CK0802 for Treatment of Steroid Refractory Graft vs. Host Disease (GVHD)
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age12+
SponsorCellenkos, Inc.
About this trial
The purpose of this study is to determine the efficacy and safety of CK0802 Tregs for treatment of refractory GVHD (graft-versus-host disease)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Age ≥12 years old (first 3 subjects will be ≥ 18 years)
2. Grade 2-4 acute GVHD (aGVHD) at baseline
3. No other prior aGVHD treatment
4. Steroid Refractory
Disqualifiers
1. 30 days prior treatment with any other investigational agent after allogeneic HSCT.
2. Known HIV seropositivity.
3. Uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy. The Protocol PI is the final arbiter of eligibility.
4. Subjects with uncontrolled inter-current illness that in the opinion of the investigator would place the subject at greater risk of severe toxicity and/or impair the activity of CK0802.
Trial design
Design model
Single group
Treatments tested in this trial
CK0802 (Allogeneic, Cryopreserved, Cord blood-derived T-regulatory cells, cells that are not HLA matched)
Biological/VaccineSubjects will receive seven planned doses of CK0802 on study day +1, +3 (+/-1 day), +5 (+/-1 day), +7 (+/- 2 day), +14 (+/- 3 days), +21 (+/-3 days) and +28 (+/-3 days). A total of 7 doses will be administered. If Day 29 assessment shows PR or MR, then 4 additional weekly infusion of CK0802 Tregs can be administered (study days: 35 (+/- 2 day), 42 (+/- 2 day), 49 (+/- 2 day), and 55(+/- 2 day)), for a total of 11 infusions
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Treatment ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Phase 1b
Dose limiting toxicities of CK0802 in SR GVHD as assessed by the incidence and severity of AE and SAEs determined by the NCI-CTCAE Version 6.0. Non-Hematologic: Any ≥ Grade 3 non-hematologic AE as per CTCAE v6.0 Hematologic: Any new or worsened Grade 4 neutropenia, thrombocytopenia, or anemia compared with baseline that persists for \>7 days despite supportive care and is not clearly and incontrovertibly attributable to the underlying disease or another extraneous cause. Death: Death within 28 days that is not clearly and incontrovertibly attributable to the underlying disease or another extraneous cause
Time frame
Day +292
Phase 2a
Overall Response (OR) at day +29. Overall response (OR) will include complete response (CR) and partial response (PR). Response to be determined from the maximum acute GVHD stage and grade in each organ. Complete Response (CR): Stage 0 in all organs (skin, liver, and GI tract) and no intervening additional therapy Partial Response (PR): Improvement of at least 1 stage in 1 or more organs without progression in other organs, and no intervening additional therapy Overall Response (OR): Includes both CR and PR Very Good PR (VGPR): Improvement by at least one stage in one or more organs and * Skin: No rash, or bullae, and residual erythematous rash involving \<25% of the body surface * Liver: Total serum bilirubin concentration of \<2 mg/dL or \<25% of baseline at enrollment * Gut: Tolerating food or enteral feeding, predominantly formed stools, no overt GI bleeding or abdominal cramping, no more than occasional nausea or vomiting * No intervening additional therapy
Time frame
D +29Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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