Study: Chimerism seen as successful in living-related kidney donors
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Key takeaways:
- A phase 3 clinical trial showed that chimerism was successful in preventing organ rejection in patients with living-related kidney donors.
- The treatment was well tolerated with no reported deaths.
PHILADELPHIA — Results from a phase 3 clinical trial show that an investigational cellular product can successfully induce tolerance in recipients of human leukocyte antigens-matched living kidney donors.
The trial tested use of MDR-101 (Medeor Acquisition Corp.) vs. the standard of care — immunosuppressive therapy — to prevent allograft failure in patients receiving a kidney transplant.
“Kidney transplantation requires life-long immunosuppressive therapies and is associated with side effects and toxicities,” Daniel C. Brennan, MD, said during a late-breaking clinical trials session at ASN Kidney Week. “It is associated with infection and malignancy and is expensive.
“MDR-101 is an investigational allogenic cellular product intended to induce mixed chimerism and immune tolerance to allow for elimination of all [immunosuppressive] drugs, while preserving transplant kidney function and averting transplant kidney rejection.”
Seventeen transplant centers in the U.S. and one in Canada participated in the trial.
Eligible patients included adult recipients of a first-time kidney transplant from an human leukocyte antigens (HLA)-matched related living donor. Patients were randomized to either an investigational arm using MDR-101 (n=20) or control arm (n=10). Patients in the investigational arm were transplanted and received total lymphoid irradiation (10 fractions) and initiation of calcineurin inhibitors, followed by an MDR-101 infusion, Brennan said.
“Steroids were withdrawn by the tenth day, and mycophenolate mofetil was given [on day 11 through day 39]. Calcineurin inhibitor monotherapy continued until [day 180] and tapered to complete withdrawal 1-year post-transplant if donor hematopoietic mixed chimerism was [greater than or equal to] 5%, and no rejection, Brennan said.
Of the 20 patients who received the infusion of MDR-101, 12 of 19 patients have remained off immunosuppressive drugs for more than 2 years, Brennan told attendees. No deaths were reported in either group.
“MDR-101 can safely achieve donor mixed chimerism and operational immune tolerance with complete elimination of all [immunosuppressive drugs] with no death, graft loss or [graft-versus-host disease] in HLA-matched [living donor] recipients,” Brennan said. “The proportion of patients experiencing any adverse event and a severe adverse event (SAE), was similar in the treated and control groups.
“The anticipated treatment success of at least 48% [immunosuppressive drug-free] for at least 24 months was met,” Brennan said.
Reference s :
Brennan DC, et al. MDR-101-MLK update – Operational immune tolerance achieved in living related HLA-matched kidney transplant recipients. Presented at: ASN Kidney Week; Nov. 1-5, 2023; Philadelphia.
Disclosures: Brennan reports being a consultant for Medeor Acquisition Corp. The study was supported by the California Institute of Regenerative Medicine.
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