Kidney TransplantationPhase 2NCT04803006
A Study of TCD601 in the Induction of Tolerance in Renal Transplantation (PANORAMA)
A Phase 2 study testing TCD601 in people with Kidney Transplantation, run by ITB-Med LLC at 1 site in United States.
Trial summary
The purpose of this study is to determine the optimal regimen for the use of siplizumab, a human anti-CD2 antibody, combined with donor bone marrow cells and non-myeloablative conditioning, for tolerance induction in living donor renal transplantation Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- TCD601
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2023to 30 Oct 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand the study requirements and provide written informed consent before any study assessment is performed
- Male or female patients ≥ 18 to 65 years of age
- Recipient of a first renal transplant from a non-HLA identical, but at least haploidentical, ABO compatible living donor
Who cannot join
- Women of child-bearing potential, unless willing to comply with the use of highly effective methods of contraception as defined by the protocol
- A history of cancer other than basal cell carcinoma of the skin or carcinoma in situ of the cervix
- Recipient with anti-HLA donor-specific antibody (DSA)
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: An Adaptive, Regimen Finding, Safety and Tolerability Study of TCD601 (Siplizumab), a Human Anti-CD2 Antibody, Combined With Donor Bone Marrow Cell Infusion and Non-myeloablative Conditioning, for Tolerance Induction in Living Donor Renal Transplantation
The purpose of this study is to determine the optimal regimen for the use of siplizumab, a human anti-CD2 antibody, combined with donor bone marrow cells and non-myeloablative conditioning, for tolerance induction in living donor renal transplantation
- Conditions
- Kidney Transplantation
- Being tested
- TCD601
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCD601Biological
Investigational Product
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | TCD601administered with non-myeloablative conditioning and standard of care immunosuppression Receives: Biological: TCD601 |
| Arm 2 | Experimental | TCD601administered with non-myeloablative conditioning and standard of care immunosuppression Receives: Biological: TCD601 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Proportion of Patients Off Immunosuppression With Good Safety and Tolerability
The proportion of patients off immunosuppression with good safety and tolerability at 24 months assessed by immunosuppression dosing; Serum creatinine (estimated glomerular filtration rate [eGFR]); Incidents of Chimeric Transition Syndrome (CTS) and biopsy proven acute rejection (BPAR); Renal biopsy
Measured: 24 months
Secondary outcomes (2)
The Incidence of de Novo Donor-specific Antibody
Measured: 24 months
The Incidence of Biopsy Proven Acute Rejection, Death and Graft Loss
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start17 Jan 2023
- Primary completion30 Oct 2025
- Study completion30 Oct 2025
Why it stopped: Sponsor decision, indication no longer under evaluation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- ITB-Med LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tracy Killingsworth, Study director, Nefro Avillion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803006
- Sponsor's protocol ID
- TCD601A201
- Status last verified
- Oct 2026
- First submitted
- 14 Mar 2021
- Last updated
- 4 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Adaptive, Regimen Finding, Safety and Tolerability Study of TCD601 (Siplizumab), a Human Anti-CD2 Antibody, Combined With Donor Bone Marrow Cell Infusion and Non-myeloablative Conditioning, for Tolerance Induction in Living Donor Renal Transplantation
- ClinicalTrials.gov ID
- NCT04803006
- Acronym / sponsor ID
- TCD601A201
- Conditions
- Kidney Transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision, indication no longer under evaluation
- Enrolment
- 4 participants (actual)
- Lead sponsor
- ITB-Med LLCIndustry (pharma, biotech, devices)
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 17 Mar 2021 (actual)
- Results
- Posted 4 Nov 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the optimal regimen for the use of siplizumab, a human anti-CD2 antibody, combined with donor bone marrow cells and non-myeloablative conditioning, for tolerance induction in living donor renal transplantation
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Biological: TCD601TCD601administered with non-myeloablative conditioning and standard of care immunosuppression |
| Arm 2 | Experimental | Biological: TCD601TCD601administered with non-myeloablative conditioning and standard of care immunosuppression |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able to understand the study requirements and provide written informed consent before any study assessment is performed
- Male or female patients ≥ 18 to 65 years of age
- Recipient of a first renal transplant from a non-HLA identical, but at least haploidentical, ABO compatible living donor
Key exclusion criteria (3 listed)
- Women of child-bearing potential, unless willing to comply with the use of highly effective methods of contraception as defined by the protocol
- A history of cancer other than basal cell carcinoma of the skin or carcinoma in situ of the cervix
- Recipient with anti-HLA donor-specific antibody (DSA)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TCD601Investigational Product | Biological | Arm 1, Arm 2 |
Primary outcome
The Proportion of Patients Off Immunosuppression With Good Safety and Tolerability
Time frame: 24 months
The proportion of patients off immunosuppression with good safety and tolerability at 24 months assessed by immunosuppression dosing; Serum creatinine (estimated glomerular filtration rate [eGFR]); Incidents of Chimeric Transition Syndrome (CTS) and biopsy proven acute rejection (BPAR); Renal biopsy
2 secondary outcomes
The Incidence of de Novo Donor-specific Antibody
Time frame: 24 months
The Incidence of Biopsy Proven Acute Rejection, Death and Graft Loss
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tracy Killingsworth study director
Nefro Avillion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TCD601 in people with Kidney Transplantation, run by ITB-Med LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Proportion of Patients Off Immunosuppression With Good Safety and Tolerability (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.