv-Barfi I, et al · · 2014 · cited 229× · PMID 24326534 · DOI 10.1182/blood-2013-08-519199
4. Developmental and Functional Control of Natural Killer Cells by Cytokines.
   Wu Y, Tian Z, Wei H. · · 2017 · cited 204× · PMID 28824650 · DOI 10.3389/fimmu.2017.00930
5. The Application of Natural Killer Cell Immunotherapy for the Treatment of Cancer.
   Rezvani K, Rouce RH. · · 2015 · cited 202× · PMID 26635792 · DOI 10.3389/fimmu.2015.00578
6. Exploiting innate immunity for cancer immunotherapy.
   Yi M, Li T, Niu M, Mei Q, et al · · 2023 · cited 151× · PMID 38008741 · DOI 10.1186/s12943-023-01885-w
7. A Phase I Trial of the Anti-KIR Antibody IPH2101 and Lenalidomide in Patients with Relapsed/Refractory Multiple Myeloma.
   Benson DM, Cohen AD, Jagannath S, Munshi NC, et al · · 2015 · cited 143× · PMID 25999435 · DOI 10.1158/1078-0432.ccr-15-0304
8. Targeting NK Cell Checkpoint Receptors or Molecules for Cancer Immunotherapy.
   Zhang C, Liu Y. · · 2020 · cited 75× · PMID 32714324 · DOI 10.3389/fimmu.2020.01295